Valemia: Dosages and Ingredients | Full Prescribing Info

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Simvastatin.

Indications/Uses

Reduction of elevated total and LDL-C levels in patients with primary hypercholesterolemia, when the response to diet and other nonpharmacological measure alone has been inadequate.
Reducing elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia).

Dosage/Direction for Use

Adult: Initially 10 mg/day. Max: 40 mg/day.
Mild to moderate hypercholesterolemia: 5 mg/day.
All doses to be taken as a single dose in the evening. Adjust dose at 4 weekly interval as required.
Administration: Avoid excessive consumption (>1 L/day) of grapefruit juice.

Contraindications

Active liver disease or persistent elevations of serum transaminases.
Pregnancy and lactation.

Special Precautions

Alcohol consumption, past history of liver disease.

Adverse Reactions

Dysfunction of certain cranial nerves, tremor, vertigo, memory loss, paresthesia, peripheral neuropathy, peripheral nerve palsy; hypersensitivity reactions; pancreatitis, anorexia, vomiting; alopecia, gynecomastia, decrease of libido, erectile dysfunction; progression of cataracts, ophthalmoplegia.

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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

Valemia FC tab 10 mg

Packing/Price

5 × 6's (Rp304,500/boks)

Form

Valemia FC tab 5 mg

Packing/Price

5 × 6's (Rp183,000/boks)

Valemia

simvastatin

Manufacturer:

Sanbe