Isormol

Isormol may be available in the countries listed below.

Ingredient matches for Isormol Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Isormol in the following countries:

Taiwan

International Drug Name Search

Morton Grove Pharmaceuticals, Inc
Address Morton Grove Pharmaceuticals, Inc, 6451 W. Main St. Morton Grove, IL 60053Contact DetailsPhone: (847) 967-5600

Xpect-AT Sustained-Release Tablets
Pronunciation: car-bay-ta-PEN-tane/gwye-FEN-e-sinGeneric Name: Carbetapentane/GuaifenesinBrand Name: Examples include Allfen CX and Xpect-AT

Innohep 20,000 IU / ml and Innohep syringe 20,000 IU / ml
1. Name Of The Medicinal Product

innohep® 20,000 IU/ml and innohep® Syringe 20,000 IU/ml

2. Qualitative And Quantitative Composition

Tinzaparin sodium 20,000 anti-Factor Xa IU/ml

3. Pharmaceutical Form

Solution for injection

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of deep vein thrombosis and of pulmonary embolus.

4.2 Posology And Method Of Administration

Administration is by subcutaneous injection only.

Adults:

175 anti-Factor Xa IU/kg bodyweight once daily, for at least 6 days and until adequate oral anti-coagulation is established. There is no need to monitor the anticoagulant activity of innohep®.

Patients with renal impairment:

Caution is recommended when treating patients with renal impairment (see Section 4.4, Special warnings and precautions for use). Monitoring of anti-factor Xa activity should be considered in patients with severe renal impairment (creatinine clearance < 30 ml/min); however, available evidence suggests that no dose reduction is needed in patients with creatinine clearance levels down to 20 ml/min.

Elderly:

Renal function should be assessed, for example with the Cockcroft-Gault formula, to estimate creatinine clearance levels. No dose reduction is needed in elderly patients with normal renal function (see Section 4.4, Special warnings and precautions for use).

Children:

There is no experience of use in children.

4.3 Contraindications

• Known hypersensitivity to constituents.

• Current or history of heparin-induced thrombocytopenia.

• Generalised or local haemorrhagic tendency, including uncontrolled severe hypertension, severe liver insufficiency, active peptic ulcer, acute or subacute septic endocarditis, intracranial haemorrhage, or injuries and operations on the central nervous system, eyes and ears, and in women with abortus imminens.

• The innohep® 20,000 IU/ml vial formulation contains 10 mg/ml of the preservative benzyl alcohol. This formulation must not be given to premature babies or neonates.

The innohep® 20,000 IU/ml syringe formulation does not contain the preservative benzyl alcohol.

• An epidural anaesthesia during birth in pregnant women treated with low molecular weight heparin is contraindicated (see section 4.6).

• In patients receiving heparin for treatment rather than prophylaxis, locoregional anaesthesia in elective surgical procedures is contraindicated because the use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.

4.4 Special Warnings And Precautions For Use

Care should be taken when innohep® is administered to patients with increased risk of bleeding complications.

In patients undergoing peridural or spinal anaesthesia or spinal puncture, the prophylactic use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. The risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants, and by traumatic or repeated puncture.

In decision making on the interval between the last administration of heparin at prophylactic doses and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account. Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed.

Should a physician decide to administer anti-coagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits and bowel or bladder dysfunction. Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these.

innohep® should not be administered by intramuscular injection due to the risk of haematoma.

Due to increased bleeding risk care should be taken when giving concomitant intramuscular injections, lumbar puncture and similar procedures.

innohep® should be used with caution in patients with hypersensitivity to heparin or to other low molecular weight heparins.

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

As with other low molecular weight heparins, in some patients undergoing surgical procedures (especially orthopaedic) or presenting with a concomitant inflammatory process, the administration of innohep® has coincided with an asymptomatic increase of platelet count, which in many cases subsided during continued administration. If an increase in platelet count occurs, evaluation of the benefit/risk of continuing therapy for that patient should be made.

Renal impairment (also see Section 4.2, Posology and method of administration): Caution is recommended in the treatment of patients with renal impairment. Monitoring of anti Xa activity should be considered in patients with severe renal impairment (creatinine clearance < 30 ml/min).

Caution is recommended in the treatment of elderly patients with renal impairment. Renal function should be assessed in all elderly patients. Monitoring of anti-factor Xa activity should be considered in patients with severe renal impairment (creatinine clearance < 30 ml/min).

For some patients with pulmonary embolism (e.g. those with severe haemodynamic instability) alternative treatment, such as surgery or thrombolysis, may be indicated.

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or taking potassium-sparing drugs. The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days.

The innohep® 20,000 IU/ml syringe and vial formulations contain sodium metabisulphite (E223). This may rarely cause severe hypersensitivity reactions and bronchospasm.

The innohep® 20,000 IU/ml vial formulation contains the preservative benzyl alcohol 10 mg/ml. This should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic reactions and allergic reactions (anaphylactoid) in this age group (see section 4.3 for premature babies and neonates).

Drugs affecting platelet function or the coagulation system should in general not be given concomitantly with innohep® (see section 4.5).

Prosthetic heart valves:

There have been no adequate studies to assess the safe and effective use of tinzaparin sodium in preventing valve thrombosis in patients with prosthetic heart valves; therefore no dosage recommendations can be given. High doses of tinzaparin sodium (175 IU/kg) may not be sufficient prophylaxis to prevent valve thrombosis in patients with prosthetic heart valves. The use of tinzaparin sodium cannot be recommended for this purpose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The anticoagulant effect of innohep® may be enhanced by concomitant medication with other drugs affecting platelet function or the coagulation system, e.g. platelet aggregation inhibitors, thrombolytic agents, salicylates, non-steroidal anti-inflammatory drugs, vitamin K antagonists, dextrans, activated protein C.

4.6 Pregnancy And Lactation

Pregnancy

No transplacental passage of innohep® was found (assessed by anti-Factor Xa and anti-Factor IIa activity) in patients given a dose of 35 to 40 anti-Factor Xa IU/kg in the second trimester of pregnancy. In rabbits, no transplacental passage of anti-Factor Xa or anti-Factor IIa activity was observed after doses of 1750 anti-Factor Xa IU/kg. Toxicological studies in rats have shown no embryotoxic or teratogenic effects, although a lower birthweight was found.

Although these animal studies show no hazard, as a precaution innohep® should not be used in pregnancy unless no safer alternative is available.

As benzyl alcohol may cross the placenta, the use of innohep® formulations containing benzyl alcohol should be avoided during pregnancy.

The use of innohep® in women with abortus imminens is contraindicated (see section 4.3).

Prosthetic heart valves:

Therapeutic failures and maternal death have been reported in pregnant women with prosthetic heart valves on full anti-coagulant doses of low molecular weight heparins. In the absence of clear dosing, efficacy and safety information in this circumstance, tinzaparin sodium is not recommended for use in pregnant women with prosthetic heart valves.

Lactation

It is not known whether innohep® is excreted in breast milk. However, patients are advised to stop breast-feeding while receiving innohep®.

4.7 Effects On Ability To Drive And Use Machines

innohep® has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

Based on reports from clinical trials the frequency rate of all adverse reactions is 17.6%. The most frequently reported undesirable effects are bleeding events, injection site reactions, various skin reactions, reversible thrombocytopenia, allergic reactions, headache and reversible increase in liver enzymes.

Based on pooled study results, from a clinical trial programme where 3167 patients received innohep®, local reactions following subcutaneous administration such as irritation, bruising, pain and ecchymosis were identified in approximately 3.7% of patients. The overall bleeding risk was approximately 11% while the risk of major bleeding was approximately 0.5%. Reversible thrombocytopenia was seen in approximately 0.6% of patients.

A list of undesirable effects is given below. Where frequencies are given, these are based on the clinical trial data, using the stated frequency classification. Where the term 'Not known' is given, these effects are derived from spontaneous reports.

Frequency classification:

Very common

>1/10

Common

>1/100 and <1/10

Uncommon

>1/1,000 and <1/100

Rare

>1/10,000 and <1/1,000

Very rare

<1/10,000

• Blood and lymphatic system disorders

 

Uncommon:

Thrombocytopenia (type I).

Not known:

Heparin induced thrombocytopenia (HIT), probably of an immuno-allergic nature (see Section 4.4). In some cases, Heparin induced thrombocytopenia has been accompanied by venous or arterial thrombi.

 

Increase in platelet count, asymptomatic and reversible (see section 4.4).

Class effect:

Valve thrombosis in patients with prosthetic heart valves has been reported rarely in patients receiving low molecular weight heparins, usually associated with inadequate dosing (see Section 4.4).

• Immune system disorders

 

Uncommon:

Allergic reactions (of all types and severities have been reported).

• Metabolism and nutrition disorders

 

Not known:

Hypoaldosteronism associated with hyperkalaemia and metabolic acidosis, especially in patients with renal impairment and diabetes mellitus (see Section 4.4).

• Nervous system disorders

 

Uncommon:

Headache.

• Vascular disorders

 

Very common:

Haemorrhage. Haemorrhagic complications may affect any organ, and may have different degrees of severity. In some cases haemorrhage has resulted in death or permanent disability. Haemorrhagic complications can occur in particular when high doses are administered. Anaemia can occur as a consequence of haemorrhage.

Not known:

Epidural and spinal haematoma (see Section 4.4).

• Hepatobiliary disorders

 

Uncommon:

Raised transaminases. These increases are reversible after drug withdrawal.

Not known:

Raised gamma-GT.

• Skin and subcutaneous tissue disorder

 

Uncommon:

Rash (such as erythematous or maculopapular), pruritus, urticaria.

Rare:

Skin necrosis.

Not known:

Angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.

• Musculoskeletal and connective tissue disorders

 

Not known:

Osteoporosis has been reported in connection with long-term treatment with heparin.

• Reproductive system and breast disorders

 

Not known:

Priapism.

• General disorders and administration site conditions

 

Common:

Injection site reactions (local irritation, pain, bruising, ecchymosis).

4.9 Overdose

Overdose of innohep® may be complicated by haemorrhage. With recommended dosages there should be no need for an antidote but in the event of accidental administration of an overdose, the effect of innohep® can be reversed by intravenous administration of 1% protamine sulphate solution.

The dose of protamine sulphate required for neutralisation should be accurately determined by titrating with the patient's plasma.

Studies in healthy volunteers indicate that 65-80% of the anti-Xa activity is neutralised by protamine sulphate 1 mg/100 anti-Xa IU of innohep®. A return of innohep® anti-Xa, anti-IIa and APTT activities are seen 3 hours after its reversal probably due to continuous absorption of innohep® from the s.c. depot. It may therefore be necessary to give protamine sulphate intermittently or as a continuous infusion to achieve and maintain neutralisation of s.c. innohep® for at least 24 hours. Potential side-effects of protamine sulphate must be considered and patients carefully observed.

Transfusion of fresh plasma may be used, if necessary. Plasma anti-Factor Xa and anti-Factor IIa activity should be measured during the management of overdose situations.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

innohep® is an antithrombotic agent. It potentiates the inhibition of several activated coagulation factors, especially Factor Xa, its activity being mediated via antithrombin III.

5.2 Pharmacokinetic Properties

The pharmacokinetics/pharmacodynamic activity of innohep® is monitored by anti-Factor Xa activity. Following subcutaneous injection of innohep®, anti-Factor Xa activity reaches a maximum at 4-6 hours (peak anti-Factor Xa activity, after administration of 175 anti-Factor Xa IU/kg bodyweight once daily, is approximately 0.5-1.0 IU/ml). Detectable anti-Factor Xa activity persists for 24 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

innohep® 20,000 IU/ml:

Sodium metabisulphite

Benzyl alcohol

Sodium hydroxide

Water for injections

innohep® Syringe 20,000 IU/ml:

Sodium metabisulphite

Sodium hydroxide

Water for injections

6.2 Incompatibilities

innohep® should be given by subcutaneous injection. It should not be mixed with any other injection.

