pravastatin sodium

pravastatin sodium

Lipostat (UK), Pravachol

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 control levels of total cholesterol, LDL, triglycerides, and apolipoprotein B in primary hypercholesterolemia, mixed dyslipidemia (including Fredrickson types IIa and IIb), primary dysbetalipoproteinemia (Fredrickson type III), and hypertriglyceridemia (including Fredrickson type IV); primary and secondary prevention of cardiovascular events

Adults: 10 to 80 mg P.O. daily. Usual dosage is 40 mg/day.

Children ages 5 to 13: 20 mg daily

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; myopathy; major surgery; trauma; alcoholism
• history of hepatic disease
• concurrent use of gemfibrozil or azole antifungals
• children under age 18 (safety not established).

Administration

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

Route	Onset	Peak	Duration
P.O.	Unknown	Unknown	Unknown

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

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 necrolysis, erythema multiforme , Stevens-Johnson syndrome, angioedema, lupus erythematosus-like reaction, and anaphylaxis )

Interactions

Drug-drug. Antacids, colestipol: decreased pravastatin blood level

Azole antifungals, cyclosporine, erythromycin, gemfibrozil, niacin, other HMG-CoA reductase inhibitors: increased risk of myopathy

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, creatine kinase, creatinine phosphokinase: increased levels

Drug-herbs. Chaparral, comfrey, eucalyptus, germander, jin bu huan, kava, pennyroyal, skullcap, valerian: increased risk of hepatotoxicity

Red yeast rice: increased risk of adverse drug reactions

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.
• 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.