Indications & Dose:
Adjunct to diet for primary hypercholesterolaemia or combined (mixed) hyperlipidaemias in patients who have not responded adequately to dietary control
% BY MOUTH
% Adult: 10–40 mg daily, dose to be taken at night, dose to be adjusted at intervals of at least 4 weeks
Prevention of cardiovascular events in patients with previous myocardial infarction or unstable angina Adjunct to diet to prevent cardiovascular events in patients with hypercholesterolaemia
% BY MOUTH
% Adult: 40 mg daily, dose to be taken at night Reduction of hyperlipidaemia in patients receiving immunosuppressive therapy following solid-organ transplantation
% BY MOUTH
% Adult: Initially 20 mg daily, then increased if necessary up to 40 mg daily, dose to be taken at night, close medical supervision is required if dose is increased to maximum dose
Contraindications:
Active liver disease, unexplained persistent elevated liver function tests
Side Effects:
CNS: Dizziness, headache
CV: Chest pain
GI: Abdominal pain, anorexia, cholestatic jaundice,
cirrhosis, constipation, fatty changes in liver,
flatulence, heartburn, hepatitis, increased serum
transaminase levels, nausea, pancreatitis, vomiting
GU: Erectile dysfunction, loss of libido
MS: Arthralgia, localized pain, myalgia, myopathy, rhabdomyolysis
SKIN: Alopecia, photosensitivity, pruritus, rash
MISC: Fatigue, gynecomastia
Cautions:
Precautions:
History of liver disease, renal function impairment, elderly, children < 18 yr, alcoholism; risk factors predisposing to the development of renal failure secondary to rhabdomyolysis (severe acute infection, trauma, hypotension, uncontrolled seizure disorder, severe metabolic disorders, electrolyte imbalance)
PREGNANCY AND LACTATION: Pregnancy category X: small amounts excreted in breast milk; should probably not be used by women who are nursing
Interaction:
Azole antifungals (fluconazole, itraconazole, ketoconazole, miconazole): Increased plasma pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis
Cholestyramine: Reduced bioavailability of pravastatin
Clarithromycin: Increased plasma pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis
Clofibrate: Small increased risk of myopathy with combination
Colestipol: Reduced bioavailability of pravastatin
Cyclosporine: Concomitant administration increases risk fo severe myopathy or rhabdomyolysis
Danazol: Increased plasma pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis
Erythromycin: Increased pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis
Fluoxetine: Increased pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis
Gemfibrozil: Small increased risk of myopathy with combination, especially at high doses of statin
Isradipine: May decrease pravastatin plasma concentrations
Niacin: Concomitant administration increases risk of severe myopathy or rhabdomyolysis
Nefazodone: May inhibit hepatic metabolism of pravastatin with risk of rhabdomyolysis
Troleandomycin: Increased pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis
Warnings:
Adverse Effects:
Lactations:
Special Precautions:
Counselling:
Side Effects Or Adverse Reactions:
Patient And Carer Advice:
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