Heparin sodium 25,000 I.U. / ml solution for injection or concentrate for solution for infusion (with preservative)
1. Name Of The Medicinal Product

Multiparin 25,000 I.U./ml solution for injection or concentrate for solution for infusion or Heparin sodium 25,000 I.U./ml solution for injection or concentrate for solution for infusion

2. Qualitative And Quantitative Composition

Heparin sodium 25,000 I.U./ml (125,000 I.U. in 5ml)

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for injection or concentrate for solution for infusion

A colourless or straw-coloured liquid, free from turbidity and from matter that deposits on standing.

4. Clinical Particulars 4.1 Therapeutic Indications

Prophylaxis of deep vein thrombosis and pulmonary embolism

Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion.

Prophylaxis of mural thrombosis following myocardial infarction.

In extracorporeal circulation and haemodialysis.

4.2 Posology And Method Of Administration

Route of administration

By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection, or by subcutaneous injection.

The intravenous injection volume of heparin injection should not exceed 15ml.

As the effects of heparin are short-lived, administration by intravenous infusion or subcutaneous injection is preferable to intermittent intravenous injections.

Recommended dosage

Prophylaxis of deep vein thrombosis and pulmonary embolism:

Adults:

2 hours pre-operatively:

5,000 units subcutaneously

followed by:

5,000 units subcutaneously every 8-12 hours, for 7-10 days or until the patient is fully ambulant.

No laboratory monitoring should be necessary during low dose heparin prophylaxis. If monitoring is considered desirable, anti-Xa assays should be used as the activated partial thromboplastin time (APTT) is not significantly prolonged.

During pregnancy:

5,000 - 10,000 units every 12 hours, subcutaneously, adjusted according to APTT or anti-Xa assay.

Elderly:

Dosage reduction and monitoring of APTT may be advisable.

Children:

No dosage recommendations.

Treatment of deep vein thrombosis and pulmonary embolism:

Adults:

Loading dose: 5,000 units intravenously (10,000 units may be required in severe pulmonary embolism)

Maintenance:

1,000-2,000 units/hour by intravenous infusion,

or 10,000-20,000 units 12 hourly subcutaneously,

or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly:

Dosage reduction may be advisable.

Children and small adults:

Loading dose: 50 units/kg intravenously

Maintenance:

15-25 units/kg/hour by intravenous infusion,

or 250 units/kg 12 hourly subcutaneously

or 100 units/kg 4-hourly by intravenous injection

Treatment of unstable angina pectoris and acute peripheral arterial occlusion:

Adults:

Loading dose: 5,000 units intravenously

Maintenance:

1,000-2,000 units/hour by intravenous infusion,

or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly:

Dosage reduction may be advisable.

Children and small adults:

Loading dose: 50 units/kg intravenously

Maintenance:

15-25 units/kg/hour by intravenous infusion,

or 100 units/kg 4-hourly by intravenous injection

Daily laboratory monitoring (ideally at the same time each day, starting 4-6 hours after initiation of treatment) is essential during full-dose heparin treatment, with adjustment of dosage to maintain an APTT value 1.5-2.5 x midpoint of normal range or control value.

Prophylaxis of mural thrombosis following myocardial infarction

Adults:

12,500 units 12 hourly subcutaneously for at least 10 days.

Elderly:

Dosage reduction may be advisable

In extracorporeal circulation and haemodialysis

Adults:

Cardiopulmonary bypass:

Initially 300 units/kg intravenously, adjusted thereafter to maintain the activated clotting time (ACT) in the range 400-500 seconds.

Haemodialysis and haemofiltration:

Initially 1-5,000 units,

Maintenance: 1-2,000 units/hour, adjusted to maintain clotting time >40 minutes.

Heparin resistance

Patients with altered heparin responsiveness or heparin resistance may require disproportionately higher doses of heparin to achieve the desired effect. Also refer to section 4.4, Special warnings and precautions for use.

4.3 Contraindications

Known hypersensitivity to heparin or any of the other ingredients.

Must not be given to premature babies or neonates (contains benzyl alcohol).

Patients who consume large amounts of alcohol, who are sensitive to the drug, who are actively bleeding or who have haemophilia or other bleeding disorders, severe liver disease (including oesophageal varices), purpura, severe hypertension, active tuberculosis or increased capillary permeability.

Patients with present or previous thrombocytopenia. The rare occurrence of skin necrosis in patients receiving heparin contra-indicates the further use of heparin either by subcutaneous or intravenous routes because of the risk of thrombocytopenia. Because of the special hazard of post-operative haemorrhage heparin is contra-indicated during surgery of the brain, spinal cord and eye, in procedures at sites where there is a risk of bleeding, in patients that have had recent surgery, and in patients undergoing lumbar puncture or regional anaesthetic block.

The relative risks and benefits of heparin should be carefully assessed in patients with a bleeding tendency or those patients with an actual or potential bleeding site eg. hiatus hernia, peptic ulcer, neoplasm, bacterial endocarditis, retinopathy, bleeding haemorrhoids, suspected intracranial haemorrhage, cerebral thrombosis or threatened abortion.

Menstruation is not a contra-indication.

4.4 Special Warnings And Precautions For Use

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.

In patients with advanced renal or hepatic disease, a reduction in dosage may be necessary. The risk of bleeding is increased with severe renal impairment and in the elderly (particularly elderly women).

Although heparin hypersensitivity is rare, it is advisable to give a trial dose of 1,000 I.U. in patients with a history of allergy. Caution should be exercised in patients with known hypersensitivity to low molecular weight heparins.

Heparin injection contains benzyl alcohol (10mg/ml) and methyl parahydroxybenzoate as preservatives. Caution should be used if prescribing Heparin injection to susceptible patients. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to three years old. Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed) and exceptionally, bronchospasm.

In most patients, the recommended low-dose regimen produces no alteration in clotting time. However, patients show an individual response to heparin, and it is therefore essential that the effect of therapy on coagulation time should be monitored in patients undergoing major surgery.

Caution is recommended in spinal or epidural anaesthesia (risk of spinal haematoma).

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalemia, 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 hyperkalemia 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 in all patients treated for more than 7 days.

Heparin resistance

There is considerable variation in individual anticoagulant responses to heparin.

Heparin resistance, defined as an inadequate response to heparin at a standard dose for achieving a therapeutic goal occurs in approximately 5 to 30% of patients.

Factors predisposing to the development of heparin resistance, include:

• Antithrombin III activity less than 60% of normal (antithrombin III-dependent heparin resistance):

Reduced antithrombin III activity may be hereditary or more commonly, acquired (secondary to preoperative heparin therapy in the main, chronic liver disease, nephrotic syndrome, cardiopulmonary bypass, low grade disseminated intravascular coagulation or drug induced, e.g. by aprotinin, oestrogen or possibly nitroglycerin)

• Patients with normal or supranormal antithrombin III levels (antithrombin III-independent heparin resistance)

 

• Thromboembolic disorders

 

• Increased heparin clearance

• Elevated levels of heparin binding proteins, factor VIII, von Willebrand factor, fibrinogen, platelet factor 4 or histidine-rich glycoprotein

 

• Active infection (sepsis or endocarditis)

• Preoperative intra-aortic balloon counterpulsation

• Thrombocytopenia

• Thrombocytosis

• Advanced age

• Plasma albumin concentration

• Relative hypovolaemia

Heparin resistance is also often encountered in acutely ill patients,in patients with malignancy and during pregnancy or the post-partum period.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Analgesics: Drugs that interfere with platelet aggregation eg. aspirin and other NSAIDs should be used with care. Increased risk of haemorrhage with ketorolac (avoid concomitant use even with low-dose heparin).

Anticoagulants, platelet inhibitors, etc: Increased risk of bleeding with oral anticoagulants, epoprostenol, clopidogrel, ticlopidine, streptokinase, dipyridamole, dextran solutions, or any other drug which may interfere with coagulation.

Cephalosporins: Some cephalosporins, e.g. cefaclor, cefixime and ceftriaxone, can affect the coagulation process and may therefore increase the risk of haemorrhage when used concurrently with heparin.

ACE inhibitors: Hyperkalaemia may occur with concomitant use.

Nitrates: Reduced activity of heparin has been reported with simultaneous intravenous glyceryl trinitrate infusion.

Probenecid: May increase the anticoagulant effects of heparin.

Tobacco smoke: Nicotine may partially counteract the anticoagulant effect of heparin. Increased heparin dosage may be required in smokers.

Interference with diagnostic tests may be associated with pseudo-hypocalcaemia (in haemodialysis patients), artefactual increases in total thyroxine and triiodothyronine, simulated metabolic acidosis and inhibition of the chromogenic lysate assay for endotoxin. Heparin may interfere with the determination of aminoglycosides by immunoassays.

4.6 Pregnancy And Lactation

Heparin is not contraindicated in pregnancy. Heparin does not cross the placenta or appear in breast milk. The decision to use heparin in pregnancy should be taken after evaluation of the risk/benefit in any particular circumstances.

Reduced bone density has been reported with prolonged heparin treatment during pregnancy.

Haemorrhage may be a problem during pregnancy or after delivery.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Haemorrhage (see also Special Warnings and Precautions and Overdosage Information).

Adrenal insufficiency secondary to adrenal haemorrhage has been associated with heparin (rarely).

Thrombocytopenia has been observed occasionally (see also Special Precautions and Warnings). Two types of heparin-induced thrombocytopenia have been defined. Type I is frequent, mild (usually >50 x 109/L) and transient, occurring within 1-5 days of heparin administration. Type II is less frequent but often associated with severe thrombocytopenia (usually <50 x 109/L). It is immune-mediated and occurs after a week or more (earlier in patients previously exposed to heparin). It is associated with the production of a platelet-aggregating antibody and thromboembolic complications which may precede the onset of thrombocytopenia. Heparin should be discontinued immediately.

There is some evidence that prolonged dosing with heparin (ie. over many months) may cause alopecia and osteoporosis. Significant bone demineralisation has been reported in women taking more than 10,000 I.U. per day of heparin for at least 6 months.

Heparin products can cause hypoaldosteronism which may result in an increase in plasma potassium. Rarely, clinically significant hyperkalemia may occur particularly in patients with chronic renal failure and diabetes mellitus (see Warnings and Precautions).

Hypersensitivity reactions to heparin are rare. They include urticaria, conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, feeling of oppression, fever, chills, angioneurotic oedema and anaphylactic shock. In some instances the precipitating agent will prove to be the preservative rather than the heparin itself.

Local irritation and skin necrosis may occur but are rare. Erythematous nodules, or infiltrated and sometimes eczema-like plaques, at the site of subcutaneous injections are common, occurring 3-21 days after starting heparin treatment.

