Lovastatin Tablets Rx

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Lovastatin Tablets

Hyperlipoproteinemias
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Generic Name and Formulations:

Lovastatin 10mg, 20mg, 40mg; tabs.

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Indications for Lovastatin Tablets:

To reduce risk of MI, unstable angina, and coronary revascularization procedures in patients without symptomatic cardiovascular disease (CVD), average to moderately elevated total-C and LDL-C, and below average HDL-C. Primary hypercholesterolemia (Types IIa and IIb) to reduce elevated total-C and LDL-C when response to nondrug therapy is inadequate. To slow progression of coronary atherosclerosis in patients with coronary heart disease to lower total-C and LDL-C. Adjunct to nondrug therapy to reduce total-C, LDL-C and apo B in patients 10–17yrs of age (≥1yr post-menarche) with heterozygous familial hypercholesterolemia if LDL-C remains >189mg/dL, or if LDL-C remains >160mg/dL with either family history of premature cardiovascular disease (CVD) or if patient has at least 2 other CVD risk factors.

Adult:

Give with evening meal. ≥17yrs: initially 10–20mg once daily, may increase at 4 week intervals; max 80mg/day in single or divided doses. Concomitant danazol, diltiazem, dronedarone, verapamil: initially 10mg/day; max 20mg/day. Concomitant amiodarone: max 40mg/day. Severe renal insufficiency (CrCl<30mL/min): 20mg/day; caution with dose increases.

Children:

<10yrs: not recommended. 10–17yrs: initially 10–20mg once daily, may increase at 4 week intervals. Usual range: 10–40mg/day; max 40mg/day.

Contraindications:

Active liver disease. Unexplained, persistent elevated serum transaminases. Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone). Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Discontinue if myopathy, elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Monitor liver function before starting therapy and repeat as clinically indicated. History of liver disease. Alcoholism. Homozygous familial hypercholesterolemia.

Interactions:

See Contraindications. Increased risk of myopathy with strong CYP3A4 inhibitors, danazol, diltiazem, dronedarone, verapamil, amiodarone. May be potentiated by voriconazole, ranolazine; consider dose adjustment of lovastatin. Avoid gemfibrozil, cyclosporine, grapefruit juice >1 quart daily. Caution with, other fibrates, macrolides, niacin (≥1g/day), colchicine. Monitor oral anticoagulants. Inhibition of endogenous steroid production with spironolactone, ketoconazole, cimetidine.

Pharmacological Class:

HMG-CoA reductase inhibitor.

Adverse Reactions:

GI upset, headache, rash, pruritus, myalgia, dizziness, blurred vision, elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction; increased HbA1c and fasting serum glucose, cognitive impairment; rare: immune-mediated necrotizing myopathy.

How Supplied:

Contact supplier.