Pravastatin Sandoz

Pravastatin Sandoz



Lek Pharma


Zuellig Pharma


Concise Prescribing Info
Primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. Reduction of CV mortality & morbidity in patients w/ moderate or severe hypercholesterolaemia & at high risk of a 1st CV event, as an adjunct to diet; patients w/ a history of MI or unstable angina pectoris & w/ either normal or increased cholesterol levels, as an adjunct to correction of other risk factors. Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid organ transplantation.
Dosage/Direction for Use
Hypercholesterolaemia 10-40 mg once daily. Max daily dose: 40 mg once daily. CV prevention Starting & maintenance dose: 40 mg daily. After transplantation Patients receiving immunosuppressive therapy Initially 20 mg daily. Heterozygous familial hypercholesterolaemia Childn & adolescents 14-18 yr 10-40 mg once daily, 8-13 yr 10-20 mg once daily. Dose adjustment: Moderate or severe renal impairment or significant hepatic impairment Initially 10 mg daily. Patients taking ciclosporin w/ or w/o other immunosuppressives Initially 20 mg once daily & carefully titrate to 40 mg.
May be taken with or without food: Take in the evening.
Hypersensitivity. Active liver disease including unexplained persistent elevations of serum transaminase elevation exceeding 3 x ULN. Pregnancy & lactation.
Special Precautions
Homozygous familial hypercholesterolaemia. Concomitant use w/ fibrates & colchicine; ciclosporin, clarithromycin, other macrolides or niacin. Patients who develop increased transaminase levels. Discontinue use if ALT & AST levels >3x ULN; interstitial lung disease. History of liver disease or heavy alcohol ingestion. Interrupt therapy if serious liver injury &/or hyperbilirubinaemia or jaundice; creatine kinase levels >5x ULN occurs during treatment. Discontinue use if to be coadministered w/ fusidic acid & w/in 7 days after stopping fusidic acid treatment. Measure CK levels before start of therapy in patients w/ special predisposing factors & those developing muscular symptoms. DM; monitor patients at risk (fasting blood glucose, raised triglycerides, HTN). Renal impairment, hypothyroidism, history of muscular toxicity, personal or familial history of hereditary muscular disorders, or alcohol abuse. Visual disturbances may occur while driving or operating machinery. Childn before puberty.
Adverse Reactions
Dizziness, headache, sleep disturbance, insomnia; vision disturbance (including blurred vision & diplopia); dyspepsia/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhoea, flatulence; pruritus, rash urticaria, scalp/hair abnormality; abnormal urination (including dysuria, frequency, nocturia); sexual dysfunction; fatigue. Musculoskeletal pain including arthralgia, muscle cramps, myalgia, muscle weakness & elevated CK levels.
Drug Interactions
Increased risk of muscle-related including rhabdomyolysis adverse events w/ fibrates eg, gemfibrozil, fenofibrates, fusidic acid, colchicine, nicotinic acid; lenalidomide. Decreased bioavailability w/ colestyramine/colestipol. Increased systemic exposure w/ ciclosporin. Increased INR w/ vit K antagonists eg, warfarin or other coumarin anticoagulant. Increased exposure w/ macrolides (eg, erythromycin, clarithromycin, roxithromycin). Increased AUC & Cmax w/ rifampicin.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA03 - pravastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Pravastatin Sandoz tab 20 mg
Pravastatin Sandoz tab 40 mg
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