Priapism has been reported. Increased serum transaminase values may occur but usually resolve on discontinuation of heparin. Heparin administration is associated with release of lipoprotein lipase into the plasma; rebound hyperlipidaemia may follow heparin withdrawal.

4.9 Overdose

A potential hazard of heparin therapy is haemorrhage, but this is usually due to overdosage and the risk is minimised by strict laboratory control. Slight haemorrhage can usually be treated by withdrawing the drug. If bleeding is more severe, clotting time and platelet count should be determined. Prolonged clotting time will indicate the presence of an excessive anticoagulant effect requiring neutralisation by intravenous protamine sulphate, at a dosage of 1 mg for every 100 I.U. of heparin to be neutralised. The bolus dose of protamine sulphate should be given slowly over about 10 minutes and not exceed 50 mg. If more than 15 minutes have elapsed since the injection of heparin, lower doses of protamine will be necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Heparin is an anticoagulant and acts by inhibiting thrombin and by potentiating the naturally occurring inhibitors of activated Factor X (Xa).

5.2 Pharmacokinetic Properties

As heparin is not absorbed from the gastrointestinal tract and sublingual sites it is administered by injection. After injection heparin extensively binds to plasma proteins.

Heparin is metabolised in the liver and the inactive metabolic products are excreted in the urine.

The half life of heparin is dependent on the dose.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol

Methyl parahydroxybenzoate (E218)

Water for injections

Sodium hydroxide solution

Hydrochloric acid

6.2 Incompatibilities

Heparin is incompatible with many injectable preparations e.g. some antibiotics, opioid analgesics and antihistamines.

The following drugs are incompatible with heparin;

Alteplase, amikacin sulphate, amiodarone hydrochloride, ampicillin sodium, aprotinin, benzylpenicillin potassium or sodium, cefalotin sodium, chlorpromazine hydrochloride, ciprofloxacin lactate, cisatracurium besilate, cytarabine, dacarbazine, daunorubicin hydrochloride, diazepam, doxorubicin hydrochloride, droperidol, erythromycin lactobionate, gentamicin sulphate, haloperidol lactate, hyaluronidase, hydrocortisone sodium succinate, kanamycin sulphate, labetolol hydrochloride, meticillin sodium, methotrimeprazine, netilmicin sulphate, nicardipine hydrochloride, oxytetracycline hydrochloride, pethidine hydrochloride, polymyxin B sulphate, promethazine hydrochloride, streptomycin sulphate, tobramycin sulphate, triflupromazine hydrochloride, vancomycin hydrochloride and vinblastine sulphate.

Dobutamine hydrochloride and heparin should not be mixed or infused through the same intravenous line, as this causes precipitation.

Heparin and reteplase are incompatible when combined in solution.

If reteplase and heparin are to be given through the same line this, together with any Y-lines, must be thoroughly flushed with a 0.9% saline or a 5% glucose solution prior to and following the reteplase injection.

6.3 Shelf Life

36 months

Following the withdrawal of the first dose the remainder should be used within 28 days. After this period, any unused material should be discarded.

6.4 Special Precautions For Storage

Do not store above 25°C

Store in the original package

Chemical and physical in use stability has been demonstrated for 28 days at 25°C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 25°C. Other in use storage times and conditions are the responsibility of the user.

6.5 Nature And Contents Of Container

5ml multidose neutral glass (Type 1, Ph Eur) vial. Carton containing 10 vials.

6.6 Special Precautions For Disposal And Other Handling

Each multidose vial should be restricted to use in a single patient.

7. Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK.

8. Marketing Authorisation Number(S)

PL 29831/0108

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 15 October 2007

10. Date Of Revision Of The Text

04 /03/2011

Zirtek Allergy Relief Tablets

Zirtek ALLERGY RELIEF

cetirizine hydrochloride

ONE A DAY

What You Should Know About Your Tablets

Please read this leaflet carefully before you start taking this medicine. It provides a summary of the information currently available on Zirtek Allergy Relief. For further information or advice ask your doctor or pharmacist.

What Is In Zirtek Allergy Relief

Each tablet contains 10 mg of cetirizine hydrochloride together with microcrystalline cellulose (E460), lactose, colloidal anhydrous silica and magnesium stearate (E572). The film coating hydroxypropylmethyl cellulose (E464), titanium dioxide (E171) and polyethylene glycol.

The tablets are small white oblong film-coated tablets, each scored and bearing the code Y/Y. Your medicine is supplied in blister packs of 7 tablets.

Your medicine belongs to the antihistamine group of drugs.

Product licence number: PL 00039 / 0561

This medicine is manufactured and licenced by:

UCB Pharma Ltd 208 Bath Road Slough SL1 3WE When Is Zirtek Allergy Relief Used

This medicine treats people suffering from hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).

Antihistamines like Zirtek Allergy Relief relieve the unpleasant symptoms and discomfort associated with the above conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.

Before Taking ZirtekAllergy Relief

If you are pregnant or if your doctor has told you that you have kidney problems, you should consult your doctor before taking these tablets. You should not take this medicine if you are breastfeeding or if you have ever had an allergic reaction to any of its constituents (see 'What is in Zirtek Allergy Relief).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

As with all antihistamines, you should avoid excessive alcohol consumption when taking your tablets.

If you have ever had a reaction to an antihistamine in the past consult your doctor or pharmacist before taking these tablets.

How To Take Your Tablets

Adults and children aged 12 years and over should take one tablet daily.

Each dose should be taken with water.

REMEMBER... If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet.

If you accidentally take a larger dose than recommended consult your doctor immediately.

You may feel drowsy or dizzy, taking half your dose twice a day may reduce this.

Zirtek Allergy Relief tablets are not for use in children under 12 years of age.

If symptoms persist consult your doctor.

After Taking Zirtek Allergy Relief Tablets

These tablets do not cause side-effects in most people. However, as with all medicines, some people can react differently. If you:

have frequent headaches have an upset stomach become agitated have diarrhoea get a dry mouth feel weak and/or unwell experience unusual touch sensation experience fatigue, dizziness or drowsiness experience itchiness and skin rash

Stop taking the tablets and tell your doctor.

Other rare side effects have been reported such as bleeding and bruising easily, rapid heart beat, difficulty focussing, blurred vision, swelling, allergic reaction/shock, changes in liver function, fits, confusion, depression, aggression, weight increase, unusual limb movements, experience a bad taste in the mouth, fainting, hallucination, insomnia, bed wetting, pain and/or difficulty passing water, red and/or blotchy skin rash.

If you notice anything unusual or have these or any other unexpected effects stop taking the tablets and tell you doctor. These tablets do not normally cause drowsiness. However, individuals can react differently to treatment. If you are affected you should not drive or operate machinery, but should persist with the tablets as any drowsiness doesn't usually last very long.

Storing Your Tablets.

Keep your tablets out of reach and sight of children.

Do not use after the expiry date shown under EXP on the end panel of the carton.

LEGAL STATUS: GSL.

Date of preparation of this leaflet: October 2005

© UCB 2004 - UCB logo

Polythiazide/Prazosin
Generic Name: Polythiazide/Prazosin (POL-ee-THYE-a-zide/PRAZ-oh-sin)Brand Name: Minizide Polythiazide/Prazosin is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Polythiazide/Prazosin is an alpha-blocker and thiazide diuretic combination. It works by widening blood vessels and helping the kidneys eliminate extra fluid from your body, which helps lower blood pressure.

Do NOT use Polythiazide/Prazosin if: you are allergic to any ingredient in Polythiazide/Prazosin or to any other sulfonamide medicine (eg, sulfamethoxazole, glyburide, acetazolamide) you are unable to urinate you are taking dofetilide, ketanserin, or modafinil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Polythiazide/Prazosin:

Some medical conditions may interact with Polythiazide/Prazosin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have gout, kidney or liver problems, lupus, diabetes, asthma, parathyroid problems, high blood cholesterol or lipid levels, chest pain, heart problems, narcolepsy, or low blood pressure if you have low blood sodium, chloride, potassium, or magnesium levels; or high blood calcium levels if you have recently had nerve surgery

Some MEDICINES MAY INTERACT with Polythiazide/Prazosin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Nonsteroidal anti-inflammatory medicines (NSAIDs) (eg, indomethacin) because they may decrease Polythiazide/Prazosin's effectiveness Barbiturates (eg, phenobarbital), corticosteroids (eg, prednisone), corticotropin (ACTH), medicines for high blood pressure, narcotic pain medicines (eg, codeine, morphine, fentanyl), or verapamil because they may increase the risk of Polythiazide/Prazosin's side effects Diazoxide or nondepolarizing muscle relaxants (eg, tubocurarine) because the risk of their side effects may be increased by Polythiazide/Prazosin Lithium because risk of toxicity may be increased by Polythiazide/Prazosin Beta-blockers (eg, propranolol), bupivacaine, digoxin, dofetilide, ketanserin, nifedipine, or phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil, vardenafil) because the risk of their side effects may be increased by Polythiazide/Prazosin Diabetes medicines (eg, glipizide, metformin), insulin, or modafinil because their effectiveness may be decreased by Polythiazide/Prazosin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Polythiazide/Prazosin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Polythiazide/Prazosin:

Use Polythiazide/Prazosin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Polythiazide/Prazosin by mouth with or without food. Polythiazide/Prazosin may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm. Continue to use Polythiazide/Prazosin even if you feel well. Do not miss any doses. Taking Polythiazide/Prazosin at the same time each day will help you remember to take it. Take Polythiazide/Prazosin regularly to receive the most benefit from it. If you miss a dose of Polythiazide/Prazosin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Polythiazide/Prazosin.

Important safety information: Polythiazide/Prazosin may cause dizziness, drowsiness, lightheadedness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Polythiazide/Prazosin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Polythiazide/Prazosin may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Tell your doctor or dentist that you take Polythiazide/Prazosin before you receive any medical or dental care, emergency care, or surgery. Diabetes patients -- Polythiazide/Prazosin may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor. Polythiazide/Prazosin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Polythiazide/Prazosin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms. Lab tests, including kidney function, blood pressure, and blood electrolyte levels, may be performed while you use Polythiazide/Prazosin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Polythiazide/Prazosin with caution in the ELDERLY; they may be more sensitive to its effects. Polythiazide/Prazosin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Polythiazide/Prazosin while you are pregnant. Polythiazide/Prazosin is found in breast milk. Do not breast-feed while taking Polythiazide/Prazosin. Possible side effects of Polythiazide/Prazosin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; flushing; headache; lightheadedness, especially when sitting up or standing; numbness or tingling of skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; changes in sexual function; confusion; decrease in amount of urine; fainting; gout; muscle pain or cramps; rapid or irregular heartbeat; red, swollen, blistered, or peeling skin; restlessness; seizures; shortness of breath; stomach pain; unusual thirst; unusual tiredness or weakness; unusually dry mouth; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Polythiazide/Prazosin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dry mouth; excessive urination followed by a decrease in amount of urine; muscle cramps; severe lightheadedness, especially upon standing; weak or irregular heartbeat.

