Primary hypercholesterolemia, Fredickson Type IIa & IIb dyslipidemia.
HMG CoA Reductase Inhibitor
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.
Hypersensitivity, Active liver disease or unexplained persistent elevations of serum transaminases, Porphyria, Pregnancy & breastfeeding, Women of child-bearing potential unless adequately protected by barrier contraceptive methods.
Headache, nausea, flatulence, heartbum, abdominal pain, diarrhoea/ constipation, dysgeusia; dose-related myopathy (e.g. myalgia. muscle weakness & dask urine); serum transaminases & GPK elevations; hypersensitivity; lens opacities; blurring of vision; din’ ; sexual dysfunction; insomnia; depression & upper resp symptoms. Severe rhabdomyolysis w/ acute renal failure.
The U.S. Food and Drug Administration (FDA) says that statins are not recommended for pregnant women. They are rated as “Pregnancy Category X” drugs, which signifies that studies have shown they may cause birth defects and that the risks clearly outweigh any benefit. It is not known if simvastatin passes into breast milk. However, because it has the potential to cause serious side effects in a nursing infant, it should not be taken by women who are breastfeeding.
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.
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