Vigamox
Generic Name: moxifloxacin hydrochloride Dosage Form: ophthalmic solutionFULL PRESCRIBING INFORMATION INDICATIONS AND USAGE

Vigamox® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Corynebacterium species*

One-Alpha Injection
1. Name Of The Medicinal Product

One-Alpha® Injection

2. Qualitative And Quantitative Composition

Alfacalcidol (1?-hydroxyvitamin D3) 2 micrograms/ml.

3. Pharmaceutical Form

Injection

4. Clinical Particulars 4.1 Therapeutic Indications

One-Alpha® is indicated in all conditions where there is a disturbance of calcium metabolism due to impaired 1 ?-hydroxylation such as when there is reduced renal function.

The main indications are:

a) Renal osteodystrophy

b) Hyperparathyroidism (with bone disease)

c) Hypoparathyroidism

d) Neonatal hypocalcaemia

e) Nutritional and malabsorptive rickets and osteomalacia

f) Pseudo - deficiency (D - dependent) rickets and osteomalacia

g) Hypophosphataemic vitamin D resistant rickets and osteomalacia

4.2 Posology And Method Of Administration

One-Alpha® Injection should be administered intravenously as a bolus over approximately 30 seconds. Shake the ampoule for a minimum of 5 seconds before use.

The dosage of One-Alpha® Injection is the same as for One-Alpha® in its oral presentations.

Initial dosage for all indications is:

Adults

1 microgram/day

Dosage in the elderly

0.5 microgram/day

Neonates and premature infants

0.05 - 0.1 microgram/kg/day

Children under 20 kg bodyweight

0.05 microgram/kg/day

Children over 20 kg bodyweight

1 microgram/day

The dose of One-Alpha® should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response.

Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone, as well as radiographic and histological investigations.

Maintenance doses are generally in the range of 0.25 - 1 microgram per day.

When administered as intravenous injection to patients undergoing haemodialysis the initial dosage for adults is 1 microgram per dialysis. The maximum dose recommended is 6 micrograms per dialysis and not more than 12 micrograms per week. The injection should be administered into the return line from the haemodialysis machine at the end of each dialysis.

(a) Renal bone disease:

Patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidism, often unresponsive to One-Alpha®. Other therapeutic measures may be indicated.

Before and during treatment with One-Alpha®, phosphate binding agents should be considered to prevent hyperphosphataemia. It is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalcaemia may aggravate the decline of renal function.

(b) Hyperparathyroidism:

In patients with primary or tertiary hyperparathyroidism about to undergo parathyroidectomy, pre-operative treatment with One-Alpha® for 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia. In order to decrease post-operative hypocalcaemia, One-Alpha® should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs.

(c) Hypoparathyroidism:

In contrast to the response to parent vitamin D, low plasma calcium levels are restored to normal relatively quickly with One-Alpha®. Severe hypocalcaemia is corrected more rapidly with higher doses of One-Alpha® (eg 3-5 micrograms) together with calcium supplements.

(d) Neonatal hypocalcaemia:

Although the normal starting dose of One-Alpha® is 0.05-0.1 microgram/kg/day (followed by careful titration), in severe cases, doses of up to 2 microgram/kg/day may be required. Whilst ionised serum calcium levels may provide a guide to response, measurement of plasma alkaline phosphatase activity may be more useful. Levels of alkaline phosphatase approximately 7.5 times above the adult range indicates active disease.

(e) Nutritional and malabsorptive rickets and osteomalacia:

Nutritional rickets and osteomalacia can be cured rapidly with One-Alpha®. Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of One-Alpha®.

(f) Pseudo-deficiency (D-dependent) rickets and osteomalacia:

Although large doses of parent vitamin D would be required, effective doses of One-Alpha® are similar to those required to heal nutritional Vitamin D deficiency rickets and osteomalacia.

(g) Hypophosphataemic vitamin D-resistant rickets and osteomalacia:

Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory. Treatment with One-Alpha® at normal dosage rapidly relieves myopathy when present and increases calcium and phosphate retention. Phosphate supplements may also be required in some patients.

4.3 Contraindications

Hypercalcaemia, metastatic calcification.

Hypersensitivity to alfacalcidol or any of the other ingredients.

4.4 Special Warnings And Precautions For Use

One-Alpha® Injection should be avoided in patients with known sensitivity to injections containing propylene glycol.

One-Alpha® should be used with caution for:

• small premature infants

• patients being treated with cardioactive glycosides or digitalis as hypercalcaemia may lead to arrhythmia in such patients

• patients with nephrolithiasis

During treatment with One-Alpha® serum calcium and serum phosphate should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses. To maintain serum phosphate at an acceptable level in patients with renal bone disease a phosphate binding agent may be used.

Hypercalcaemia may appear in patients treated with One-Alpha®, the early symptoms are as follows:

• polyurina

• polydipsia

• weakness, headache, nausea, constipation

• dry mouth

• muscle and bone pain

• metallic taste

Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (in about one week). One-Alpha® treatment may then be restarted at a reduced dose (half the previous dose).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients taking barbiturates or anticonvulsants may require larger doses of One-Alpha® to produce the desired effect due to the induction of hepatic detoxification enzymes.

Use with caution in patients being treated with thiazide diuretics as they may have an increased risk of developing hypercalcaemia.

4.6 Pregnancy And Lactation

There are no adequate data from the use of alfacalcidol in pregnant women. Animal studies are insufficient with respect to effects on pregnancy. The potential risks for humans are unknown. Caution should be taken when prescribing to pregnant women as hypercalcaemia during pregnancy may produce congenital disorders in the offspring.

Although it has not been established, it is likely that increased amounts of 1,25 dihydroxyvitamin D will be found in the milk of lactating mothers treated with One-Alpha®. This may influence calcium metabolism in the infant.

4.7 Effects On Ability To Drive And Use Machines

One-Alpha® has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

The most frequently reported undesirable effects are hypercalcaemia and various skin reactions. Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (about 1 week). One-Alpha® treatment may then be restarted at half the previous dose.

Based on data from post-market use the total undesirable effect 'reporting rate' is rare or very rare being approximately 1:10,000 patients treated.

•Metabolism and Nutrition Disorders

Hypercalcaemia

Hyperphosphataemia

•Skin and Subcutaneous Tissue Disorders

Pruritus

Rash

Urticaria

•Renal and Urinary Disorders

Nephrocalcinosis

Renal impairment

4.9 Overdose

Hypercalcaemia is treated by suspending the administration of One-Alpha®.

In severe cases of hypercalcaemia general supportive measures should be undertaken. Keep the patient well hydrated by i.v. infusion of saline (force diuresis), measure electrolytes, calcium and renal function indices; assess electrocardiographic abnormalities, especially in patients on digitalis. More specifically, treatment with glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and eventually haemodialysis with low calcium content should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Alfacalcidol is converted rapidly in the liver to 1,25 dihydroxyvitamin D. This is the metabolite of vitamin D which acts as a regulator of calcium and phosphate metabolism. Since this conversion is rapid, the clinical effects of One-Alpha® and 1,25 dihydroxyvitamin D are very similar.

Impaired 1 ?-hydroxylation reduces 1,25 dihydroxyvitamin D production. This contributes to the disturbances in mineral metabolism found in several disorders, including renal bone disease, hypoparathyroidism, neonatal hypocalcaemia and vitamin D dependent rickets. These disorders, which require high doses of parent vitamin D for their correction, will respond to small doses of One-Alpha®.

