PT. Pyridam Farma Tbk.

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Rocoz Kaplet

Description

Composition:
Simvastatin 10 mg

Pharmacological Classification :
Antihyperlipidaemic agent

Indication:
CHD: Reduce risk of death, major vascular events, major coronary events & stroke. Reduce the need for coronary,  peripheral &
noncoronary revascularization  procedures. Reduces the risk of hospitalization for angina pectoris. Hyperlipidemia: Adjunct to
diet to reduce elevated total-C, LDL-C, TG & Apo-B & to increase HDL-C in patients with primary hypercholesterolemia or mixed
hyperlipidemia, when response to diet & other nonpharmacological measures is inadequate. Treatment of hyperlipidemia &
dysbetalipoproteinemia.

Dosage:.
Dosage range: 5-80 mg/day, given as single dose in the evening. Adjust at 4 weeks intervals as required.

Contra Indication:
Active liver disease or unexplained persistent elevations of  serum transaminase. Pregnancy & lactation. Hypersensitivity.

Special  Precaution:
Elevations of serum transamineses. If the transaminase level rises persistently to 3 times the upper limit of normal,
discontinue drug. Liver function tests recommended before treatment begins & periodically thereafter (eg semi-annually) for
the 1st year of treatment or until 1 year after the last elevation in dose in all patients. Cautions in patients who consume
substantial quantities of alcohol & / or have a history of liver disease. If muscle symptoms &/or marked elevation of CPK levels
occur, discontinue drug. Administer Rocoz to women of childbearing age only when highly unlike conceive.

Adverse Reaction:
Abdominal pain, flatulence constipation, asthenia & headache. Rarely hepatitis, hypersensitivity syndrome.

Drug Interaction:
Use with caution with coumarin anticoagulants & in combination with immunosuppressive agents, gemfibrozil or lipid lowering
doses of niacin.

Presentation :
Film-coated Caplet 10 mg x 30’s.  Reg. No. DKL0821015409A1