Proper storage of Polythiazide/Prazosin:

Store Polythiazide/Prazosin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Polythiazide/Prazosin out of the reach of children and away from pets.

General information: If you have any questions about Polythiazide/Prazosin, please talk with your doctor, pharmacist, or other health care provider. Polythiazide/Prazosin is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Polythiazide/Prazosin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Polythiazide/Prazosin resources Polythiazide/Prazosin Side Effects (in more detail)Polythiazide/Prazosin Use in Pregnancy & BreastfeedingPolythiazide/Prazosin Drug InteractionsPolythiazide/Prazosin Support Group0 Reviews for Polythiazide/Prazosin - Add your own review/rating Compare Polythiazide/Prazosin with other medications High Blood Pressure

Humira 40 mg solution for injection in pre-filled syringe

Humira

40 mg solution for injection in pre-filled syringe

Adalimumab

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. Your doctor must also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira. Keep this Patient Alert Card with you. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What Humira is and what it is used for 2. Before you use Humira 3. How to use Humira

Chloral Hydrate Suppositories
Generic Name: Chloral Hydrate (KLOR-uhl HYE-drate)Brand Name: Aquachloral Supprettes Chloral Hydrate Suppositories are used for:

Treating sleep disorders. It may be used to prevent symptoms of alcohol withdrawal or to treat existing withdrawal symptoms. It may also be used to produce sedation or sleep before certain procedures, or to relieve anxiety due to certain procedures or substance withdrawal. It may also be used along with other medicines after surgery to help decrease pain. It may also be used for other conditions as determined by your doctor.

Chloral Hydrate Suppositories are a nonbarbiturate sedative and hypnotic. It works by depressing the central nervous system (brain). This causes drowsiness and helps you to fall asleep. It is less likely to cause a slower breathing rate than barbiturate-type sedatives/hypnotics.

Do NOT use Chloral Hydrate Suppositories if: you are allergic to any ingredient in Chloral Hydrate Suppositories you have moderate to severe liver or kidney problems, severe heart problems, or severe inflammation of your stomach or rectum you are currently taking dofetilide, H1 antagonists (eg, astemizole, terfenadine), or sodium oxybate (GHB) you have a history of alcohol or other substance abuse or dependence

Contact your doctor or health care provider right away if any of these apply to you.

Before using Chloral Hydrate Suppositories:

Some medical conditions may interact with Chloral Hydrate Suppositories. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have an inflammation of the esophagus, an ulcer, a blood disorder (eg, porphyria), suicidal thoughts, or you have a history of depression

Some MEDICINES MAY INTERACT with Chloral Hydrate Suppositories. Tell your health care provider if you are taking any other medicines, especially any of the following:

Arsenic, cisapride, dofetilide, or H1 antagonists (eg, astemizole, terfenadine) because side effects, such as serious heart problems, may occur Barbiturates (eg, phenobarbital), paraldehyde, or sodium oxybate (GHB) because the actions and side effects of these medicines may be increased Loop diuretics (eg, furosemide) because unexpected side effects, such as fast heart rate and changing blood pressure, may occur Anticoagulants (eg, warfarin) because actions and side effects may be altered by Chloral Hydrate Suppositoriess

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chloral Hydrate Suppositories may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Chloral Hydrate Suppositories:

Use Chloral Hydrate Suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.

If the suppository is too soft to use, run cold water over it. Then remove the wrapper and moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum, then use your finger to push it in completely. Wash your hands thoroughly after using Chloral Hydrate Suppositories. If you miss a dose of Chloral Hydrate Suppositories and you are taking it regularly, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chloral Hydrate Suppositories.

Important safety information: Chloral Hydrate Suppositories may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Chloral Hydrate Suppositories. Using Chloral Hydrate Suppositories alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Chloral Hydrate Suppositories. Chloral Hydrate Suppositories will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Chloral Hydrate Suppositories. Chloral Hydrate Suppositories may contain tartrazine dye (FD&C Yellow No. 5), which can cause allergic reactions in certain patients. If you have previously had an allergic reaction to tartrazine, contact your pharmacist to determine if the medicine you are taking contains tartrazine. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Chloral Hydrate Suppositories during pregnancy. Chloral Hydrate Suppositories are excreted in breast milk. If you are or will be breast-feeding while you are using Chloral Hydrate Suppositories, check with your doctor or pharmacist to discuss the risks to your baby.

Chloral Hydrate Suppositories may be habit-forming and lead to DEPENDENCE if used in high doses or for a long period of time. If you are on long-term or high dosage therapy, you may have WITHDRAWAL symptoms (eg, convulsions, tremor, stomach and muscle cramps, vomiting, sweating) if you suddenly stop taking Chloral Hydrate Suppositories. Do not stop therapy abruptly or change dosage without asking your pharmacist or doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Chloral Hydrate Suppositories:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness upon awakening; gas; nausea; unpleasant taste in mouth; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); disorientation; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Chloral Hydrate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased pupil size; slow or fast and shallow breathing; vomiting.

Proper storage of Chloral Hydrate Suppositories:

Store Chloral Hydrate Suppositories at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Do not refrigerate. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chloral Hydrate Suppositories out of the reach of children and away from pets.

General information: If you have any questions about Chloral Hydrate Suppositories, please talk with your doctor, pharmacist, or other health care provider. Chloral Hydrate Suppositories are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Chloral Hydrate Suppositories. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Chloral Hydrate resources Chloral Hydrate Side Effects (in more detail)Chloral Hydrate Use in Pregnancy & BreastfeedingChloral Hydrate Drug InteractionsChloral Hydrate Support Group10 Reviews for Chloral Hydrate - Add your own review/rating Compare Chloral Hydrate with other medications InsomniaSedation

Adcortyl Intra-Articular / Intradermal Injection 10mg / ml

The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

ADCORTYL

INTRA-ARTICULAR/INTRADERMAL INJECTION 10 mg/ml

Triamcinolone acetonide

Adcortyl IA/ID Injection is a steroid medicine, prescribed for many different conditions, including serious illnesses. You need to take it regularly to get the maximum benefit. Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually. Adcortyl IA/ID Injection can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away. Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information). If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you. Keep away from people who have chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.

Your doctor has prescribed Adcortyl injection for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

Q. What Is In Adcortyl Intra-Articular / Intradermal (Ia/Id) Injection?

A. Adcortyl IA/ID Injection belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Adcortyl IA/ID Injection) is an effective way to treat various illnesses involving inflammation in the body. Adcortyl IA/ID Injection reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

The injection contains triamcinolone acetonide 10mg/ml and is supplied in packs of 5 x 1.0ml glass ampoules or a single 5ml glass vial. The other ingredients are benzyl alcohol, polysorbate 80, carmellose, sodium chloride and water for injection.

UK PRODUCT LICENCE

Held by:

E. R. Squibb & Sons Limited Uxbridge UB8 1DH England Tel.:0800 7311736

IRISH PRODUCT AUTHORISATION

Held by:

Bristol-Myers Squibb Pharmaceuticals Ltd. Swords County Dublin Tel.:1-800-749-749

MANUFACTURER

Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR) Italy Q. What Is This Medicine For?

A. Adcortyl IA/ID Injection is for the treatment of joint pain, swelling and stiffness in inflammatory disorders such as rheumatoid arthritis. It is also used to treat various forms of allergic dermatitis, skin overgrowths such as thickened scar tissue, and patchy baldness, which is usually reversible.

Before Receiving Your Medicine Q. Should I be receiving Adcortyl IA/ID injection?

A. You should not receive this medicine if you have ever had an allergic reaction to similar medicines or to any of the ingredients in Adcortyl IA/ID injection. You should not receive this medicine if you are suffering from an infection unless your doctor has also prescribed a treatment for the infection.

Q. Is there anything else I should discuss with my doctor before receiving Adcortyl IA/ID injection?

A. Check with your doctor before receiving Adcortyl IA/ID injection if you have had any recent infection, tuberculosis (TB), bowel disorders, an ulcer, blood clots, cancer, thin (brittle) bones, high blood pressure or heart failure, mental disorders, epilepsy, myasthenia gravis or glaucoma (increased pressure in your eyes).

Check with your doctor first:

If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Adcortyl IA/ID Injection. If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Adcortyl IA/ID Injection.

Q. What if I have been in contact with someone who has an infectious disease such as Chickenpox, Shingles or Measles?

A. Steroid medicines suppress your body's natural immune response. Therefore, if you come into contact with anyone who has an infectious disease such as chickenpox, shingles or measles, consult your doctor promptly, especially if you have not had the disease before. You should take particular care to avoid these diseases.

Q. Can I be immunised (vaccinated)?

A. While you are being treated with this medicine (or if you have recently stopped a course of treatment) do not have any immunisation without consulting your doctor.

Q. What if I am pregnant or think I may be pregnant? What if I am planning to become pregnant? What if I am breast-feeding?

A. You should make sure you discuss this with your doctor as soon as possible before receiving Adcortyl IA/ID injection.

Q. What if I have had problems with my kidneys, liver or thyroid?

A. Remind your doctor as the dose of Adcortyl may need to be adjusted.

Q. Can I take other medicines?

A. Corticosteroids can increase the chance of bleeding from the gut caused by aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs). If you have hypothrombinaemia (a tendency to bleed), your doctor will be more careful about giving you Adcortyl IA/ID injection if you are taking ibuprofen or another NSAID. Always tell your doctor about all other medicines you are taking, even those you have bought at a pharmacy or other places, e.g. supermarket. Some medicines used to treat epilepsy, tuberculosis or breast cancer can reduce the effectiveness of Adcortyl. On the other hand, Adcortyl can affect the action of some medicines used to treat diabetes, high blood pressure or to thin the blood.

Always tell your doctor if you are taking oral contraceptives, hormone replacement therapy (HRT), growth hormone, thyroid drugs, cyclosporin, or medicines for treating fungal infections, or if you are to be vaccinated or to be given an anaesthetic.

Q. Is it all right to take exercise?

A. You must take care not to over-use a joint which feels better after you receive Adcortyl IA/ID injection as the joint will still need to recover from the inflammation which caused your symptoms.

Q. Is it all right to drive?

A. This medicine does not usually affect your ability to drive but it can affect your eyesight. Tell your doctor immediately if you have any pain in the eyes or visual disturbances.