The delay in response and high dosage required in treating these disorders with parent vitamin D makes dosage adjustment difficult. This can result in unpredictable hypercalcaemia which may take weeks or months to reverse. The major advantage of One-Alpha® is the more rapid onset of response, which allows a more accurate titration of dosage. Should inadvertent hypercalcaemia occur it can be reversed within days of stopping treatment.

5.2 Pharmacokinetic Properties

In patients on regular haemodialysis administration of doses between 1 - 4 micrograms of intravenous 1 ?-hydroxyvitamin D3 resulted in increased levels of 1,25 dihydroxyvitamin D. Formation of 1,25 dihydroxyvitamin D3 occurred within 1 hour after intravenous 1 ?-hydroxyvitamin D3 and peak concentrations were reached between 2 and 5 hours. Elimination half life of the formed 1,25 dihydroxyvitamin D was between 14 and 30 hours.

5.3 Preclinical Safety Data

There are no pre-clinical 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

Citric acid, ethanol, sodium citrate, propylene glycol and water for injection.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store at 2-8°C.

Keep the ampoule in the outer carton in order to protect it from light.

6.5 Nature And Contents Of Container

10 x 0.5ml amber glass ampoules.

10 x 1.0ml amber glass ampoules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks

HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0183

9. Date Of First Authorisation/Renewal Of The Authorisation

11/11/2005

10. Date Of Revision Of The Text

May 2009

Vinorelbine Tartrate

Class: Antineoplastic AgentsVA Class: AN900Chemical Name: 3?,4?-Didehydro-4?-deoxy-C?-norvincaleukoblastine [R-(R*, R*)]-2,3-dihydroxybutane dioate (1:2)

Intertocine-S

Intertocine-S may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Intertocine-S Oxytocin

Oxytocin is reported as an ingredient of Intertocine-S in the following countries:

Portugal Switzerland

International Drug Name Search

Trental

Generic Name: pentoxifylline (Oral route)

pen-tox-IF-i-lin

Commonly used brand name(s)

In the U.S.

Pentopak Pentoxil Trental

Available Dosage Forms:

Tablet, Extended Release

Therapeutic Class: Hemorheologic

Chemical Class: Methylxanthine

Uses For Trental

Pentoxifylline improves the flow of blood through blood vessels. It is used to reduce leg pain caused by poor blood circulation. Pentoxifylline makes it possible to walk farther before having to rest because of leg cramps.

Pentoxifylline is available only with your doctor's prescription.

Before Using Trental

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of pentoxifylline in children with use in other age groups.

Geriatric

Side effects may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of pentoxifylline.

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. When you are taking this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Aceclofenac Acemetacin Alclofenac Benoxaprofen Bromfenac Bufexamac Carprofen Clometacin Clonixin Dexketoprofen Diclofenac Diflunisal Dipyrone Droxicam Etodolac Etofenamate Felbinac Fenbufen Fenoprofen Fentiazac Floctafenine Flufenamic Acid Flurbiprofen Ibuprofen Indomethacin Indoprofen Isoxicam Ketoprofen Ketorolac Lornoxicam Meclofenamate Mefenamic Acid Meloxicam Nabumetone Naproxen Niflumic Acid Nimesulide Oxaprozin Oxyphenbutazone Phenylbutazone Pirazolac Piroxicam Pirprofen Propyphenazone Proquazone Sulindac Suprofen Tenidap Tenoxicam Tiaprofenic Acid Tolmetin Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cimetidine Dicumarol Theophylline 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Any condition in which there is a risk of bleeding (e.g., recent stroke)—Pentoxifylline may make the condition worse Kidney disease or Liver disease—The chance of side effects may be increased Proper Use of pentoxifylline

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

Swallow the tablet whole. Do not crush, break, or chew it before swallowing.

Pentoxifylline should be taken with meals to lessen the chance of stomach upset. Taking an antacid with the medicine may also help.

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 oral dosage form (extended-release tablets): For peripheral vascular disease (circulation problems): Adults—400 milligrams (mg) two to three times a day, taken with meals. Children—Use must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 Trental

It may take several weeks for this medicine to work. If you feel that pentoxifylline is not working, do not stop taking it on your own. Instead, check with your doctor.

Smoking tobacco may worsen your condition since nicotine may further narrow your blood vessels. Therefore, it is best to avoid smoking.

Trental 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:

Rare Chest pain irregular heartbeat Signs and symptoms of overdose (in the order in which they may occur) Drowsiness flushing faintness unusual excitement convulsions (seizures)

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 Dizziness headache nausea or vomiting stomach discomfort

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: Trental side effects (in more detail)

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.

More Trental resources Trental Side Effects (in more detail)Trental Use in Pregnancy & BreastfeedingDrug ImagesTrental Drug InteractionsTrental Support Group2 Reviews for Trental - Add your own review/rating Trental MedFacts Consumer Leaflet (Wolters Kluwer) Trental Concise Consumer Information (Cerner Multum) Trental Prescribing Information (FDA) Pentoxifylline Prescribing Information (FDA) Pentoxifylline Professional Patient Advice (Wolters Kluwer) Pentoxifylline Monograph (AHFS DI) Pentoxil Prescribing Information (FDA) Compare Trental with other medications Intermittent Claudication

Friars' Balsam BP
1. Name Of The Medicinal Product

Benzoin Tincture Compound BP or Friars Balsam BP

2. Qualitative And Quantitative Composition

Storax prepared BP 10.0% w/v

Benzoin sumatra crushed BP 10.0% w/v

3. Pharmaceutical Form

Tincture

4. Clinical Particulars 4.1 Therapeutic Indications

1. As an inhalant for relief of the symptoms of colds.

2. As a mild antiseptic dressing.

4.2 Posology And Method Of Administration

1. Through the mouth and nasal passages.

2. Topical.

1. As an inhalant

Adults, children over 3 months of age and the elderly: Add one 5ml spoonful to a pint of hot, but not boiling water.

The dose may be repeated after 4 hours if required.

The product is suitable for use under this clinical indication by adults, children over 3 months and the elderly.

Not suitable for children under 3 months of age.

2. As an antiseptic

Adults, children and the elderly: Apply undiluted to the affected area twice daily. The product is suitable for use under this clinical indication by adults, children and the elderly.

4.3 Contraindications

Contraindicated in patients with known sensitivity to sumatra benzoin or storax.

4.4 Special Warnings And Precautions For Use

Not suitable for children under 3 months when used as an inhalant.

For external use only.

Keep all medicines away from children.

Caution: Highly flammable. Keep away from a naked flame.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use of this product by the indicated routes is not considered likely to cause any undesirable effects in the above conditions.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

This product is for external use only. Accidental ingestion is likely to cause a severe burning sensation in the mouth and mucous membranes due to the high alcohol content and the bitter taste of the aloes and balsamic acids. Dilution of the product in the mouth will cause the separation of an unpleasant gummy residue. It is considered unlikely that a significant quantity could be swallowed. However the main effects would be those of alcohol intoxication.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Sumatra benzoin has been used as an ingredient in inhalations used in the treatment of catarrh of the upper respiratory tract for many years. It has also been used topically for its antiseptic and protective properties.

Storax has mild antiseptic action.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Aloes powdered BP, purified water BP, ethanol (96%) BP

6.2 Incompatibilities

None known.

