Lochol

In hyperlipidemia: Adjunct to diet to reduce elevated total-C & LDL-C level in primary hypercholesterolemia & mixed dyslipidemia (IIa & IIb) when response to diet & other non-pharmacological measures alone has been inadequate. In CHD: Reduce coronary death, reduce risk of non-fatal MI; undergoing myocardial revascularization procedures; stroke & transient ischemic attacks (TIA).

Hyperlipidemia Initially 10-20 mg daily as a single dose in the evening. Recommended dose range: 5-80 mg daily as a single dose in the evening. CHD Initially 10-20 mg daily as a single dose in the evening. Max: 80 mg daily as a single dose in the evening. Adjust dosage intervals of not <4 wk.

May be taken with or without food.

Hypersensitivity to simvastatin & HMG-CoA reductase inhibitors. Active liver disease or unexplained persistent elevation of serum transaminase. Pregnancy & lactation.

Discontinue if markedly elevated creatine kinase level occur or if myopathy is diagnosed or suspected; if patient develops persistent elevated LFTs (3x ULN). Not to be used in patients w/ active liver disease or unexplained transaminase elevation. Sleep disturbance. Photosensitivity. Patients w/ diffuse myalgias, muscle tenderness &/or marked elevations of creatine kinase levels (10x ULN); HoFH. Carefully monitor for any signs & symptoms of muscle pain, tenderness, or weakness, particularly during initial mth of therapy & during any periods of upward dosage titration. Control hypercholesterolemia w/ diet, exercise & wt reduction on obese patients. Place patient on a standard cholesterol-lowering diet before & during treatment. Determine prothrombin time prior treatment & frequently during early therapy. Perform LFTs before treatment, at 6-12 wk after initiation & after dose elevation & periodically thereafter (about 6 mth intervals). Ensure protective measures against UV exposure or sunlight (eg, sunscreens, protective clothing). Immunosuppressive therapy including cyclosporin. Concomitant use w/ fibric acid derivative or lipid-lowering doses of niacin (nicotinic acid). Not recommended during pregnancy & breast-feeding. Not recommended in childn.

Nausea, vomiting, diarrhea, skin rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, peripheral neuropathy & anemia. Rarely, rhabdomyolysis, hepatitis & jaundice. Hypersensitivity syndrome including angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia, increased ESR, arthritis, arthralgia, urticaria, photosensitivity, fever, flushing, dyspnea & malaise.

Increased plasma level & risk of myopathy w/ potent CYP3A4 inhibitors (eg, cyclosporin, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV PIs & nefazodone). Increased risk of myopathy w/ gemfibrozil. Decreased antihyperlipidemic activity w/ propanolol. Increased anticoagulant effect of warfarin.

Dyslipidaemic Agents

C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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