Generic Name and Formulations:
Lovastatin 20mg, 40mg, 60mg; ext-rel tabs.
Covis Pharmaceuticals, Inc.
Indications for ALTOPREV:
To reduce risk of MI, unstable angina, and coronary revascularization procedures in patients without coronary heart disease (CHD), but at high risk. To slow progression of coronary atherosclerosis in patients with CHD by lowering total-C and LDL-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. Limitations of use: not studied in Fredrickson Types I, III, and V dyslipidemias.
≥20yrs: 20–60mg once daily at bedtime. Elderly (≥65yrs): initially 20mg once daily at bedtime. Concomitant danazol, diltiazem, dronedarone, verapamil: max 20mg/day. Concomitant amiodarone: max 40mg/day. Severe renal impairment (CrCl<30mL/min): usual max 20mg/day.
<20yrs: not recommended.
Active liver disease. Unexplained persistent elevated hepatic transaminase levels. Pregnancy. Nursing mothers. Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, clarithromycin, telithromycin, nefazodone), erythromycin.
Discontinue if myopathy suspected or 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. Interrupt therapy if serious hepatic injury and/or hyperbilirubinemia, or jaundice occurs; do not restart if alternate etiology is not found. History of liver disease. Alcoholism. Females of reproductive potential should use effective contraception during treatment.
See Contraindications. Increased risk of myopathy with strong CYP3A4 inhibitors. Avoid gemfibrozil, cyclosporine, grapefruit juice >1 quart daily. Caution with other fibrates, niacin (≥1g/day), colchicine, ranolazine (lovastatin dose adjustment may be needed). Monitor with oral anticoagulants. Caution with drugs that may decrease levels or activity of endogenous steroid hormones (eg, spironolactone, cimetidine).
HMG-CoA reductase inhibitor.
Infection, headache, accidental injury, flu syndrome, pain, asthenia, arthralgia, myalgia, diarrhea, dizziness, sinusitis, urinary tract infection; elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction, increases in HbA1c and fasting serum glucose levels; rare: immune-mediated necrotizing myopathy.