6.3 Shelf Life

25ml: 36 months unopened.

50ml: 36 months unopened.

500ml: 36 months unopened.

2000ml: 36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container    

25ml:

glass bottle and plastic cap with liner.

50ml:

glass bottle and plastic cap with liner or white 28mm polypropylene cap with Tamper Evident band and EPE/Saranex liner.

500ml:

glass bottle and plastic cap with liner.

2000ml:

glass bottle and plastic cap with liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd.,

Linthwaite Laboratories

Huddersfield

HD7 5QH

England

8. Marketing Authorisation Number(S)

PL 12965/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

11/10/93 19/11/98

10. Date Of Revision Of The Text

March 2005

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable

Actidose-Aqua Advance
1. Name Of The Medicinal Product

Actidose-Aqua Advance

2. Qualitative And Quantitative Composition

Actidose-Aqua Advance contains 1.04 g of Activated Charcoal/5 ml.

3. Pharmaceutical Form

Suspension for oral administration.

4. Clinical Particulars 4.1 Therapeutic Indications

For the emergency treatment of acute poisoning and drug overdosage where substances such as those listed in section 5.1 have been ingested. The list is not exhaustive and Actidose-Aqua Advance may be of benefit following ingestion of many other toxins.

Also indicated for a limited number of systemic poisonings resulting from parenteral overdosage or when the ingested toxin has been totally absorbed. This usually involves repeated doses of Actidose-Aqua Advance to remove compounds which undergo enterohepatic recycling or which can diffuse into the gastrointestinal tract along a concentration gradient. Under these circumstances multiple doses of Actidose-Aqua Advance adsorb the toxin thereby preventing its reabsorption and increasing the concentration gradient in favour of further diffusion of the toxin into the gastrointestinal tract. Compounds most effectively transferred by this mechanism are lipophilic, uncharged and not excessively protein-bound. Examples of compounds which can be eliminated more rapidly by "gastrointestinal dialysis" in this way are phenobarbitone and theophylline.

4.2 Posology And Method Of Administration

The container should be shaken thoroughly prior to administration. If the dose of poison that has been ingested is known, a ratio of 10:1 (activated charcoal:toxin) may be used to determine the optimal dose of activated charcoal, subject to the limits of practicality. In the absence of any information regarding the amount of poison ingested, the following doses are recommended:

Adults (including the elderly) and children over 12 years of age:

For single dose therapy, 50-100 grams of activated charcoal (240-480 ml) taken as soon as possible after ingestion of the poison.

For multiple dose therapy, 25-50 grams of activated charcoal (120-240 ml) every 4-6 hours.

Children aged 1-12 years

For single dose therapy, 25-50 grams of activated charcoal (120-240 ml) taken as soon as possible after ingestion of the poison. For multiple dose therapy, the dose may be repeated every 4-6 hours.

Children under one year of age:

For single dose therapy, 1 g or 5 ml per kg bodyweight taken as soon as possible after ingestion of the poison. For multiple dose therapy, the dose may be repeated every 4-6 hours.

When syrup of ipecac is used to produce emesis, administration of Actidose-Aqua Advance should be delayed until 30-60 minutes after vomiting has ceased. If gastric lavage is being used to facilitate stomach evacuation a single dose of Actidose-Aqua Advance may be administered early in the procedure. This has the advantage of prompt administration of activated charcoal, but the gastric lavage returns will be black which may make it difficult to evaluate what the patient ingested by visual examination.

Actidose-Aqua Advance may be effective even when several hours have elapsed after ingestion of the poison if gastrointestinal motility is reduced by the toxin or if the drug is subject to enterohepatic or enteroenteric recycling.

4.3 Contraindications

Use of Actidose-Aqua Advance is contra-indicated in persons who are not fully conscious.

4.4 Special Warnings And Precautions For Use

Actidose-Aqua Advance is not recommended for patients who have ingested corrosive agents such as strong acids or alkalis since the activated charcoal may obscure endoscopic visualisation of oesophageal and gastric lesions produced by the toxin. Actidose-Aqua Advance is of little or no value in the treatment of poisoning with cyanides, alcohols, iron salts, malathion and DDT.

Actidose-Aqua Advance is an adjunct in the management of poisoning emergencies. Prior to its use, proper basic life support measures must be implemented where required as well as the appropriate gastric emptying technique if indicated.

Actidose-Aqua Advance should be used with caution in patients who have been exposed to toxins which interfere with gastrointestinal motility (e.g. anticholinergics, opioids). Bowel sounds should be monitored frequently to assess peristaltic action, especially in patients undergoing multiple dose activated charcoal therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Actidose-Aqua Advance will adsorb most medicaments and many other chemical substances. If a specific antidote is to be administered the likelihood of its adsorption by activated charcoal should be borne in mind, and a parenteral route of administration used if possible. Thus in the case of paracetamol, Actidose-Aqua Advance should not be given as well as oral methionine but may be used alone or in conjunction with intravenous N-acetylcysteine.

Other concurrent medications to counteract shock or associated infection should also be given parenterally since orally administered drugs may be bound to the activated charcoal in the gut.

4.6 Pregnancy And Lactation

The safety of this medicinal product for use in human pregnancy has not been established. Experimental animal studies are insufficient to assess the safety with respect to the development of the embryo or foetus, the course of gestation and peri- and postnatal development.

Activated charcoal is however essentially inert pharmacologically and is not absorbed from the gastrointestinal tract. No hazard is therefore anticipated from its use during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Both the patient and health care professionals should be aware that Actidose-Aqua Advance will produce black stools. A laxative may be given concurrently to accelerate the removal of the activated charcoal-toxin complex, but should be used with caution and only intermittently during multiple dose activated charcoal therapy since profuse and protracted diarrhoea may lead to fluid and electrolyte imbalance.

Aspiration of activated charcoal has been reported to produce airways obstruction and appropriate precautions should be taken. Gastrointestinal obstruction associated with the use of multiple dose activated charcoal therapy has been reported rarely.

4.9 Overdose

Actidose-Aqua Advance is well tolerated and due to its lack of toxicity overdosage requiring treatment is unlikely. A laxative may be administered to enhance elimination of the product.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Activated charcoal has a high adsorptive capacity for a wide range of compounds including many of those which are most commonly encountered in deliberate and accidental poisoning. Substances adsorbed include the following:

Aspirin and other salicylates

Barbiturates

Benzodiazepines

Chlormethiazole

Chloroquine

Chlorpromazine and related phenothiazines

Clonidine

Cocaine and other stimulants

Digoxin and digitoxin

Ibuprofen

Mefenamic acid

Mianserin

Nicotine

Paracetamol

Paraquat

Phenelzine and other monoamine oxidase inhibitors

Phenytoin

Propranolol and other beta-blockers

Quinine

Theophylline

Zidovudine

5.2 Pharmacokinetic Properties

Activated charcoal is not absorbed from the gastrointestinal tract or subject to any metabolic processes. It is eliminated in the faeces.

5.3 Preclinical Safety Data

Activated charcoal is essentially inert pharmacologically and it would therefore be expected to be virtually devoid of toxicity, other than any ill effects arising from mechanical obstruction of the gut, or, if inhaled, the lungs.

The excipients in the product are all well known and widely used in medicinal products and should not give rise to any toxicological problems.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sucrose

Propylene glycol

Glycerine

Citric Acid

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Two years

6.4 Special Precautions For Storage

Store at 15 - 30°C. Do not refrigerate.

