Vastocor
Simvastatin USP 10 mg tablet

Presentation
Each Vastocor tablet contains Simvastatin USP 10 mg.

Description
Vastocor tablet is a cholesterol lowering agent containing Simvastatin USP 10 mg. It acts by inhibiting 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, an enzyme which catalyses the biosynthesis of cholesterol.

Mode of action
The main mechanism of reduction of low-density lipoprotein (LDL) cholesterol is that, following inhibition of HGM-CoA reductase activity, the LDL receptor density on the liver cells is increased and this leads to an increased removal of LDL cholesterol from the plasma and increased catabolism of LDL cholesterol. In addition, there is a reduction in very low-density lipoprotein (VLDL) cholesterol and reduced formation of LDL from VLDL.

Indications
Vastocor (Simvastatin) is indicated in patients with primary hypercholesterolaemia who have not responded adequately to diet and other appropriate measures. It can also be given to reduce incidence of clinical coronary events and slow progression of coronary atherosclerosis in patients with coronary heart disease and cholesterol concentration of 5.5 mmol/litre or greater.

Dosage and Administration
The patients should be placed on a standard cholesterol-lowering diet before receiving Vastocor (Simvastatin) and maintained on it during treatment. Individual doses depend on baseline LDL-Cholesterol levels and also on the patient's response to the drug. In hyper cholesterolaemia the initial recommended dose is 10 mg daily at night. Adjustment of the dose should be done at intervals of not less than 4 weeks. The recommended dose range is 10-40 mg once daily at night. In case of heart diseases initial dose should be 20 mg once daily at night.

Side-effects
Vastocor (Simvastatin) is generally well tolerated, no potential life-threatening effects have been reported. Headache, fatigue, insomnia, gastrointestinal effects like nausea, constipation or diarrhoea, flatulence, dyspepsia, abdominal cramps and effects like myositis have been reported. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been associated with Simvastatin therapy. Hepatitis, pancreatitis, rash, angio-oedema have also been reported.

Contraindications
Simvastatin should not be used in -
* Active liver disease
* Pregnant and breast feeding mother
* Women of child bearing age unless they have been adequately protected by
contraception
* Hypersensitivity to any component of the preparation
* Patients with the homozygous familial hypercholesterolemia who have a complete
absence of LDL receptors

Precautions
* If there is a history of liver disease
* Who take high alcohol
* Liver function test should be done before and during treatment
* If serum transaminase rises three times the upper limit of normal, treatment should be
discontinued
* Avoid pregnancy during and for one month after treatment

Drug Interactions
Coumarin derivatives : The administration of Simvastatin appeared to slightly enhance the anticoagulant effect of Warfarin (mean change in prothrombin time less than two seconds) in normal volunteers maintained in a state of low therapeutic anticoagulation.
Digoxin : Concomitant administration of digoxin and Simvastatin results in a slight increase (less than 0.3 micro gm/l) in plasma digoxin levels.
Others : In clinical studies, Simvastatin was used concomitantly with ACE inhibitors, diuretics and NSAID's without evidence of clinically significant adverse interactions.

Overdosage
In case of acute overdose no specific data is available. There is no specific antidote available. General measures should be adopted and liver function should be monitored.

Commercial Pack
Vastocor : Box containing 3 blister strips of 10 film coated tablets.