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Pregnancy Category: X
Pharmacologic: hmg coa reductase inhibitors
ClassificationTherapeutic: lipid lowering agents
Pharmacologic: hmg coa reductase inhibitors
Adjunctive management of primary hypercholesterolemia and mixed dyslipidemias.Primary prevention of coronary heart disease (myocardial infarction, coronary revascularization, cardiovascular mortality) in asymptomatic patients with increased total and low-density lipiprotein (LDL) cholesterol and decreased high-density lipoprotein (HDL) cholesterol.Secondary prevention of myocardial infarction, coronary revascularization, stroke, and overall mortality in patients with clinically evident coronary heart disease.
Inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which is responsible for catalyzing an early step in the synthesis of cholesterol.
Lowering of total and LDL cholesterol and triglycerides. Slightly increases HDL cholesterol.
Slows the progression of coronary atherosclerosis with resultant decrease in coronary heart disease-related events.
Absorption: Poorly and variably absorbed following oral administration.
Metabolism and Excretion: Extensively metabolized by the liver, most during first pass; excreted in bile and feces. 20% excreted unchanged by the kidneys.
Half-life: 1.3–2.7 hr.
Time/action profile (cholesterol-lowering effect)
Contraindicated in: Hypersensitivity; Active liver disease or unexplained persistent ↑ in AST and ALT; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: History of liver disease; Alcoholism; Renal impairment; Pediatric: Children <8 yr (safety not established); Women of childbearing age.
Adverse Reactions/Side Effects
Central nervous system
- memory loss
Ear, Eye, Nose, Throat
- chest pain
- peripheral edema
- abdominal cramps (most frequent)
- constipation (most frequent)
- diarrhea (most frequent)
- flatus (most frequent)
- heartburn (most frequent)
- altered taste
- drug-induced hepatitis
- ↑ liver enzymes
- erectile dysfunction
- rash (most frequent)
- rhabdomyolysis (life-threatening)
- immune-mediated necrotizing myopathy
- hypersensitivity reactions
Drug-Drug interactionCholesterol-lowering effect may be ↑ with bile acid sequestrants (cholestyramine, colestipol ).Bioavailability may be ↓ by bile acid sequestrants ; administer pravastatin ≥1 hr before or 4 hr after bile acid sequestrants.Risk of myopathy is ↑ by concurrentcyclosporine, fibrates, colchicine, erythromycin, clarithromycin, or large doses of niacin ; concurrent use with gemfibrozil should be avoided; consider lower dose of pravastatin with niacin.May ↑ effects of warfarin.Levels may be significantly ↑ by azoleantifungals (temporarily discontinue HMG-CoA reductase inhibitor, effect is less than with other statins).Saquinavir and ritonavir may ↓ levels and effectiveness.
Oral (Adults) 10–20 mg once daily at bedtime, may be adjusted at 4-wk intervals as needed (usual range 10–40 mg/day); Concurrent cyclosporine therapy—Dose should not exceed 20 mg/day; Concurrent clarithromycin therapy—Dose should not exceed 40 mg/day.
Oral (Children 14-18 yrs) 40 mg once daily.
Oral (Children 8-13 yrs) 20 mg once daily.
Oral (Geriatric Patients) 10–20 mg once daily at bedtime, may be adjusted at 4-wk intervals as needed (usual range 10–20 mg/day).
Renal ImpairmentOral (Adults) 10–20 mg once daily at bedtime, may be adjusted at 4-wk intervals as needed (usual range 10–20 mg/day).
Availability (generic available)
Tablets: 10 mg, 20 mg, 40 mg, 80 mg
- Obtain a diet history, especially with regard to fat consumption.
- Lab Test Considerations: Evaluate serum cholesterol and triglyceride levels before initiating, after 4–6 wk of therapy, and periodically thereafter.
- Monitor liver function tests prior to initiation of therapy and as clinically indicated. If symptoms of serious liver injury, hyperbilirubinemia, or jaundice occurs should be discontinue pravastatin and do not restart. May also cause ↑ alkaline phosphatase and bilirubin levels.
- If patient develops muscle tenderness during therapy, CPK levels should be monitored. If CPK levels are markedly ↑ or myopathy occurs, therapy should be discontinued.
Potential Nursing DiagnosesNoncompliance (Patient/Family Teaching)
- Oral: Administer once daily in the evening. May be administered without regard to food.
- Avoid grapefruit and grapefruit juice during therapy; may increase risk of toxicity.
- If administered in conjunction with bile acid sequestrants (cholestyramine, colestipol), administer 1 hr before or 4 hr after bile acid sequestrant.
- Instruct patient to take medication as directed, not to skip doses or double up on missed doses. Advise patient to avoid drinking more that 200 mL/day of grapefruit juice during therapy. Medication helps control but does not cure elevated serum cholesterol levels.
- Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
- Instruct patient to notify health care professional if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
- Advise patient to wear sunscreen and protective clothing to prevent photosensitivity reactions (rare).
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
- Instruct female patients to notify health care professional promptly if pregnancy is planned or suspected.
- Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.
- Decrease in LDL and total cholesterol levels.
- Increase in HDL cholesterol levels.
- Decrease in triglyceride levels.
- Slowing of the progression of coronary artery disease.
A trademark for the drug pravastatin.