Simplaqor

Simplaqor

simvastatin

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Simvastatin
Indications/Uses
Treatment of primary hypercholesterolaemia or mixed hyperlipidaemia when response to diet & other nonpharmacological measures are not sufficient. Treatment of homozygous familial hypercholesterolaemia. Reduction of CV-induced deaths & events in patient w/ atherosclerotic heart disease or DM.
Dosage/Direction for Use
Hyperlipidaemia Initially 10-20 mg. Patients requiring higher starting dose may be given 20-40 mg. Homozygous familial hypercholesterolaemia 40 mg/day or 80 mg/day in 3 divided doses. Prevention of CV events 20-40 mg. 80 mg should be use only in patients who have been taking this dose for ≥12 mth w/o evidence of muscle toxicity. Do not start an 80-mg dose in new patients. Max dose of 80 mg/day. Concomitant w/ verapamil, diltiazem & other fibrates Max dose of 10 mg/day. Concomitant w/ amiodarone, amlodipine & ranolazine Max dose of 20 mg/day. Childn & adolescent (10-17 yr) 10 mg/day as a single dose in the evening at the beginning of treatment. Max dose of 40 mg/day.
Administration
May be taken with or without food: Avoid excessive consumption of grapefruit juice.
Contraindications
Hypersensitivity. Concurrent w/ gemfibrozil, danazol & cyclosporine. Active liver disease or unexplained, persistent elevation of transaminases. Pregnancy & lactation.
Special Precautions
Severe lung disease. Risk of myopathy & rhabdomyolysis. Renal impairment, uncontrolled hypothyroidism, history of hereditary muscular disorders (including muscular toxicity), alcohol abuse. Temporarily discontinue treatment pre-op. Perform liver function tests before & during treatment. Childn <10 yr. Elderly >70 yr.
Adverse Reactions
Insomnia, nightmares, depression, memory loss. Sexual dysfunction. Anaemia, headache, paraesthesia, peripheral neuropathy & polyneuropathy, GI disorders, hepatitis, jaundice, rash, pruritus, alopecia, myopathy, myositis, rhabdomyolysis w/ or w/o acute renal failure, myalgia, muscular cramps, polymyositis. Increased serum transaminases, alkaline phosphatase & creatine kinase levels, fatigue.
Drug Interactions
Itraconazole, ketoconazole, posaconazole, fluconazole, erythromycin, clarithromycin, telithromycin, HIV-protease inhibitors (eg, nelfinavir), nefazodone. Gemfibrozil, other fibrates, ciclosporin, verapamil, diltiazem, amlodipine, amiodarone, danazol, oral anticoagulants, fusidic acid, rifampicin, colchicine, niacin, nicotinic acid, grapefruit juice.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Simplaqor film-coated tab 10 mg
Packing/Price
30's
Form
Simplaqor film-coated tab 20 mg
Packing/Price
30's;90's
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