6.3 Shelf Life

innohep® 20,000 IU/ml:

2 years.

innohep® Syringe 20,000 IU/ml:

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

innohep® 20,000 IU/ml:

2 ml glass vial containing 20,000 anti-Factor Xa IU/ml in packs of 1 vial.

innohep® Syringe 20,000 IU/ml:

A prefilled variable dose graduated syringe with needle safety device containing:

0.5 ml (10,000 anti-Factor Xa IU)

0.7 ml (14,000 anti-Factor Xa IU)

0.9 ml (18,000 anti-Factor Xa IU)

in packs of 2 and 6 syringes

6.6 Special Precautions For Disposal And Other Handling

innohep® 20,000 IU/ml:

The vial should be discarded 14 days after first use.

innohep® Syringe 20,000 IU/ml:

Contains no bactericide, any portion of the contents not used at once should be discarded together with the syringe.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks HP27 9RR

8. Marketing Authorisation Number(S)

innohep® 20,000 IU/ml

PL 00043/0192

innohep® Syringe 20,000 IU/ml

PL 00043/0197

9. Date Of First Authorisation/Renewal Of The Authorisation

innohep® 20,000 IU/ml

18 October 1994

innohep® Syringe 20,000 IU/ml

3 October 1996

10. Date Of Revision Of The Text

1 September 2011

LEGAL CATEGORY

POM

pegfilgrastim Subcutaneous

peg-fil-GRA-stim

Commonly used brand name(s)

In the U.S.

Neulasta

Available Dosage Forms:

Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Colony Stimulating Factor

Uses For pegfilgrastim

Pegfilgrastim is a synthetic (man-made) version of a substance that is naturally produced in your body called a colony stimulating factor. It helps the bone marrow to make new white blood cells.

When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Pegfilgrastim is used to reduce the risk of infection while you are being treated with cancer medicines.

pegfilgrastim is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, pegfilgrastim is used in certain patients with the following medical conditions:

Harvesting of peripheral blood stem cells, prior to autologous stem-cell transplantation. Before Using pegfilgrastim

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pegfilgrastim, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pegfilgrastim or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pegfilgrastim in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegfilgrastim in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pegfilgrastim. Make sure you tell your doctor if you have any other medical problems, especially:

Bone marrow cancer or other bone marrow problems—Pegfilgrastim may make cancer or other problems worse. Liver problems—Safety of pegfilgrastim in patients with liver problems has not been studied. Lung disease or breathing problems—Use with caution. May make these conditions worse. Peripheral blood progenitor cell (PBPC) mobilization—Use of pegfilgrastim is not recommended for PBPC mobilization. Sepsis (serious infection)—There have been reports of acute respiratory distress syndrome (ARDS) in patients who had a serious infection and were receiving a similar medicine called filgrastim. Sickle cell disease—Pegfilgrastim may increase the risk of unwanted effects. Proper Use of pegfilgrastim

pegfilgrastim is given as a shot under your skin. You may be taught how to give pegfilgrastim at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

pegfilgrastim comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:

How to prepare the injection. The proper use of disposable syringes. How to give the injection. How long the injection can be stored at home.

If you have any questions about any of this, check with your doctor.

Dosing

The dose of pegfilgrastim will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pegfilgrastim. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injectable dosage form: To increase white blood cell count: Adults—6 milligrams (mg) as a single injection one time every chemotherapy cycle. Children—Use and dose must be determined by your doctor. Missed Dose

pegfilgrastim needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using pegfilgrastim

It is very important that your doctor check your progress at regular visits to make sure that pegfilgrastim is working properly. Blood tests may be needed to check for unwanted effects.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause an allergic reaction in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using pegfilgrastim.

If you have left upper stomach pain or shoulder tip pain, contact your doctor right away. This could be a symptom of a serious side effect with the spleen.

Check with your doctor right away at the first sign of any infection such as fever; chills; cough; diarrhea; sore throat; or redness, swelling, or pain around a cut or sore.

Stop using pegfilgrastim and check with your doctor right away if you develop fever, shortness of breath, chest pain or tightness, fast breathing, or wheezing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome (ARDS).

pegfilgrastim may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; swelling of the face, tongue, or throat; trouble with breathing; or chest pain after you receive the medicine.

You should not use pegfilgrastim for 14 days before and up to 24 hours after you receive cancer medicines.

pegfilgrastim Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Chills cough fever sore throat ulcers; sores, or white spots in the mouth Rare Bluish lips or skin pain, left upper abdomen or shoulder shortness of breath tightness in the chest troubled breathing wheezing Incidence not known Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site difficulty with swallowing dizziness fast heartbeat flushing or redness of the skin hives or welts itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs skin rash sores on the skin unusual tiredness or weakness unusually warm skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal or stomach pain acid or sour stomach belching bone pain change in sense of taste constipation cracked lips diarrhea hair loss or thinning of hair headache heartburn indigestion joint pain lack or loss of strength loss of appetite muscle soreness nausea stomach discomfort, upset, or pain swelling of the hands, ankles, feet, or lower legs swelling or inflammation of the mouth trouble sleeping vomiting weakness, generalized weight loss Incidence not known Body produces substance that can bind to drug making it less effective or cause side effects

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pegfilgrastim Subcutaneous side effects (in more detail)

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More pegfilgrastim Subcutaneous resources Pegfilgrastim Subcutaneous Side Effects (in more detail)Pegfilgrastim Subcutaneous Use in Pregnancy & BreastfeedingPegfilgrastim Subcutaneous Drug InteractionsPegfilgrastim Subcutaneous Support Group7 Reviews for Pegfilgrastim Subcutaneous - Add your own review/rating Compare pegfilgrastim Subcutaneous with other medications Neutropenia Associated with Chemotherapy

pegaptanib Intraocular

peg-AP-ta-nib

Commonly used brand name(s)

In the U.S.

Macugen

Available Dosage Forms:

Solution

Therapeutic Class: Ophthalmologic Agent

Uses For pegaptanib

Pegaptanib is used to treat neovascular (wet) age-related macular degeneration (AMD). AMD is a disorder of the retina of the eye that causes blurring of vision or blindness .

pegaptanib is available only with your doctor's prescription .

Before Using pegaptanib

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pegaptanib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pegaptanib or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pegaptanib in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of pegaptanib in the elderly .

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pegaptanib. Make sure you tell your doctor if you have any other medical problems, especially:

Eye infection—Pegaptanib should NOT be used in patients with an infection in or around the eye . Glaucoma—pegaptanib may increase eye pressure after injection. Your doctor will monitor your eye pressure during the week after every injection . Proper Use of pegaptanib

A doctor will give you pegaptanib. Pegaptanib is given through a shot into your eye. .

Precautions While Using pegaptanib

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you receive pegaptanib .

Serious eye problems may occur after treatment with pegaptanib. Check with your doctor immediately if your eye becomes red, sensitive to light, painful or develops a change in vision several days after your treatment.

pegaptanib Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common Bladder pain blindness bloody eye bloody or cloudy urine blurred vision burning, dry, or itching eyes cough producing mucus decreased vision or other changes in vision difficult, burning, or painful urination difficulty breathing discharge, excessive tearing disturbed color perception double vision drainage from eyes eye pain frequent urge to urinate gradual loss of vision halos around lights itching of eyelid looking through water lower back or side pain nausea night blindness overbright appearance of lights painful irritation of the clear front part of the eye redness, pain, swelling of eye, eyelid, or inner lining of eyelid seeing flashes or sparks of light seeing floating spots before the eyes shortness of breath sore eyes swelling of the eye tightness in chest tunnel vision vomiting wheezing Less Common Bigger, dilated, or enlarged pupils (black part of the eye) change in vision not present before treatment chest pain confusion decrease in frequency of urination decrease in urine volume difficulty in passing urine (dribbling) dizziness or lightheadedness dry mouth eye irritation fatigue feeling of constant movement of self or surroundings flushed, dry skin fruit-like breath odor headache hearing loss inability to speak increased hunger increased sensitivity of eyes to light increased thirst increased urination loss of consciousness numbness or tingling in face, arms, or legs seeing floaters, veil or curtain appearing across part of vision seizures sensation of spinning severe or sudden headache slurred speech stomachache sweating temporary blindness trouble speaking, thinking, or walking troubled breathing unexplained weight loss weakness in arm and/or leg on one side of the body, sudden and severe Incidence not determined Difficulty swallowing fast heartbeat hives itching puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue skin rash unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Diarrhea Less common Acid or sour stomach belching blistering, burning, crusting, dryness, or flaking of skin bruise difficulty in moving heartburn indigestion itching, scaling, severe redness, soreness, swelling of skin muscle pain or stiffness pain, swelling, or redness in joints stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pegaptanib Intraocular side effects (in more detail)

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Methotrexate Injection
1. Name Of The Medicinal Product

Methotrexate Injection 5mg/2ml., Methotrexate Injection 25 mg/ml and Methotrexate Injection 100 mg/ml

2. Qualitative And Quantitative Composition

Active Constituent

 

 

5 mg/2 ml

25 mg/ml

100 mg/ml

Methotrexate

Ph Eur

5 mg

25 mg

100 mg

Other Constituents

 

 

 

 

 

 

 

 

Sodium Chloride

BP

17.2 mg

4.9 mg

None

Sodium Hydroxide

BP

QS

QS

QS

Water for Injections

BP

To 2 ml

To 1 ml

To 1 ml

There is a 5 % manufacturing overage included in the formulation.

3. Pharmaceutical Form

Sterile solution of Methotrexate in Water for Injections.

4. Clinical Particulars 4.1 Therapeutic Indications

Methotrexate is indicated in the treatment of neoplastic disease, such as trophoblastic neoplasms and leukaemia, and the symptomatic treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy.

Methotrexate Injection B.P. may be given by the intramuscular, intravenous, intra-arterial, intrathecal routes.

Note: Methotrexate Injection B.P, 1g /10ml and 5g /50ml presentations are hypertonic and therefore are not suitable for intrathecal use. In addition, the 500mg/20ml and 1g/40ml presentations are not suitable for intrathecal use

4.2 Posology And Method Of Administration

Adults and children

Antineoplastic Chemotherapy

Methotrexate is active orally and parenterally. Methotrexate Injection B.P. may be given by the intramuscular, intravenous, intra-arterial or intrathecal routes. Dosage is related to the patient's body weight or surface area. Methotrexate has been used with beneficial effect in a wide variety of neoplastic diseases, alone and in combination with other cytotoxic agents.

Note: Methotrexate Injection B.P, 1g /10ml and 5g /50ml presentations are hypertonic and therefore are not suitable for intrathecal use. In addition, the 500mg/20ml and 1g/40ml presentations are not suitable for intrathecal use

Choriocarcinoma and Similar Trophoblastic Diseases

Methotrexate is administered orally or intramuscularly in doses of 15-30mg daily for a 5 day course. Such courses may be repeated 3-5 times as required, with rest periods of one or more weeks interposed between courses until any manifesting toxic symptoms subside.

The effectiveness of therapy can be evaluated by 24 hours quantitative analysis of urinary chorionic gonadotrophin hormone (HCG). Combination therapy with other cytotoxic drugs, has also been reported as useful.

Hydatidiform mole may precede or be followed by choriocarcinoma, and Methotrexate has been used in similar doses for the treatment of hydatidiform mole and chorioadenoma destruens.

Breast Carcinoma

Prolonged cyclic combination with Cyclophosphamide, Methotrexate and Fluorouracil has given good results when used as adjuvant treatment to radical mastectomy in primary breast cancer with positive axillary lymph nodes. Methotrexate dosage was 40mg/m2 intravenously on the first and eighth days.

Leukaemia

Acute granulocytic leukaemia is rare in children but common in adults and this form of leukaemia responds poorly to chemotherapy.

Methotrexate is not generally a drug of choice for induction of remission of lymphoblastic leukaemia. Oral Methotrexate dosage 3.3mg/m2 daily, and Prednisolone 40-60mg/m2 daily for 4-6 weeks has been used. After a remission is attained, Methotrexate in a maintenance dosage of 20-30mg/m2 orally or by I.M. injection has been administered twice weekly. Twice weekly doses appear to be more effective than daily drug administration. Alternatively, 2.5mg/kg has been administered I.V. every 14 days.

