Lovastatin 20 mg/1
Lovastatin · TABLET · PD-Rx Pharmaceuticals, Inc.
Lovastatin is a tablet containing lovastatin at 20 mg/1, taken oral. Manufactured by PD-Rx Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Lovastatin
- Generic Name
- Lovastatin
- NDC Code (Product)
43063-983- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075991
- Drug Class
- HMG-CoA Reductase Inhibitor [EPC]
- Marketing Start
- 11/25/2002
Recall History
AVKARE Inc.
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Lupin Pharmaceuticals Inc.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Aidapak Services, LLC
Labeling: Label Mixup: LOVASTATIN, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: AD28349_1, EXP: 2/28/2014; FLUVASTATIN SODIUM, Capsule, 20 mg, NDC 00078017615, Pedigree: AD73597_7, EXP: 5/31/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: W003247, EXP: 6/17/2014.
American Health Packaging
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Therapy with Lovastatin Tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, Lovastatin Tablets USP are indicated to reduce the risk of: - Myocardial infarction - Unstable angina - Coronary revascularization procedures (See CLINICAL PHARMACOLOGY , Clinical Studies in Adults .) Coronary Heart Disease Lovastatin Tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia Therapy with lipid-altering agents should be a component of multiple risk factor i…
Dosage & Administration
DOSAGE AND ADMINISTRATION The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin tablets and should continue on this diet during treatment with lovastatin tablets (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin tablets should be given with meals. Adult Patients The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range of lovastatin is 10 to 80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Treatment Guidelines and CLINICAL PHARMACOLOGY ). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE ) should be started on 20 mg/day of lovastatin tablets. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more. Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin tablets if cholesterol levels fall significantly below the targeted r…
Warnings
WARNINGS Myopathy/Rhabdomyolysis Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma. The risk of myopathy/rhabdomyolysis is dose related. In a clinical study (EXCEL) in which patients were carefully monitored and some interacting drugs were excluded, there was one case of myopathy among 4933 patients randomized to lovastatin 20 to 40 mg daily for 48 weeks, and 4 among 1649 patients randomized to 80 mg daily. There have been rare reports of immune-mediated necrotizing myopathy (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; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosup…
Contraindications
CONTRAINDICATIONS Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases (see WARNINGS ). Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone and cobicistat-containing products) (see WARNINGS , Myopathy/Rhabdomyolysis ). Pregnancy and Lactation (See PRECAUTIONS , Pregnancy and Nursing Mothers .) Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase such as lovastatin to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, lovastatin is contraindicated during pregnancy and in nursing mothers. Lovastatin sho…
Drug Interactions
Drug Interactions CYP3A4 Interactions Lovastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Strong inhibitors of CYP3A4 (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, erythromycin, and cobicistat-containing products), and grapefruit juice increase the risk of myopathy by reducing the elimination of lovastatin (see CONTRAINDICATIONS , WARNINGS , Myopathy/Rhabdomyolysis , and CLINICAL PHARMACOLOGY , Pharmacokinetics ). Interactions With Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone The risk of myopathy is also increased by the following lipid-lowering drugs that are not strong CYP3A4 inhibitors, but which can cause myopathy when given alone. See WARNINGS, Myopathy/Rhabdomyolysis. Gemfibrozil Other fibrates Niacin (nicotinic acid) (≥ 1 g/day) Other Drug Interactions Cyclosporine The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine (see WARNINGS , Myopathy/Rhabdomyolysis ). Danazol, Diltiazem, Droneda…
Adverse Reactions
ADVERSE REACTIONS Phase III Clinical Studies In Phase III controlled clinical studies involving 613 patients treated with lovastatin, the adverse experience profile was similar to that shown below for the 8,245 patient EXCEL study (see Expanded Clinical Evaluation of Lovastatin [EXCEL] Study ). Persistent increases of serum transaminases have been noted (see WARNINGS, Liver Dysfunction ). About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine were 9 percent. This was attributable to the noncardiac fraction of CK. Large increases in CK have sometimes been reported (see WARNINGS , Myopathy/Rhabdomyolysis ). Expanded Clinical Evaluation of Lovastatin (EXCEL) Study Lovastatin was compared to placebo in 8,245 patients with hypercholesterolemia (total-C 240 to 300 mg/dL [6.2 to 7.8 mmol/L]) in the randomized, double-blind, parallel, 48 week EXCEL study. Clinical adverse experiences reported as possibly, probably or definitely drug-related in ≥ 1% in any treatment group are shown in the table below. For no event was the incidence on drug and placebo statistically different…
Frequently Asked Questions
What is Lovastatin used for?
Lovastatin contains Lovastatin. It is a tablet taken oral. Consult your doctor for specific uses.
Is Lovastatin a controlled substance?
Lovastatin is not classified as a controlled substance by the DEA.
What is the generic name for Lovastatin?
The generic name for Lovastatin is Lovastatin. There are no other listed brand versions of Lovastatin.
What is the NDC code for Lovastatin 20 mg/1?
The NDC (National Drug Code) for Lovastatin 20 mg/1 is 43063-983, listed by PD-Rx Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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