Pravastatin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Hyperlipidaemias; Cardiovascular risk reduction 10-40 mg once daily at night, adjust at 4-wkly intervals if needed. Max: 80 mg once daily.
Dosage Details
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.
Administration
May be taken with or without food.
Contraindications
Active liver disease or unexplained persistent increases in serum aminotransferases. Pregnancy and lactation. Concomitant use w/ gemfibrozil, fusidic acid.
Special Precautions
History of liver disease; alcoholism; untreated hypothyroidism; patients at risk of myopathy. Renal impairment.
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.
MonitoringParameters
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.
Overdosage
Management: Symptomatic and supportive treatment.
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.
Food Interaction
May decrease serum levels w/ St John's wort.
Action
Description: Pravastatin inhibits HMG-CoA reductase, the enzyme which catalyses the rate-limiting step in cholesterol biosynthesis. It reduces concentration of total cholesterol and LDL cholesterol and triglyceride. It produces an increase in HDL cholesterol and it increases hepatic cholesterol uptake from blood.
Pharmacokinetics:
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.
Storage
Store at 25°C.
References
Anon. Pravastatin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 24/10/2013.

Buckingham R (ed). Pravastatin sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/10/2013.

Joint Formulary Committee. Pravastatin sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/10/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Pravastatin sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 24/10/2013.

Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury. U.S. FDA. https://www.fda.gov/. Accessed 12/10/2013.

Disclaimer: This information is independently developed by MIMS based on Pravastatin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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