6.5 Nature And Contents Of Container

(1) Low density polyethylene bottles containing 120 ml.

(2) Low density polyethylene bottles containing 240 ml.

(3) Low density polyethylene tubes containing 120 ml.

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

2 Bath Road

Chippenham

Wiltshire,

SN15 2BB

UK

8. Marketing Authorisation Number(S)

PL 16853/ 0119

9. Date Of First Authorisation/Renewal Of The Authorisation

26 March 1996.

10. Date Of Revision Of The Text

14th July 2010

11. DOSIMETRY

(IF APPLICABLE)

Text

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)

Text

Natrecor
nesiritide Dosage Form: injection, powder, lyophilized, for solutionNatrecor® (nesiritide)

FOR INTRAVENOUS INFUSION ONLY

Natrecor Description

Natrecor® (nesiritide) is a sterile, purified preparation of a new drug class, human B-type natriuretic peptide (hBNP), and is manufactured from E. coli using recombinant DNA technology. Nesiritide has a molecular weight of 3464 g/mol and an empirical formula of C143H244N50O42S4. Nesiritide has the same 32 amino acid sequence as the endogenous peptide, which is produced by the ventricular myocardium.

Natrecor is formulated as the citrate salt of rhBNP, and is provided in a sterile, single-use vial. Each 1.5 mg vial contains a white- to off-white lyophilized powder for intravenous (IV) administration after reconstitution. The quantitative composition of the lyophilized drug per vial is: nesiritide 1.58 mg, mannitol 20.0 mg, citric acid monohydrate 2.1 mg, and sodium citrate dihydrate 2.94 mg.

Mechanism of Action

Human BNP binds to the particulate guanylate cyclase receptor of vascular smooth muscle and endothelial cells, leading to increased intracellular concentrations of guanosine 3'5'-cyclic monophosphate (cGMP) and smooth muscle cell relaxation. Cyclic GMP serves as a second messenger to dilate veins and arteries. Nesiritide has been shown to relax isolated human arterial and venous tissue preparations that were precontracted with either endothelin-1 or the alpha-adrenergic agonist, phenylephrine.

In human studies, nesiritide produced dose-dependent reductions in pulmonary capillary wedge pressure (PCWP) and systemic arterial pressure in patients with heart failure.

In animals, nesiritide had no effects on cardiac contractility or on measures of cardiac electrophysiology such as atrial and ventricular effective refractory times or atrioventricular node conduction.

Naturally occurring atrial natriuretic peptide (ANP), a related peptide, increases vascular permeability in animals and humans and may reduce intravascular volume. The effect of nesiritide on vascular permeability has not been studied.

Pharmacokinetics

In patients with congestive heart failure (CHF), Natrecor administered intravenously by infusion or bolus exhibits biphasic disposition from the plasma. The mean terminal elimination half-life (t1/2) of Natrecor is approximately 18 minutes and was associated with approximately 2/3 of the area-under-the-curve (AUC). The mean initial elimination phase was estimated to be approximately 2 minutes. In these patients, the mean volume of distribution of the central compartment (Vc) of Natrecor was estimated to be 0.073 L/kg, the mean steady-state volume of distribution (Vss) was 0.19 L/kg, and the mean clearance (CL) was approximately 9.2 mL/min/kg. At steady state, plasma BNP levels increase from baseline endogenous levels by approximately 3-fold to 6-fold with Natrecor infusion doses ranging from 0.01 to 0.03 mcg/kg/min.

Elimination

Human BNP is cleared from the circulation via the following three independent mechanisms, in order of decreasing importance: 1) binding to cell surface clearance receptors with subsequent cellular internalization and lysosomal proteolysis; 2) proteolytic cleavage of the peptide by endopeptidases, such as neutral endopeptidase, which are present on the vascular lumenal surface; and 3) renal filtration.

Special Populations

Although Natrecor is eliminated, in part, through renal clearance, clinical data suggest that dose adjustment is not required in patients with renal insufficiency. The effects of Natrecor on PCWP, cardiac index (CI), and systolic blood pressure (SBP) were not significantly different in patients with chronic renal insufficiency (baseline serum creatinine ranging from 2 mg/dL to 4.3 mg/dL), and patients with normal renal function. The population pharmacokinetic (PK) analyses carried out to determine the effects of demographics and clinical variables on PK parameters showed that clearance of Natrecor is proportional to body weight, supporting the administration of weight-adjusted dosing of Natrecor (i.e., administration on a mcg/kg/min basis). Clearance was not influenced significantly by age, gender, race/ethnicity, baseline endogenous hBNP concentration, severity of CHF (as indicated by baseline PCWP, baseline CI, or New York Heart Association [NYHA] classification), or concomitant administration of an ACE inhibitor.

Effects of Concomitant Medications

The co-administration of Natrecor with enalapril did not have significant effects on the PK of Natrecor. The PK effect of co-administration of Natrecor with other IV vasodilators such as nitroglycerin, nitroprusside, milrinone, or IV ACE inhibitors has not been evaluated. During clinical studies, Natrecor was administered concomitantly with other medications, including: diuretics, digoxin, oral ACE inhibitors, anticoagulants, oral nitrates, statins, class III antiarrhythmic agents, beta-blockers, dobutamine, calcium channel blockers, angiotensin II receptor antagonists, and dopamine. Although no PK interactions were specifically assessed, there did not appear to be evidence suggesting any clinically significant PK interaction.

Pharmacodynamics

The recommended dosing regimen of Natrecor is a 2 mcg/kg IV bolus followed by an intravenous infusion dose of 0.01 mcg/kg/min. With this dosing regimen, 60% of the 3-hour effect on PCWP reduction is achieved within 15 minutes after the bolus, reaching 95% of the 3-hour effect within 1 hour. Approximately seventy percent of the 3-hour effect on SBP reduction is reached within 15 minutes. The pharmacodynamic (PD) half-life of the onset and offset of the hemodynamic effect of Natrecor is longer than what the PK half-life of 18 minutes would predict. For example, in patients who developed symptomatic hypotension in the VMAC (Vasodilation in the Management of Acute Congestive Heart Failure) trial, half of the recovery of SBP toward the baseline value after discontinuation or reduction of the dose of Natrecor was observed in about 60 minutes. When higher doses of Natrecor were infused, the duration of hypotension was sometimes several hours.

Clinical Trials

Natrecor has been studied in 10 clinical trials including 941 patients with CHF (NYHA class II–III 61%, NYHA class IV 36%; mean age 60 years, women 28%). There were five randomized, multi-center, placebo- or active-controlled studies (comparative agents included nitroglycerin, dobutamine, milrinone, nitroprusside, or dopamine) in which 772 patients with decompensated CHF received continuous infusions of Natrecor at doses ranging from 0.01 to 0.03 mcg/kg/min. (See the ADVERSE REACTIONS section for relative frequency of adverse events at doses ranging from the recommended dose up to 0.03 mcg/kg/min). Of these patients, the majority (n = 541, 70%) received the Natrecor infusion for at least 24 hours; 371 (48%) received Natrecor for 24–48 hours, and 170 (22%) received Natrecor for greater than 48 hours.