Meningeal Leukaemia

Some patients with leukaemia are subject to leukaemic invasions of the central nervous system and the CSF should be examined in all leukaemia patients.

Passage of Methotrexate from blood to the cerebrospinal fluid is minimal and for adequate therapy the drug should be administered intrathecally. Methotrexate may be given in a prophylactic regimen in all cases of lymphocytic leukaemia. Methotrexate is administered by intrathecal injection in doses of 200-500 microgram/kg body weight. The administration is at intervals of 2 to 5 days and is usually repeated until the cell count of cerebrospinal fluid returns to normal. At this point one additional dose is advised. Alternatively, Methotrexate 12mg/m2 can be given once weekly for 2 weeks, and then once monthly. Large doses may cause convulsions and untoward side effects may occur as with any intrathecal injection, and are commonly neurological in character.

Note: Methotrexate Injection B.P, 1g /10ml and 5g /50ml presentations are hypertonic and therefore are not suitable for intrathecal use. In addition, the 500mg/20ml and 1g/40ml presentations are not suitable for intrathecal use.

Lymphomas

In Burkitt's Tumour, stages 1-2, Methotrexate has prolonged remissions in some cases. Recommended dosage is 10-25mg per day orally for 4 to 8 days. In stage 3, Methotrexate is commonly given concomitantly with other antitumour agents. Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods, and in stage 3 they respond to combined drug therapy with Methotrexate given in doses of 0.625mg to 2.5mg/kg daily. Hodgkin's Disease responds poorly to Methotrexate and to most types of chemotherapy.

Mycosis Fungoides

Therapy with Methotrexate appears to produce clinical remissions in one half of the cases treated. Recommended dosage is usually 2.5 to 10mg daily by mouth for weeks or months and dosage should be adjusted according to the patient's response and haematological monitoring. Methotrexate has also been given intramuscularly in doses of 50mg once weekly or 25mg twice weekly.

Psoriasis Chemotherapy

Cases of severe uncontrolled psoriasis, unresponsive to conventional therapy, have responded to weekly single, oral, I.M. or I.V. doses of 10-25mg per week, and adjusted according to the patient's response. An initial test dose one week prior to initiation of therapy is recommended to detect any idiosyncrasy. A suggested dose range is 5-10mg.

An alternative dosage schedule consists of 2.5 to 5mg of Methotrexate administered orally at 12 hour intervals for 3 doses each week or at 8-hour intervals for 4 doses each week; weekly dosages should not exceed 30mg.

A daily oral dosage schedule of 2 to 5mg administered orally for 5 days followed by a rest period of at least 2 days may also be used. The daily dose should not exceed 6.25mg.

The patient should be fully informed of the risks involved and the clinician should pay particular attention to the appearance of liver toxicity by carrying out liver function tests before starting Methotrexate treatment, and repeating these at 2 to 4 month intervals during therapy. The aim of therapy should be to reduce the dose to the lowest possible level with the longest possible rest period. The use of Methotrexate may permit the return to conventional topical therapy which should be encouraged.

4.3 Contraindications

Significantly impaired renal function.

Significantly impaired hepatic function

Pre-existing blood dyscrasias, such as significant marrow hypoplasia, leukopenia, thrombocytopenia or anaemia.

Methotrexate is contraindicated in pregnancy.

Because of the potential for serious adverse reactions from methotrexate in breast fed infants, breast feeding is contra-indicated in women taking methotrexate.

Patients with a known allergic hypersensitivity to methotrexate should not receive methotrexate.

4.4 Special Warnings And Precautions For Use

WARNINGS

Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy.

Because of the possibility of fatal or severe toxic reactions, the patient should be fully informed by the physician of the risks involved and be under his constant supervision.

Deaths have been reported with the use of Methotrexate in the treatment of psoriasis.

In the treatment of psoriasis, Methotrexate should be restricted to severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established by biopsy and/or after dermatological consultation.

1. Full blood counts should be closely monitored before, during and after treatment. If a clinically significant drop in white-cell or platelet count develops, methotrexate should be withdrawn immediately. Patients should be advised to report all symptoms or signs suggestive of infection.

2. Methotrexate may be hepatotoxic, particularly at high dosage or with prolonged therapy. Liver atrophy, necrosis, cirrhosis, fatty changes, and periportal fibrosis have been reported. Since changes may occur without previous signs of gastrointestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy. If substantial hepatic function abnormalities develop, methotrexate dosing should be suspended for at least 2 weeks.Special caution is indicated in the presence of pre-existing liver damage or impaired hepatic function. Concomitant use of other drugs with hepatotoxic potential (including alcohol) should be avoided.

3. Methotrexate has been shown to be teratogenic; it has caused foetal death and/or congenital anomalies. Therefore it is not recommended in women of childbearing potential unless there is appropriate medical evidence that the benefits can be expected to outweigh the considered risks. Pregnant psoriatic patients should not receive Methotrexate.

4. Renal function should be closely monitored before, during and after treatment. Caution should be exercised if significant renal impairment is disclosed. Reduce dose of methotrexate in patients with renal impairment. High doses may cause the precipitation of methotrexate or its metabolites in the renal tubules. A high fluid throughput and alkalinisation of the urine to pH 6.5 – 7.0, by oral or intravenous administration of sodium bicarbonate (5 x 625mg tablets every three hours) or acetazolamide (500mg orally four times a day) is recommended as a preventative measure . Methotrexate is excreted primarily by the kidneys. Its use in the presence of impaired renal function may result in accumulation of toxic amounts or even additional renal damage.

5. Diarrhoea and ulcerative stomatitis are frequent toxic effects and require interruption of therapy, otherwise haemorrhagic enteritis and death from intestinal perforation may occur.

6. Methotrexate affects gametogenesis during the period of its administration and may result in decreased fertility which is thought to be reversible on discontinuation of therapy. Conception should be avoided during the period of Methotrexate administration and for at least 6 months thereafter. Patients and their partners should be advised to this effect.

7. Methotrexate has some immunosuppressive activity and immunological responses to concurrent vaccination may be decreased. The immunosuppressive effect of Methotrexate should be taken into account when immune responses of patients are important or essential.

8. Pleural effusions and ascites should be drained prior to initiation of methotrexate therapy.

9. Deaths have been reported with the use of methotrexate. Serious adverse reactions including deaths have been reported with concomitant administration of methotrexate (usually in high doses) along with some non-steroidal anti-inflammatory drugs (NSAIDs).

10. Concomitant administration of folate antagonists such as trimethoprim/sulphamethoxazole has been reported to cause an acute megaloblastic pancytopenia in rare instances.

11. Systemic toxicity may occur following intrathecal administration. Blood counts should be monitored closely.

12. A chest X-ray is recommended prior to initiation of methotrexate therapy.

13. If acute methotrexate toxicity occurs, patients may require folinic acid.

PRECAUTIONS

Methotrexate has a high potential toxicity, usually dose related, and should be used only by physicians experienced in antimetabolite chemotherapy, in patients under their constant supervision. The physician should be familiar with the various characteristics of the drug and its established clinical usage.

Before beginning methotrexate therapy or reinstituting methotrexate after a rest period, assessment of renal function, liver function and blood elements should be made by history, physical examination and laboratory tests.

It should be noted that intrathecal doses are transported into the cardiovascular system and may give rise to systemic toxicity. Systemic toxicity of methotrexate may also be enhanced in patients with renal dysfunction, ascites, or other effusions due to prolongation of serum half-life.

Carcinogenesis, mutagenesis, and impairment of fertility: Animal carcinogenicity studies have demonstrated methotrexate to be free of carcinogenic potential. Although methotrexate has been reported to cause chromosomal damage to animal somatic cells and bone marrow cells in humans, these effects are transient and reversible. In patients treated with methotrexate, evidence is insufficient to permit conclusive evaluation of any increased risk of neoplasia.

Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans, during and for a short period after cessation of therapy. In addition, methotrexate causes, embryotoxicity, abortion and foetal defects in humans. Therefore the possible risks of effects on reproduction should be discussed with patients of childbearing potential (see 'Warnings').

Patients undergoing therapy should be subject to appropriate supervision so that signs or symptoms of possible toxic effects or adverse reactions may be detected and evaluated with minimal delay. Pretreatment and periodic haematological studies are essential to the use of Methotrexate in chemotherapy because of its common effect of haematopoietic suppression. This may occur abruptly and on apparent safe dosage, and any profound drop in blood cell count indicates immediate stopping of the drug and appropriate therapy. In patients with malignant disease who have pre-existing bone marrow aplasia, leukopenia, thrombocytopenia or anaemia, methotrexate should be used with caution, if at all.

In general, the following laboratory tests are recommended as part of essential clinical evaluation and appropriate monitoring of patients chosen for or receiving Methotrexate therapy: complete haemogram; haematocrit; urinalysis; renal function tests; liver function tests and chest X-ray.

The purpose is to determine any existing organ dysfunction or system impairment. The tests should be performed prior to therapy, at appropriate periods during therapy and after termination of therapy.

Liver biopsy may be considered after cumulative doses> 1.5g have been given, if hepatic impairment is suspected.

Methotrexate is bound in part to serum albumin after absorption, and toxicity may be increased because of displacement by certain drugs such as salicylates, sulphonamides, phenytoin, and some antibacterials such as tetracycline, chloramphenicol and para-aminobenzoic acid. These drugs, especially salicylates and sulphonamides, whether antibacterial, hypoglycaemic or diuretic, should not be given concurrently until the significance of these findings is established.

Vitamin preparations containing folic acid or its derivatives may alter response to Methotrexate.

Methotrexate should be used with extreme caution in the presence of infection, peptic ulcer, ulcerative colitis, debility, and in extreme youth and old age. If profound leukopenia occurs during therapy, bacterial infection may occur or become a threat. Cessation of the drug and appropriate antibiotic therapy is usually indicated. In severe bone marrow depression, blood or platelet transfusions may be necessary.

Since it is reported that Methotrexate may have an immunosuppressive action, this factor must be taken into consideration in evaluating the use of the drug where immune responses in a patient may be important or essential.

In all instances where the use of Methotrexate is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risks of toxic effects or adverse reactions. Most such adverse reactions are reversible if detected early. When such effects or reactions do occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgement of the physician. Reinstitution of Methotrexate therapy should be carried out with caution, with adequate consideration of further need for the drug and alertness as to the possible recurrence of toxicity.

Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Methotrexate is extensively protein bound and may be displaced by certain drugs such as salicylates, hypoglycaemics, diuretics, sulphonamides, diphenylhydantoins, tetracyclines, chloramphenicol and p-aminobenzoic acid, and the acidic anti-inflammatory agents, so causing a potential for increased toxicity when used concurrently.

Concomitant use of other drugs with nephrotoxic or hepatotoxic potential (including alcohol) should be avoided.

Vitamin preparations containing folic acid or its derivatives may decrease the effectiveness of methotrexate.

Caution should be used when NSAIDs and salicylates are administered concomitantly with methotrexate. These drugs have been reported to reduce the tubular secretion of methotrexate and thereby may enhance its toxicity. Concomitant use of NSAIDs and salicylates has been associated with fatal methotrexate toxicity.

However, patients using constant dosage regimens of NSAIDs have received concurrent doses of methotrexate without problems observed.

Renal tubular transport is also diminished by probenecid and penicillins; use of these with methotrexate should be carefully monitored.

Severe bone marrow depression has been reported following the concurrent use of methotrexate and co-trimoxazole or trimethoprim. Concurrent use should probably be avoided.

Methotrexate-induced stomatitis and other toxic effects may be increased by the use of nitrous oxide.

An increased risk of hepatitis has been reported following the use of methotrexate and the acitretin metabolite, etretinate. Consequently, the concomitant use of methotrexate and acitretin should be avoided.

