Simbado Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info

Concise Prescribing Info

Contents

Simvastatin

Indications/Uses

Reduction of total & LDL cholesterol levels in patients w/ primary hypercholesterolemia when diet & other nonpharmacological measures result in inadequate response.

Dosage/Direction for Use

Initially, 5-10 mg once daily in the evening. Dosage may be increased at intervals of 4 wk to 40 mg once daily.

Administration

May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.

Contraindications

Acute hepatic disorders, unexplained persistent elevation of SGOT/SGPT. Pregnancy & lactation.

Special Precautions

Alcoholism. Hypertriglyceridemia. Perform LFTs prior to therapy. Evaluate myopathy effects if diffuse muscle pain & elevation of creatine phosphokinase occurs. Childn & adolescents.

Adverse Reactions

Muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgia. Tremor, dizziness, vertigo, lack of memory, paresthesia, peripheral neuropathy. Pancreatitis, hepatitis, cholestatic jaundice. Gynecomastia, loss of libido, erectile dysfunction. Skin disorders.

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Drug Interactions

May increase the anticoagulant effects of warfarin. May increase the risk of myopathy & rhabdomyolysis w/ ciclosporin, erythromycin, gemfibrozil & niacin. Heart activity may be elevated w/ concomitant use of digoxin.

MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Regulatory Classification

Presentation/Packing

Form

Simbado tab 10 mg

Packing/Price

30's (Rp90,000/pak)

Form

Simbado tab 5 mg

Packing/Price

30's (Rp60,000/pak)

Simbado

simvastatin

Manufacturer:

Lapi