In controlled trials, Natrecor has been used alone or in conjunction with other standard therapies, including diuretics (79%), digoxin (62%), oral ACE inhibitors (55%), anticoagulants (38%), oral nitrates (32%), statins (18%), class III antiarrhythmic agents (16%), beta-blockers (15%), dobutamine (15%), calcium channel blockers (11%), angiotensin II receptor antagonists (6%), and dopamine (4%). Natrecor has been studied in a broad range of patients, including the elderly (42% > 65 years of age), women (30%), minorities (26% black), and patients with a history of significant morbidities such as hypertension (67%), previous myocardial infarction (50%), diabetes (44%), atrial fibrillation/flutter (34%), nonsustained ventricular tachycardia (25%), ventricular tachycardia/fibrillation (12%), preserved systolic function (9%), and acute coronary syndromes less than 7 days before the start of Natrecor (4%).

The VMAC (Vasodilation in the Management of Acute Congestive Heart Failure) trial was a randomized, double-blind study of 489 patients (246 patients requiring a right heart catheter, 243 patients without a right heart catheter) who required hospitalization for management of shortness of breath at rest due to acutely decompensated CHF. The study compared the effects of Natrecor, placebo, and IV nitroglycerin when added to background therapy (IV and oral diuretics, non-IV cardiac medications, dobutamine, and dopamine). Patients with acute coronary syndrome, preserved systolic function, arrhythmia, and renal insufficiency were not excluded. The primary endpoints of the study were the change from baseline in PCWP and the change from baseline in patients' dyspnea, evaluated after three hours. Close attention was also paid to the occurrence and persistence of hypotension, given nesiritide's relatively long (compared to nitroglycerin) PK and PD half-life.

Natrecor was administered as a 2 mcg/kg bolus over approximately 60 seconds, followed by a continuous fixed dose infusion of 0.01 mcg/kg/min. After the 3-hour placebo-controlled period, patients receiving placebo crossed over to double-blinded active therapy with either Natrecor or nitroglycerin. The nitroglycerin dose was titrated at the physician's discretion. A subset of patients in the VMAC trial with central hemodynamic monitoring who were treated with Natrecor (62 of 124 patients) were allowed dose increases of Natrecor after the first 3 hours of treatment if the PCWP was ? 20 mm Hg and the SBP was ? 100 mm Hg. Dose increases of a 1 mcg/kg bolus followed by an increase of the infusion dose by 0.005 mcg/kg/min were allowed every 3 hours, up to a maximum dose of 0.03 mcg/kg/min. Overall, 23 patients in this subset had the dose of Natrecor increased in the VMAC trial.

In a second double-blind study, 127 patients requiring hospitalization for symptomatic CHF were randomized to placebo or to one of two doses of Natrecor (0.015 mcg/kg/min preceded by an IV bolus of 0.3 mcg/kg, and 0.03 mcg/kg/min preceded by an IV bolus of 0.6 mcg/kg). The primary endpoint of the trial was the change in PCWP from baseline to 6 hours, but the effect on symptoms also was examined.

Effects on Symptoms

In the VMAC study, patients receiving Natrecor reported greater improvement in their dyspnea at 3 hours than patients receiving placebo (p = 0.034).

In the dose-response study, patients receiving both doses of Natrecor reported greater improvement in dyspnea at 6 hours than patients receiving placebo.

Effects on Hemodynamics

The PCWP, right atrial pressure (RAP), CI, and other hemodynamic variables were monitored in 246 of the patients in the VMAC trial. There was a reduction in mean PCWP within 15 minutes of starting the Natrecor infusion, with most of the effect seen at 3 hours being achieved within the first 60 minutes of the infusion (see Pharmacodynamics).

In several studies, hemodynamic parameters were measured after Natrecor withdrawal. Following discontinuation of Natrecor, PCWP returns to within 10% of baseline within 2 hours, but no rebound increase to levels above baseline state was observed. There was also no evidence of tachyphylaxis to the hemodynamic effects of Natrecor in the clinical trials.

The following table and graph summarize the changes in the VMAC trial in PCWP and other measures during the first 3 hours.

Mean Hemodynamic Change from Baseline Effects at 3 Hours Placebo

hydrochlorothiazide and aliskiren

Generic Name: hydrochlorothiazide and aliskiren (HYE droe KLOR oh THYE a zide and a LIS ke rin) Brand Names: Tekturna HCT

What is hydrochlorothiazide and aliskiren?

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

Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

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

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

What is the most important information I should know about hydrochlorothiazide and aliskiren? You should not use this medication if you are allergic to aliskiren or hydrochlorothiazide, if you are unable to urinate, or if you are also using itraconazole (Sporanox) or cyclosporine (Gengraf, Neoral, Sandimmune). FDA pregnancy category D. Do not use hydrochlorothiazide and aliskiren if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant.

Before you take hydrochlorothiazide and aliskiren, tell your doctor if you have asthma, low or high levels of potassium in your blood, kidney or liver disease, glaucoma, gout, lupus, diabetes, or an allergy to sulfa drugs or penicillin.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and aliskiren, unless your doctor has told you to. It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. What should I discuss with my healthcare provider before taking hydrochlorothiazide and aliskiren? You should not use this medication if:

you are allergic to aliskiren (Tekturna) or hydrochlorothiazide (Carozide, Diaqua, Ezide HCTZ, HydroDiuril, Microzide, and others);

you are unable to urinate; or

you are also using itraconazole (Sporanox) or cyclosporine (Gengraf, Neoral, Sandimmune).

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

low or high levels of potassium in your blood;

asthma;

glaucoma;

kidney disease; liver disease;

gout;

systemic lupus erythematosus (SLE);

diabetes; or

an allergy to sulfa drugs or penicillin.

FDA pregnancy category D. Do not use hydrochlorothiazide and aliskiren if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Hydrochlorothiazide and aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking hydrochlorothiazide and aliskiren. It is not known whether hydrochlorothiazide and aliskiren passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using hydrochlorothiazide and aliskiren. Do not give this medication to anyone under 18 years old without medical advice. How should I take hydrochlorothiazide and aliskiren?

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.

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

You may take this medication with or without food, but take it the same way every time.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Visit your doctor regularly.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

High blood pressure is sometimes treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and aliskiren. You may need to stop using the medicine for a short time.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using this medication.

Store at room temperature away from moisture and heat.

See also: Hydrochlorothiazide and aliskiren 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 dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid while taking hydrochlorothiazide and aliskiren?

Avoid taking this medication with a high-fat meal, which can make it harder for your body to absorb hydrochlorothiazide and aliskiren.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and aliskiren, unless your doctor has told you to.

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.

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

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.

Hydrochlorothiazide and aliskiren 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 hydrochlorothiazide and aliskiren and call your doctor at once if you have a serious side effect such as:

eye pain, vision problems;

feeling like you might pass out;

high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

urinating less than usual, or not at all;

joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or

severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

dizziness, spinning sensation;

diarrhea, stomach pain, indigestion;

tired feeling;

flu symptoms; or

dry cough.

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 aliskiren Dosing Information

Usual Adult Dose for Hypertension:

Initial: 150 mg-12.5 mg or 150 mg-25 mg once a day to a maximum of 300 mg-25 mg once a day. Patients should establish a routine pattern for taking aliskiren-hydrochlorothiazide with regard to meals since high-fat meals substantially decrease absorption.The antihypertensive effect is generally seen within 1 week, with maximal effects seen at around 4 weeks. If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to a maximum of 300 mg-25 mg.