4.6 Pregnancy And Lactation

Abortion, foetal death, and/or congenital anomalies have occurred in pregnant women receiving Methotrexate, especially during the first trimester of pregnancy. Methotrexate is contraindicated in the management of psoriasis or rheumatoid arthritis in pregnant women. Women of childbearing potential should not receive Methotrexate until pregnancy is excluded. For the management of psoriasis or rheumatoid arthritis, Methotrexate therapy in women should be started immediately following a menstrual period and appropriate measures should be taken in men or women to avoid conception during and for at least 6 months following cessation of Methotrexate therapy.

Both men and women receiving Methotrexate should be informed of the potential risk of adverse effects on reproduction. Women of childbearing potential should be fully informed of the potential hazard to the foetus should they become pregnant during Methotrexate therapy. In cancer chemotherapy, Methotrexate should not be used in pregnant women or women of childbearing potential who might become pregnant unless the potential benefits to the mother outweigh the possible risks to the foetus.

Defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, and infertility have been reported in patients receiving Methotrexate.

Methotrexate is distributed into breast milk. Because of the potential for serious adverse reactions to Methotrexate in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

The most common adverse reactions include ulcerative stomatitis, leukopenia, nausea and abdominal distress. Although very rare, anaphylactic reactions to methotrexate have occurred. Others reported are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection. In general, the incidence and severity of side effects are considered to be dose-related. Adverse reactions as reported for the various systems are as follows:

Skin: Stevens-Johnson syndrome, epidermal necrolysis, erythematous rashes, pruritus, urticaria, photosensitivity, pigmentary changes, alopecia, ecchymosis, telangiectasia, acne, furunculosis. Lesions of psoriasis may be aggravated by concomitant exposure to ultraviolet radiation. Skin ulceration in psoriatic patients and rarely painful erosion of psoriatic plaques have been reported. The recall phenomenon has been reported in both radiation and solar damaged skin.

Blood: Bone marrow depression, leukopenia, thrombocytopenia, anaemia, hypogammaglobulinaemia, haemorrhage from various sites, septicaemia.

Alimentary System: Gingivitis, pharyngitis, stomatitis, anorexia, vomiting, diarrhoea, haematemesis, melaena, gastrointestinal ulceration and bleeding, enteritis, hepatic toxicity resulting in active liver atrophy, necrosis, fatty metamorphosis, periportal fibrosis, or hepatic cirrhosis. In rare cases the effect of methotrexate on the intestinal mucosa has led to malabsorption or toxic megacolon.

Hepatic: Hepatic toxicity resulting in significant elevations of liver enzymes, acute liver atrophy, necrosis, fatty metamorphosis, periportal fibrosis or cirrhosis or death may occur, usually following chronic administration.

Urogenital System: Renal failure, azotaemia, cystitis, haematuria, defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, infertility, abortion, foetal defects, severe nephropathy. Vaginitis, vaginal ulcers, cystitis, haematuria and nephropathy have also been reported.

Pulmonary System: Infrequently an acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported. Acute pulmonary oedema has also been reported after oral and intrathecal use. Pulmonary fibrosis is rare. A syndrome consisting of pleuritic pain and pleural thickening has been reported following high doses.

Central Nervous System: Headaches, drowsiness, blurred vision, aphasia, hemiparesis and convulsions have occurred possibly related to haemorrhage or to complications from intra-arterial catheterization. Convulsion, paresis, Guillain-Barre syndrome and increased cerebrospinal fluid pressure have followed intrathecal administration.

Other reactions related to, or attributed to the use of Methotrexate such as pneumonitis, metabolic changes, precipitation of diabetes, osteoporotic effects, abnormal changes in tissue cells and even sudden death have been reported.

There have been reports of leukoencephalopathy following intravenous methotrexate in high doses, or low doses following cranial-spinal radiation.

Adverse reactions following intrathecal methotrexate are generally classified into three groups, acute, subacute, and chronic. The acute form is a chemical arachnoiditis manifested by headache, back or shoulder pain, nuchal rigidity, and fever. The subacute form may include paresis, usually transient, paraplegia, nerve palsies, and cerebellar dysfunction. The chronic form is a leukoencephalopathy manifested by irritability, confusion, ataxia, spasticity, occasionally convulsions, dementia, somnolence, coma, and rarely, death. There is evidence that the combined use of cranial radiation and intrathecal methotrexate increases the incidence of leukoencephalopathy.

Additional reactions related to or attributed to the use of methotrexate such as osteoporosis, abnormal (usually 'megaloblastic') red cell morphology, precipitation of diabetes, other metabolic changes, and sudden death have been reported.

4.9 Overdose

Calcium Folinate (Calcium Leucovorin) is a potent agent for neutralizing the immediate toxic effects of Methotrexate on the haematopoietic system. Where large doses or overdoses are given, Calcium Folinate may be administered by intravenous infusion in doses up to 75mg within 12 hours, followed by 12mg intramuscularly every 6 hours for 4 doses. Where average doses of Methotrexate appear to have an adverse effect 6-12mg of Calcium Folinate may be given intramuscularly every 6 hours for 4 doses. In general, where overdosage is suspected, the dose of Calcium Folinate should be equal to or higher than, the offending dose of Methotrexate and should be administered as soon as possible; preferably within the first hour and certainly within 4 hours after which it may not be effective.

Other supporting therapy such as blood transfusion and renal dialysis may be required. Effective clearance of methotrexate has been reported with acute, intermittent haemodialysis using a high flux dialyser.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Methotrexate is an antimetabolite which acts principally by competitively inhibiting the enzyme, dihydrofolate reductase. In the process of DNA synthesis and cellular replication, folic acid must be reduced to tetrahydrofolic acid by this enzyme, and inhibition by Methotrexate interferes with tissue cell reproduction. Actively proliferating tissues such as malignant cells are generally more sensitive to this effect of Methotrexate. It also inhibits antibody synthesis.

Methotrexate also has immunosuppressive activity, in part possibly as a result of inhibition of lymphocyte multiplication. The mechanism(s) of action in the management of rheumatoid arthritis of the drug is not known, although suggested mechanisms have included immunosuppressive and/or anti-inflammatory effect.

5.2 Pharmacokinetic Properties

In doses of 0.1mg (of Methotrexate) per kg, Methotrexate is completely absorbed from the G.I. tract; larger oral doses may be incompletely absorbed. Peak serum concentrations are achieved within 0.5 - 2 hours following I.V. / I.M. or intra-arterial administration. Serum concentrations following oral administration of Methotrexate may be slightly lower than those following I.V. injection.

Methotrexate is actively transported across cell membranes. The drug is widely distributed into body tissues with highest concentrations in the kidneys, gall bladder, spleen, liver and skin. Methotrexate is retained for several weeks in the kidneys and for months in the liver. Sustained serum concentrations and tissue accumulation may result from repeated daily doses. Methotrexate crosses the placental barrier and is distributed into breast milk. Approximately 50% of the drug in the blood is bound to serum proteins.

In one study, Methotrexate had a serum half-life of 2-4 hours following I.M. administration. Following oral doses of 0.06mg/kg or more, the drug had a serum half-life of 2-4 hours, but the serum half-life was reported to be increased to 8-10 hours when oral doses of 0.037mg/kg were given.

Methotrexate does not appear to be appreciably metabolised. The drug is excreted primarily by the kidneys via glomerular filtration and active transport. Small amounts are excreted in the faeces, probably via the bile. Methotrexate has a biphasic excretion pattern. If Methotrexate excretion is impaired accumulation will occur more rapidly in patients with impaired renal function. In addition, simultaneous administration of other weak organic acids such as salicylates may suppress Methotrexate clearance.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Other Constituents

 

 

5 mg/2 ml

25 mg/ml

100 mg/ml

Sodium Chloride

BP

17.2 mg

4.9 mg

None

Sodium Hydroxide

BP

QS

QS

QS

Water for Injections

BP

To 2 ml

To 1 ml

To 1 ml

There is a 5 % manufacturing overage included in the formulation.

6.2 Incompatibilities

Immediate precipitation or turbidity results when combined with certain concentrations of

Droperidol, Heparin Sodium, Metoclopramide Hydrochloride, Ranitidine

Hydrochloride in syringe.

6.3 Shelf Life

5 mg/2 ml and 25 mg/ml – 24 months

100 mg/ ml - 30 months

6.4 Special Precautions For Storage

For the 1g/40ml presentation : Store between 2-8°C. Protect from light.

For all other prersentations: Store below 25°C. Protect from light and freezing.

Unused portions of opened vials must not be stored and should be discarded immediately. Prepared infusions, not used immediately, must be stored at 2-8°C for no longer than 24 hours from the time of preparation.

6.5 Nature And Contents Of Container

Conventional Glass Vials (5 mg/ 2 ml, 50mg/2ml, 250mg/10ml, 500mg/20ml, 1 g/10 ml and 5 g/50 ml):

Type I glass vial, 2ml, 13mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in packs of 5 vials.

Type I glass vial, 10ml, 13mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in packs of 5 vials.

Type I glass vial, 20ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Type I glass vial, 10ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Type I glass vial, 50ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Onco-TainTM Vials (5 mg/2 ml, 50mg/2ml, 500mg/20ml, 1 g/10 ml and 5 g/50 ml only):

Clear Type I Onco-TainTM vial, 2ml, 13mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in packs of 5 vials.

Clear Type I Onco-TainTM vial, 20ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Clear Type I Onco-TainTM vial, 10ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Clear Type I Onco-TainTM vial, 50ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Onco-Vial TM (Shell Glass Vials )(500mg/20ml, 1g/40ml, 1 g/10 ml and 5 g/ 50 ml only):

Clear Type I shell glass vial, 10ml, 15mm, west type 4405/50 rubber closure in single vial packs.

Clear Type I shell glass vial, 50ml, 27mm, west type 4405/50 rubber closure in single vial packs.

Clear Type I shell glass vial, 50ml, 27mm, west type 4416/50 rubber closure in single vial packs.

Not all presentations and pack sizes listed above may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Faulding Pharmaceuticals Plc

Queensway

Royal Leamington Spa

Warwickshire, CV31 3RW

8. Marketing Authorisation Number(S)

5 mg/2 ml presentation: PL 04515/0013

25 mg/ml presentation: PL 04515/0015

100 mg/ml presentation: PL 04515/0038

9. Date Of First Authorisation/Renewal Of The Authorisation

21st August 1985/11th March 1996

10. Date Of Revision Of The Text

12th July 2000

Itraspor

Itraspor may be available in the countries listed below.

Ingredient matches for Itraspor Itraconazole

Itraconazole is reported as an ingredient of Itraspor in the following countries:

Greece Turkey

International Drug Name Search

Atelvia

Generic Name: risedronate (rih SED ro nayt) Brand Names: Actonel, Atelvia

What is risedronate?

Risedronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Risedronate is used to treat or prevent osteoporosis in men and women. Risedronate is also used to treat Paget's disease of bone.

Risedronate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about risedronate?

Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking a risedronate tablet.

For at least the first 30 minutes after taking a risedronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to risedronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my healthcare provider before taking risedronate? Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication. You should not take this medication if you are allergic to risedronate, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

To make sure you can safely take risedronate, tell your doctor if you have any of these other conditions:

low blood calcium (hypocalcemia);

a vitamin D deficiency;

kidney disease; or

an ulcer in your stomach or esophagus.

Some people using medicines similar to risedronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether risedronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether risedronate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking risedronate. How should I take risedronate?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Risedronate tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day. Some tablets are taken once each week, or only 1 or 2 times each month.

Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking a risedronate tablet.

After taking a risedronate tablet, carefully follow these instructions:

Do not lie down or recline for at least 30 minutes after taking risedronate.

Do not eat or drink anything other than plain water.

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking risedronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

Do not take two different strengths of risedronate tablet at the same time.

If you take risedronate only once a week, take it on the same day and time each week.

Do not crush, chew, or suck the risedronate tablet. Swallow the pill whole. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. Visit your doctor regularly.

Risedronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

If you take risedronate tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take risedronate tablets once a week, or once or twice per month: If you forget to take risedronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking risedronate?

Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a risedronate tablet. Some medicines can make it harder for your body to absorb risedronate.

Risedronate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using risedronate and call your doctor at once if you have a serious side effect such as:

chest pain;

difficulty or pain when swallowing;

pain or burning under the ribs or in the back;

new or worsening heartburn;

severe or ongoing indigestion;

severe joint, bone, or muscle pain;

new or unusual pain in your thigh or hip; or

jaw pain, numbness, or swelling.

Less serious side effects may include:

flu symptoms, muscle pain;

mild stomach pain or upset stomach;

diarrhea, constipation;

mild joint or back pain; or

headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

What other drugs will affect risedronate?

Before using risedronate, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with risedronate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Atelvia resources Atelvia Side Effects (in more detail)Atelvia Use in Pregnancy & BreastfeedingAtelvia Drug InteractionsAtelvia Support Group0 Reviews for Atelvia - Add your own review/rating Atelvia Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Atelvia Advanced Consumer (Micromedex) - Includes Dosage Information Atelvia Consumer Overview Atelvia Prescribing Information (FDA) Risedronate Prescribing Information (FDA) Risedronate MedFacts Consumer Leaflet (Wolters Kluwer) Actonel MedFacts Consumer Leaflet (Wolters Kluwer) Actonel Consumer Overview Actonel Prescribing Information (FDA) Actonel Monograph (AHFS DI) Compare Atelvia with other medications Osteoporosis Where can I get more information? Your pharmacist can provide more information about risedronate.

See also: Atelvia side effects (in more detail)

Armour Thyroid
Pronunciation: THYE-roidGeneric Name: ThyroidBrand Name: Examples include Armour Thyroid and Bio-Throid

Tresaderm
Dosage Form: FOR ANIMAL USE ONLYTresaderm®

Allergenic Extract, Egg and Meat
Allergenic Extract Warning

Diagnostic and therapeutic allergenic extracts are intended to be administered by a physician who is an allergy specialist and experienced in allergenic diagnostic testing and immunotherapy and the emergency care of anaphylaxis.

This product should not be injected intravenously. Deep subcutaneous routes have been safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. (See Adverse Reactions)

Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to: MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, Md. 20852-9787, call 1-800-FDA-1088.

Extreme caution should be taken when using allergenic extracts for patients who are taking beta-blocker medications. In the event of a serious adverse reaction associated with the use of allergenic extracts, patients receiving beta-blockers may not be responsive to epinephrine or inhaled brochodialators.(1)(See Precautions)

Allergenic extracts should be used with caution for patients with unstable or steroid-dependent asthma or underlying cardiovascular disease. (See Contraindications)

Allergenic Extract, Egg and Meat Description

Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts)

For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.

Allergenic Extract, Egg and Meat - Clinical Pharmacology

The pharmacological action of allergenic extracts used diagnostically is based on the liberation of histamine and other substances when the allergen reacts with IgE antibodies attached to the mast cells. When allergenic extracts are used for immunotherapy, the effect is an increase in immunoglobulin G (IgG) and an increased T suppresser lymphocyte which interferes with the allergic response.(2) With repeated administration of allergenic extracts changes develop in regards to IgG and IgE production and mediator-releasing cells. The histamine release response is reduced in some patients.

Indications and Usage for Allergenic Extract, Egg and Meat

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity.

Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.

Contraindications

Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergic disease is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment. Allergenic extracts are not indicated for use in patients who are not clinically allergic or who are not skin reactive to an allergen. Allergenic extracts should be discontinued or the concentration of potency substantially reduced in patients who experience unacceptable adverse reactions.

Warnings

DO NOT INJECT INTRAVENOUSLY.

Epinephrine 1:1000 should be available.

Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing. All concentrates of glycerinated allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death.(4)(See Adverse Reactions) An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. When switching patients to a new lot of the same extract the initial dose should be reduced 3/4 so that 25% of previous dose is administered.

Precautions

GENERAL: Epinephrine 1:1000 should be available as well as personnel trained in administering emergency treatment. Allergenic Extracts are not intended for intravenous injections. For safe and effective use of allergenic extracts, sterile diluents, sterile vials, sterile syringes should be used and aseptic precautions observed when making a dilution and/or administering the allergenic extract injection. A sterile tuberculin syringe graduated in 0.1 ml units to measure each dose for the prescribed dilution should be used. To reduce the risk of an occurrence of adverse reactions, begin with a careful personal history plus a physical exam. Confirm your findings with scratch or intradermal skin testing.

Standardized extracts are those labeled in AU/ml units or BAU/ml units. Standardized extracts are not interchangeable with extracts previously labeled as wt/vol or PNU/ml. Before administering a standardized extract, read the accompanying insert contained with standardized extracts.

Information for Patients: All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Patients should be informed of this risk prior to skin testing and immunotherapy. Patients should be instructed to recognize adverse reaction symptoms that may occur and to report all adverse reactions to a physician. Patients should be instructed to remain in the office for 30 minutes during testing using allergenic extracts and at least 30 minutes after therapeutic injections using allergenic extracts.

DRUG INTERACTIONS: Some drugs may affect the reactivity of the skin; patients should be instructed to avoid medications, particularly antihistamines and sympathomimetic drugs, for at least 24 hours prior to skin testing. Antihistamines and Hydroxyzine can significantly inhibit the immediate skin test reactions as they tend to neutralize or antagonize the action of histamine.(3) This effect has been primarily documented when testing was performed within 1 to 2 hours after drug ingestion. Partial inhibition of the skin test reaction had been observed for longer periods. Epinephrine injection inhibits the immediate skin test reactions for several hours. Patients on delayed absorption antihistamine tablets should be free of such medication for 48 hours before testing. Patients using Astemizole (Hismanal) may experience prolonged suppression and should be free from such medication for up to 6 to 8 weeks prior to testing. Refer to package insert from an applicable long acting antihistamine manufacturer for additional information.

Extreme caution should be taken when using allergenic extracts on patients who are taking beta-blockers. Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.

Carcinogenesis, mutagenesis, impairment of fertility:

Long term studies in animals have not been conducted with allergenic extracts to determine their potential carcinogenicity, mutagenicity or impairment of fertility.

Pregnancy: Category C: Animal reproduction studies have not been conducted with Allergenic Extracts. It is not known whether allergenic extracts can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Allergenic extracts should be given to pregnant women only if clearly needed.

Nursing Mothers: It is not known whether this drug appears in human milk. Because many drugs are detected in human milk, caution should be exercised when Allergenic Extracts are administered to a nursing woman. There are no current studies on extract components in human milk, or their effect on the nursing infant.

Pediatric Use: Allergenic extracts have been used in children over two years of age.(5)

Adverse Reactions

Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration. Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur. Severe reactions may cause anaphylaxis or shock and loss of consciousness and rarely death.

The treatment of systemic allergic reactions is dependent upon the system complex. Antihistamines may offer relief of recurrent urticaria, associated skin reactions and gastrointestinal symptoms. Corticosteroids may provide benefit if symptoms are prolonged or recurrent. (See Overdose section)

Local Reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site. These reactions may appear within a few minutes to hours and persist for several days. Local cold applications and oral antihistamines may be effective treatment. For marked and prolonged local reactions the use of antihistamines or anti-inflammatory medications may be dictated. Serious adverse reactions should be reported to Nelco Laboratories immediately and a report can be filed to: MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, MD 20852-9787, call 1-800-FDA-1088.

Overdosage

Overdose can cause both local and systemic reactions. An overdose may be prevented by careful observation and questioning of the patient about the previous injection.

If systemic or anaphylactic reaction, does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5ml of 1:1000 Epinephrine Hydrochloride into the opposite arm. The dose may be repeated in 5-10 minutes if necessary. Loosen the tourniquet at least every 10 minutes. The Epinephrine Hydrochloride 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml, for children 2 to 6 years it is 0.15 ml, for children 6-12 years it is 0.2 ml.

Patients unresponsive to Epinephrine may be treated with Theophylline. Studies on asthmatic subjects reveal that plasma concentrations of Theophylline of 5 to 20 µg/ml are associated with therapeutic effects. Toxicity is particularly apparent at concentrations greater than 20 µg/ml. A loading dose of Aminophylline of 5.8 mg/kg intravenously followed by 0.9 mg/kg per hour results in plasma concentrations of approximately 10 µg/ml for patients not previously receiving theophylline. (Mitenko and Ogilive, Nicholoson and Chick,1973)

Other beta-adrenergic drugs such as Isoproterenol, Isoetharine, or Albuterol may be used by inhalation. The usual dose to relieve broncho-constriction in asthma is 0.5 ml of the 0.5% solution for Isoproterenol HCl. The Albuterol inhaler delivers approximately 90 mcg of Albuterol from the mouthpiece. The usual dosage for adults and children would be two inhalations repeated every 4-6 hours. Isoetharine supplied in the Bronkometer unit delivers approximately 340 mcg Isoetharine. The average dose is one to two inhalations. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require oxygen, intubation and the use of life support systems.

Allergenic Extract, Egg and Meat Dosage and Administration

General Precautions

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permits.

The dosage of allergenic extracts is dependent upon the purpose of the administration. Allergenic extracts can be administered for diagnostic use or for therapeutic use.

When allergenic extracts are administered for diagnostic use, the dosage is dependent upon the method used. Two methods commonly used are scratch testing and intradermal testing. Both types of tests result in a wheal and flare response at the site of the test which usually develops rapidly and may be read in 20-30 minutes.

Diagnostic Use: Scratch Testing Method

Scratch testing is considered a simple and safe method although less sensitive than the intradermal test. Scratch testing can be used to determine the degree of sensitivity to a suspected allergen before using the intradermal test. This combination lessens the severity of response to an allergen which can occur in a very sensitive patient.

The most satisfactory testing site is the patient's back or volar surface of the arms from the axilla to 2.5 or 5cm above the wrist, skipping the anti-cubital space. If using the back as a testing site, the most satisfactory area are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins.

Allergenic extracts for diagnostic use are to be administered in the following manner: To scratch surface of skin, use a circular scarifier. Do not draw blood. Tests sites should be 4 cm apart to allow for wheal and flare reaction. 1-30 scratch tests may be done at a time. A separate sterile scratch instrument is to be used on each patient to prevent transmission of homologous serum hepatitis or other infectious agents from one patient to another.

The recommended usual dosage for Scratch testing is one drop of allergen applied to each scratch site. Do not let dropper touch skin. Always apply a control scratch with each test set. Sterile Diluent (for a negative control) is used in exactly the same way as an active test extract. Histamine may be used as a positive control. Scratch or prick test sites should be examined at 15 and 30 minutes. To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears. Record the size of the reaction.

Interpretation of Scratch Test

Skin tests are graded in terms of the wheal and erythema response noted at 10 to 20 minutes. Wheal and erythema size may be recorded by actual measurement as compared with positive and negative controls. A positive reaction consists of an area of erythema surrounding the scarification that is larger than the control site. For uniformity in reporting reactions, the following system is recommended. (6)

REACTION SYMBOL CRITERIA Negative - No wheal. Erythema absent or very slight (not more than 1 mm diameter). One Plus + Wheal absent or very slight erythema present (not more than 3 mm diameter). Two Plus ++ Wheal not more than 3mm or erythema not more than 5mm diameter. Three Plus +++ Wheal between 3mm and 5mm diameter, with erythema. Possible pseudopodia and itching. Four Plus ++++ A larger reaction with itching and pain.

Diagnostic Use: Intradermal Skin Testing Method

Do not perform intradermal test with allergens which have evoked a 2+ or greater response to a Scratch test. Clean test area with alcohol, place sites 5 cm apart using separate sterile tuberculin syringe and a 25 gauge needle for each allergen. Insert needle tip, bevel up, into intracutaneous space. Avoid injecting into blood vessel, pull back gently on syringe plunger, if blood enters syringe change position of needle. The recommended dosage and range for intradermal testing is 0.05 ml of not more than 100 pnu/ml or 1:1000 w/v (only if puncture test is negative) of allergenic extract. Inject slowly until a small bleb is raised. It is important to make each bleb the same size.

