Vogdia

Adjunct to diet for primary hypercholesterolaemia or mixed dyslipidaemia when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. Primary prevention, as adjunct to diet, to reduce CV mortality & morbidity in patients w/ moderate or severe hypercholesterolaemia & at high risk of 1st CV event. Secondary prevention, as adjunct to correction of other risk factors, to reduce CV mortality & morbidity (MI, revascularization, ischemic stroke & transient ischemic attack) in patients w/ history of MI or unstable angina pectoris & w/ either normal or increased cholesterol levels. Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid-organ transplantation.

Hypercholesterolemia 10-40 mg once daily. Max daily dose: 40 mg. CV prevention Initial & maintenance dose: 40 mg daily. Following organ transplantation Patients receiving immunosuppressive therapy Initially 20 mg daily, may be adjusted up to 40 mg. Moderate or severe renal & significant hepatic impairment Initially 10 mg daily. Coadministration w/ bile-acid binding resin Give 1 hr before or at least 4 hr after resin. Coadministration w/ or w/o other immunosuppressants Initially 20 mg once daily, titrated to 40 mg.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained persistent serum transaminase elevations. Pregnancy & lactation.

Discontinue therapy in patient w/ markedly elevated CPK levels (>10x ULN) or if myopathy is suspected/diagnosed; suspected immune-mediated necrotizing myopathy; myalgia at calf, back or whole body; transaminase level >3x ULN. Interrupt therapy if hepatic failure has been reported. Temporarily withhold therapy in patients experiencing conditions predisposing to development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, uncontrolled epilepsy, severe metabolic, endocrine, or electrolyte disorders). Increased risk of rhabdomyolysis w/ high dose, elderly, hepatic or renal insufficiency, alcoholism & hypothyroidism; blood sugar level. Evaluate patients w/ signs & symptoms of endocrine dysfunction. Liver function abnormalities; rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Unexplained muscle pain, tenderness, weakness or brown urine. Patients w/ recent (<6 mth) hepatic disease, history of hepatic disease, signs of suspected hepatic disease (unexplained aminotransferase elevations, jaundice), or are heavy alcohol users; inadequately treated hypothyroidism & those taking other drugs associated w/ myopathy eg, colchicine; pre-existing amyotrophic lateral sclerosis. Perform LFTs at baseline; before, 6 & 12 wk after taking the drug; every 6 mth for patients routinely using the drug. Concomitant use w/ medication that may reduce steroid hormone levels/activity (eg, spironolactone, cimetidine, ketoconazole); digoxin, warfarin. Increased risk of myopathy/rhabdomyolysis w/ azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone, colchicine; dose-related risk of rhabdomyolysis w/ concurrent use of erythromycin, cyclosporine, fibric acid derivatives (eg, gemfibrozil) or niacin (doses ≥1 g daily). Adequate contraception is recommended in females of reproductive potential. Discontinue treatment immediately if unplanned pregnancy occurs during treatment; in females planning pregnancy 1-2 mth prior to attempting to conceive. Not recommended in childn <18 yr. Elderly.

Rash; diarrhea, nausea & vomiting; musculoskeletal pain; headache; cough, rhinitis, URTI. DM; pancreatitis; increased liver enzymes; autoimmune necrotizing myopathy, rhabdomyolysis, tendon rupture.

Increased creatine kinase conc w/ nefazodone. Reduced plasma conc w/ ritonavir-boosted saquinavir; efavirenz. Increased risk of rhabdomyolysis w/ colchicine. Concurrent use w/ fusidic acid. Increased myopathy including rhabdomyolysis w/ fusidic acid. Increased plasma conc w/ cyclosporine; gemfibrozil. Increased risk of myopathy & myositis w/ statins & fibric acid derivatives. Reduced effectiveness w/ cholestyramine or colestipol.

Dyslipidaemic Agents

C10AA03 - pravastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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