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Pronunciation: PRUH-vuh-stuh-tin SO-dee-uhm
Class: HMG-CoA reductase inhibitor
- Tablets 20 mg
- Tablets 40 mg
- Tablets 80 mg
- Tablets 10 mg
CO Pravastatin (Canada)
Sandoz Pravastatin (Canada)
Increases rate at which body removes cholesterol from blood and reduces production of cholesterol in body by inhibiting enzyme that catalyzes early rate-limiting step in cholesterol synthesis.
Rapidly absorbed (34%). T max is 1 to 1.5 h. Bioavailability is 17%. Food reduces systemic bioavailability.
Protein binding is approximately 50%.
Extensive first-pass extraction in the liver. The major degradation product is 3-alpha-hydroxy isomeric metabolite.
Urine (20% excreted); feces (70% excreted). The t ½ is 77 h.
Mean AUC was approximately 27% greater and mean cumulative urinary excretion was approximately 19% lower in elderly men. Mean AUC was approximately 46% higher and mean cumulative urinary excretion was approximately 18% lower in elderly women.
Indications and Usage
As an adjunct to diet for reduction of elevated total and LDL cholesterol, apolipoprotein B, and triglyceride levels and to increase HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson types IIa and IIb); as adjunctive therapy to diet for treatment of patients with elevated serum triglyceride levels (Frederickson type IV); treatment of primary dysbetalipoproteinemia (Frederickson type III) who do not respond adequately to diet; in hypercholesterolemic patients without clinically evident coronary heart disease (CHD) to reduce risk of MI or CV mortality with no increase in death from noncardiovascular causes; in patients with clinically evident CHD, to reduce risk of total mortality by reducing coronary death, MI, undergoing myocardial revascularization procedures, stroke, and stroke/transient ischemic attack and slow progression of coronary arteriosclerosis.
Active liver disease or unexplained persistent elevations of LFTs; pregnancy; lactation.
Dosage and AdministrationAdults
PO 10 to 40 mg/day.Children 8 to 13 yr of age
PO 20 mg once daily.Children 14 to 18 yr of age
PO 40 mg once daily.
- Administer without regard to meals. Administer with food if GI upset occurs.
- Administer pravastatin at least 1 h before or 4 h after administration of a bile acid sequestrant (eg, cholestyramine).
Store tablets at controlled room temperature (59° to 86°F). Protect from moisture and light.
Drug InteractionsBile acid sequestrants
Large decrease in pravastatin bioavailability.Cyclosporine, gemfibrozil
Severe myopathy or rhabdomyolysis; decreased urinary excretion and protein binding of pravastatin.Protease inhibitors (eg, ritonavir)
Pravastatin plasma levels may be reduced, decreasing the efficacy.
Laboratory Test Interactions
None well documented.
Dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis); lens opacities.
Nausea; vomiting; diarrhea; abdominal pain; constipation; flatulence; heartburn; dyspepsia; pancreatitis.
Hepatitis; jaundice; fatty changes in liver; cirrhosis; fulminant hepatic necrosis; hepatoma; increased serum transaminases.
Common cold; rhinitis; cough; influenza.
Localized pain; myalgia; myopathy; rhabdomyolysis; fatigue; paresthesia; peripheral neuropathy. An apparent hypersensitivity syndrome has been reported rarely that has included 1 or more of the following features: anaphylaxis; angioedema; lupus erythematous-like syndrome; polymyalgia rheumatica; vasculitis; purpura; thrombocytopenia; leukopenia; hemolytic anemia; positive antinuclear antibodies; increase in erythrocyte sedimentation rate; arthritis; arthralgia; urticaria; asthenia; photosensitivity; fever; chills; flushing; malaise; dyspnea; toxic epidermal necrolysis; erythema multiforme, including Stevens-Johnson syndrome.
Monitor patient for symptoms of myopathy (muscle pain, tenderness, weakness) when medication is started and when dose is increased.Serum transaminases
Assess serum transaminases before starting therapy, before increasing the dose, and periodically thereafter as clinically indicated.
Category X .
Excreted in breast milk.
Use in children not recommended.
Monitor patients closely.
Use with caution in patients who consume substantial quantities of alcohol or those with history of liver disease. Marked, persistent increases in serum transaminases have occurred.
Skeletal muscle effects
Rhabdomyolysis with renal dysfunction secondary to myoglobinuria has occurred. Ensure that therapy is temporarily withheld in patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery).
- Advise patient that dose of medication may change, based on results of cholesterol blood tests, in an effort to reach LDL-C goal.
- Advise patient to take prescribed dose once daily without regard to meals, but to take with food if stomach upset occurs.
- Advise patient to try to take each dose at about the same time each day.
- Advise patient that if a dose is missed to take as soon as remembered but to never take more than 1 dose of pravastatin a day.
- Caution patient not to change the dose or stop taking unless advised by health care provider.
- Advise patient that pravastatin helps control, but does not cure, cholesterol abnormality and to continue taking as prescribed when LDL-C goal has been reached.
- Instruct patient to continue taking other cholesterol-lowering medications as prescribed by health care provider.
- Advise patient who is also taking a bile acid sequestrant (eg, cholestyramine) to take the pravastatin at least 1 h before or 4 h after the sequestrant.
- Instruct patient to immediately notify health care provider if experiencing any unexplained muscle pain, tenderness, and/or weakness, or if they note any other unusual feelings.
- Emphasize to patient importance of other modalities on cholesterol control: dietary changes (reduced saturated fat intake, increase soluble fiber intake), weight control, regular exercise, and smoking cessation.
- Advise women of childbearing potential to use effective contraception during treatment with pravastatin.
Copyright © 2009 Wolters Kluwer Health.