Simstatin -10 tablets (simvastatin)

SIMSTATIN-10 NAFDAC NO: A4 – 5621

(SIMVASTATIN TABLETS)

COMPOSITION

SIMSTATIN-10

Each film coated tablet contains:

Simvastatin USP                    10mg

Excipients                               q.s

 

THERAPEUTIC CATEGORY

Lipid-regulating drugs.

 

MECHANISM OF ACTION

Simvastatin is a prodrug and is  hydrolyzed to its active B-hydoxy acid form, simvastatin acid, after administration.simvastatin is a specific inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate,an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, simvastatin reduces VLDL and TG and increases HDL-C.

 

INDICATIONS

SIMSTATIN 10/20/40(Simvastatin Tablets) is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:

-Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events.

-Reduce elevated total-C, LDL-C,Apo B, TG , and increase HDL-C in patients with primary hyperlipidemia(heterozygous familial and nonfamilial) and mixed dyslipidemia.

-Reduce elevate TG in patients with hypertrigiyceridemia and reduce TG and VLDL-C in patient with primary dysbetalipoproteinemia.

-Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia.

-Reduce elevated total-C, LDL-C,and Apo B in boys and postmenarchal girls,10 to 17years of age with  heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

 

DOSAGE & ADMINISTRATION

Dose range is 5-80mg/day

Recommended usually starting dose is 20-40mg once a day in the evening.

Recommended starting dose for patients at high risk of CHD is 40 mg /day.

Adolescents (10-17years of age) with HeFH: starting dose is 10 mg/day: maximum recommended dose is 40 mg/day.

 

CONTRA-INDICATIONS

Hypersensitivity to any component of this medication.

Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels.

Women who are pregnant or may become pregnant.

Nursing mothers

 

SPECIAL WARNING AND PRECAUTIONS

Advice to patients: Promptly report any unexplained muscle pain, tenderness or weakness, especially if accompanied by malaise or fever. Follow prescribed diet; take with meals. Avoid large quantity of grapefruit juice (>1quart daily).

 

Nursing action: Administer as a single dose in the evening with meals.

Liver enzyme elevation may be observed during simvastatin therapy.

Combination with other hypolipidemic agent may be required to achieve optimal reductions of LDL cholesterol.

Diet ,weight reduction and exercise should be attempted to control hypercholesterolemia before the institution of simvastatin therapy.

Advice patients to continue with the diet and exercise regimen during therapy.

 

SIDE EFFECTS

Commonly found adverse effects with SIMSTATIN 10 /20/ 40 are constipation, diarrhea, nausea, dyspepsia, flatulence, dizziness, skin rash, fatigue, and myopathy.

 

DRUG INTERACTIONS

Do not use simvastatin with: Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, HIV protease inhibitors, Nefazodone.

Do not exceed 10mg simvastatin daily with Gemfibrozil, cyclosporine, danazole.

Do not exceed 20mg simvastatin daily when taken with Amiodarone, verapamil.

 

STORAGE

Keep in a cool, dry, dark place & away from reach of children.

 

PRESENTATION

Strip of 14 tablets

PACK :28’S