ALTOPREV Dosage & Rx Info | Uses, Side Effects

Altoprev Generic Name & Formulations

Legal Class

General Description

Lovastatin 20mg, 40mg, 60mg; ext-rel tabs.

Pharmacological Class

HMG-CoA reductase inhibitor.

How Supplied

Tabs—30

Manufacturer

Covis Pharmaceuticals, Inc.

Generic Availability

Mechanism of Action

Lovastatin is a lactone that is readily hydrolyzed in vivo to the corresponding β-hydroxyacid, a strong inhibitor of HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate. The conversion of HMG-CoA to mevalonate is an early step in the biosynthetic pathway for cholesterol.

Altoprev Indications

Indications

To reduce risk of MI, unstable angina, and coronary revascularization procedures in adults at high risk for coronary heart disease (CHD). Adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of coronary atherosclerosis in adults with coronary heart disease. Adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

Altoprev Dosage and Administration

Adult

20–60mg once daily in the evening. Concomitant danazol, diltiazem, dronedarone, verapamil: max 20mg/day. Concomitant amiodarone: max 40mg/day. Severe renal impairment (CrCl<30mL/min): usual max 20mg/day.

Children

Not established.

Altoprev Contraindications

Contraindications

Active liver failure or decompensated cirrhosis. Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, select antiviral medications [eg, dasabuvir/ombitasvir/paritprevir/ritonavir] including cobicistat-containing products [eg, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate], nefazodone), erythromycin.

Altoprev Boxed Warnings

Not Applicable

Altoprev Warnings/Precautions

Warnings/Precautions

Discontinue if myopathy suspected or markedly elevated CP levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Risk factors for myopathy (eg, renal impairment, uncontrolled hypothyroidism, age ≥65yrs, concomitant certain drugs including other lipid-lowering therapies). Immune-mediated necrotizing myopathy; discontinue if suspected. Monitor liver function before starting therapy and repeat as clinically indicated. Discontinue if serious hepatic injury with clinical symptoms and/or hyperbilirubinemia, or jaundice occurs. Substantial alcohol ingestion and/or history of liver disease. Renal impairment: monitor; (severe): reduce dose (see Adult dose). Elderly (≥65yrs): monitor. Advise females of reproductive potential to use effective contraception during treatment. Pregnancy: discontinue when recognized. Nursing mothers: not recommended.

Altoprev Pharmacokinetics

Distribution

>95% plasma protein bound.

Altoprev Interactions

Interactions

See Contraindications and Adult dose. Increased risk of myopathy and rhabdomyolysis with strong CYP3A4 inhibitors, amiodarone, danazol, diltiazem, dronedarone, verapamil. 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.

Altoprev Adverse Reactions

Adverse Reactions

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.

Altoprev Clinical Trials

See Literature

Altoprev Note