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Dosage/Direction for Use
Oral Hyperlipidaemias, Cardiovascular risk reduction Adult: As sodium: 10-40 mg once daily in the evening, adjust according to response at 4-wk intervals. Max: 80 mg once daily. Child: Heterozygous familial hypercholestrolaemia: 8-13 yr 10-20 mg once daily; 14-18 yr 10-40 mg once daily. Renal impairment: Moderate to severe: Initial dose: 10 mg/day. Hepatic impairment: Moderate to severe: Initial dose: 10 mg/day. |
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Administration
May be taken with or without food.
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Contraindications
Active liver disease or unexplained persistent increases in serum aminotransferases. Pregnancy and lactation. Concomitant use w/ gemfibrozil, fusidic acid.
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Special Precautions
History of liver disease; alcoholism; untreated hypothyroidism; patients at risk of myopathy. Renal impairment. Monitoring Parameters Monitor creatine kinase (CK) periodically and LFT. Discontinue if there is significant or persistent increase in CK levels, serum aminotransferase levels or evidence of myopathy.
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Adverse Reactions
Nausea, vomiting, heartburn, diarrhoea, headache, cough, insomnia, chest pain, rash, fatigue, dizziness, influenza, blurred vision, myalgia, elevated serum transaminase, alopoecia, paraesthesia, impotence, gynaecomastia.
Potentially Fatal: Severe rhabdomyolysis w/ acute renal failure. Hepatitis, pancreatitis. Rare: Stevens-Johnson syndrome, anaphylaxis, toxic epidermal necrolysis. |
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Overdosage
Management: Symptomatic and supportive treatment.
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Drug Interactions
May increase risk of myopathy w/ colchicine, fenofibrate, nicotinic acid. Ciclosporin, clarithromycin, and erythromycin may increase serum pravastatin levels. May increase bleeding risk w/ warfarin. Decreased serum levels w/ concomitant colestyramine.
Potentially Fatal: Increased risk of rhabdomyolysis w/ gemfibrozil, fenofibrate, fusidic acid. |
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Food Interaction
May decrease serum levels w/ St John's wort.
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Action
Pravastatin inhibits HMG-CoA reductase, the enzyme which catalyses the rate-limiting step in cholesterol biosynthesis. It reduces concentration of total cholesterol, LDL cholesterol and triglyceride. It produces an increase in HDL cholesterol and it increases hepatic cholesterol uptake from blood.
Absorption: Rapidly but incompletely absorbed from the GI tract. Absolute bioavailability: Approx 17%. Time to peak plasma concentration: 1-1.5 hr. Distribution: Plasma protein binding: Approx 50%. Metabolism: Undergoes extensive first-pass hepatic metabolism. Excretion: Via faeces (approx 70% as unchanged drug); urine (approx 20%). Elimination half-life: 1.5-2 hr. |
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Storage
Oral: Store at 25°C.
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CIMS Class
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ATC Classification
C10AA03 - pravastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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