pravastatin sodium


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pravastatin sodium

Pharmacologic class: HMG-CoA reductase inhibitor

Therapeutic class: Antilipemic

Pregnancy risk category X

Action

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.

Availability

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

Dosage adjustment

• Significant renal impairment
• Concurrent use of niacin

Contraindications

• Hypersensitivity to drug or other HMG-CoA reductase inhibitors
• Active hepatic disease or unexplained, persistent transaminase elevations
• Pregnancy, breastfeeding, females of childbearing age

Precautions

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).

Administration

• If patient's also receiving bile-acid resin, give pravastatin at bedtime, at least 4 hours after resin.

Adverse reactions

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)

Interactions

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

Patient monitoring

• 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).

Patient teaching

• 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.

References in periodicals archive ?
The addition of pravastatin sodium tablets and oxycodone HCl controlled-release tablets, both distributed generic products with lower gross margins, contributed to the year over year decline.
5 million in the prior year period, primarily due to the Company's launch of pravastatin sodium tablets during the quarter and the addition of oxycodone HCl controlled-release tablets C-II in the fourth quarter 2005.
Excluding the launch of pravastatin sodium, our generic business grew in both sales and gross profit compared to the first quarter, despite higher facility rationalization costs.
a leading specialty pharmaceutical company, announced today that under a distribution agreement with Bristol-Myers Squibb Company , the Company has initiated shipments of pravastatin sodium tablets in the 10, 20 and 40 mg.
Additionally, Sankyo discovered and developed pravastatin sodium (marketed in the United States by licensee Bristol Myers-Squibb).