pravastatin sodium(redirected from Sandoz Pravastatin)
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.