Stroke
Primary hypercholesterolemia (type IIa and IIb) in patients who have not responded adequately to diet and other appropriate measures. Coronary heart disease and elevated plasma cholesterol level.
Simvastatin is a preparation of Simvastatin which acts as a Cholesterol lowering agent. The main mechanism of reduction of low density lipoprotein (LDL) cholesterol is that following inhibition of HMG-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 the very low- density lipoprotein (VLDL) cholesterol and reduced formation of LDL from VLDL. Simvastatin is extensively metabolised in the liver; which is also the main site of action of the drug.
Digoxin: Concomitant administration of Simvastatin and Digoxin in normal volunteers resulted in a slight elevation (less than 0.3 µgm/ml) in drug concentrations in plasma compared to concomitant administration of placebo and Digoxin.
Coumarin derivatives: Slightly enhance the anticoagulant effect of Warfarin (mean changes in p rothrombin time less than two seconds) in normal volunteers maintained in a state of low therapeutic anticoagulation.
Others: In clinical studies, Simvastatin was used concomitantly with ACE inhibitors, beta-blockers, calcium channel blockers, diuretics and NSAIDs without evidence of clinically significant adverse interactions.
Simvastatin is generally well tolerated. Headache, fatigue, insomnia, gastrointestinal effects like nausea, constipation or diarrhoea, flatulence, dyspepsia, abdominal cramps and muscular effects like myalgia, myositis and myopathy 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. No potentially life threatening effects have been reported.
Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
- 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
Other Anti-anginal & Anti-ischaemic drugs, Statins
There are no data available on overdose. No antidote is available. General measures should be adopted and liver function should be monitored.
Store in a cool, dry place, Away from light keep out of reach of children.
