pravastatin sodium

pravastatin sodium

(prah va sta' tin)

Pravachol

Pregnancy Category X

Drug classes

Antihyperlipidemic

HMG-CoA reductase inhibitor

Therapeutic actions

Inhibits the enzyme HMG-CoA that catalyzes the first step in the cholesterol synthesis pathway, resulting in a decrease in serum cholesterol, serum LDLs (associated with increased risk of CAD), and either an increase or no change in serum HDLs (associated with decreased risk of CAD).

Indications

·        Prevention of first MI and reduction of death from CV disease in patients with hypercholesterolemia at risk of first MI

·        Adjunct to diet in the treatment of elevated total cholesterol and LDL cholesterol with primary hypercholesterolemia (types IIa and IIb) in patients unresponsive to dietary restriction of saturated fat and cholesterol and other nonpharmacologic measures

·        Slow the progression of coronary atherosclerosis in patients with clinically evident CAD to reduce the risk of acute coronary events in hypercholesterolemia patients

·        Reduce the risk of stroke or TIA in patients with history of MI and normal cholesterol levels

·        Reduce the risk of recurrent MI and death from heart disease in patients with history of MI and normal cholesterol levels

·        Treatment of children > 8 yr with heterozygous familial hypercholesterolemia as an adjust to diet and exercise.

Contraindications and cautions

·        Contraindicated with allergy to pravastatin, fungal byproducts, pregnancy, lactation.

·        Use cautiously with impaired hepatic function, cataracts, alcoholism.

Available forms

Tablets—10, 20, 40, 80 mg

Dosages

ADULTS

Initially, 40 mg/day PO given once daily. Adjust dose q 4 wk based on response. Maximum daily dose is 80 mg. Maintenance doses range from 40–80 mg/day in single hs dose.

·        Concomitant immunosuppressive therapy: 10 mg PO daily hs to a maximum of 20 mg/day.

PEDIATRIC PATIENTS

8–13 yr: 20 mg/day PO.

14–18 yr: 40 mg/day PO.

GERIATRIC PATIENTS AND PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT

10 mg PO once daily at bedtime; may increase up to 20 mg/day.

Pharmacokinetics

Route	Onset	Peak
Oral	Slow	60–90 min

Metabolism: Hepatic; T_1/2: 1.8 hr

Distribution: Crosses placenta; enters breast milk

Excretion: Feces, urine

Adverse effects

·        CNS: Headache, blurred vision, dizziness, insomnia, fatigue, muscle cramps, cataracts

·        GI: Flatulence, abdominal pain, cramps, constipation, nausea, vomiting, heartburn

·        Hematologic: Elevations of CPK, alkaline phosphatase, and transaminases

Interactions

Drug-drug

·        Possible severe myopathy or rhabdomyolysis with cyclosporine, erythromycin, gemfibrozil, niacin

·        Possible increased digoxin, warfarin levels if combined; monitor patient and decrease dosage as needed

·        Increased pravastatin levels with itraconazole; avoid this combination

·        Decreased pravastatin levels if combined with bile acid sequestrants; space at least 4 hr apart

Nursing considerations

Assessment

·        History: Allergy to pravastatin, fungal byproducts; impaired hepatic function; cataracts; pregnancy; lactation

·        Physical: Orientation, affect, ophthalmologic examination; liver evaluation; lipid studies, LFTs

Interventions

·        Ensure that patient is on a cholesterol-lowering diet before and during therapy.

·        Caution patient that this drug cannot be used during pregnancy; advise patient to use barrier contraceptives.

·        Administer drug hs; highest rates of cholesterol synthesis are between midnight and 5 AM.

·        Arrange for periodic ophthalmologic examination to check for cataract development; monitor liver function.

Teaching points

·        Take drug at bedtime.

·        Continue your cholesterol-lowering diet and exercise program.

·        This drug cannot be taken during pregnancy; using barrier contraceptives is advised.

·        Have periodic ophthalmic examinations while you are using this drug.

·        You may experience these side effects: Nausea (eat frequent small meals); headache, muscle and joint aches and pains (may lessen); sensitivity to sunlight (use sunblock and wear protective clothing).

·        Report severe GI upset, changes in vision, unusual bleeding or bruising, dark urine or light-colored stools, muscle pain or weakness.

Adverse effects in Italic are most common; those in Bold are life-threatening.