Q. Is it all right to drink alcohol?

A. There is no known interaction between Adcortyl and alcohol.

Q. What if I am diabetic?

A. Remind your doctor as your insulin dose may need to be changed.

Q. Who should I tell that I have received this injection?

A. Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine. YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse - before having any surgery or emergency treatment or if any new treatment is prescribed. Dentist - before having any dental surgery Pharmacist - before buying any medicine Optician - it is advisable to have regular eye tests Q. Is there any important information about the ingredients of Adcortyl that I need to know?

A. Adcortyl IA/ID Injection contains 15mg/ml benzyl alcohol which may cause harmful or allergic reactions in infants and children. Adcortyl IA/ID injection must not be given to premature or newly born babies.

Administraton Of Your Medicine Q. How will Adcortyl IA/ID injection be given and how often?

A. The effect of the injection will vary from patient to patient and further injections may be given when symptoms return and not at regular intervals.

Use in inflammatory joint disorders:

The dose of injection to be given into a joint or into a tendon sheath depends upon the size of the joint to be treated and the severity of the condition. Doses of 2.5 - 5mg (0.25-0.5ml) for smaller joints and 5-15mg (0.5-1.5ml) for larger joints usually give relief of symptoms. This medicine should not be used for injection into the Achilles tendon.

Use in allergic dermatitis:

The dose is usually 2-3mg (0.2-0.3ml) depending on the size of the problem area of the skin but no more than 5mg (0.5ml) should be injected at any one site. If several sites are injected the total dose given should not exceed 30mg (3ml). Further doses may be given if necessary at one or two week intervals.

Children: Adcortyl IA/ID is not recommended for children under 6 years of age. It may be given to older children but the dose is adjusted according to their size and weight and is always kept as low as possible for the shortest possible time.

During times of illness or stress, patients on long-term treatment may require the addition of oral steroid tablets or, if they have recently finished a course of Adcortyl IA/ID injections, may need to start taking oral steroid tablets for a while.

Q. How long should I continue receiving Adcortyl IA/ID injection?

A. Your doctor will advise you whether it is wise for you to have further injections.

Treatment with steroids is usually kept as short as possible and must not be stopped abruptly. Joints may become permanently damaged by repeated injections over a long period of time.

When the treatment is stopped you may notice flu-like symptoms, runny nose or itchy eyes or skin.

Mental problems while taking Adcortyl IA/ID injection

Mental health problems can happen while taking steroids like Adcortyl IA/ID Injection (see also section 4 Possible Side Effects).

These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

Undesirable Effects Q. Are there any unwanted effects of Adcortyl IA/ID injection?

A. All medicines may cause some unwanted or “side” effects. Some which can occur with steroid treatment are as follows. Tell your doctor immediately if you get ulcer pains in your stomach or severe pain in your abdomen, facial swelling or an unexpected rash. Patients have reported increased appetite, weight gain, indigestion, sickness, feeling tired or weak. Steroid treatment may cause increased risk of infection, thinning of bones or tendons causing fractures or torn muscles, water retention, irregular heart beat, high blood pressure or blood clots. Skin disorders or eye problems, including glaucoma and cataracts, may occur and wounds or broken bones may be slow to heal. Treatment with steroids can stop the body from producing some hormones and may slow or stop children’s growth rate. If you are female, your periods may become irregular. Elevation or depression of mood, sleeplessness and severe headaches have been reported. Very rare instances of blindness have been reported following injection to the face.

In particular, when Adcortyl IA/ID is injected into a joint you may notice some indentation appearing after a while in the surrounding area. There may also be some temporary worsening of the pain and discomfort after the injection. Similarly, injections given under the skin may cause slight changes in skin colour around the site of injection. These changes should disappear in time.

Serious effects: tell a doctor straight away

Steroids including Adcortyl IA/ID injection can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Adcortyl IA/ID injection.

Feeling depressed, including thinking about suicide. Feeling high (mania) or moods that go up and down. Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory. Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Tell your doctor or pharmacist if you notice any other troublesome side effects.

Looking After Your Medicine

Adcortyl IA/ID injection will be kept in the pharmacy until it is given to you by your doctor or nurse. It should be stored upright, at a temperature not exceeding 25°C and should not be allowed to freeze. After first opening, the 5ml multidose vial may be stored for 28 days below 25°C. It should not be used after the expiry date shown on the outer packaging. Keep out of reach and sight of children.

DATE OF LAST REVISION April 2008

1041116A7

Timoptic Ocumeter

Generic Name: timolol (Ophthalmic route)

TIM-oh-lol

Commonly used brand name(s)

In the U.S.

Betimol Istalol Timoptic Ocudose Timoptic Ocumeter Timoptic Ocumeter Plus Timoptic-XE Ocumeter Timoptic-XE Ocumeter Plus

Available Dosage Forms:

Solution Gel Forming Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Uses For Timoptic Ocumeter

Timolol is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called ocular (eye) hypertension. This medicine is a beta-blocker .

This medicine is available only with your doctor's prescription .

Before Using Timoptic Ocumeter

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

Appropriate studies have not been performed on the relationship of age to the effects of timolol 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 timolol 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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 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.

Albuterol Amiodarone Arformoterol Bambuterol Bitolterol Broxaterol Clenbuterol Clonidine Colterol Diltiazem Dronedarone Epinephrine Fenoldopam Fenoterol Formoterol Hexoprenaline Indacaterol Isoetharine Levalbuterol Metaproterenol Pirbuterol Procaterol Reproterol Rimiterol Ritodrine Salmeterol Terbutaline Timolol Tretoquinol Tulobuterol Verapamil

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.

Acarbose Aceclofenac Acemetacin Acetohexamide Alclofenac Alfuzosin Amlodipine Apazone Arbutamine Benfluorex Benoxaprofen Bromfenac Bufexamac Bunazosin Carprofen Chlorpropamide Cimetidine Clometacin Clonixin Dexketoprofen Diclofenac Diflunisal Digoxin Dipyrone Doxazosin Droxicam Etodolac Etofenamate Felbinac Felodipine Fenbufen Fenoprofen Fentiazac Floctafenine Flufenamic Acid Flurbiprofen Gliclazide Glimepiride Glipizide Gliquidone Glyburide Guar Gum Ibuprofen Indomethacin Indoprofen Insulin Insulin Aspart, Recombinant Insulin Glulisine Insulin Lispro, Recombinant Isoxicam Ketoprofen Ketorolac Lacidipine Lercanidipine Lornoxicam Manidipine Meclofenamate Mefenamic Acid Meloxicam Metformin Methyldopa Mibefradil Miglitol Moxisylyte Nabumetone Naproxen Nicardipine Nifedipine Niflumic Acid Nilvadipine Nimesulide Nimodipine Nisoldipine Nitrendipine Oxaprozin Oxyphenbutazone Phenoxybenzamine Phentolamine Phenylbutazone Pirazolac Piroxicam Pirprofen Pranidipine Prazosin Propyphenazone Proquazone Quinidine Repaglinide St John's Wort Sulindac Suprofen Tamsulosin Tenidap Tenoxicam Terazosin Tiaprofenic Acid Tolazamide Tolbutamide Tolmetin Trimazosin Troglitazone Urapidil Zomepirac 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:

Asthma or Bradycardia (slow heartbeat) or Chronic obstructive pulmonary disease (COPD), severe or Heart block or Heart failure—Should not use in patients with these conditions . Blood vessel disease (especially blood vessels of the brain) or Stroke, history of—Use with caution. This medicine may worsen these conditions . Diabetes or Hyperthyroidism (overactive thyroid) or Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat . Lung disease—Use with caution. May cause difficulty with breathing in patients with this condition . Myasthenia gravis—May worsen symptoms of this condition, such as muscle weakness . Proper Use of timolol

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

Shake the regular eye drops well just before each use. If you are using the gel-forming eye drops, turn the bottle upside down and shake it once. You do not need to shake the gel-forming eye drops more than once .

To use the eye drops (solution and gel):

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Immediately after using the medicine, wash your hands to remove any medicine that may be on them. 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. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines .

If your doctor ordered two different eye medicines to be used together, wait at least 10 minutes after the regular eye drops before using the second medicine. This will help prevent the second medicine from “washing out” the first one. The gel-forming eye drops should always be the last medicine used if two medicines are ordered. Wait 10 minutes before using the gel-forming eye drops .

You should not use the regular eye drops if you have contact lenses in your eyes. Remove your contact lenses before you use this medicine. Wait at least 15 minutes after you use the medicine before putting the contact lenses back in .

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 glaucoma or ocular hypertension: For ophthalmic gel-forming solution dosage form (eye drops): Adults—One drop in the affected eye(s) once a day. Children—Use and dose must be determined by your doctor . For ophthalmic solution dosage form (eye drops): Adults—One drop in the affected eye(s) two times a day. Children—Use and dose must be determined by your doctor . Missed Dose

If you miss a dose of this medicine, apply 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.

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.

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

Precautions While Using Timoptic Ocumeter

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, stop using this medicine and check with your doctor. These signs may mean that you are allergic to this medicine .

Timolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

The gel-forming eye drops may cause blurred vision or other vision problems that last about 30 seconds to 5 minutes after you put them in your eye. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these eye changes are bothersome, check with your doctor .

Timoptic Ocumeter 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 Blurred vision burning or stinging in eye Less common Arm, back, or jaw pain blisters, hives, welts, or itching blue lips, fingernails, or skin burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings change in vision chest pain or discomfort chest tightness or heaviness confusion about identity, place, and time continuing ringing or buzzing or other unexplained noise in ears coughing that sometimes produces a pink frothy sputum depression difficult, fast, noisy breathing, sometimes with wheezing difficulty in chewing, swallowing, or talking dilated neck veins discharge, excessive tearing disturbed color perception dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly double vision drooping eyelids dry or itching eyes extreme fatigue false sense of well-being fast, slow, irregular, pounding, or racing heartbeat or pulse fear, nervousness feeling of having something in the eye fever and chills flashes of light, floaters in vision general feeling of discomfort or illness hair loss halos around lights headaches inability to speak increased sweating irregular, fast or slow, or shallow breathing large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs lightheadedness, dizziness, or fainting loss of vision memory loss mood swings muscle or joint pain muscle weakness nausea night blindness no blood pressure or pulse overbright appearance of lights pain, tension, and weakness upon walking that subsides during periods of rest pale skin paleness or cold feeling in fingertips, toes, hands, and feet personality changes pounding in the ears puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue redness of skin redness, pain, swelling or irritation of eye, eyelid, or inner lining of eyelid seeing double seeing, hearing, or feeling things that are not there seizures severe numbness, especially on one side of the face or body severe or sudden headache severe tiredness shortness of breath or troubled breathing skin irritation or rash, including rash that looks like psoriasis slurred speech sore throat stopping of heart sweating swelling of face, fingers, feet, lower legs, and ankles swollen glands temporary blindness tingling or pain in fingers or toes when exposed to cold tunnel vision unconsciousness unusual tiredness or weakness weakness in arm and/or leg on one side of the body, sudden and severe weight gain wheezing

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 Acid or sour stomach belching body aches or pain diarrhea dry mouth ear congestion hearing loss heartburn indigestion lack or loss of strength loss of appetite loss of voice nightmares runny nose sleepiness or unusual drowsiness sleeplessness sneezing stomach discomfort, upset, or pain stuffy nose trouble sleeping unable to sleep weight loss

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: Timoptic Ocumeter 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.

