Endovaz

Endovaz

simvastatin

Manufacturer:

Unique

Distributor:

Ambica
Concise Prescribing Info
Contents
Simvastatin
Indications/Uses
10-mg FC tab Adjunct therapy in patients w/ homozygous familial hypercholesterolemia who have some LDL-receptor function; CV risk reduction. Reduction of LDL-cholesterol, apolipoprotein B & triglycerides. Increase of HDL-cholesterol in the treatment of hyperlipidemia including hypercholesterolemia, combined (mixed) hyperlipidemia (type IIa & IIb hyperlipoproteinemia), hypertriglyceridemia (type IV) & primary dysbetalipoproteinemia (type II). 20-mg FC tab Reduction of elevated total & LDL-cholesterol levels in patients w/ primary hypercholesterolemia (types IIa & IIb).
Dosage/Direction for Use
Initially 5-10 mg once a day in the evening. Max: 40 mg/day. Patient requiring reduction in LDL-cholesterol of ≥20% to achieve their goal Initially 10 mg/day. Patient requiring smaller reductions & elderly Initially 5 mg/day. Adjustment of dose should be made at ≥4 wk interval. Max LDL-cholesterol reduction in elderly Daily doses of 20 mg or less. Patient w/ severe renal insufficiency Initially 5 mg/day & closely monitored.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Acute liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation.
Special Precautions
May cause elevation of creatine phosphokinase & transaminase levels. Monitor unexplained muscle pain, tenderness or weakness (particularly if accompanied by malaise or fever); rhabdomyolysis w/ acute renal failure secondary to myoglobinuria when used alone or concomitantly w/ immunosuppressive therapy, fibrates or erythromycin in seriously ill patients. Perform liver function tests before initiation of treatment at 6 or 12 wk, after initiation of therapy or elevation in dose & periodically thereafter (ie, semiannually). Concomitant use w/ drugs (eg, ketoconazole, spironolactone, cimetidine) that may decrease the levels of activity of endogenous steroid hormones. Childn.
Adverse Reactions
Abdominal pain, asthenia, constipation, diarrhea, dyspepsia, flatulence, nausea, headache, upper resp tract infections, skin rashes, dizziness, blurred insomnia & dysgeusia.
Drug Interactions
Rhabdomyolysis w/ immunosuppressive drugs, itraconazole, gemfibrozil, nicotinic acid, erythromycin. Modestly potentiated the effect of coumarin anticoagulants (warfarin) resulting in increased prothrombin time.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Endovaz FC tab 20 mg
Packing/Price
100's
Form
Endovaz FC tab 10 mg
Packing/Price
100's;30's
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