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Pharmacologic class: HMG-CoA reductase inhibitor
Therapeutic class: Antilipemic
Pregnancy risk category X
Inhibits HMG-CoA reductase, an enzyme that catalyzes cholesterol synthesis pathway. This action decreases cholesterol, triglyceride, apolipoprotein B, and low-density lipoprotein (LDL) levels and increases high-density lipoprotein levels.
Tablets: 10 mg, 20 mg, 40 mg, 80 mg
Indications and dosages
➣ Adjunct to diet to reduce risk of total mortality by reducing coronary death, myocardial infarction, revascularization, stroke or transient ischemic attack, and progression of coronary atherosclerosis in patients with clinically evident coronary heart disease; to reduce elevated total cholesterol, LDL cholesterol (LDL-C), apolipoprotein B, and triglyceride (TG) levels and increase high-density lipoprotein levels in patients with primary hypercholesterolemia and mixed dyslipidemia; to reduce elevated serum TG levels in patients with hypertriglyceridemia; to treat patients with primary dysbetalipoproteinemia who aren't responding to diet
Adults: 40 mg P.O. once daily. Use 80-mg dose only for patients not reaching LDL-C goal with 40 mg. Adjust dosage at 4 weeks according to patient's response and established treatment guidelines.
➣ Heterozygous familial hypercholesterolemia after failure of adequate trial of diet therapy
Adolescents ages 14 to 18: 40 mg P.O. daily
Children ages 8 to 13: 20 mg P.O. daily
• Significant renal impairment
• Concurrent use of niacin
• Hypersensitivity to drug or other HMG-CoA reductase inhibitors
• Active hepatic disease or unexplained, persistent transaminase elevations
• Pregnancy, breastfeeding, females of childbearing age
Use cautiously in:
• renal impairment; severe hypotension or hypertension; severe acute infection; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures; visual disturbances; myopa-thy; major surgery; trauma; alcoholism
• history of hepatic disease
• concurrent use of gemfibrozil (avoid use)
• concurrent use of colchicine, fibrates, or lipid-modifying doses of niacin (1 g/day or greater)
• children younger than age 8 (safety not established).
• If patient's also receiving bile-acid resin, give pravastatin at bedtime, at least 4 hours after resin.
CNS: headache, malaise, fatigue, dizziness, insomnia, anxiety, depression, tremor, vertigo, memory loss, peripheral nerve palsy, paresthesia, peripheral neuropathy, asthenia
EENT: impaired extraocular eye movements, cataract progression, ophthalmoplegia, dry eyes
GI: nausea, vomiting, diarrhea, constipation, abdominal or biliary pain, flatulence, dyspepsia, heartburn, anorexia, pancreatitis
GU: decreased libido, erectile dysfunction, gynecomastia
Hematologic: anemia, thrombocytopenia, leukopenia
Hepatic: jaundice, cholestatic jaundice, fatty liver changes, hepatoma, hepatic necrosis, hepatitis
Musculoskeletal: joint pain, myalgia, myositis, rhabdomyolysis
Respiratory: dyspnea, upper respiratory tract infection
Skin: nodules, skin discoloration, alopecia, dry skin, pruritus, rash, urticaria, nail changes, photosensitivity
Other: altered taste, localized pain, rare hypersensitivity reactions (including polymyalgia rheumatica, arthritis, dermatomyositis, vasculitis, purpura, positive antinuclear antibody, eosinophilia, fever, chills, flushing, hemolytic anemia, epidermal necrol-ysis, erythema multiforme, Stevens-Johnson syndrome, angioedema, lupus erythematosus-like reaction, and anaphylaxis)
Drug-drug. Clarithromycin, colchicine, cyclosporine, erythromycin, fibrates, gemfibrozil, lipid-modifying doses of niacin, other HMG-CoA reductase inhibitors: increased risk of myopathy
Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, creatine kinase, creatinine phosphokinase: increased levels
• Watch for signs and symptoms of allergic reaction.
• Monitor vital signs and cardiovascular status.
☞ Evaluate liver function tests before starting therapy, 6 to 12 weeks later, and at least semiannually thereafter. Also monitor lipid levels, and watch for evidence of hepatic disorders (rare).
☞ Assess creatine kinase level if patient has muscle pain or is receiving other drugs associated with myopathy. Discontinue drug if myopathy is diagnosed or suspected. Continue to monitor for signs and symptoms of rhabdomyolysis (rare).
• Caution patient not to take with antacids.
☞ Teach patient to recognize and immediately report signs and symptoms of allergic response and other adverse reactions, especially myositis.
• Tell patient drug may cause headache and musculoskeletal pain. Encourage him to discuss activity recommendations and pain management with prescriber.
☞ Advise patient to promptly report unusual fatigue, yellowing of skin or eyes, and unexplained muscle pain, tenderness, or weakness.
• Advise female of childbearing age to notify prescriber of suspected pregnancy. Caution her not to breastfeed during therapy.
• Tell male patient that drug may cause erectile dysfunction and abnormal ejaculation. Suggest that he discuss these issues with prescriber.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and vision.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.
ClassificationTherapeutic: lipid lowering agents
Pharmacologic: hmg coa reductase inhibitors
Time/action profile (cholesterol-lowering effect)
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.
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)
- 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.