What other drugs will affect hydrochlorothiazide and aliskiren?

Tell your doctor about all other medicines you use, especially:

lithium (Eskalith, Lithobid);

a blood thinner such as warfarin (Coumadin, Jantoven);

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as 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;

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);

cholesterol medication such as atorvastatin (Lipitor), cholestyramine (Prevalite, Questran) or colestipol (Colestid);

insulin or diabetes medicine you take by mouth; or

steroid medication such as prednisone (Deltasone, Sterapred), methylprednisolone (Medrol), fluticasone (Advair , Flonase, Flovent, Veramyst), beclomethasone (Qvar), budesonide (Pulmicort, Rhinocort, Symbicort), dexamethasone (Cortastat, Dexasone, Solurex, DexPak), mometasone (Asmanex, Nasonex), triamcinolone (Nasacort), and others.

This list is not complete and other drugs may interact with hydrochlorothiazide and aliskiren. 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 aliskiren resources Hydrochlorothiazide and aliskiren Side Effects (in more detail)Hydrochlorothiazide and aliskiren DosageHydrochlorothiazide and aliskiren Use in Pregnancy & BreastfeedingHydrochlorothiazide and aliskiren Drug InteractionsHydrochlorothiazide and aliskiren Support Group4 Reviews for Hydrochlorothiazide and aliskiren - Add your own review/rating Compare hydrochlorothiazide and aliskiren with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about hydrochlorothiazide and aliskiren.

See also: hydrochlorothiazide and aliskiren side effects (in more detail)

Estrogen receptor antagonists

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Estrogen receptor antagonists bind to estrogen receptors and inhibit the action of estrogen. Estrogen controls the growth of certain types of breast cancers called estrogen receptor positive cancers. So estrogen receptor antagonists are useful in treating patients with estrogen sensitive breast cancers.

See also

Medical conditions associated with estrogen receptor antagonists:

Breast CancerBreast Cancer, Metastatic Drug List:Faslodex

Cortomycin
Dosage Form: ear dropsNeomycin and Polymyxin B Sulfates

atropine and pralidoxime

Generic Name: atropine and pralidoxime (AT roe peen and PRAL i DOX eem) Brand Names: DuoDote

What is atropine and pralidoxime?

Atropine blocks the action of chemical called acetylcholine (ah see til KO leen), which may exist in high levels in the body after a poisoning. Atropine also stimulates the heart and reduces the secretions of the nose, mouth, and lungs to improve breathing.

Pralidoxime reverses muscle weakness or paralysis caused by a poison or nerve agent.

The combination of atropine and pralidoxime is used as an antidote to treat poisoning by a pesticide (insect spray) or a chemical that interferes with the central nervous system, such as nerve gas.

This medication is not effective as an antidote for all types of pesticide poisonings. You may need medications or additional treatments.

Atropine and pralidoxime may also be used for purposes not listed in this medication guide.

What is the most important information I should know about atropine and pralidoxime? If possible, before you receive atropine and pralidoxime, tell your doctor if you have heart disease, coronary artery disease, a heart rhythm disorder, high blood pressure, narrow-angle glaucoma, kidney disease, enlarged prostate, urination problems, a breathing disorder such as asthma or COPD, if you are allergic to any medication, or if you have recently had a heart attack. Also tell your doctor if you are pregnant or breast-feeding. In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast-feeding. Make sure any doctor caring for you afterward knows that you have received this medication. What should I discuss with my health care provider before receiving atropine and pralidoxime? If possible, before you receive atropine and pralidoxime, tell your doctor if you have:

an allergy to any medication;

heart disease, coronary artery disease;

high blood pressure;

kidney disease;

asthma, COPD (chronic obstructive pulmonary disorder), bronchitis, emphysema, or other breathing problem;

a heart rhythm disorder;

narrow-angle glaucoma;

an enlarged prostate or urination problems; or

if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether atropine and pralidoxime will harm an unborn baby. Tell your doctor if you are pregnant. Atropine and pralidoxime can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby. In an emergency situation, it may not be possible before you are treated with atropine and pralidoxime to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication. How is atropine and pralidoxime given?

Atropine and pralidoxime is injected into a muscle in your upper thigh. A healthcare provider will give you this injection.

Atropine and pralidoxime is usually given as soon as possible after the onset of poisoning symptoms. If you still have symptoms after 10 to 15 minutes, you will receive 2 more injections.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving this medication.

After treatment with atropine and pralidoxime, you may be watched for up to 72 hours to make sure the medicine has been effective and you no longer have any effects of the poison.

What happens if I miss a dose?

Since atropine and pralidoxime is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

What happens if I overdose?

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

Overdose may occur if you receive atropine and pralidoxime but you have not actually been exposed to the specific poisons this medication is designed to treat. Symptoms may include vision problems, feeling unsteady, loss of balance or coordination, trouble concentrating, fast heart rate, confusion, hallucinations (seeing or hearing things), decreased sweating, hot and dry skin, fainting, weak or shallow breathing, or breathing that stops. What should I avoid after receiving atropine and pralidoxime?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Atropine can decrease sweating and you may be more prone to heat stroke for a short time after receiving this medication.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Atropine and pralidoxime side effects

Some of the side effects of atropine and pralidoxime may be similar to the symptoms of poisoning. Your caregivers will watch you closely to determine whether your body is responding well to the medication, or if you are having any serious 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. Tell your caregivers at once if you have a serious side effect such as:

pounding heartbeats or fluttering in your chest;

painful or difficult urination;

trouble swallowing;

feeling like you might pass out;

confusion;

loss of movement in any part of your body;

slow heart rate, weak pulse, fainting, slow breathing (breathing may stop); or

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

dry mouth, dry nose, dry skin;

dry eyes, blurred vision;

increased sensitivity of your eyes to light;

headache;

dizziness, drowsiness;

muscle weakness;

constipation, stomach pain, bloating, nausea, vomiting;

loss of interest in sex, impotence; or

mild skin rash.

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.

Atropine and pralidoxime Dosing Information

Usual Adult Dose for Organophosphate Poisoning:

TREATMENT OF MILD SYMPTOMS Mild symptoms include blurred vision, miosis, excessive, unexplained runny nose, increased salivation such as sudden drooling, chest tightness or difficulty breathing, tremors throughout the body or muscular twitching, nausea and/or vomiting, unexplained wheezing, coughing or increased airway secretions, acute onset of stomach cramps, and tachycardia or bradycardia.

Clopixol Injection and Conc Injection
1. Name Of The Medicinal Product

Clopixol® Injection.

Clopixol® Conc Injection.

2. Qualitative And Quantitative Composition

Clopixol Injection:

Zuclopenthixol Decanoate 20.0% w/v (equivalent to zuclopenthixol base 14.445% w/v).

Clopixol Conc Injection:

Zuclopenthixol Decanoate 50.0% w/v (equivalent to zuclopenthixol base 36.1% w/v).

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars 4.1 Therapeutic Indications

The maintenance treatment of schizophrenia and paranoid psychoses.

4.2 Posology And Method Of Administration

Route of administration

By deep intramuscular injection into the upper outer buttock or lateral thigh.

Note

As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.

Adults

Dosage and dosage interval should be adjusted according to the patient's symptoms and response to treatment.