Interpretation of Intradermal Test:

The patient's reaction is graded on the basis of size of wheal and flare as compared to control. Use 0.05 ml sterile diluent as a negative control to give accurate interpretation. The tests may be accurately interpreted only when the saline control site has shown a negative response. Observe patient for at least 30 minutes. Tests can be read in 15-20 minutes. Edema, erythema and presence of pseudopods, pain and itching may be observed in 4 plus reactions. For uniformity in reporting reactions the following system is recommended. (6)

REACTION SYMBOL CRITERIA Negative - No increase in size of bleb since injection. No erythema. One Plus + An increase in size of bleb to a wheal not more than 5mm diameter, with associated erythema. Two Plus ++ Wheal between 5mm and 8mm diameter with erythema. Three Plus +++ Wheal between 8mm and 12mm diameter with erythema and possible pseudopodia and itching or pain. Four Plus ++++ Any larger reaction with itch and pain, and possible diffuse blush of the skin surrounding the reaction area.

Therapeutic Use: Recommended dosage & range

Check the listed ingredients to verify that it matches the prescription ordered. When using a prescription set, verify the patient's name and the ingredients listed with the prescription order. Assess the patient's physical and emotional status prior to giving as injection. Do not give injections to patients who are in acute distress. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response and tolerance to the extract administered during the early phases of an injection regimen. The dosage must be reduced when transferring a patient from non-standardized or modified extract to standardized extract. Any evidence of a local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy as well as during maintenance therapy. After therapeutic injections patients should be observed for at least 20 minutes for reaction symptoms.

SUGGESTED DOSAGE SCHEDULE

The following schedule may act as a guide. This schedule has not been proven to be safe or effective. Sensitive patients may begin with smaller doses of weaker solutions and the dosage increments can be less.

STRENGTH DOSE VOLUME Vial #1 1 0.05 1:100,000 w/v 2 0.10 10 pnu/ml 3 0.15 1 AU/ml 4 0.20 1 BAU/ml 5 0.30 6 0.40 7 0.50 Vial #2 8 0.05 1:10,000 w/v 9 0.10 100 pnu/ml 10 0.15 10 AU/ml 11 0.20 10 BAU/ml 12 0.30 13 0.40 14 0.50 Vial #3 15 0.05 1:1,000 w/v 16 0.10 1,000 pnu/ml 17 0.15 100 AU/ml 18 0.20 100 BAU/ml 19 0.30 20 0.40 21 0.50 Vial #4 22 0.05 1:100 w/v 23 0.07 10,000 pnu/ml 24 0.10 1,000 AU/ml 25 0.15 1,000 BAU/ml 26 0.20 27 0.25 Maintenance Refill 28 0.25 1:100 w/v 29 0.25 10,000 pnu/ml 30 0.25 1,000 AU/ml 31 0.25 1,000 BAU/ml 32 0.25 subsequent doses 33 0.25

Preparation Instructions:

All dilutions may be made using sterile buffered diluent. The calculation may be based on the following ratio:

Volume desired x Concentration desired = Volume needed x Concentration available.

Example 1: If a 1:10 w/v extract is available and it is desired to use a 1:1,000 w/v extract substitute as follows:

Vd x Cd = Vn x Ca

10ml x 0.001 = Vn x 0.1

0.1 ml = Vn

Using a sterile technique, remove 0.10 ml of extract from the 1:10 vial and place it into a vial containing 9.90 ml of sterile diluent. The resulting ratio will be a 10 ml vial of 1:1,000 w/v.

Example 2: If a 10,000 pnu/ml extract is available and it is desired to use a 100 pnu/ml extract substitute as follows:

10ml x 100 = Vn x 10,000

0.1 ml = Vn

Using a sterile technique, remove 0.10 ml of extract from the 10,000 pnu/ml vial and place it into a vial containing 9.90 ml of sterile diluent. The resulting concentration will be a 10 ml vial of 100 pnu/ml.

Example 3: If a 10,000 AU/ml or BAU/ml extract is available and it is desired to use a 100 AU/ml or BAU/ml extract substitute as follows: Vd x Cd = Vn x Ca

10ml x 100 = Vn x 10,000

0.1 ml = Vn

Using a sterile technique, remove 0.10 ml of extract from the 10,000 AU/ml or BAU/ml vial and place it into a vial containing 9.90 ml of sterile diluent. The resulting concentration will be 10ml vial of 100 AU/ml or BAU/ml.

Intervals between doses: The optimal interval between doses of allergenic extract has not been definitely established. The amount of allergenic extract is increased at each injection by not more than 50%-100% of the previous amount and the next increment is governed by the response to the last injection. There are three generally accepted methods of pollen hyposensitizing therapy.

1. PRESEASONAL

Treatment starts each year 6 to 8 weeks before onset of seasonal symptoms. Maximal dose reached just before symptoms are expected. Injections discontinued during and following season until next year.

2. CO-SEASONAL

Patient is first treated during season with symptoms. Low initial doses are employed to prevent worsening of condition. This is followed by an intensive schedule of therapy (i.e. injections given 2 to 3 times per week). Fewer Allergists are resorting to this Co-seasonal therapy because of the availability of more effective, symptomatic medications that allow the patient to go through a season relatively symptom free.

3. PERENNIAL

Initially this is the same as pre seasonal. The allergen is administered twice weekly or weekly for about 20 injections to achieve the maximum tolerated dose. Then, maintenance therapy may be administered once a week or less frequently.

Duration of Treatment: The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.

How is Allergenic Extract, Egg and Meat Supplied

Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml).

Sizes:

Diagnostic Scratch: 5 ml dropper application vials

Diagnostic Intradermal: 5 ml or 10 ml vials.

Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.

STORAGE

The expiration date of allergen extracts is listed on the container label. Store extracts upon arrival at 2° to 8°C and keep them in this range during office use.

WARRANTY:We warrant that this product was prepared and tested according to the standards of the FDA and is true to label. Because of biological differences in individuals and because allergenic extracts are manufactured to be potent and because we have no control over the conditions of use, we cannot and do not warrant either a good effect or against an ill effect following use.

REFERENCES

1 Jacobs, Robert L., Geoffrey W.Rake,Jr., et.al. Potentiated Anaphylaxis in Patients with Drug-induced Beta-adrenergic Blockade. J.Allergy & Clin. Immunol., 68(2): 125-127. August 1981.

2 Ishizaka,K.: Cellular Events in the IgE Antibody Response. Adv. in Immuno. 23:50-75, 1976.

3. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

4. Reid,M.J., Lockey,R.F., Turkeltaub,P.C., Platts-Mills,T.A.E., Survey of fatalities from skin testing and immunotherapy 1985-1989. Journal of Allergy Clin. Immunol. 92 (1): 6-15, July 1993.

5. Murray, A.B., Ferguson, A., Morrison, B., The frequency and severity of cat allergy vs dog allergy in atopic children. J. Allergy Clin. Immunolo: 72, 145-9, 1983.

6. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

CONTAINER LABELING EGG WHITE 

Indatab

Indatab may be available in the countries listed below.

Ingredient matches for Indatab Indapamide

Indapamide is reported as an ingredient of Indatab in the following countries:

Vietnam

International Drug Name Search

Mega-C

Generic Name: ascorbic acid (Oral route)

as-KORE-bik AS-id

Commonly used brand name(s)

In the U.S.

Ascocid C-500 Cecon Cemill 1000 Cemill 500 Cevi-Bid C-Time w/Rose Hips Mega-C One-Gram C Protexin Sunkist Vitamin C

In Canada

Ce-Vi-Sol Revitalose-C-1000 Revitonus C-1000 Yellow Ampule Vitamin C Powder

Available Dosage Forms:

Tablet Powder Powder for Solution Capsule, Liquid Filled Tablet, Chewable Granule Capsule Syrup Powder for Suspension Liquid Solution Tablet, Extended Release Lozenge/Troche Capsule, Extended Release Wafer

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin C

Uses For Mega-C

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Ascorbic acid, also known as vitamin C, is necessary for wound healing. It is needed for many functions in the body, including helping the body use carbohydrates, fats, and protein. Vitamin C also strengthens blood vessel walls.

Lack of vitamin C can lead to a condition called scurvy, which causes muscle weakness, swollen and bleeding gums, loss of teeth, and bleeding under the skin, as well as tiredness and depression. Wounds also do not heal easily. Your health care professional may treat scurvy by prescribing vitamin C for you.

Some conditions may increase your need for vitamin C. These include:

AIDS (acquired immune deficiency syndrome) Alcoholism Burns Cancer Diarrhea (prolonged) Fever (prolonged) Infection (prolonged) Intestinal diseases Overactive thyroid (hyperthyroidism) Stomach ulcer Stress (continuing) Surgical removal of stomach Tuberculosis

Also, the following groups of people may have a deficiency of vitamin C:

Infants receiving unfortified formulas Smokers Patients using an artificial kidney (on hemodialysis) Patients who undergo surgery Individuals who are exposed to long periods of cold temperatures

Increased need for vitamin C should be determined by your health care professional.

Vitamin C may be used for other conditions as determined by your health care professional.

Claims that vitamin C is effective for preventing senility and the common cold, and for treating asthma, some mental problems, cancer, hardening of the arteries, allergies, eye ulcers, blood clots, gum disease, and pressure sores have not been proven. Although vitamin C is being used to reduce the risk of cardiovascular disease and certain types of cancer, there is not enough information to show that these uses are effective.

Injectable vitamin C is given by or under the supervision of a health care professional. Other forms of vitamin C are available without a prescription.

Once a medicine or dietary supplement has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, vitamin C is used in certain patients with the following medical conditions:

Overdose of iron (to help another drug in decreasing iron levels in the body) Methemoglobinemia (a blood disease) Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin C is found in various foods, including citrus fruits (oranges, lemons, grapefruit), green vegetables (peppers, broccoli, cabbage), tomatoes, and potatoes. It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, exposure to air, drying, salting, or cooking (especially in copper pots), mincing of fresh vegetables, or mashing potatoes may reduce the amount of vitamin C in foods. Freezing does not usually cause loss of vitamin C unless foods are stored for a very long time.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of vitamin C needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for vitamin C are generally defined as follows:

Persons U.S. (mg) Canada (mg) Infants and children

collagenase clostridium histolyticum

Generic Name: collagenase clostridium histolyticum (KOL a JEN ase klos TRID ee um HIS toe LIT ik um) Brand Names: Xiaflex

What is collagenase clostridium histolyticum?

Collagenase clostridium histolyticum is made from a mixture of proteins derived from a certain bacteria.

Collagenase clostridium histolyticum is used to treat Dupuytren's contracture in adults. This condition causes an abnormal thickening of the tissue in the palm of the hand. This condition may get worse over time and form a "cord" in your palm, causing a permanent bend in your finger.

Collagenase clostridium histolyticum may also be used for purposes not listed in this medication guide.

What is the most important information I should know about collagenase clostridium histolyticum?

Before you receive this medication, tell your doctor if you have a bleeding or blood clotting disorder, such as hemophilia.

The day after your injection, your doctor will need to examine your hand to see if your condition has improved. Avoid any strenuous activity using the treated hand until your doctor tells you to resume normal activities.

Tell your caregiver at once if you have a serious side effect in the treated hand, such as bruising, bleeding, swelling, redness, warmth, numbness, tingling, or sudden pain or loss of movement. Call your doctor if you have fever, chills, body aches, flu symptoms, or swollen glands in your elbow or underarm. What should I discuss with my health care provider before receiving collagenase clostridium histolyticum? You should not use this medication if you are allergic to it.

To make sure you can safely receive this medication, tell your doctor if you have a bleeding or blood clotting disorder, such as hemophilia.

FDA pregnancy category B. Collagenase clostridium histolyticum is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether collagenase clostridium histolyticum passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is collagenase clostridium histolyticum given?

This medication is injected directly into the "cord" of the affected hand. A healthcare provider will give you this injection.

