Pravastatin sodium
Pravastatin sodium (Pravachol)
Pravastatin sodium
(prah-vah- STAH-tin)
Pregnancy Category: X Pravachol (Rx)

Classification: Antihyperlipidemic agent

Action/Kinetics: Drug increases survival in heart transplant recipients. Rapidly absorbed from the GI tract. Peak plasma levels: 1-1.5 hr. Significant first-pass extraction and metabolism in the liver, which is the site of action of the drug; thus, plasma levels may not correlate well with lipid-lowering effectiveness. t 1/2, elimination: 77 hr. Metabolized in the liver; approximately 20% of a PO dose is excreted through the urine and 70% in the feces.

Uses: (1) Adjunct to diet for reducing elevated total and LDL cholesterol and triglyceride levels in clients with primary hypercholesterolemia (type IIa and IIb) and mixed dyslipidemia when the response to a diet with restricted saturated fat and cholesterol has not been effective. Reduction of apolipoprotein B serum levels. (2) Reduce the risk of recurrent MI in those with previous MI and normal cholesterol levels; reduce risk of undergoing myocardial revascularization procedures; reduce risk of stroke or TIA. (3) Reduce risk of MI in hypercholesterolemia without evidence of coronary heart disease; reduce risk of CV mortality with no increase in death from noncardiovascular causes. (4) Slow the progression of coronary atherosclerosis and reduce risk of acute coronary events in hypercholesterolemia with clinically evident CAD, including prior MI. Investigational: To lower cholesterol levels in those with heterozygous familial hypercholesterolemia, familial combined hyperlipidemia, diabetic dyslipidemia in non-insulin-dependent diabetics, hypercholesterolemia secondary to nephrotic syndrome, homozygous familial hypercholesterolemia in those not completely devoid of LDL receptors but who have a decreased level of LDL receptor activity.

Contraindications: [.]

Additional Contraindications To treat hypercholesterolemia due to hyperalphaproteinemia.

Special Concerns: Use with caution in clients with a history of liver disease or renal insufficiency.

Side Effects: Musculoskeletal: Rhabdomyolysis with renal dysfunction secondary to myoglobinuria, myalgia, myopathy, arthralgias, localized pain, muscle cramps, leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis. CNS: CNS vascular lesions characterized by perivascular hemorrhage edema, and mononuclear cell infiltration of perivascular spaces; headache, dizziness, psychic disturbances. Dizziness, vertigo, memory loss, anxiety, insomnia, somnolence, abnormal dreams, emotional lability, incoordination, hyperkinesia, torticollis, psychic disturbances. GI: N&V;, diarrhea, abdominal pain, cramps, constipation, flatulence, heartburn, anorexia, gastroenteritis, dry mouth, rectal hemorrhage, esophagitis, eructation, glossitis, mouth ulceration, increased appetite, stomatitis, cheilitis, duodenal ulcer, dysphagia, enteritis, melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomach. CV: Palpitation, vasodilation, syncope, migraine, postural hypotension, phlebitis, arrhythmia. Hepatic: Hepatitis (including chronic active hepatitis), fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma pancreatitis, cholestatic jaundice, biliary pain. GU: Gynecomastia, erectile dysfunction, loss of libido, cystitis, hematuria, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, albuminuria, breast enlargement, nephritis, urinary frequency, incontinence, retention and urgency, abnormal ejaculation, vaginal or uterine hemorrhage, metrorrhagia, UTI. Ophthalmic: Progression of cataracts, lens opacities, ophthalmoplegia. Hypersensitivity reaction: Vasculitis, purpura, polymyalgia rheumatica, angioedema lupus erythematosus-like syndrome, thrombocytopenia, hemolytic anemia leukopenia, positive ANA, arthritis, arthralgia, urticaria, asthenia, ESR increase, fever, chills, photosensitivity, malaise, dyspnea, toxic epidermal necrolysis, Stevens-Johnson syndrome. Dermatologic: Alopecia, pruritus, rash, skin nodules, discoloration of skin, dryness of skin and mucous membranes, changes in hair and nails, contact dermatitis, sweating, acne, urticaria, eczema, seborrhea, skin ulcer. Neurologic: Dysfunction of certain cranial nerves resulting in alteration of taste, impairment of extraocular movement, and facial paresis; paresthesia, peripheral neuropathy, tremor, vertigo, memory loss peripheral nerve palsy. Respiratory: Common cold, rhinitis, cough. Hematologic: Anemia, transient asymptomatic eosinophilia, thrombocytopenia, leukopenia, ecchymosis, lymphadenopathy, petechiae. Miscellaneous: Cardiac chest pain, fatigue, influenza.

Laboratory Test Alterations: CPK, AST, ALT, alkaline phosphatase, bilirubin. Abnormalities in thyroid function tests.

Drug Interactions: [.]

Additional Drug Interactions Bile acid sequestrants / Bioavailability of pravastatin Clofibrate / Risk of myopathy

How Supplied: Tablet: 10 mg, 20 mg, 40 mg

Dosage
?Tablets
Initial: 10-20 mg once daily at bedtime. Maintenance dose: 10-40 mg once daily at bedtime. Use a starting dose of 10 mg/day at bedtime in renal/hepatic dysfunction and in the elderly (maximum maintenance dose for geriatric clients is 20 mg/day).