The usual dosage range of zuclopenthixol decanoate is 200 - 500 mg every one to four weeks, depending on response, but some patients may require up to 600 mg per week. In patients who have not previously received depot antipsychotics, treatment is usually started with a small dose (e.g. 100 mg) to assess tolerance. An interval, of at least one week should be allowed before the second injection is given at a dose consistent with the patient's condition.

Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse.

Injection volumes of greater than 2 ml should be distributed between two injection sites.

Elderly

In accordance with standard medical practice initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or elderly.

Children

Not indicated for children.

Dosage in reduced renal function

Clopixol can be given in usual doses to patients with reduced renal function. Where there is renal failure dosage should be reduced to half the normal dosage.

Dosage in reduced hepatic function

Use with caution in patients with liver disease (see section 4.4). Patients with compromised hepatic function should receive half the recommended dosages. Serum-level monitoring is advised.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients having: liver disease; cardiac disease, or arrhythmias; severe respiratory disease; renal failure; epilepsy (and conditions predisposing to epilepsy, e.g. alcohol withdrawal or brain damage); Parkinson's disease; narrow angle glaucoma; prostatic hypertrophy; hypothyroidism; hyperthyroidism; myasthenia gravis; phaeochromocytoma and patients who have shown hypersensitivity to thioxanthenes or other antipsychotics.

The elderly require close supervision because they are especially prone to experience such adverse effects as sedation, hypotension, confusion and temperature changes.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.The plasma concentrations of Clopixol Conc Injection 500 mg/ml gradually decrease over several weeks which make gradual dosage tapering unnecessary.

When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.

The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation and opiate and alcohol abuse are over-represented among fatal cases.

Treatment:

Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful. Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs.

Like other neuroleptics, zuclopenthixol should be used with caution in patients with organic brain syndrome, convulsions or advanced hepatic disease.

Blood dyscrasias have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection.

An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.

Zuclopenthixol should be used with caution in patients with risk factors for stroke.

As with other drugs belonging to the therapeutic class of antipsychotics, zuclopenthixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, zuclopenthixol should be used with caution in susceptible individuals (with hypokalemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Clopixol and preventive measures undertaken.

Concomitant treatment with other antipsychotics should be avoided (see section 4.5).

As described for other psychotropics zuclopenthixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated.

There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Clopixol is not licensed for the treatment of dementia-related behavioural disturbances.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In common with other antipsychotics, zuclopenthixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants.

Zuclopenthixol may potentiate the effects of general anaesthetics and anticoagulants and prolong the action of neuromuscular blocking agents.

The anticholinergic effects of atropine or other drugs with anticholinergic properties may be increased.

Concomitant use of drugs such as metoclopramide, piperazine or antiparkinson drugs may increase the risk of extrapyramidal effects such as tardive dyskinesia.

Combined use of antipsychotics and lithium or sibutramine has been associated with an increased risk of neurotoxicity.

Antipsychotics may enhance the cardiac depressant effects of quinidine; the absorption of corticosteroids and digoxin.

The hypotensive effect of vasodilator antihypertensive agents such as hydralazine and ? blockers (e.g. doxazosin), or methyl-dopa may be enhanced.

Concomitant use of zuclopenthixol and drugs known to cause QT prolongation or cardiac arrhythmias, such as tricyclic antidepressants or other antipsychotics should be avoided.

Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co administration of other drugs known to significantly increase the QT interval. Co-administration of such drugs should be avoided.

Relevant classes include:

• class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide)

• some antipsychotics (e.g. thioridazine)

• some macrolides (e.g. erythromycin)

• some antihistamines

• some quinolone antibiotics (e.g. moxifloxacin)

The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided. Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalemia) and drugs known to increase the plasma concentration of zuclopenthixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrhythmias (see section 4.4).

Antipsychotics may antagonise the effects of adrenaline and other sympathomimetic agents, and reverse the antihypertensive effects of guanethidine and similar adrenergic-blocking agents.

Antipsychotics may also impair the effect of levodopa, adrenergic drugs and anticonvulsants.

The metabolism of tricyclic antidepressants may be inhibited and the control of diabetes may be impaired.

Since zuclopenthixol is partly metabolised by CYP2D6 concomitant use of drugs known to inhibit this enzyme may lead to to higher than expected plasma concentrations of zuclopenthixol, increasing the risk of adverse effects and cardiotoxicity.

4.6 Pregnancy And Lactation

Pregnancy

Zuclopenthixol should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus.

The newborn of mothers treated with neuroleptics in late pregnancy, or labour, may show signs of intoxication such as lethargy, tremor and hyper excitability, and have a low Apgar score.

Animal-reproduction studies have not given evidence of an increased incidence of foetal damage or other deleterious effects on the reproduction process.

Lactation

As zuclopenthixol is found in breast milk in low concentrations it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is less than 1% of the weight related maternal dose (in mg/kg). Breast-feeding can be continued during zuclopenthixol therapy if considered of clinical importance but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.

4.7 Effects On Ability To Drive And Use Machines

Zuclopenthixol is a sedative drug.

Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol; patients should be warned of this risk and advised not to drive or operate machinery until their susceptibility is known.

Patients should not drive if they have blurred vision.

4.8 Undesirable Effects

Undesirable effects are for the majority dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.

Extrapyramidal reactions may occur, especially in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended.

Antiparkinsonian drugs do not alleviate tardive dyskinsea and may aggravate them. Reduction in dosage or, if possible, discontinuation of zuclopenthixol therapy is recommeneded. In persistent akathisia a benzodiazepine or propranolol may be useful.

Cardiac disorders

Tachycardia, palpitations.

Electrocardiogram QT prolonged.

Blood and lymphatic system Disorders

Thrombocytopenia, neutropenia, leukopenia, agranulocytosis.

Nervous system disorders

Somnolence, akathisia, hyperkinesia, hypokinesia.

Tremor, dystonia, hypertonia, dizziness, headache, paraesthesia, disturbance in attention, amnesia, gait abnormal.

Tardive dyskinesia, hyperreflexia, dyskinesia, parkinsonism, syncope, ataxia, speech disorder, hypotonia, convulsion, migraine.

Neuroleptic malignant syndrome.

Eye disorders

Accommodation disorder, vision abnormal.

Oculogyration, mydriasis.

Ear and labyrinth disorders

Vertigo

Hyperacusis, tinnitus.

Respiratory, thoracic and medistianal disorders

Nasal congestion, dyspnoea.

Gastrointestinal disorders

Dry mouth.

Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea.

Abdominal pain, nausea, flatulence.

Renal and urinary disorders

Micturition disorder, urinary retention, polyuria.

Skin and subcutaneous tissue

Hyperhidrosis, pruritus.

Rash, photosensitivity reaction, pigmentation disorder, seborrhoea, dermatitis, purpura.

Musculoskeletal and connective

Myalgia.

Muscle rigidity, trismus, torticollis.

Endocrine disorders

Hyperprolactinaemia.

Metabolism and nutrition disorders

Increased appetite, weight increased.

Decreased appetite, weight decreased.

Hyperglycaemia, glucose tolerance impaired, hyperlipidaemia.

Vascular disorders

Hypotension, hot flush.

General disorders and administration site conditions

Asthenia, fatigue, malaise, pain.

Thirst, hypothermia, pyrexia.

Immune system disorders

Hypersensitivity, anaphylactic reaction.

Hepato-biliary disorders

Liver function test abnormal.

Cholestatic hepatitis, jaundice.