After your injection, do not touch or put pressure on the treated area of the hand for the rest of the day. Keep the treated hand elevated until bedtime.

The day after your injection, your doctor will need to examine your hand to see if your condition has improved. If you still have the cord, your doctor may try to break it by extending your treated finger.

Collagenase clostridium histolyticum is usually given once every 4 weeks and you may receive more than one injection at a time. Follow your doctor's dosing instructions very carefully.

You may need to wear a splint on your hand for a short time to keep your fingers straight, especially at night. You may also need to perform daily finger exercises. Follow your doctor's instructions.

Call your doctor if you have trouble bending the treated finger after the swelling goes down. What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your collagenase clostridium histolyticum injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid before and after receiving collagenase clostridium histolyticum? Until you visit your doctor the day after your injection, do not flex or extend the fingers of your treated hand. Doing so may cause the medicine to spread away from the treatment area, making it less effective.

Avoid any strenuous activity using the treated hand until your doctor tells you to resume normal activities.

Collagenase clostridium histolyticum side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your caregiver at once if you have a serious side effect such as:

feeling like you might pass out (even while lying down);

bruising or bleeding in the treated hand;

severe pain, itching, redness, warmth, swelling, or other irritation in the treated hand;

numbness or tingling in the treated hand;

fever, chills, body aches, flu symptoms, swollen glands;

swollen glands in your elbow or underarm; or

sudden pain, snapping or popping sound, bruising, loss of movement, or swelling in the joints of your hand.

Less serious side effects may include:

mild pain or tenderness in the treated hand;

cracked skin; or

underarm pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Collagenase clostridium histolyticum Dosing Information

Usual Adult Dose for Dupuytren's Contracture:

0.58 mg as a single injection into the target cord, followed by a finger extension procedure approximately 24 hours later to facilitate disruption of the cord in those individuals who did not experience spontaneous disruption, and up to two follow-up injections at 4 week intervals, if necessary.Additional cords are to be handled sequentially

What other drugs can affect collagenase clostridium histolyticum?

Before you receive this medication, tell your doctor about all other medicines you have used within the past 7 days, especially medication used to prevent blood clots, such as:

high doses of aspirin (more than 150 milligrams per day);

a blood thinner such as warfarin (Coumadin);

argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);

dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra); or

abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

This list is not complete and other drugs may interact with collagenase clostridium histolyticum. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More collagenase clostridium histolyticum resources Collagenase clostridium histolyticum Side Effects (in more detail)Collagenase clostridium histolyticum Use in Pregnancy & BreastfeedingCollagenase clostridium histolyticum Drug InteractionsCollagenase clostridium histolyticum Support Group0 Reviews for Collagenase clostridium histolyticum - Add your own review/rating collagenase clostridium histolyticum Injection Advanced Consumer (Micromedex) - Includes Dosage Information Collagenase Clostridium Histolyticum Professional Patient Advice (Wolters Kluwer) Collagenase Clostridium Histolyticum MedFacts Consumer Leaflet (Wolters Kluwer) Xiaflex Prescribing Information (FDA) Xiaflex Consumer Overview Compare collagenase clostridium histolyticum with other medications Dupuytren's contracture Where can I get more information? Your doctor or pharmacist can provide more information about collagenase clostridium histolyticum.

See also: collagenase clostridium histolyticum side effects (in more detail)

Genteal Mild

Generic Name: hypromellose (Ophthalmic route)

hye-PROE-me-lose

Commonly used brand name(s)

In the U.S.

Genteal Genteal Mild Gonak Goniosoft Goniovisc Isopto Tears Nature's Tears Tearisol Tears Again Mc

Available Dosage Forms:

Solution Gel/Jelly

Therapeutic Class: Surgical Aid, Ocular

Uses For Genteal Mild

Hydroxypropyl methylcellulose belongs to the group of medicines known as artificial tears. It is used to relieve dryness and irritation caused by reduced tear flow. It helps prevent damage to the eye in certain eye diseases. Hydroxypropyl methylcellulose may also be used to moisten hard contact lenses and artificial eyes. In addition, it may be used in certain eye examinations.

Some of these preparations are available only with your doctor's prescription.

Before Using Genteal Mild

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of hydroxypropyl methylcellulose in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicine have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydroxypropyl methylcellulose in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of hypromellose

This section provides information on the proper use of a number of products that contain hypromellose. It may not be specific to Genteal Mild. Please read with care.

To use:

First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients wearing hard contact lenses:

Take care not to float the lens from your eye when applying this medicine. If you have any questions about this, check with your health care professional. Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For dry eyes: For ophthalmic solution (eye drops) dosage form: Adults and children—Use 1 drop three or four times a day. Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Genteal Mild

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if your symptoms continue for more than 3 days or become worse, check with your doctor.

Genteal Mild Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Eye irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common - more common with 1% solution Blurred vision matting or stickiness of eyelashes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Fer-In-Sol

Generic Name: iron supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

Beef,Iron & Wine Bifera Elite Iron Femiron Feosol Fergon Ferrex 150 Hemocyte

In Canada

Fer-In-Sol Palafer Pms-Ferrous Sulfate

Available Dosage Forms:

Tablet, Chewable Liquid Tablet Capsule Solution Tablet, Enteric Coated Tablet, Extended Release Suspension Syrup Capsule, Extended Release Elixir Capsule, Liquid Filled Uses For Fer-In-Sol

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Although many people in the U.S. get enough iron from their diet, some must take additional amounts to meet their needs. For example, iron is sometimes lost with slow or small amounts of bleeding in the body that you would not be aware of and which can only be detected by your doctor. Your doctor can determine if you have an iron deficiency, what is causing the deficiency, and if an iron supplement is necessary.

Lack of iron may lead to unusual tiredness, shortness of breath, a decrease in physical performance, and learning problems in children and adults, and may increase your chance of getting an infection.

Some conditions may increase your need for iron. These include:

Bleeding problems Burns Hemodialysis Intestinal diseases Stomach problems Stomach removal Use of medicines to increase your red blood cell count

In addition, infants, especially those receiving breast milk or low-iron formulas, may need additional iron.

Increased need for iron supplements should be determined by your health care professional.

Injectable iron is administered only by or under the supervision of your health care professional. Other forms of iron are available without a prescription; however, your health care professional may have special instructions on the proper use and dose for your condition.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Iron is found in the diet in two forms—heme iron, which is well absorbed, and nonheme iron, which is poorly absorbed. The best dietary source of absorbable (heme) iron is lean red meat. Chicken, turkey, and fish are also sources of iron, but they contain less than red meat. Cereals, beans, and some vegetables contain poorly absorbed (nonheme) iron. Foods rich in vitamin C (e.g., citrus fruits and fresh vegetables), eaten with small amounts of heme iron-containing foods, such as meat, may increase the amount of nonheme iron absorbed from cereals, beans, and other vegetables. Some foods (e.g., milk, eggs, spinach, fiber-containing, coffee, tea) may decrease the amount of nonheme iron absorbed from foods. Additional iron may be added to food from cooking in iron pots.

The daily amount of iron needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for iron are generally defined as follows (Note that the RDA and RNI are expressed as an actual amount of iron, which is referred to as “elemental”' iron. The product form [e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate] has a different strength):

Persons U.S. (mg) Canada (mg) Infants birth to 3 years of age 6–10 0.3–6 Children 4 to 6 years of age 10 8 Children 7 to 10 years of age 10 8–10 Adolescent and adult males 10 8–10 Adolescent and adult females 10–15 8–13 Pregnant females 30 17–22 Breast-feeding females 15 8–13 Before Using Fer-In-Sol

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. Iron supplements, when prescribed by your health care professional, are not expected to cause different side effects in children than they do in adults. However, it is important to follow the directions carefully, since iron overdose in children is especially dangerous.

Studies on sodium ferric gluconate have shown that this supplement is safe to use in children ages 6 to 15 years. The safety of sodium ferric gluconate has not been determined in patients who are younger than 6 years of age.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Elderly people sometimes do not absorb iron as easily as younger adults and may need a larger dose. If you think you need to take an iron supplement, check with your health care professional first. Only your health care professional can decide if you need an iron supplement and how much you should take.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. Healthy fetal growth and development depend on a steady supply of nutrients from mother to fetus. During the first 3 months of pregnancy, a proper diet usually provides enough iron. However, during the last 6 months, in order to meet the increased needs of the developing baby, an iron supplement may be recommended by your health care professional.

However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is especially important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. Iron normally is present in breast milk in small amounts. When prescribed by a health care professional, iron preparations are not known to cause problems during breast-feeding. However, nursing mothers are advised to check with their health care professional before taking iron supplements or any other medication. Taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or infant and should be avoided.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Altretamine Amygdalin Deferoxamine Digoxin Eltrombopag Rilpivirine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse (or history of) or Blood transfusions (with high red blood cell iron content) or Kidney infection or Liver disease or Porphyria cutaneous tarda—Higher blood levels of the iron supplement may occur, which may increase the chance of side effects. Arthritis (rheumatoid) or Asthma or allergies or Heart disease—The injected form of iron may make these conditions worse. Colitis or other intestinal problems or Iron overload conditions (e.g., hemochromatosis, hemosiderosis, hemoglobinopathies) or Stomach ulcer—Iron supplements may make these conditions worse. Other anemias—Iron supplements may increase iron to toxic levels in anemias not associated with iron deficiency. Proper Use of iron supplement

This section provides information on the proper use of a number of products that contain iron supplement. It may not be specific to Fer-In-Sol. Please read with care.

After you start using this dietary supplement, continue to return to your health care professional to see if you are benefiting from the iron. Some blood tests may be necessary for this.

Iron is best absorbed when taken on an empty stomach, with water or fruit juice (adults: full glass or 8 ounces; children: ? glass or 4 ounces), about 1 hour before or 2 hours after meals. However, to lessen the possibility of stomach upset, iron may be taken with food or immediately after meals.

For safe and effective use of iron supplements:

Follow your health care professional's instructions if this dietary supplement was prescribed. Follow the manufacturer's package directions if you are treating yourself. If you think you still need iron after taking it for 1 or 2 months, check with your health care professional.

Liquid forms of iron supplement tend to stain the teeth. To prevent, reduce, or remove these stains:

Mix each dose in water, fruit juice, or tomato juice. You may use a drinking tube or straw to help keep the iron supplement from getting on the teeth. When doses of liquid iron supplement are to be given by dropper, the dose may be placed well back on the tongue and followed with water or juice. Iron stains on teeth can usually be removed by brushing with baking soda (sodium bicarbonate) or medicinal peroxide (hydrogen peroxide 3%). Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules, tablets, oral solution): To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adult and teenage males—10 milligrams (mg) per day. Adult and teenage females—10 to 15 mg per day. Pregnant females—30 mg per day. Breast-feeding females—15 mg per day. Children 7 to 10 years of age—10 mg per day. Children 4 to 6 years of age—10 mg per day. Children birth to 3 years of age—6 to 10 mg per day. For Canada Adult and teenage males—8 to 10 mg per day. Adult and teenage females—8 to 13 mg per day. Pregnant females—17 to 22 mg per day. Breast-feeding females—8 to 13 mg per day. Children 7 to 10 years of age—8 to 10 mg per day. Children 4 to 6 years of age—8 mg per day. Children birth to 3 years of age—0.3 to 6 mg per day. To treat deficiency: Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition. For injection dosage forms: Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition. Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Fer-In-Sol

When iron is combined with certain foods it may lose much of its value. If you are taking iron, the following foods should be avoided, or only taken in very small amounts, for at least 1 hour before or 2 hours after you take iron:

Cheese and yogurt Eggs Milk Spinach Tea or coffee Whole-grain breads and cereals and bran

Do not take iron supplements and antacids or calcium supplements at the same time. It is best to space doses of these 2 products 1 to 2 hours apart, to get the full benefit from each medicine or dietary supplement.