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Sab-Tobramycin

Generic Name: tobramycin (Ophthalmic route)

toe-bra-MYE-sin

Commonly used brand name(s)

In the U.S.

AKTob Tobrasol Tobrex

In Canada

Apo-Tobramycin Sab-Tobramycin Tomycine

Available Dosage Forms:

Ointment Solution

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For Sab-Tobramycin

Ophthalmic tobramycin is used in the eye to treat bacterial infections of the eye. Tobramycin works by killing bacteria.

Ophthalmic tobramycin may be used alone or with other medicines for eye infections. Either the drops or the ointment form of this medicine may be used alone during the day. In addition, both forms may be used together, with the drops being used during the day and the ointment at night.

Tobramycin ophthalmic preparations are available only with your doctor's prescription.

Before Using Sab-Tobramycin

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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines 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 or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic tobramycin in the elderly with use in other age groups.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. 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 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.

Alcuronium Atracurium Cidofovir Cisatracurium Colistimethate Sodium Decamethonium Doxacurium Ethacrynic Acid Fazadinium Furosemide Gallamine Hexafluorenium Lysine Metocurine Mivacurium Pancuronium Pipecuronium Rapacuronium Rocuronium Succinylcholine Tacrolimus Tubocurarine Vancomycin Vecuronium

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.

Cisplatin Cyclosporine 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 tobramycin

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

For patients using tobramycin ophthalmic solution (eye drops):

The bottle is only partially full to provide proper drop control. To use: First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection. If you think you did not get the drop of medicine into your eye properly, use another drop. 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. If your doctor ordered two different ophthalmic solutions to be used together, wait at least 5 minutes between the times you apply the medicines. This will help to keep the second medicine from ``washing out'' the first one.

For patients using tobramycin ophthalmic ointment (eye ointment):

To use: First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1.25-cm (approximately ?-inch) strip of ointment usually is enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes and keep them closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using tobramycin eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your eye infection completely, keep using tobramycin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

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 ophthalmic ointment dosage forms: For mild to moderate infections: Adults and children—Use every eight to twelve hours. For severe infections: Adults and children—Use every three to four hours until improvement occurs. For ophthalmic solution (eye drops) dosage forms: For mild to moderate infections: Adults and children—One drop every four hours. For severe infections: Adults and children—One drop every hour until improvement occurs. 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 Sab-Tobramycin

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

Sab-Tobramycin 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:

Less common Itching, redness, swelling, or other sign of eye or eyelid irritation not present before use of this medicine Symptoms of overdose Increased watering of the eyes itching, redness, or swelling of the eyes or eyelids painful irritation of the clear front part of the eye

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 Burning or stinging of the eyes

Eye ointments usually cause your vision to blur for a few minutes after application.

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.

More Sab-Tobramycin resources Sab-Tobramycin Use in Pregnancy & BreastfeedingSab-Tobramycin Support Group3 Reviews for Sab-Tobramycin - Add your own review/rating Compare Sab-Tobramycin with other medications Conjunctivitis, Bacterial

Chirocaine 2.5mg / ml solution for injection / concentrate for solution for infusion
1. Name Of The Medicinal Product

Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion.

2. Qualitative And Quantitative Composition

One ml contains 2.5 mg levobupivacaine as levobupivacaine hydrochloride.

Each ampoule contains 25 mg in 10 ml.

Excipients: 3.6mg/ml of sodium per ampoule.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection/concentrate for solution for infusion.

Clear colourless solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Adults

Surgical anaesthesia

- Major, e.g. epidural (including for caesarean section), intrathecal, peripheral nerve block.

- Minor, e.g. local infiltration, peribulbar block in ophthalmic surgery.

Pain management

- Continuous epidural infusion, single or multiple bolus epidural administration for the management of pain especially post-operative pain or labour analgesia.

Children

Analgesia (ilioinguinal/iliohypogastric blocks).

4.2 Posology And Method Of Administration

Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training and experience.

The table below is a guide to dosage for the more commonly used blocks. For analgesia (e.g. epidural administration for pain management), the lower concentrations and doses are recommended. Where profound or prolonged anaesthesia is required with dense motor block (e.g. epidural or peribulbar block), the higher concentrations may be used. Careful aspiration before and during injection is recommended to prevent intravascular injection.

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in incremental doses, at a rate of 7.5–30 mg/min, while closely observing the patient's vital functions and maintaining verbal contact.

If toxic symptoms occur, the injection should be stopped immediately.

Maximum dose

The maximum dosage must be determined by evaluating the size and physical status of the patient, together with the concentration of the agent and the area and route of administration. Individual variation in onset and duration of block does occur. Experience from clinical studies shows onset of sensory block adequate for surgery in 10-15 minutes following epidural administration, with a time to regression in the range of 6-9 hours.

The recommended maximum single dose is 150 mg.Where sustained motor and sensory block are required for a prolonged procedure, additional doses may be required. The maximum recommended dose during a 24 hour period is 400 mg. For post-operative pain management, the dose should not exceed 18.75 mg/hour.

Obstetrics

For caesarean section, higher concentrations than the 5.0 mg/ml solution should not be used (See section 4.3). The maximum recommended dose is 150 mg.

For labour analgesia by epidural infusion, the dose should not exceed 12.5 mg/hour.

Children

In children, the maximum recommended dose for analgesia (ilioinguinal/iliohypogastric blocks) is 1.25 mg/kg/side.

The safety and efficacy of levobupivacaine in children for other indications have not been established.

Special populations

Debilitated, elderly or acutely ill patients should be given reduced doses of levobupivacaine commensurate with their physical status.

In the management of post-operative pain, the dose given during surgery must be taken into account.

There are no relevant data in patients with hepatic impairment (see sections 4.4 and 5.2).

Table of Doses

 

Concentration (mg/ml)1

Dose

Motor Block

Surgical Anaesthesia

     

Epidural (slow) bolus2 for surgery

- Adults

 

5.0-7.5

 

10-20 ml (50-150 mg)

 

Moderate to complete

Epidural slow injection3 for Caesarean Section

5.0

15-30 ml (75-150 mg)

Moderate to complete

Intrathecal

5.0

3 ml (15 mg)

Moderate to complete

Peripheral Nerve

Ilioinguinal/Iliohypogastric blocks in children <12 years

2.5-5.0

2.5-5.0

1-40 ml (2.5-150 mg max.)

0.25-0.5 ml/kg (0.625-2.5 mg/kg)

Moderate to complete

Not applicable

Ophthalmic (peribulbar block)

7.5

5–15 ml (37.5-112.5 mg)

Moderate to complete

Local Infiltration

- Adults

 

2.5

 

1-60 ml (2.5-150 mg max.)

 

Not applicable

Pain Management4

Labour Analgesia (epidural bolus5)

 

2.5

 

6-10 ml (15-25 mg)

 

Minimal to moderate

Labour Analgesia (epidural infusion)

1.256

4-10 ml/h (5-12.5 mg/h)

Minimal to moderate

Post-operative pain

1.256

2.5

10-15ml/h (12.5-18.75mg/h)

5-7.5ml/h (12.5 –18.75mg/h)

Minimal to moderate

1 Levobupivacaine solution for injection/concentration for solution for infusion is available in 2.5, 5.0 and 7.5 mg/ml solutions.

2 Spread over 5 minutes (see also text).

3 Given over 15-20 minutes.

4 In cases where levobupivacaine is combined with other agents e.g. opioids in pain management, the levobupivacaine dose should be reduced and use of a lower concentration (e.g. 1.25 mg/ml) is preferable.

5 The minimum recommended interval between intermittent injections is 15 minutes.

6 For information on dilution, see section 6.6.

4.3 Contraindications

General contra-indications related to regional anaesthesia, regardless of the local anaesthetic used, should be taken into account.

Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients (see section 4.8).

Levobupivacaine solutions are contra-indicated for intravenous regional anaesthesia (Bier's block).

Levobupivacaine solutions are contra-indicated in patients with severe hypotension such as cardiogenic or hypovolaemic shock.

Levobupivacaine solutions are contra-indicated for use in paracervical block in obstetrics (see section 4.6).

4.4 Special Warnings And Precautions For Use

All forms of local and regional anaesthesia with levobupivacaine should be performed in well-equipped facilities and administered by staff trained and experienced in the required anaesthetic techniques and able to diagnose and treat any unwanted adverse effects that may occur.

Levobupivacaine can cause acute allergic reactions, cardiovascular effects and neurological damage, see section 4.8.

Levobupivacaine should be used with caution for regional anaesthesia in patients with impaired cardiovascular function e.g. serious cardiac arrhythmias.

The introduction of local anesthetics via either intrathecal or epidural administration into the central nervous system in patients with preexisting CNS diseases may potentially exacerbate some of these disease states. Therefore, clinical judgment should be exercised when contemplating epidural or intrathecal anesthesia in such patients.

This medicinal product contains 3.6 mg/ml sodium in the bag or ampoule solution to be taken into consideration by patients on a controlled sodium diet.

Epidural Anesthesia

During epidural administration of levobupivacaine, concentrated solutions (0.5-0.75%) should be administered in incremental doses of 3 to 5 ml with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. When a large dose is to be injected, e.g. in epidural block, a test dose of 3-5 ml lidocaine with adrenaline is recommended. An inadvertent intravascular injection may then be recognised by a temporary increase in heart rate and accidental intrathecal injection by signs of a spinal block.

Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given.

Epidural anaesthesia with any local anaesthetic may cause hypotension and bradycardia. All patients must have intravenous access established. The availability of appropriate fluids, vasopressors, anaesthetics with anticonvulsant properties, myorelaxants, and atropine, resuscitation equipment and expertise must be ensured (see section 4.9).

Major regional nerve blocks

The patient should have I.V. fluids running via an indwelling catheter to assure a functioning intravenous pathway. The lowest dosage of local anesthetic that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible.

