Rx Item-Altoprev 40MG ER 30 Tab by Covis Pharma USA , Clinical Information:
Generic Code And Description: 50557 Lovastatin Oral Tab Er 24H 40 Mg
Strength: 40 Mg
Dose Form: Tablet Extended Release 24 Hr
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 24060800 Hmg-Coa Reductase Inhibitors
Active Ingredients: 2063 Lovastatin 75330755
Inactive Ingredients: 10143 Yellow Dye
2432 Lactose 64044515
2598 Sucrose 57501 Drug Class: Drug Class: 24060800 Hmg- Coa Reductase Inhibitors, OMP Family: Waiting for Details, Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 30 , Brand Label Flag: BRANDBRAND , Storage Temperature Zone: 10 Room Temperature, Item Size Code:30 , Item Strength Code:40MG ER , Item Abbreviation: Altoprev , Generic Form: TAB
These highlights do not include all the information needed to use ALTOPREV® safely and effectively. See full prescribing information for Altoprev®.
ALTOPREV® (lovastatin extended-release) Tablets for oral administration
Initial U.S. Approval: 2002
RECENT MAJOR CHANGES
Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (IMNM) (5.2) 07/2020
INDICATIONS AND USAGE
Altoprev® is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
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Reduce the risk of MI, revascularization procedures, and angina in patients without CHD, but with multiple risk factors. (1.1)
•
Slow the progression of coronary atherosclerosis in patients with CHD as part of a treatment strategy to lower Total-C and LDL-C. (1.1)
•
Reduce elevated Total-C, LDL-C, Apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2)
Limitations of Use
Altoprev®has not been studied in Fredrickson Types I, III, and V dyslipidemias. (1.3)
DOSAGE AND ADMINISTRATION
Dose range: 20 to 60 mg once daily. (2.1)
Recommended start dose: 20, 40 or 60 mg once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
20, 40, and 60 mg tablets (3)
CONTRAINDICATIONS
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Concomitant administration of strong CYP3A inhibitors. (4, 5.1)
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Concomitant administration of erythromycin. (4, 5.1)
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Hypersensitivity to any component of this medication. (4)
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Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. (4, 5.3)
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Pregnancy. (4, 8.1, 8.3)
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Lactation. (4, 8.2)
WARNINGS AND PRECAUTIONS
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Skeletal muscle effects (e.g., myopathy and rhabdomyolysis) Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Altoprev®. Predisposing factors include advanced age (≥ 65), female gender, uncontrolled hypothyroidism, and renal impairment. Advise patients to report promptly to their physician any unexplained and/or persistent muscle pain, tenderness, or weakness. Altoprev therapy should be discontinued immediately if myopathy is diagnosed or suspected. (5.1)
•
Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. (5.2)
•
Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. (5.3)
ADVERSE REACTIONS
The most commonly reported adverse reactions (incidence ≥ 5%) in patients treated with Altoprev® in placebo-controlled trials were: infection, headache and accidental injury. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-866-488-4423 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drug Interactions Associated with Increased
Risk of Myopathy/Rhabdomyolysis (2.3, 5.1, 7, 12.3)
Interacting Agents
Prescribing Recommendations
Strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, and nefazodone), Erythromycin
Contraindicated with lovastatin
Gemfibrozil, cyclosporine
Avoid with lovastatin
Danazol, diltiazem, dronedarone, verapamil
Do not exceed 20 mg lovastatin daily
Amiodarone
Do not exceed 40 mg lovastatin daily
Grapefruit juice
Avoid grapefruit juice
•
Other Lipid-Lowering Medications: Use with other fibrate products or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with Altoprev®. (7)
USE IN SPECIFIC POPULATIONS
•
Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with Altoprev. (8.3)
•
Elderly patients should be started at 20 mg/day. (2.2, 8.5)
•
Severe renal impairment patients: dosage increases above 20 mg/day should be carefully considered. (2.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2020
