Formulary
Pravastatin sodium: Indications, Dosing, Side Effects and Interactions
Statins competitively inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme involved in cholesterol synthesis, especially in the liver.
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Pravastatin sodium: Indications, Dosing, Side Effects and Interactions
Statins competitively inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme involved in cholesterol synthesis, especially in the liver.
Drug action
Statins competitively inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme involved in cholesterol synthesis, especially in the liver.
Indications and dose
**Adjunct to diet**
- **Adult** (By Mouth): for primary hypercholesterolaemia or combined (mixed) hyperlipidaemias in patients who have not responded adequately to dietary control 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**
- **Adult** (By Mouth): 40 mg daily, dose to be taken at night.
**Reduction of hyperlipidaemia in patients receiving immunosuppressive therapy following solid-organ transplantation**
- **Adult** (By Mouth): 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.
**Hyperlipidaemia including familial hypercholesterolaemia for pravastatin sodium**
- **Child 8-13 years** (By mouth): 10 mg daily, then increased if necessary up to 20 mg daily, dose to be taken at night, dose to be adjusted at intervals of at least 4 weeks.
- **Child 14-17 years** (By mouth): 10 mg daily, then increased if necessary up to 40 mg daily, dose to be taken at night, dose to be adjusted at intervals of at least 4 weeks.
Cautions
Risk factors for muscle toxicity, including myopathy or rhabdomyolysis Cautions, further information Muscle effects Muscle toxicity can occur with all statins, however the likelihood increases with higher doses and in certain patients. Statins should be used with caution in patients at increased risk of muscle toxicity. This includes the elderly, those with a personal or family history of muscular disorders, history of muscular toxicity or unexplained persistent muscle pain, history of liver disease, a high alcohol intake, known genetic polymorphisms-consult product literature, renal impairment, hypothyroidism, or those who undertake strenuous exercise. M See also Monitoring requirements . Hypothyroidism Hypothyroidism should be managed adequately before starting treatment with a statin.
Side effects
Common or very common Arthralgia; asthenia; constipation; diarrhoea; dizziness; flatulence; gastrointestinal discomfort; headache; muscle complaints; nausea; sleep disorders; thrombocytopenia Uncommon Alopecia; hepatic disorders; memory loss; pancreatitis; paraesthesia; sexual dysfunction; skin reactions; vomiting Rare or very rare Lupus-like syndrome; myopathy; peripheral neuropathy; tendon disorders Frequency not known Depression; diabetes mellitus (in those at risk); interstitial lung disease; neuromuscular dysfunction Side-effects, further information Muscle effects Although myalgia has been reported commonly in patients receiving statins, muscle toxicity truly attributable to statin use is rare. The risk of myopathy, myositis, and rhabdomyolysis associated with statin use is also rare. If muscle pain, weakness, or cramps occur during treatment, creatine kinase concentrations should be measured; if the concentration is more than 5 times the ULN (in the absence of strenuous exercise), treatment should be discontinued. If muscular symptoms are severe and cause daily discomfort, treatment discontinuation should be considered, even if creatine kinase concentrations are less than 5 times the ULN. If symptoms resolve and creatine kinase concentrations return to normal, the statin can be reintroduced, or introduction of an alternative statin can be considered, at the lowest dose and the patient monitored closely. Diabetes Statins should not be discontinued if there is an increase in the blood-glucose concentration as the benefits continue to outweigh the risks. Interstitial lung disease If patients develop symptoms such as dyspnoea, cough, and weight loss, they should seek medical attention. Side-effects For pravastatin sodium Uncommon Hair abnormal; scalp abnormal; urinary disorders; vision disorders Frequency not known Muscle weakness; musculoskeletal pain
Interactions
**Severe interactions:**
- There was no clinically significant decrease in bioavailability or therapeutic effect when pravastatin was administered one hour before or four hours after colestyramine or one hour before...
- In one of two interaction studies with pravastatin and erythromycin a statistically significant increase in pravastatin AUC (70%) and Cmax (121%) was observed.
- In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed.
- This is why products that are metabolised by, or inhibitors of, the cytochrome P450 system can be added to a stable regimen of pravastatin without causing significant changes in the plasma levels of...
- The absence of a significant pharmacokinetic interaction with pravastatin has been specifically demonstrated for several products, particularly those that are substrates/inhibitors of CYP3A4 e.g.
**Other interactions (16):**
- An increased risk of muscle related adverse events, including rhabdomyolysis, have been reported when fibrates are co-administered with other statins.
- These adverse events with pravastatin cannot be excluded; therefore the combined use of pravastatin and fibrates (e.g.
- Colestyramine/Colestipol: concomitant administration resulted in approximately 40 to 50% decrease in the bioavailability of pravastatin .
- Ciclosporin: concomitant administration of pravastatin and ciclosporin leads to an approximately 4-fold increase in pravastatin systemic exposure.
- Vitamin K antagonists: As with other HMG-CoA reductase inhibitors, the initiation of treatment or dosage up-titration of Pravastatin in patients treated concomitantly with vitamin K antagonists (e.g.
- Pravastatin should be used cautiously with macrolide antibiotics (e.g.
Pregnancy
Statins should be avoided in pregnancy (discontinue 3 months before attempting to conceive) as congenital anomalies have been reported and the decreased synthesis of cholesterol possibly affects fetal development.
Breast feeding
Manufacturer advises avoid-small amount of drug present in breast milk.
Hepatic impairment
In general, manufacturers advise caution (risk of increased exposure); avoid in active disease or unexplained persistent elevations in serum transaminases. Hepatic impairment For pravastatin sodium Dose adjustments Manufacturer advises initial dose reduction to 10 mg daily; adjust according to response.
Renal impairment
Dose adjustments Manufacturer advises initial dose of 10 mg once daily in moderate to severe impairment.
Medicinal forms
Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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