Use in Head and Neck Area

Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Reactions may be due to intraarterial injection of the local anesthetic with retrograde flow to the cerebral circulation. They may also be due to puncture of the dural sheath of the optic nerve during retrobulbar block with diffusion of any local anesthetic along the subdural space to the midbrain. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available.

Use in Ophthalmic Surgery

Clinicians who perform retrobulbar blocks should be aware that there have been reports of respiratory arrest following local anaesthetic injection. Prior to retrobulbar block, as with all other regional procedures, the immediate availability of equipment, drugs, and personnel to manage respiratory arrest or depression, convulsions, and cardiac stimulation or depression should be assured. As with other anesthetic procedures, patients should be constantly monitored following ophthalmic blocks for signs of these adverse reactions.

Special populations

Debilitated, elderly or acutely ill patients: levobupivacaine should be used with caution in debilitated, elderly or acutely ill patients (see section 4.2).

Hepatic impairment: since levobupivacaine is metabolised in the liver, it should be used cautiously in patients with liver disease or with reduced liver blood flow e.g. alcoholics or cirrhotics (see section 5.2).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In vitro studies indicate that the CYP3A4 isoform and CYP1A2 isoform mediate the metabolism of levobupivacaine. Although no clinical studies have been conducted, metabolism of levobupivacaine may be affected by CYP3A4 inhibitors eg: ketoconazole, and CYP1A2 inhibitors eg: methylxanthines.

Levobupivacaine should be used with caution in patients receiving anti-arrhythmic agents with local anaesthetic activity, e.g., mexiletine, or class III anti-arrhythmic agents since their toxic effects may be additive.

No clinical studies have been completed to assess levobupivacaine in combination with adrenaline.

4.6 Pregnancy And Lactation

Pregnancy

Levobupivacaine solutions are contraindicated for use in paracervical block in obstetrics. Based on experience with bupivacaine foetal bradycardia may occur following paracervical block (see section 4.3).

For levobupivacaine, there are no clinical data on first trimester-exposed pregnancies. Animal studies do not indicate teratogenic effects but have shown embryo-foetal toxicity at systemic exposure levels in the same range as those obtained in clinical use (see section 5.3). The potential risk for human is unknown. Levobupivacaine should therefore not be given during early pregnancy unless clearly necessary.

Nevertheless, to date, the clinical experience of bupivacaine for obstetrical surgery (at the term of pregnancy or for delivery) is extensive and has not shown a foetotoxic effect.

Lactation

Levobupivacaine excretion in breast milk is unknown. However, levobupivacaine is likely to be poorly transmitted in the breast milk, as for bupivacaine. Thus breast feeding is possible after local anaesthesia.

4.7 Effects On Ability To Drive And Use Machines

Levobupivacaine can have a major influence on the ability to drive or use machines. Patients should be warned not to drive or operate machinery until all the effects of the anaesthesia and the immediate effects of surgery are passed.

4.8 Undesirable Effects

The adverse drug reactions for Chirocaine are consistent with those known for its respective class of medicinal products. The most commonly reported adverse drug reactions are hypotension, nausea, anaemia, vomiting, dizziness, headache, pyrexia, procedural pain, back pain and foetal distress syndrome in obstetric use (see table below).

Adverse reactions reported either spontaneously or observed in clinical trials are depicted in the following table. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, using the following convention: very common (

System Organ Class

Frequency

Adverse Reaction

Blood and lymphatic system disorders

Very Common

Anaemia

Immune system disorders

Not known

Not known

Allergic reactions (in serious cases anaphylactic shock)

Hypersensitivity

Nervous system disorders

Common

Common

Not known

Not known

Not known

Not known

Not known

Not known

Dizziness

Headache

Convulsion

Loss of consciousness

Somnolence

Syncope

Paraesthesia

Paraplegia

Eye disorder

Not known

Vision blurred

Cardiac disorders

Not known

Not known

Not known

Not known

Not known

Atrioventricular block

Cardiac arrest

Ventricular tachyarrhythmia

Tachycardia

Bradycardia

Vascular disorders

Very common

Hypotension

Respiratory, thoracic and mediastinal disorders

Not known

Not known

Not known

Not known

Respiratory arrest

Laryngeal oedema

Apnoea

Sneezing

Gastrointestinal disorders

Very Common

Common

Not known

Nausea

Vomiting

Hypoaesthesia oral

Loss of sphincter control

Skin and subcutaneous tissue disorders

Not known

Not known

Not known

Not known

Not known

Angioedema

Urticaria

Pruritus

Hyperhidrosis

Erythema

Musculoskeletal and connective tissue disorders

Common

Not known

Not known

Back pain

Muscle twitching

Muscular weakness

Renal and urinary disorders

Not known

Bladder dysfunction

Pregnancy, puerperium and perinatal conditions

Common

Foetal distress syndrome

General disorders and administration site conditions

Common

Pyrexia

Investigations

Not known

Not known

Cardiac output decreased

Electrocardiogram change

Injury, poisoning and procedural complications

Common

Procedural pain

Adverse reactions with local anaesthetics of the amide type are rare, but they may occur as a result of overdosage or unintentional intravascular injection and may be serious.

Cross-sensitivity among members of the amide-type local anesthetic group have been reported (see section 4.3).

Accidental intrathecal injection of local anaesthetics can lead to very high spinal anaesthesia.

Cardiovascular effects are related to depression of the conduction system of the heart and a reduction in myocardial excitability and contractility. Usually these will be preceded by major CNS toxicity, i.e. convulsions, but in rare cases, cardiac arrest may occur without prodromal CNS effects.

Neurological damage is a rare but well recognised consequence of regional and particularly epidural and spinal anaesthesia. It may be due to direct injury to the spinal cord or spinal nerves, anterior spinal artery syndrome, injection of an irritant substance or an injection of a non-sterile solution. These may result in localised areas of paraesthesia or anaesthesia, motor weakness, loss of sphincter control and paraplegia. Rarely, these may be permanent.

4.9 Overdose

Accidental intravascular injection of local anaesthetics may cause immediate toxic reactions. In the event of overdose, peak plasma concentrations may not be reached until 2 hours after administration depending upon the injection site and, therefore, signs of toxicity may be delayed. The effects of the drug may be prolonged.

Systemic adverse reactions following overdose or accidental intravascular injection reported with long acting local anaesthetic agents involve both CNS and cardiovascular effects.

CNS Effects

Convulsions should be treated immediately with intravenous thiopentone or diazepam titrated as necessary. Thiopentone and diazepam also depress central nervous system, respiratory and cardiac function. Therefore their use may result in apnoea. Neuro-muscular blockers may be used only if the clinician is confident of maintaining a patent airway and managing a fully paralysed patient.

If not treated promptly, convulsions with subsequent hypoxia and hypercarbia plus myocardial depression from the effects of the local anaesthetic on the heart, may result in cardiac arrhythmias, ventricular fibrillation or cardiac arrest.

Cardiovascular Effects

Hypotension may be prevented or attenuated by pre-treatment with a fluid load and/or the use of vasopressors. If hypotension occurs it should be treated with intravenous crystalloids or colloids and/or incremental doses of a vasopressor such as ephedrine 5-10 mg. Any coexisting causes of hypotension should be rapidly treated.

If severe bradycardia occurs, treatment with atropine 0.3-1.0 mg will normally restore the heart rate to an acceptable level.

Cardiac arrhythmia should be treated as required and ventricular fibrillation should be treated by cardioversion.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Local anaesthetics, amide

ATC Code N01B B10

Levobupivacaine is a long acting local anaesthetic and analgesic. It blocks nerve conduction in sensory and motor nerves largely by interacting with voltage sensitive sodium channels on the cell membrane, but also potassium and calcium channels are blocked. In addition, levobupivacaine interferes with impulse transmission and conduction in other tissues where effects on the cardiovascular and central nervous systems are most important for the occurrence of clinical adverse reactions.

The dose of levobupivacaine is expressed as base, whereas, in the racemate bupivacaine the dose is expressed as hydrochloride salt. This gives rise to approximately 13% more active substance in levobupivacaine solutions compared to bupivacaine. In clinical studies at the same nominal concentrations levobupivacaine showed similar clinical effect to bupivacaine.

In a clinical pharmacology study using the ulnar nerve block model, levobupivacaine was equipotent with bupivacaine.

5.2 Pharmacokinetic Properties

In human studies, the distribution kinetics of levobupivacaine following i.v. administration are essentially the same as bupivacaine. The plasma concentration of levobupivacaine following therapeutic administration depends on dose and, as absorption from the site of administration is affected by the vascularity of the tissue, on route of administration.

There are no relevant data in patients with hepatic impairment (see section 4.4).

There are no data in patients with renal impairment. Levobupivacaine is extensively metabolised and unchanged levobupivacaine is not excreted in urine.

Plasma protein binding of levobupivacaine in man was evaluated in vitro and was found to be> 97% at concentrations between 0.1 and 1.0 ?g/ml.

In a clinical pharmacology study where 40 mg levobupivacaine was given by intravenous administration, the mean half-life was approximately 80 + 22 minutes, Cmax 1.4 + 0.2 ?g/ml and AUC 70 + 27 ?g•min/ml.

The mean Cmax and AUC(0-24h) of levobupivacaine were approximately dose-proportional following epidural administration of 75 mg (0.5%) and 112.5 mg (0.75%) and following doses of 1 mg/kg (0.25%) and 2 mg/kg (0.5%) used for brachial plexus block. Following epidural administration of 112.5 mg (0.75%) the mean Cmax and AUC values were 0.58 µg/ml and 3.56?µg•h/ml respectively.

The mean total plasma clearance and terminal half-life of levobupivacaine after intravenous infusion were 39 litres/hour and 1.3 hours, respectively. The volume of distribution after intravenous administration was 67 litres.

Levobupivacaine is extensively metabolised with no unchanged levobupivacaine detected in urine or faeces. 3-hydroxylevobupivacaine, a major metabolite of levobupivacaine, is excreted in the urine as glucuronic acid and sulphate ester conjugates. In vitro studies showed that CYP3A4 isoform and CYP1A2 isoform mediate the metabolism of levobupivacaine to desbutyl-levobupivacaine and 3-hydroxylevobupivacaine respectively.These studies indicate that the metabolism of levobupivacaine and bupivacaine are similar.

Following intravenous administration, recovery of levobupivacaine was quantitative with a mean total of about 95% being recovered in urine (71%) and faeces (24%) in 48 hours.

There is no evidence of in vivo racemisation of levobupivacaine.

5.3 Preclinical Safety Data

In an embryo-foetal toxicity study in rats, an increased incidence of dilated renal pelvis, dilated ureters, olfactory ventricle dilatation and extra thoraco-lumbar ribs was observed at systemic exposure levels in the same range as those obtained at clinical use. There were no treatment-related malformations.

