Priacin

Simvastatin

Existing or high risk of CHD: Reduce the risk of total mortality by reducing CHD death, non-fatal MI & stroke, need for coronary & non-coronary revascularization procedures. Hyperlipidemia: Adjunct to diet to reduce elevated total-C, LDL-C, TG & apolipoprotein B (apo B) & to increase HDL-C in patients w/ primary hypercholesterolemia including heterozygous familial hypercholesterolemia (Fredrickson type IIa) or combined (mixed) hyperlipidemia (Fredrickson type IIb) when response to diet & other nonpharmacological measures are inadequate. Adjunct to diet & other non-dietary measures for the treatment of patients w/ homozygous familial hypercholesterolemia to reduce elevated total-C, LDL-C & apo B.

Dosage range: 5-80 mg/day, adjust dose at intervals not <4 wk up to a max of 80 mg/day if needed. Existing or high risk of CHD 20 or 40 mg/day. Hyperlipidemia 10 or 40 mg/day. Homozygous familial hypercholesterolemia 40 mg/day or 80 mg/day in 3 divided doses (20 mg, 20 mg & 40 mg). Concomitant therapy w/ cyclosporine, danazol, gemfibrozil or other fibrates (except fenofibrate) Max: 10 mg/day; w/ amiodarone or verapamil Max: 20 mg/day; w/ diltiazem Max: 40 mg/day. All doses to be taken as single dose in the evening.

May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Concomitant administration of potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV PIs, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin & nefazodone) & gemfibrozil, cyclosporine or danazol. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation.

Perform liver function tests before initiating treatment & periodically thereafter (eg, semi-annually) for the 1st yr of treatment. Discontinue use if transaminase levels increase to 3 x ULN & if myopathy is suspected. Substantial alcohol consumption. Predisposing factors for rhabdomyolysis. Creatinine kinase (CK) measurement should not be done following strenuous exercise or in the presence of any alternative cause of CK increase. Female gender. Renal impairment. Uncontrolled hypothyroidism. Personal or familial history of hereditary muscular disorder or previous history of muscular toxicity w/ a statin or fibrate. Alcohol abuse. CK levels should be measured if muscular pain, weakness or cramps occur while on statin treatment. Therapy should be temporarily stopped a few days prior to elective major surgery & when any major or surgical condition supervenes. Chinese patients taking concomitant lipid-modifying doses (≥1 g/day) of niacin or niacin-containing products. Elderly >65 yr.

Rarely anaemia; headache, paresthesia, dizziness, peripheral neuropathy; constipation, abdominal pain, flatulence, dyspepsia, diarrhoea, nausea, vomiting, pancreatitis; hepatitis/jaundice; rash, pruritus, alopecia; myopathy, rhabdomyolysis, myalgia, muscle cramps; asthenia; increased serum transaminases (alanine & aspartate aminotrasferases, γ-glutamyl transpeptidases), alkaline phosphatase & serum CK levels; HbA1c & fasting serum glucose levels.

Potent CYP3A4 inhibitors (itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, boceprevir, telaprevir, nefazodone); other fibrates (except fenofibrate); risk of myopathy/rhabdomyolysis w/ fusidic acid, Ca channel blockers (eg, verapamil, diltiazem or amlodipine), CYP3A4 moderate inhibitors, niacin (nicotinic acid ≥ 1 g/day), colchicine, ciclosporin, danazol, amiodarone. Increased AUC w/ gemfibrozil. Increased prothrombin time w/ oral anticoagulants. Increased plasma levels w/ grapefruit juice.

Dyslipidaemic Agents

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

POM