Fenofibric Acid 45 mg/1
Fenofibric Acid · CAPSULE, DELAYED RELEASE · Alembic Pharmaceuticals Inc.
Fenofibric Acid is a capsule, delayed release containing fenofibric acid at 45 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Inc..
Key Facts
- Brand Name
- Fenofibric Acid
- Generic Name
- Fenofibric Acid
- NDC Code (Product)
62332-244- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- 45 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208705
- Drug Class
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- Marketing Start
- 05/15/2017
Recall History
Mutual Pharmaceutical Company, Inc.
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Tribute Pharmaceuticals US Inc.
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Tribute Pharmaceuticals US Inc.
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Mutual Pharmaceutical Company, Inc.
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Mutual Pharmaceutical Company, Inc.
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: Reduce TG in patients with severe hypertriglyceridemia ( 1.1 ). Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2 ). Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1 ). 1.1 Treatment of Severe Hypertriglyceridemia Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied. 1.2 Trea…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Hypertriglyceridemia: 45 mg to 135 mg once daily ( 2.2 ). Primary hypercholesterolemia or mixed dyslipidemia: 135 mg once daily ( 2.3 ). Renally impaired patients: 45 mg once daily ( 2.4 ). Maximum dose: 135 mg once daily ( 2.1 ). May be taken without regard to food ( 2.1 ). 2.1 General Considerations Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid delayed-release capsules and should continue this diet during treatment. Fenofibric acid delayed-release capsules can be taken without regard to meals. Patients should be advised to swallow fenofibric acid delayed-release capsules whole. Do not open, crush, dissolve, or chew capsules. Serum lipids should be monitored periodically. 2.2 Severe Hypertriglyceridemia The initial dose of fenofibric acid delayed-release capsules are 45 mg to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily. 2.3 Primary Hypercholesterolemia or Mixed Dyslipidemia The dose of fenofibric acid delayed-release capsules are …
Contraindications
4 CONTRAINDICATIONS Fenofibric acid delayed-release capsules are contraindicated in: patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology ( 12.3 )] . patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions ( 5.2 )] . patients with preexisting gallbladder disease [see Warnings and Precautions ( 5.5 )] . nursing mothers [see Use in Specific Populations ( 8.2 )] . patients with hypersensitivity to fenofibric acid or fenofibrate [see Warnings and Precautions ( 5.9 )] . Severe renal dysfunction, including patients receiving dialysis ( 4 , 12.3 ). Active liver disease ( 4 , 5.2 ). Gallbladder disease ( 4 , 5.5 ). Nursing mothers ( 4 , 8.2 ). Known hypersensitivity to fenofibric acid or fenofibrate ( 4 , 5.9 ).
Drug Interactions
7 DRUG INTERACTIONS Coumarin Anticoagulants: ( 7.1 ). Bile Acid Binding Resins: ( 7.2 ). Immunosuppressants: ( 7.3 ). 7.1 Coumarin Anticoagulants Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR. Caution should be exercised when oral coumarin anticoagulants are given in conjunction with fenofibric acid. The dosage of the anticoagulant should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized [see Warnings and Precautions ( 5.6 )]. 7.2 Bile Acid Binding Resins Since bile acid binding resins may bind other drugs given concurrently, patients should take fenofibric acid at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption. 7.3 Immunosuppressants Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of drugs of the fibrate class including fenofibric acid, there is a risk that an intera…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions ( 5.1 )] Hepatoxicity [see Warnings and Precautions ( 5.2 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.9 )] Venothromboembolic disease [see Warnings and Precautions ( 5.10 )] The most common adverse events reported during clinical trials with fenofibrate (≥ 2% and at least 1% greater than placebo) were abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Laurus Generics Inc. at 1-833-3-LAURUS (1-833-352-8787) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Fenofibric acid is the active metabolite of fenofibrate. Adverse events reported by 2% or more of…
Frequently Asked Questions
What is Fenofibric Acid used for?
Fenofibric Acid contains Fenofibric Acid. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.
Is Fenofibric Acid a controlled substance?
Fenofibric Acid is not classified as a controlled substance by the DEA.
What is the generic name for Fenofibric Acid?
The generic name for Fenofibric Acid is Fenofibric Acid. There are 8 other brand versions of Fenofibric Acid.
What is the NDC code for Fenofibric Acid 45 mg/1?
The NDC (National Drug Code) for Fenofibric Acid 45 mg/1 is 62332-244, listed by Alembic Pharmaceuticals Inc..