If you are taking iron supplements without a prescription:

Do not take iron supplements by mouth if you are receiving iron injections. To do so may result in iron poisoning. Do not regularly take large amounts of iron for longer than 6 months without checking with your health care professional. People differ in their need for iron, and those with certain medical conditions can gradually become poisoned by taking too much iron over a period of time. Also, unabsorbed iron can mask the presence of blood in the stool, which may delay discovery of a serious condition.

If you have been taking a long-acting or coated iron tablet and your stools have not become black, check with your health care professional. The tablets may not be breaking down properly in your stomach, and you may not be receiving enough iron.

It is important to keep iron preparations out of the reach of children. Keep a 1-ounce bottle of syrup of ipecac available at home to be taken in case of an iron overdose emergency when a doctor, poison control center, or emergency room orders its use.

If you think you or anyone else has taken an overdose of iron medicine:

Call your doctor, a poison control center, or the nearest hospital emergency room at once. Always keep these phone numbers readily available. Follow any instructions given to you. If syrup of ipecac has been ordered and given, do not delay going to the emergency room while waiting for the ipecac syrup to empty the stomach, since it may require 20 to 30 minutes to show results Go to the emergency room without delay Take the container of iron with you.

Early signs of iron overdose may not appear for up to 60 minutes or more. Do not delay going to the emergency room while waiting for signs to appear.

Fer-In-Sol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common - with injection only Backache , groin, side, or muscle pain chest pain chills dizziness fainting fast heartbeat fever with increased sweating flushing headache metallic taste nausea or vomiting numbness, pain, or tingling of hands or feet pain or redness at injection site redness of skin skin rash or hives swelling of mouth or throat troubled breathing More common - when taken by mouth only Abdominal or stomach pain cramping (continuing) or soreness Less common or rare - with injection only Double vision general unwell feeling weakness without feeling dizzy or faint Less common or rare - when taken by mouth only Chest or throat pain, especially when swallowing stools with signs of blood (red or black color) Early symptoms of iron overdose

Symptoms of iron overdose may not occur for up to 60 minutes or more after the overdose was taken. By this time you should have had emergency room treatment. Do not delay going to emergency room while waiting for signs to appear.

Diarrhea (may contain blood) fever nausea stomach pain or cramping (sharp) vomiting, severe (may contain blood) Late symptoms of iron overdose Bluish-colored lips, fingernails, and palms of hands convulsions (seizures) pale, clammy skin shallow and rapid breathing unusual tiredness or weakness weak and fast heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Constipation diarrhea leg cramps nausea vomiting Less common

Stools commonly become dark green or black when iron preparations are taken by mouth. This is caused by unabsorbed iron and is harmless. However, in rare cases, black stools of a sticky consistency may occur along with other side effects such as red streaks in the stool, cramping, soreness, or sharp pains in the stomach or abdominal area. Check with your health care professional immediately if these side effects appear.

If you have been receiving injections of iron, you may notice a brown discoloration of your skin. This color usually fades within several weeks or months.

Darkened urine heartburn stained teeth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

hydrochlorothiazide and metoprolol

Generic Name: hydrochlorothiazide and metoprolol (HYE droe klor oh THYE a zide and me TOE proe lole) Brand names: Lopressor HCT, Dutoprol

What is hydrochlorothiazide and metoprolol?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Metoprolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

The combination of hydrochlorothiazide and metoprolol is used to treat high blood pressure (hypertension).

Hydrochlorothiazide and metoprolol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrochlorothiazide and metoprolol? You should not use this medication if you have severe or uncontrolled heart failure, a heart condition called "sick sinus syndrome" or "AV block," severe blood circulation problems, an adrenal gland tumor, an allergy to beta-blockers, or if you are unable to urinate.

Before using this medication, tell your doctor if you have congestive heart failure, kidney or liver disease, cirrhosis, glaucoma, asthma or bronchitis, gout, lupus, diabetes, a thyroid disorder, or if you are allergic to sulfa drugs or penicillin.

If you are diabetic, check your blood sugar carefully. Using metoprolol can make it harder for you to tell when you have low blood sugar. Your insulin or diabetic medication needs may change while you are taking hydrochlorothiazide and metoprolol. Talk with your doctor before changing any doses.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and metoprolol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Keep taking this medication even if you feel fine. High blood pressure often has no symptoms.

There are many other medicines that can interact with hydrochlorothiazide and metoprolol. Tell your doctor about all the prescription and over-the-counter medications you use.

What should I discuss with my doctor before taking hydrochlorothiazide and metoprolol? You should not use this medication if you are allergic to hydrochlorothiazide or metoprolol, or if you have:

severe or uncontrolled heart failure;

a heart condition called "sick sinus syndrome" or "AV block" (2nd or 3rd degree);

severe blood circulation problems;

an adrenal gland tumor (pheochromocytoma);

if you are unable to urinate; or

if you are allergic to any beta-blocker medication, such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

To make sure you can safely take hydrochlorothiazide and metoprolol, tell your doctor if you have any of these other conditions:

congestive heart failure;

kidney disease; liver disease (or cirrhosis);

glaucoma;

asthma or bronchitis;

a thyroid disorder;

lupus;

gout;

diabetes; or

if you are allergic to sulfa drugs or penicillin.

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hydrochlorothiazide and metoprolol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medication. How should I take hydrochlorothiazide and metoprolol?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take the medicine with a meal or right after you eat.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not stop using hydrochlorothiazide and metoprolol suddenly, or you could have a serious or life-threatening heart problem. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Your blood pressure will need to be checked often. Your blood and urine may both be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.

If you are diabetic, check your blood sugar carefully. Using metoprolol can make it harder for you to tell when you have low blood sugar. Your insulin or diabetic medication needs may change while you are taking hydrochlorothiazide and metoprolol. Talk with your doctor before changing any doses.

Hydrochlorothiazide and metoprolol can affect the results of certain thyroid tests. Tell any doctor who treats you that you are using this medication.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and metoprolol. You may need to stop using the medicine for a short time. Keep taking this medication even if you feel fine. High blood pressure often has no symptoms. Store this medication in a tightly closed container at room temperature, away from heat, moisture, and light.

See also: Hydrochlorothiazide and metoprolol dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include fast or slow heart rate, feeling like you might pass out, trouble breathing, or increased urination. What should I avoid while taking hydrochlorothiazide and metoprolol? Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and metoprolol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Hydrochlorothiazide and metoprolol side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

eye pain, vision problems;

swelling, rapid weight gain, feeling short of breath, even with mild exertion;

fast, slow, or uneven heartbeat;

easy bruising or bleeding;

numbness or tingly feeling in your hands or feet;

feeling weak, drowsy, restless, or light-headed;

nausea, vomiting, dry mouth, extreme thirst, headache, confusion, hallucinations, seizure (convulsions);

increased urination, leg discomfort, muscle pain or weakness or limp feeling;

urinating less than usual or not at all;

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

diarrhea, constipation, upset stomach;

dizziness, spinning sensation;

sore throat, body aches;

blurred vision; or

ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Hydrochlorothiazide and metoprolol Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 2 tablets of hydrochlorothiazide-metoprolol 25 mg-50 mg per day in single or divided doses, or 1 to 2 tablets of hydrochlorothiazide-metoprolol 25 mg-100 mg per day in single or divided doses, or 1 tablet of hydrochlorothiazide-metoprolol 50 mg-100 mg per day in single or divided doses. Determine dosage by individual titration.

What other drugs will affect hydrochlorothiazide and metoprolol? Tell your doctor if you regularly use other medicines that make you light-headed (especially narcotic pain medication or barbiturates). They can add to the side effects of hydrochlorothiazide and metoprolol.

Many drugs can interact with hydrochlorothiazide and metoprolol. Below is just a partial list. Tell your doctor if you are using:

insulin or oral diabetes medication;

colestipol (Colestid) or cholestyramine (Prevalite, Questran);

theophylline (Elixophyllin, Respbid, Slo-Bid, Theo-Dur, Uniphyl, and others);

steroids (prednisone and others);

HIV or AIDS medicine such as ritonavir (Norvir, Kaletra);

an antidepressant such as bupropion (Wellbutrin, Zyban), fluoxetine (Prozac), or paroxetine (Paxil);

an antibiotic such as rifampin (Rifadin, Rifamate, Rimactane) or terbinafine (Lamisil);

anti-malaria medication such as hydroxychloroquine (Plaquenil);

medicine to treat psychiatric or mood disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), lithium (Lithobid), or thioridazine (Mellaril);

NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

other heart or blood pressure medications such as clonidine (Catapres), propafenone (Rythmol), quinidine (Quin-G) reserpine, or verapamil (Calan, Covera, Isoptin, Verelan).

This list is not complete and other drugs may interact with hydrochlorothiazide and metoprolol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More hydrochlorothiazide and metoprolol resources Hydrochlorothiazide and metoprolol DosageHydrochlorothiazide and metoprolol Use in Pregnancy & BreastfeedingDrug ImagesHydrochlorothiazide and metoprolol Drug InteractionsHydrochlorothiazide and metoprolol Support Group0 Reviews for Hydrochlorothiazide and metoprolol - Add your own review/rating Compare hydrochlorothiazide and metoprolol with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about hydrochlorothiazide and metoprolol.

valdecoxib

Generic Name: valdecoxib (val deh COCK sib) Brand Names: Bextra

What is valdecoxib?

Valdecoxib (Bextra) was withdrawn from the U.S. market in 2005.

Valdecoxib is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Valdecoxib works by reducing substances in the body that cause inflammation, pain, and fever.

Valdecoxib is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Valdecoxib is also used to treat painful menstruation.

Valdecoxib may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about valdecoxib?

Valdecoxib (Bextra) was withdrawn from the U.S. market in 2005.

The manufacturer of valdecoxib (Bextra) has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (valdecoxib is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking valdecoxib.

Do not take valdecoxib without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to valdecoxib. Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects. Serious skin reactions have occurred in patients taking valdecoxib. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking valdecoxib and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction. What should I discuss with my healthcare provider before taking valdecoxib?

The manufacturer of valdecoxib (Bextra) has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (valdecoxib is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking valdecoxib.

Do not take valdecoxib without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to valdecoxib.

Valdecoxib should not be used for the treatment of pain after coronary artery bypass surgery (CABG). The use of valdecoxib in such patients has led to an increased incidence of cardiovascular events, deep surgical infections and wound complications. Talk to your doctor before taking valdecoxib if you are being treated for pain associated with CABG.

Before taking valdecoxib, tell your doctor if you

smoke;

drink alcohol;

have an ulcer or bleeding in the stomach;

have liver disease; have kidney disease;

have asthma;

have congestive heart failure;

have fluid retention;

have heart disease;

have high blood pressure;

have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or

are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.

You may not be able to take valdecoxib, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.

Valdecoxib is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Valdecoxib should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take valdecoxib without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether valdecoxib passes into breast milk. Do not take valdecoxib without first talking to your doctor if you are breast-feeding a baby. If you are over the age of 65 years, you may be more likely to experience side effects from valdecoxib. You may require a lower dosage or special monitoring during your therapy. How should I take valdecoxib?

Take valdecoxib exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Valdecoxib can be taken with or without food or milk. Follow your doctor's instructions.

Store valdecoxib at room temperature away from moisture and heat.

See also: Valdecoxib dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a valdecoxib overdose include drowsiness, nausea, vomiting, and stomach pain.

What should I avoid while taking valdecoxib?

There are no restrictions on food, beverages, or activity while taking valdecoxib unless otherwise directed by your doctor.

Valdecoxib side effects Serious skin reactions have occurred in patients taking valdecoxib. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking valdecoxib and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction. Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

Other, less serious side effects may be more likely to occur. Continue to take valdecoxib and talk to your doctor if you experience

diarrhea;

nausea or upset stomach; or

headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Valdecoxib Dosing Information

Usual Adult Dose for Osteoarthritis:

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.Initial dose: 10 mg once daily

Usual Adult Dose for Rheumatoid Arthritis:

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Zonalon Cream
Pronunciation: DOX-e-pinGeneric Name: DoxepinBrand Name: Zonalon

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