Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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ALTOPREV |
| Manufacturer |
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Sciele Pharma, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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HMG-CoA reductase inhibitor. |
| Generic Name |
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Lovastatin 10mg, 20mg, 40mg, 60mg; ext-rel tabs. |
| Indications |
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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. Adjunct to diet in primary hypercholesterolemia and mixed dyslipidemias (Types IIa and IIb) to lower elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, when response to nondrug therapy alone is inadequate. To slow progression of coronary atherosclerosis in patients with coronary heart disease by lowering total-C and LDL-C. |
| Children |
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<20yrs: not recommended. |
| Adults |
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Swallow whole. >20yrs: 10–60mg once daily at bedtime; adjust at intervals of ≥4 weeks. Concomitant cyclosporine: initially 10mg daily; max 20mg/day. Concomitant amiodarone or verapamil: max 40mg/day. Concomitant fibrates or niacin: max 20mg/day. Severe renal insufficiency (CrCl <30mL/min): usual max 20mg/day. |
| Contraindications |
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Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Monitor liver function (before therapy, at 6 and 12 weeks after start or dose increases, then periodically); discontinue if serum transaminase levels ≥3xULN persist. History of liver disease. Renal dysfunction. Alcoholism. Discontinue if myopathy is suspected, or if elevated creatine phosphokinase or ALT (SGOT) levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Homozygous familial hypercholesterolemia. Suspend treatment before elective major surgery. |
| Interactions |
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Not recommended with ketoconazole, itraconazole, voriconazole, HIV protease inhibitors, erythromycin, clarithromycin, nefazodone, grapefruit juice >1 quart daily; increased risk of myopathy with these and other CYP3A4 inhibitors (eg, cyclosporine); suspend lovastatin and monitor if a short course of these antifungals or antibiotics is needed. Avoid gemfibrozil, other fibrates, macrolides, niacin. Monitor oral anticoagulants. Caution with spironolactone, cimetidine, other steroid hormone suppressive drugs, amiodarone, verapamil. |
| Adverse Reactions |
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GI upset, abdominal pain, headache, insomnia, asthenia, myalgia, arthralgia, dizziness, sinusitis, elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction. |
| Extra Text |
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Note: This product was formerly named Altocor. |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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