Levobupivacaine was not genotoxic in a standard battery of assays for mutagenicity and clastogenicity. No carcinogenicity testing has been conducted.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Chloride

Sodium Hydroxide

Hydrochloric acid

Water for Injections

6.2 Incompatibilities

Levobupivacaine may precipitate if diluted with alkaline solutions and should not be diluted or co-administered with sodium bicarbonate injections. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf Life

Shelf life as packaged for sale: 3 years

Shelf life after first opening: The product should be used immediately

Shelf life after dilution in sodium chloride solution 0.9%: Chemical and physical in-use stability has been demonstrated for 7 days at 20-22°C. Chemical and physical in-use stability with clonidine, morphine or fentanyl has been demonstrated for 40 hours at 20-22°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special Precautions For Storage

Polypropylene ampoules: polypropylene ampoules do not require any special storage conditions.

For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5 Nature And Contents Of Container

Chirocaine is available in two presentations;

10 ml polypropylene ampoule in packs of 5, 10 & 20

10 ml polypropylene ampoule, in sterile blister packs of 5, 10 & 20

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

For single use only. Discard any unused solution.

The solution/dilution should be inspected visually prior to use. Only clear solutions without visible particles should be used.

A sterile blister container should be chosen when a sterile ampoule surface is required. Ampoule surface is not sterile if sterile blister is pierced.

Dilutions of levobupivacaine standard solutions should be made with sodium chloride 9 mg/ml (0.9%) solution for injection using aseptic techniques.

Clonidine 8.4 ?g/ml, morphine 0.05 mg/ml and fentanyl 4 ?g/ml have been shown to be compatible with levobupivacaine in sodium chloride 9 mg/ml (0.9%) solution for injection.

7. Marketing Authorisation Holder

Abbott Laboratories Ltd

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00037/0300

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 06 January 2000

Date of last renewal: 18th December 2008

10. Date Of Revision Of The Text

02nd July 2010

Marplan

Generic Name: isocarboxazid (eye so kar BOX a zid) Brand Names: Marplan

What is Marplan (isocarboxazid)?

Isocarboxazid is a monoamine oxidase inhibitor (MAOI) that works by increasing the levels of certain chemicals in the brain.

Isocarboxazid is used to treat symptoms of depression that may include anxiety, panic, or phobias. This medication is usually given after other antidepressants have been tried without successful treatment of symptoms.

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

What is the most important information I should know about Marplan (isocarboxazid)?

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with isocarboxazid. Do not take isocarboxazid before telling your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. While you are taking isocarboxazid, you must not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while taking isocarboxazid?" section of this leaflet. Eating tyramine while you are taking isocarboxazid can raise your blood pressure to dangerous levels, causing symptoms that include sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, vision problems, and sensitivity to light. Stop taking isocarboxazid and call your doctor at once if you have any of these symptoms. Isocarboxazid can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What should I discuss with my doctor before taking Marplan (isocarboxazid)? Do not use this medication if you have used another MAOI such as phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take isocarboxazid before another MAOI has cleared from your body. Do not take this medication if you are allergic to isocarboxazid, or if you have:

pheochromocytoma (tumor of the adrenal gland);

a history of stroke or blood clots;

liver disease;

kidney disease;

heart disease;

high blood pressure; or

a history of severe or frequent headaches.

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with isocarboxazid. The following drugs should not be used while you are taking isocarboxazid:

diet pills, caffeine, stimulants, ADHD medication, asthma medication, over-the-counter cough and cold or allergy medicines;

blood pressure medication;

diuretics (water pills);

bupropion (Wellbutrin, Zyban);

buspirone (BuSpar);

carbamazepine (Carbatrol, Tegretol);

furazolidone (Furoxone);

meperidine (Demerol, Mepergan);

pargyline (Eutonyl);

procarbazine (Matulane);

alcohol or medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety).

antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adepin, Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or

antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

If you have any of these other conditions, you may need an isocarboxazid dose adjustment or special tests:

high blood pressure;

diabetes;

a thyroid disorder;

schizophrenia;

epilepsy or other seizure disorder;

if you have taken another antidepressant within the past 5 weeks; or

if you are also taking tryptophan (L-tryptophan), guanethidine (Ismelin), levodopa (Larodopa, Parcopa, Sinemet), or methyldopa (Aldomet).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether isocarboxazid 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 isocarboxazid 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. Do not give isocarboxazid to anyone younger than 16 years old without the advice of a doctor. How should I take Marplan (isocarboxazid)?

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.

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

Take this medication for the entire length of time prescribed by your doctor. It may take up to 6 weeks or longer before you notice improvement in your symptoms. Store at room temperature away from moisture and heat.

See also: Marplan 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 shallow breathing, fast heart rate, sweating, fever, slow reflexes, feeling light-headed, fainting, or seizure (convulsions). What should I avoid while taking Marplan (isocarboxazid)? While you are taking isocarboxazid you must not eat foods that are high in tyramine, including:

cheese (especially strong or aged cheeses);

sour cream and yogurt;

beer (including non-alcoholic beer), sherry, Chianti wine, liquers;

dry sausage (such as hard salami, pepperoni), anchovies, caviar, liver, pickled herring;

canned figs, raisins, bananas;

avocados;

chocolate or caffeine;

soy sauce;

sauerkraut;

fava beans;

yeast extracts;

meat extracts;

meat prepared with tenderizer; or

over-the-counter supplements or cough and cold medicines that contain dextromethorphan or tyramine.

You should become very familiar with the list of foods and medicines you must avoid while you are taking isocarboxazid. Eating tyramine while you are taking isocarboxazid can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

Isocarboxazid may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Marplan (isocarboxazid) 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.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using isocarboxazid and call your doctor at once if you have any of these serious side effects:

sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, sweating, vision problems, sensitivity to light;

chest pain, fast or slow heart rate;

swelling, rapid weight gain;

jaundice (yellowing of the skin or eyes); or

feeling light-headed, fainting.

Less serious side effects may include:

dizziness, headache;

tremors or shaking;

constipation, nausea; or

dry mouth.

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 Marplan (isocarboxazid)?

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with isocarboxazid. Do not take isocarboxazid before telling your doctor about all other prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

More Marplan resources Marplan Side Effects (in more detail)Marplan DosageMarplan Use in Pregnancy & BreastfeedingDrug ImagesMarplan Drug InteractionsMarplan Support Group2 Reviews for Marplan - Add your own review/rating Marplan Prescribing Information (FDA) Marplan Advanced Consumer (Micromedex) - Includes Dosage Information Marplan MedFacts Consumer Leaflet (Wolters Kluwer) Isocarboxazid Professional Patient Advice (Wolters Kluwer) Compare Marplan with other medications Depression Where can I get more information? Your pharmacist can provide more information about isocarboxzazid.

See also: Marplan side effects (in more detail)

MOVICOL Chocolate 13.9g, sachet powder for oral solution

MOVICOL Chocolate 13.9g, sachet powder for oral solution

Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take MOVICOL Chocolate carefully to get the best results from it.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What is MOVICOL Chocolate and what is it used for? 2. Before you take MOVICOL Chocolate. 3. How to take MOVICOL Chocolate. 4. Possible side effects. 5. How to store MOVICOL Chocolate. 6. Further information. What is MOVICOL Chocolate and what is it used for?

The name of this product is MOVICOL Chocolate 13.9 g sachet, powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age.

MOVICOL Chocolate helps you to have a comfortable bowel movement even if you have been constipated for a long time. MOVICOL Chocolate also works in very bad constipation known as faecal impaction.

Before you take Movicol Chocolate

Do not take MOVICOL Chocolate if your doctor has told you that you have:

A blockage in your intestine (gut obstruction, ileus) A perforated gut wall Severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon An allergy to any of the ingredients Take special care with MOVICOL Chocolate

Heart conditions

Follow the special instructions in section 3 if you are taking MOVICOL Chocolate for faecal impaction.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines including medicines obtained without a prescription.

Taking MOVICOL Chocolate with food and drink

This medicine can be taken any time with or without food and drink.

Pregnancy and breast feeding

If you are pregnant or breast feeding talk to your doctor before taking MOVICOL Chocolate.

Driving and using machines

MOVICOL Chocolate does not affect your ability to drive or use machines.

How to take MOVICOL Chocolate Constipation:

A dose of MOVICOL Chocolate is 1 sachet.

Take this 1-3 times a day according to the severity of your constipation.

Faecal Impaction:

A dose of 8 sachets a day of MOVICOL Chocolate is needed for the treatment of faecal impaction. The 8 sachets should be taken within 6 hours for up to 3 days if required. If you have a heart condition, do not take more than 2 sachets in any one hour.

How to mix:

Open the sachet and pour the contents into a glass. Add about 125 ml or quarter pint of water to the glass. Stir well until all the powder has dissolved and the MOVICOL Chocolate solution is clear or slightly hazy, then drink it. If you are taking MOVICOL Chocolate for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment

Constipation:

Treatment with MOVICOL Chocolate usually lasts for about 2 weeks.

If your constipation is caused by an illness such as Parkinson’s disease or multiple sclerosis (MS), or if you take medicines that cause constipation your doctor may recommend that you take MOVICOL Chocolate for longer than 2 weeks.

Usually for long term treatment the dose can be lowered to either 1 or 2 sachets a day.

Faecal impaction:

Treatment with MOVICOL Chocolate can be for up to 3 days.

If you take more MOVICOL Chocolate than you should

You may develop diarrhoea. Stop taking MOVICOL Chocolate until it clears, and then start again at a lower dose.

If you are worried contact your doctor or pharmacist.

If you forget to take MOVICOL Chocolate

Take the dose as soon as you remember to take it.

Possible side effects

Like all medicines, MOVICOL Chocolate can have side effects.

Tell your doctor immediately and stop taking MOVICOL Chocolate if: You feel weak, increasingly tired, breathless, very thirsty with a headache or get puffy ankles. You have a skin rash or itching which may be signs of an allergic reaction. Other possible signs of an allergic reaction include difficulty in breathing or dizziness. Other side effects that you may have include:

Very rare side effects (less than 1 person in 10,000)

Stomach pain or diarrhoea but this will usually improve when the dose is reduced Feeling sick or actually being sick or suffering from wind

If any of the above become serious or last more that a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

How to store Movicol Chocolate

Keep out of the reach and sight of children.

Do not use MOVICOL Chocolate after the expiry date shown on the sachet.

Do not store sachet above 25°C. Once you have made up MOVICOL Chocolate in water, if you cannot drink it straight away, keep it covered and in the fridge (2-8°C).

