Apo-Pravastatin

Adjunct to diet for the reduction of elevated total cholesterol (total-C) & LDL-C levels in patients w/ primary hypercholesterolemia (types IIa & IIb) when the response to diet & other non-pharmacologic measures alone has been inadequate. Adjunct to diet to reduce the risk of MI, for undergoing myocardial revascularization procedures, of CV mortality w/ no increase in death from non-CV causes in hypercholesterolemic patients w/o clinically evident CHD. Reduce the risk of total mortality due to CHD, MI, undergoing myocardial revascularization procedures, stroke & transient ischemic attack & total hospitalization in patients w/ total-C in the normal to moderately elevated range who have clinically evident CHD.

Hypercholesterolemia & CHD Starting dose:10-20 mg once daily at bedtime. May be initiated at 40 mg daily if serum cholesterol is markedly elevated [eg, total-C >7.75 mmol/L (300 mg/dL)]. Concomitant therapy w/ cyclosporine Initiate at 10 mg daily. Max daily dose: 20 mg.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained persistent elevations in LFTs. Pregnancy & lactation.

Promptly report any signs of hypersensitivity (eg, angioedema, urticaria, photosensitivity, polyarthralgia, fever, malaise); discontinue treatment if hypersensitivity is suspected. Perform LFTs at baseline & at 12 wk following initiation of therapy or dose elevation; repeat to confirm elevation & subsequently monitor at more frequent intervals; discontinue therapy if ALT & AST increase ≥3x ULN & persist. History of liver disease or heavy alcohol ingestion; discontinue use if active liver disease or unexplained serum transaminase elevations develop. Reported cases of creatinine phosphokinase (CPK) levels elevations, myalgia, myopathy & rhabdomyolysis; discontinue use if marked CPK levels or myopathy is diagnosed or suspected. Concomitant use w/ itraconazole & cyclosporine; immunosuppressives, erythromycin, systemic azole derivative antifungal agents or lipid-lowering niacin doses; gemfibrozil, erythromycin. Avoid combined use w/ fibrates. Consider treatment interruption in any patient w/ acute, serious condition, suggestive of myopathy or having risk factor predisposing to the development of renal failure or rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders & uncontrolled seizures). May induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia; discontinue use in case of symptom aggravation; reported recurrence when same or different statin was re-administered. Follow-up serum lipoprotein(a) measurements during treatment. Significant short-term decrease in plasma CoQ10 levels. Appropriately evaluate patient who develop clinical evidence of endocrine dysfunction. Concomitant use w/ other drugs (eg, ketoconazole, spironolactone or cimetidine) that may decrease endogenous steroid hormone levels. Patients w/ severe hypercholesterolemia who are significantly renally impaired or elderly. Renal impairment. Women of childbearing potential; discontinue treatment in patient who becomes pregnant. Childn. Elderly >65 yr.

Nausea/vomiting, diarrhea, constipation, abdominal pain, flatulence; localized musculoskeletal pain, myalgia; common cold, rhinitis; headache, dizziness; fatigue, non-cardiac chest pain; rash; chest pain.

Concomitant therapy w/ other lipid metabolism regulators. Decreased mean AUC w/ bile acid sequestrants, cholestyramine/colestipol. Possible myopathy including rhabdomyolysis w/ fibric acid derivatives & niacin particularly in subjects w/ pre-existing renal insufficiency. Increased steady state digoxin conc; closely monitor patient taking digoxin. Carefully monitor prothrombin time in patients concomitantly taking coumarin anticoagulants. Bioavailability may be minimally reduced w/ antacids & increased w/ cimetidine. Reduced AUC levels of propranolol. Higher AUC values w/ cyclosporine.

Dyslipidaemic Agents

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

POM