Concise Prescribing Info
Adjunct to diet for the reduction of elevated total & LDL-cholesterol levels in patients w/ primary hypercholesterolemia (types IIa & IIb) when the response to diet & other measures alone has been inadequate.
Dosage/Direction for Use
Initially 20 mg daily as single dose in the evening. Adjust dosage at intervals of not less than 4 wk if required to a max of 80 mg daily.
Should be taken with food.
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation.
Special Precautions
Discontinue use if the transaminase levels show evidence of progression, particularly up to 3 times the upper limit of normal & are persistent; if marked elevation of creatine phosphokinase (CPK) levels occurs or if myopathy & hypersensitivity are diagnosed or suspected. Perform liver function test at baseline & periodically thereafter in all patients. Substantial alcohol consumption or history of liver disease. May elevate creatinine phosphokinase & transaminase levels. Impaired renal function. Administer to women of childbearing age only when highly unlikely to conceive. Childn. Elderly >60 yr.
Adverse Reactions
Asthenia; abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea; muscle cramps, myalgia; dizziness, headache; rash; blurred vision. Hepatitis, cholestatic jaundice, vomiting, anorexia, paresthesia & psychic disturbances including anxiety, erythema multiforme including Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
Concomitant therapy w/ other lipid metabolism regulators. Additive cholesterol-lowering effects w/ bile acid sequestrant cholestyramine. Myopathy including rhabdomyolysis may occur w/ fibric acid derivatives (eg, gemfibrozil & fenofibrate) & niacin. Muscle effects w/ erythromycin. Hyperkalemia associated w/ myositis (myalgia & elevated CPK) w/ ACE inhibitors (eg, lisinopril). Clinically evident bleeding &/or increased prothrombin time w/ coumarin anticoagulants. Slight decreased in the AUC & significant decreased in Cmax w/ β-adrenergic blockers (eg, propranolol). Caution w/ immunosuppresants & itraconazole.
ATC Classification
C10AA02 - lovastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Apo-Lovastatin tab 20 mg
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