Reproductive system and breast disorders

Ejaculation failure, erectile dysfunction, female orgasmic disorder, vulvovaginal dryness.

Gynaecomastia, galactorrhoea, amenorrhoea, priapism.

Psychiatric disorders

Insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, libido decreased.

Apathy, nightmare, libido increased, confusional state.

As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrhythmias - ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for zuclopenthixol (see section 4.4).

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown.

Abrupt discontinuation of zuclopenthixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.

4.9 Overdose

Symptoms: somnolence, coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.

Treatment: treatment is symptomatic and supportive. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted.

Adrenaline (epinephrine) must not be used in these patients. There is no specific antidote.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The action of zuclopenthixol, as with other antipsychotics is mediated through dopamine receptor blockade. Zuclopenthixol has a high affinity for D1 and D2 receptors and activity has been demonstrated in standard animal models used to assess antipsychotic action.

Serotonergic blocking properties, a high affinity for alpha-adrenoreceptors and slight antihistamine properties have been observed.

5.2 Pharmacokinetic Properties

After deep intramuscular injection of Clopixol, serum levels of zuclopenthixol increase during the first week and decline slowly thereafter. A linear relationship has been observed between Clopixol dosage and serum level. Metabolism proceeds by sulphoxidation, dealkylation and glucuronic acid conjugation. Sulphoxide metabolites are mainly excreted in the urine while unchanged drug and the dealkylated form tend to be excreted in the faeces.

5.3 Preclinical Safety Data

Nil of relevance.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Thin vegetable oil

6.2 Incompatibilities

This product may be mixed in the same syringe with other products in the Clopixol Injection range, including Clopixol Acuphase Injection (zuclopenthixol acetate 50 mg/ml).

It should not be mixed with any other injection fluids.

6.3 Shelf Life

Clopixol Injection:

1 ml ampoules: 36 months.

10 ml vials: 36 months (unopened), shelf life after opening vials: 1 day

Clopixol Conc Injection:

48 months.

6.4 Special Precautions For Storage

Store at or below 25°C. Protect from light.

6.5 Nature And Contents Of Container

Clopixol Injection:

Ampoules containing 1 ml of 200 mg/ml zuclopenthixol decanoate in thin vegetable oil. Pack size : 10 ampoules per box.

10 ml clear glass vials with a rubber stopper secured with an aluminium collar having a fliptop cap. Pack size: 1 vial per box.

Clopixol Conc Injection:

Ampoules containing 1 ml of 500 mg/ml zuclopenthixol decanoate in thin vegetable oil. Pack size : 5 ampoules per box.

6.6 Special Precautions For Disposal And Other Handling

Nil.

7. Marketing Authorisation Holder

Lundbeck Limited

Lundbeck House

Caldecotte Lake Business Park

Caldecotte

Milton Keynes

MK7 8LF

8. Marketing Authorisation Number(S)

Clopixol Injection

PL 0458/0017

Clopixol Conc Injection

PL 0458/0060

9. Date Of First Authorisation/Renewal Of The Authorisation

Clopixol Injection

15 May 1978

Clopixol Conc Injection

21 November 1988

10. Date Of Revision Of The Text

28/01/2010

Gatifloxacin Drops
Pronunciation: ga-ti-FLOKS-a-sinGeneric Name: GatifloxacinBrand Name: Zymar

Cytovene
Pronunciation: gan-SYE-kloe-virGeneric Name: GanciclovirBrand Name: Cytovene

Vi-Q-Tuss

Generic Name: guaifenesin and hydrocodone (gwye FEN e sin and HYE droe KOE done) Brand Names: A-Cof DH, Canges-XP, Codiclear DH, Condasin, Cotuss V, Execlear, Extendryl HC, Hycotuss Expectorant, Hydrocod-GF, Kwelcof, Monte-G HC, Narcof, Pancof XP, Pneumotussin 2.5, Relasin-HCX, Touro HC, Tussicle, Tusso-DF, Vi-Q-Tuss, Vitussin Expectorant, Xpect-HC, Z-Cof HCX

What is Vi-Q-Tuss (guaifenesin and hydrocodone)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Hydrocodone is a narcotic cough suppressant.

Guaifenesin and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

Guaifenesin and hydrocodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Vi-Q-Tuss (guaifenesin and hydrocodone)? This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. What should I discuss with my healthcare provider before taking Vi-Q-Tuss (guaifenesin and hydrocodone)? Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not use this medicine if you are allergic to hydrocodone or guaifenesin.

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

liver or kidney disease;

asthma;

urination problems;

an enlarged prostate;

a thyroid disorder;

seizures or epilepsy;

gallbladder disease;

a head injury; or

Addison's disease.

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. Guaifenesin and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Vi-Q-Tuss (guaifenesin and hydrocodone)?

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.

Guaifenesin and hydrocodone can be taken with or without food.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, or if they get worse. Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Guaifenesin and hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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 extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dry mouth, confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, seizure (convulsions), weak or shallow breathing, or breathing that stops.

What should I avoid while taking Vi-Q-Tuss (guaifenesin and hydrocodone)? This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone.

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, or sleep medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.

Vi-Q-Tuss (guaifenesin and hydrocodone) 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 a serious side effect such as:

slow heart rate, weak or shallow breathing;

feeling like you might pass out;

confusion, fear, unusual thoughts or behavior;

seizure (convulsions); or

urinating less than usual or not at all.

Less serious side effects may include:

dizziness, drowsiness;

nausea, vomiting, upset stomach;

blurred vision;

constipation;

dry mouth; or

sweating.

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 Vi-Q-Tuss (guaifenesin and hydrocodone)? Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone.

Tell your doctor about all other medicines you use, especially:

antidepressants such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and other drugs may interact with guaifenesin and hydrocodone. 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 Vi-Q-Tuss resources Vi-Q-Tuss Side Effects (in more detail)Vi-Q-Tuss Use in Pregnancy & BreastfeedingVi-Q-Tuss Drug InteractionsVi-Q-Tuss Support Group0 Reviews for Vi-Q-Tuss - Add your own review/rating CodiCLEAR DH Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Entuss Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Tusso-HC Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Compare Vi-Q-Tuss with other medications Cough Where can I get more information? Your pharmacist can provide more information about guaifenesin and hydrocodone.

See also: Vi-Q-Tuss side effects (in more detail)

Gonadorelin
Pronunciation: goe-nad-oh-RELL-inGeneric Name: GonadorelinBrand Name: Factrel

Kenalog Cream
Pronunciation: TRY-am-SIN-oh-lone ah-SEE-toe-nideGeneric Name: TriamcinoloneBrand Name: Examples include Aristocort A and Kenalog

Lumizyme
alglucosidase alfa Dosage Form: injection, powder, for solutionFULL PRESCRIBING INFORMATION Warning

Life-threatening anaphylactic reactions, severe allergic reactions and immune mediated reactions have been observed in some patients during Lumizyme® infusions. Therefore, appropriate medical support should be readily available when Lumizyme is administered [see Warnings and Precautions (5.1, 5.2)].

Isopropyl Alcohol
MWI 99% Isopropyl Alcohol quart MWI 99% Isopropyl Alcohol quart

CONTAINS:

Active Ingredients:

   Isopropyl Alcohol .........................99%

Inert Ingredients:

   Water ...............................................1%

INDICATIONS: Widely used by veterinarians and artificial inseminators as a bactericide and antiseptic.

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