Ifistatin

Ifistatin

simvastatin

Manufacturer:

Unique Pharm

Distributor:

Uni Drug
Concise Prescribing Info
Contents
Simvastatin
Indications/Uses
In CHD & hypercholesterolemia to reduce the risk of total mortality, coronary death & non-fatal MI & reduce the risk for undergoing myocardial revascularisation procedures. Reduction of elevated total & LDL cholesterol levels in patients w/ primary hypercholesterolemia (types IIa & IIb). Reduction of elevated LDL cholesterol in patients w/ combined hypercholesterolemia & hypertriglyceridemia.
Dosage/Direction for Use
Initially 5-10 mg once daily in the evening. Maintenance: 5-40 mg once daily. Max dose: 40 mg daily. Elderly & severe renal insufficiency 5 mg daily. Patient taking concomitant cyclosporine Initially 5 mg daily. Max dose: 10 mg daily. In combination w/ gemfibrozil or niacin Max dose: 10 mg daily. Patient taking concomitant amiodarone or verapamil Max dose: 20 mg daily.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Concomitant administration of potent CYP3A4, gemfibrozil, cyclosporine or danazol. Pregnancy & lactation.
Special Precautions
Predisposing factors for myopathy eg, uncontrolled hypothyroidism & seizures, hypotension, severe infection, major surgery, trauma; severe metabolic, endocrine & electrolyte disorders. Perform liver function tests before initiation of therapy & periodically thereafter. Asian patients. Concomitant use w/ other agents used to lower cholesterol levels, ketoconazole, spironolactone, cimetidine. Severe renal insufficiency. Pregnancy & lactation. Childn.
Adverse Reactions
Abdominal pain, asthenia, constipation, diarrhoea, dyspepsia, flatulence, nausea, headache, upper resp tract infections.
Drug Interactions
Rhabdomyolysis w/ immunosuppressants, itraconazole, gemfibrozil, nicotinic acid, erythromycin. Increased digoxin conc. Potentiated effect of coumarin anticoagulants (eg, warfarin). Increased risk of myopathy w/ potent CYP3A4 inhibitors eg, ketoconazole, clarithromycin, HIV PIs, nefazodone, cyclosporin, amiodarone, verapamil, colchicine. Avoid use w/ grapefruit juice.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Ifistatin tab 10 mg
Packing/Price
3 × 10's
Form
Ifistatin tab 20 mg
Packing/Price
3 × 10's
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