Pravastatin

ATC code

C10AA03

Therapeutic class

Statin (HMG-CoA reductase inhibitor) · HMG-CoA reductase inhibitor

Forms

oral tablet

Brand names

Pravastatina Cinfa (ES) · Pravachol (US) · Elisor (FR) · Vasten (FR)

Overall confidence

medium

Regulatory sources consulted

AEMPS CIMA Ficha Técnica 70155 (https://cima.aemps.es/cima/dochtml/ft/70155/FT_70155.html)
AEMPS CIMA · nº registro 70155 ↗
RxNorm rxcui 42463 ↗

Treatment of primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) is inadequate.
Primary prevention: Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolemia and at high risk of a first cardiovascular event, as an adjunct to diet.
Secondary prevention: Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable angina and with normal or elevated cholesterol levels, as an adjunct to the correction of other risk factors.
Post-transplantation: Reduction of post-transplant hyperlipidemia in patients receiving immunosuppressive therapy following solid organ transplantation.

Hypersensitivity to the active substance or to any of the excipients.
Active liver disease, including unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (ULN).
Pregnancy and lactation.

Major warning · Muscle disorders: As with other HMG-CoA reductase inhibitors (statins), treatment with pravastatin has been associated with the occurrence of myalgia, myopathy and, very rarely, rhabdomyolysis. — AEMPS CIMA
Major warning · Hepatic effects: Liver function tests are recommended before initiating treatment and thereafter when clinically indicated. — AEMPS CIMA
Diabetes Mellitus: Some evidence suggests that statins as a class raise blood glucose and in some patients at high risk of future diabetes, may produce a level of hyperglycemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and should therefore not be a reason for stopping treatment. — AEMPS CIMA

HighCyclosporineL04AD01
Mechanism: Inhibition of transporter proteins (e.g., OATP1B1), resulting in a 4-fold increase in systemic exposure to pravastatin.
Recommendation: Concomitant therapy requires dose adjustment. Start pravastatin at 10 mg/day and do not exceed a maximum dose of 20 mg/day.
AEMPS CIMA
HighFibratesC10AB
Mechanism: Increased risk of muscle toxicity, including rhabdomyolysis, due to a synergistic pharmacodynamic effect. Fibrates alone can cause myopathy.
Recommendation: Concomitant use of pravastatin and fibrates (e.g., gemfibrozil, fenofibrate) should be avoided. If the combination is deemed necessary, close clinical and CK monitoring of the patient is required.
AEMPS CIMA
ModerateColchicineM04AC01
Mechanism: Mechanism not fully elucidated, but an increased risk of myopathy and rhabdomyolysis is postulated due to additive or synergistic effects on skeletal muscle.
Recommendation: Caution is advised when prescribing pravastatin with colchicine. Monitor for signs and symptoms of myopathy.
AEMPS CIMA

myalgia · headache · dizziness · digestive disorders (dyspepsia, nausea, diarrhea) · fatigue · skin rash

rhabdomyolysis · myopathy · hepatotoxicity · pancreatitis · hypersensitivity reactions (including anaphylaxis)

FDA category: X

Pravastatin is contraindicated during pregnancy and lactation. If a patient becomes pregnant while on treatment, it must be discontinued immediately.