Throw away any solution not used within a 6 hour period.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

Each 13.9g sachet of MOVICOL Chocolate contains the following:

Macrogol 3350: 13.125g Sodium Chloride: 0.3507g Sodium Hydrogen Carbonate: 0.1785g

insulin glargine, recombinant Subcutaneous

IN-su-lin GLAR-jeen, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

Lantus Lantus SoloStar

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Long Acting

Uses For insulin glargine, recombinant

Insulin glargine is a type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have type 2 diabetes mellitus, your body does not produce enough insulin, or the insulin produced is not used properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Insulin glargine is a long-acting insulin that works slowly over about 24 hours. You may have to use insulin glargine in combination with another type of insulin or with a type of oral diabetes medicine to keep your blood sugar under control.

insulin glargine, recombinant is available only with your doctor's prescription.

Before Using insulin glargine, recombinant

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 insulin glargine, recombinant, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to insulin glargine, recombinant 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

insulin glargine, recombinant has been tested in a limited number of children 6 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Geriatric

insulin glargine, recombinant has been tested in a limited number of patients 65 years of age or older and has not been shown 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.

Other Medical Problems

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

Emotional disturbances or Infection or Stress—These conditions increase blood sugar and may increase the amount of insulin or insulin glargine you need Kidney disease or Liver disease—Effects of insulin glargine may be increased; this may change the amount of insulin glargine you need Proper Use of insulin glargine, recombinant Dosing

The dose of insulin glargine, recombinant 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 insulin glargine, recombinant. 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.

Each package of insulin glargine contains a patient information sheet. Read this sheet carefully and make sure you understand:

How to prepare the medicine. How to inject the medicine. How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over 24 hours, it should be taken once daily at bedtime

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

For injection dosage form: For type 2 diabetes mellitus: Adults, teenagers, and children 6 years of age or older—The dose is based on your blood sugar and must be determined by your doctor. Children up to 6 years of age—Use and dose must be determined by your doctor. 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.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using insulin glargine, recombinant

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take insulin glargine, recombinant.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team. Other medicines—Do not take other medicines during the time you are taking insulin glargine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems. Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy. Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines. Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs. Keep some kind of quick-acting sugar handy to treat low blood sugar. Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin glargine can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin glargine with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have emotional stress or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

insulin glargine, recombinant 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 Convulsions (seizures) unconsciousness

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

More common Low blood sugar, including anxious feeling; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue Less common or rare Allergic reaction, including fast pulse, shortness of breath, skin rash or itching over the entire body, sweating, and wheezing

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 or rare Bloating or swelling of face, hands, lower legs, and/or feet depression of skin at injection site injection site pain local allergy, including itching, redness, or swelling at injection site thickening of skin at injection site

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: insulin glargine, recombinant Subcutaneous 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 insulin glargine, recombinant Subcutaneous resources Insulin glargine, recombinant Subcutaneous Side Effects (in more detail)Insulin glargine, recombinant Subcutaneous Use in Pregnancy & BreastfeedingInsulin glargine, recombinant Subcutaneous Drug InteractionsInsulin glargine, recombinant Subcutaneous Support Group15 Reviews for Insulin glargine, recombinant Subcutaneous - Add your own review/rating Compare insulin glargine, recombinant Subcutaneous with other medications Diabetes, Type 1Diabetes, Type 2

Trizivir
Pronunciation: a-BAK-a-vir/la-MIV-ue-deen/zye-DOE-vue-deenGeneric Name: Abacavir/Lamivudine/ZidovudineBrand Name: Trizivir

Sodium Sulfacetamide Sulfur Cleansing Pads
Generic Name: sulfacetamide sodium and sulfur swab Dosage Form: swabSodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads In a vehicle containing Green Tea and Aloe Rx Only

DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent.

Cyklokapron Tablet
Generic Name: Tranexamic Acid (tran-ex-AM-ik ASS-id)Brand Name: Cyklokapron Cyklokapron is used for:

Short-term use (2 to 8 days) for reducing or preventing excessive bleeding and reducing the need for blood clotting factor transfusions during or after tooth extractions in patients with hemophilia.

Cyklokapron is an antifibrinolytic agent. It works by blocking the breakdown of blood clots.

Do NOT use Cyklokapron if: you are allergic to any ingredient in Cyklokapron you have blood clots, bleeding within the brain, or eye problems (retinal disease) you are colorblind you are using factor IX complex concentrates or anti-inhibitor coagulant concentrates

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cyklokapron:

Some medical conditions may interact with Cyklokapron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have kidney disease, upper respiratory tract bleeding, certain blood problems (disseminated intravascular coagulation [DIC]), or a history of blood clots

Some MEDICINES MAY INTERACT with Cyklokapron. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anti-inhibitor coagulant concentrates, factor IX complex concentrates, or tretinoin because risk of blood clots may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyklokapron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cyklokapron:

Use Cyklokapron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Cyklokapron may be taken with or without food. Continue to use Cyklokapron for the full course of treatment even if you feel well. Do not miss any doses. If you miss a dose of Cyklokapron, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cyklokapron.

Important safety information: Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Cyklokapron. LAB TESTS, including eye exams, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Use Cyklokapron with caution in the ELDERLY because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cyklokapron, discuss with your doctor the benefits and risks of using Cyklokapron during pregnancy. Cyklokapron is excreted in breast milk. If you are or will be breast-feeding while you are using Cyklokapron, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Cyklokapron:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; giddiness; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain, swelling, or tenderness; changes in vision (disturbance of color, sharpness, or field of vision); chest pain; decreased urination; one-sided weakness; severe headache; shortness of breath; speech problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cyklokapron side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include dizziness on standing; lightheadedness; severe nausea or vomiting.

Proper storage of Cyklokapron:

Store Cyklokapron at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cyklokapron out of the reach of children and away from pets.

General information: If you have any questions about Cyklokapron, please talk with your doctor, pharmacist, or other health care provider. Cyklokapron is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cyklokapron. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Cyklokapron resources Cyklokapron Side Effects (in more detail)Cyklokapron Use in Pregnancy & BreastfeedingCyklokapron Drug InteractionsCyklokapron Support Group0 Reviews for Cyklokapron - Add your own review/rating Compare Cyklokapron with other medications Bleeding DisorderFactor IX DeficiencyHemophilia A

Pralatrexate
Pronunciation: PRAL-a-TREX-ateGeneric Name: PralatrexateBrand Name: Folotyn

Gianvi
drospirenone and ethinyl estradiol Dosage Form: tabletsGianvi™

Leukemia Medications

Definition of Leukemia:

Any of a group of diseases of the reticuloendothelial system involving uncontrolled proliferation of white blood cells (leukocytes). For information about a specific type of leukemia see one of the following:

chronic myelogenous leukemia (CML) hairy cell leukemia chronic lymphocytic leukemia (CLL) acute lymphocytic leukemia acute nonlymphocytic leukemia (AML) chronic myelomonocytic leukemia

See also Leukemia Resources.

Drugs associated with Leukemia

The following drugs and medications are in some way related to, or used in the treatment of Leukemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under LeukemiaAcute Lymphoblastic Leukemia (10 drugs) Acute Lymphocytic Leukemia (14 drugs) Acute Myeloblastic Leukemia (1 drug) Acute Myeloid Leukemia (8 drugs in 2 topics) Acute Nonlymphocytic Leukemia (13 drugs) Chronic Eosinophilic Leukemia (1 drug) Chronic Lymphocytic Leukemia (24 drugs in 2 topics) Chronic Myelogenous Leukemia (16 drugs) Hairy Cell Leukemia (5 drugs) Meningeal Leukemia (3 drugs) Learn more about Leukemia

Medical Encyclopedia:

Leukemia

Harvard Health Guide:

Symptoms and treatment for Leukemia Drug List:BaycadronClinalog-InjectionDe-Sone-La-InjectionDeltasoneDexacort-Phosphate-In-TurbinaireDexasone-InjectionDexpak-Tablets-Dose-PackIdamycinKen-Jec-40-InjectionMeticortenSolurex-InjectionSprycelSterapred-DsTarabine-PfsTriamcot-InjectionU-Tri-Lone-InjectionZema-Pak-10-Day

Quinaretic
quinapril hydrochloride and hydrochlorothiazide Dosage Form: tablets

Quinaretic®

Care Decongestant Nasal Spray
1. Name Of The Medicinal Product

Oxymetazoline 0.05% w/v Nasal Spray

Care Decongestant Nasal Spray

2. Qualitative And Quantitative Composition

The nasal solution contains Oxymetazoline (as hydrochloride) 0.05% w/v.

For excipients, see 6.1

3. Pharmaceutical Form

Nasal spray, solution

4. Clinical Particulars 4.1 Therapeutic Indications

Oxymetazoline Nasal Spray or Care Decongestant Nasal Spray is recommended for the relief of nasal congestion in such conditions as the common cold, catarrh and hayfever.

4.2 Posology And Method Of Administration

Adults and Elderly

While holding upright the spray nozzle should be inserted into each nostril in turn and squeezed firmly twice while breathing in. The application may be repeated up to 2 times a day, or used at bedtime to give relief through the night.

Children

Not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to any component of the medicinal product.

Patients who are receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment; patients suffering from porphyria, glaucoma, coronary artery disease, hypertension, hyperthyroidism or diabetes.

4.4 Special Warnings And Precautions For Use

If symptoms persist, consult your doctor. Prolonged use may result in rhinitis medicamentosa and should therefore be avoided. Treatment should be limited to a maximum of seven days. Keep all medicines safely away from children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

If you are taking other medicines, you should see your doctor for advice before taking this medicine.

4.6 Pregnancy And Lactation

The safety to use in pregnancy has not been established and administration of oxymetazoline during pregnancy should be avoided.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that it may cause local skin reactions (e.g. contact dermatitis) and discolouration.

Benzalkonium chloride may cause local skin irritation.

4.9 Overdose

No statement.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group (ATC code): S01G A04 Sympathomimetics used as decongestants.

Oxymetazoline is an alpha-adrenoceptor agonist which causes local vasoconstriction when applied to nasal membrane.

5.2 Pharmacokinetic Properties

When applied locally to nasal mucosa, oxymetazoline acts within a few minutes and its effects last for up to 12 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

Benzalkonium chloride

Thiomersal

Sodium chloride

Levomenthol

Cineole

Camphor

Methyl salicylate

Poloxamer 188

Sodium citrate (dihydrate) (E331)

Citric acid (anhydrous) (E330)

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

White, low density polyethylene/polyethylene copolymer 15ml bottle.

White, high density polyethylene 15ml and 20ml bottle.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0343

9. Date Of First Authorisation/Renewal Of The Authorisation

24/01/2007

10. Date Of Revision Of The Text

20/12/2010

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable

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