Pravastatin Sandoz

Pravastatin Sandoz

pravastatin

Manufacturer:

Lek Pharma

Distributor:

Zuellig Pharma

Marketer:

Sandoz
Concise Prescribing Info
Contents
Pravastatin
Indications/Uses
Adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate in patients w/ primary hypercholesterolaemia or mixed dyslipidaemia. Reduction of CV mortality & morbidity in patients w/ moderate or severe hypercholesterolaemia & at high risk of 1st CV event, as an adjunct to diet; (MI, revascularization, ischemic stroke & transient ischaemic attack) patients w/ 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. CV prevention Starting & maintenance dose: 40 mg daily. After transplantation Patient receiving immunosuppressive therapy Initially 20 mg daily, may be adjusted to 40 mg. Heterozygous familial hypercholesterolaemia Childn & adolescent 14-18 yr 10-40 mg daily, 8-13 yr 10-20 mg once daily. Patient taking ciclosporin w/ or w/o other immunosuppressive medicinal products Initially 20 mg once daily & carefully titrate to 40 mg. Moderate or severe renal impairment or significant hepatic impairment Initially 10 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease including unexplained persistent serum transaminase elevation exceeding 3x ULN. Pregnancy & lactation.
Special Precautions
Discontinue use if increases in ALT & AST >3x ULN & persist; throughout duration of fusidic acid treatment in patients where use of systemic fusidic acid is essential; suspected patient has developed ILD. Promptly interrupt therapy if serious liver injury w/ clinical symptoms &/or hyperbilirubinaemia or jaundice occurs during treatment. Temporarily interrupt therapy when creatine kinase (CK) levels are >5x ULN or when there are severe clinical symptoms. Interrupt therapy if a markedly elevated (>5x ULN) CK level is detected. Not suitable when hypercholesterolaemia is due to elevated HDL-C. Not recommended in asymptomatic patients on treatment the routine monitoring of CK or other muscle enzyme levels. Not recommended to restart therapy if hereditary muscular disease is suspected. Cases of myopathy, including rhabdomyolysis in co-administration w/ colchicine. History of liver disease or heavy alcohol ingestion. Immune-mediated necrotising myopathy (IMNM) during or after treatment. Re-measure CK levels about 5-7 days later if CK levels are significantly elevated at baseline (>5x ULN). Measure CK levels prior to initiation of therapy in patients w/ predisposing factors eg, renal impairment, hypothyroidism, previous history of muscular toxicity w/ a statin or fibrate, personal or familial history of hereditary muscular disorders, or alcohol abuse. Monitor both clinically & biochemically those patients at risk of future diabetes (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m2, raised triglycerides, HTN). Avoid in combination w/ fibrates. Co-administration w/ nicotinic acid. Combination w/ inhibitors of cytochrome P450 metabolism. Not to be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. May impair ability to drive or operate machines. Hepatic failure. Renal impairment. Adolescent females of childbearing potential. Discontinue use if patient plans to become pregnant or becomes pregnant. Childn before puberty.
Adverse Reactions
Very rarely, hypersensitivity reactions eg, anaphylaxis, angioedema, lupus erythematous-like syndrome.
Drug Interactions
Combination w/ fibrates; lenalidomide. Decreased bioavailability w/ colestyramine/colestipol. Increased systemic exposure w/ ciclosporin. Concomitant administration of systemic fusidic acid. Increased INR w/ vit K antagonists eg, warfarin or other coumarin anticoagulant. Increased exposure w/ macrolides (eg, erythromycin, clarithromycin, roxithromycin). Increased AUC & Cmax w/ erythromycin; rifampicin. Concomitant use w/ colchicine, nicotinic acid. Substrates/inhibitors of CYP3A4, eg, diltiazem, verapamil, itraconazole, ketoconazole, PIs, grapefruit juice & CYP2C9 inhibitors (eg, fluconazole).
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA03 - pravastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Pravastatin Sandoz tab 20 mg
Packing/Price
3 × 10's
Form
Pravastatin Sandoz tab 40 mg
Packing/Price
3 × 10's
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