pravastatin sodium: clinical use

Prescribing considerations

• Exclude secondary causes of dyslipidaemia and assess cardiovascular risk factors before treatment.
• Evaluate muscle-toxicity risk, including renal impairment, untreated hypothyroidism, previous statin or fibrate toxicity, hereditary muscle disorders, interacting medicines and heavy alcohol use.
• Use caution in significant renal or hepatic impairment and after transplantation, particularly with ciclosporin.
• Counsel patients to report unexplained muscle symptoms, jaundice and new or worsening myasthenic symptoms promptly.
• The selected product contains lactose.

Contraindications and cautions

• Hypersensitivity to pravastatin or an excipient.
• Active liver disease or persistent unexplained transaminase elevation exceeding three times the upper limit of normal.
• Pregnancy.
• Breastfeeding under the selected product licence.

Monitoring

• Check baseline liver enzymes, renal function and a lipid profile; assess glucose-related risk where relevant.
• Consider baseline creatine kinase when muscle symptoms or recognised predisposing factors are present.
• Reassess lipids and liver enzymes after initiation or a clinically relevant treatment change, then review periodically according to the individual monitoring plan.
• Measure creatine kinase if unexplained muscle pain, tenderness or weakness develops; routine CK testing is not required in asymptomatic patients.
• Monitor INR when pravastatin is started, changed or stopped in a patient taking a vitamin K antagonist.

Clinical pharmacology

Pravastatin is administered in its active form, acts mainly in the liver and undergoes substantial hepatic first-pass extraction. It is not metabolised to a clinically significant extent by cytochrome P450, but transporter-mediated and pharmacodynamic interactions remain important. Elimination occurs through both renal and biliary routes.

Formulation and product differences

• The selected product is a yellow, mottled, uncoated, capsule-shaped tablet with a double score and can be divided into equal halves.
• It contains lactose monohydrate and iron oxide yellow.
• It is supplied in moisture-protective blister or bottle packaging; not all listed pack sizes may be marketed.

Tablet

Route: Oral

Strengths: 10 mg, 20 mg, 40 mg