Generic
Pravastatin Sodium
2 brands available in the market
At a glance
Pravastatin Sodium is an HMG-CoA reductase inhibitor (statin) used as adjunctive therapy to diet to reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients, and to reduce elevated LDL-C, ApoB, and TG levels and increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia.
Description
Pravastatin is a specific inhibitor of hepatic HMG-CoA reductase. Inhibition of this enzyme reduces cholesterol biosynthesis, increasing the number of LDL receptors on cell surfaces and enhancing receptor-mediated metabolism and clearance of LDL. It also inhibits VLDL synthesis.
Indications
- Reduce risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD
- Reduce coronary death, MI, revascularization, stroke/TIA, and progression of coronary atherosclerosis in patients with clinically evident CHD
- Primary hypercholesterolemia and mixed dyslipidemia
- Hypertriglyceridemia
- Primary dysbetalipoproteinemia (not responding to diet)
- Heterozygous familial hypercholesterolemia in children and adolescents ages 8 years and older
Therapeutic class
Other Anti-anginal & Anti-ischaemic drugs, Statins
Pharmacological class
HMG-CoA Reductase Inhibitor (Statin)
Pharmacology
Pravastatin is a specific inhibitor of hepatic HMG-CoA reductase. Inhibition of this enzyme reduces cholesterol biosynthesis, increasing the number of LDL receptors on cell surfaces and enhancing receptor-mediated metabolism and clearance of LDL. It also inhibits VLDL synthesis.
Mechanism of action
Prevents cholesterol synthesis by inhibiting HMG-CoA reductase.
Dosage
Adult Dose (Oral):
- Starting dose: 40 mg once daily
- May increase to 80 mg/day if needed
- Severe renal impairment: 10 mg/day
Pediatric Dose (8-13 years):
- 20 mg once daily
Adolescent Dose (14-18 years):
- Starting dose: 40 mg once daily
Administration
- May be taken at any time of day with or without food
- Take at the same time each day
- Continue cholesterol-lowering diet
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Common Side Effects (≥2%):
- Musculoskeletal pain
- Nausea/vomiting
- Upper respiratory infection
- Diarrhea
- Headache
Precautions & warnings
- Skeletal muscle effects (myopathy, rhabdomyolysis): Risk increases with advanced age (>65), uncontrolled hypothyroidism, renal impairment
- Liver enzyme abnormalities; check before initiating therapy and as clinically indicated
Contraindications
- Hypersensitivity to pravastatin or any component
- Active liver disease or unexplained, persistent serum transaminase elevations
- Pregnancy or women who may become pregnant
- Nursing mothers
Drug interactions
- Fibrates or niacin (≥1 g/day): Increased risk of skeletal muscle effects
- Cyclosporine: Increased exposure; limit pravastatin to 20 mg once daily
- Clarithromycin: Increased exposure; limit pravastatin to 40 mg once daily
Food interactions
It is not known whether it is safe to consume alcohol with Pravastatin.
Use in pregnancy
Use in Pregnancy: Pregnancy Category X; safety not established in pregnant women; use only if potential benefit outweighs potential risk to fetus.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Small amount excreted in human milk; due to potential serious adverse reactions in nursing infants, women taking pravastatin should not nurse.
Pediatric use
Dose established for children and adolescents ages 8-18 years; safety not established in children under 8 years.
Geriatric use
Elderly patients (>65) have increased risk of muscle effects; caution required.
Renal / hepatic impairment
Renal Impairment: Severe renal impairment: 10 mg/day starting dose; consult your doctor.
Hepatic Impairment: Contraindicated in active liver disease; caution; consult your doctor.
Overdose effects
No overdose information available; consult your doctor if taken in excess.
Storage conditions
Store below 30°C, away from light and moisture; keep out of reach of children.
Chemical structure
Pravastatin Sodium