Drug Catalog - Product Detail
FENOFIBRIC ACID DR CP 45MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00115-1459-10 | IMPAX GENERICS | 90 | 45MG | CAPSULE |
PACKAGE FILES
Generic Name
FENOFIBRIC ACID
Substance Name
FENOFIBRIC ACID
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA022224
Description
11 DESCRIPTION Fenofibric acid delayed release capsules (fenofibric acid) are a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula: The empirical formula is C 22 H 28 ClNO 5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hypromellose, povidone, water, hydroxypropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, black iron oxide, and red iron oxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue #2. Chemical structure for fenofibric acid.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Fenofibric acid delayed release capsules 45 mg: A reddish brown to orange brown cap and a yellow body imprinted in black ink the number “45”, available in bottles of 90 (NDC 0115-1554-10). A reddish brown to orange brown cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “45”, available in bottles of 90 (NDC 0115-1459-10). Fenofibric acid delayed release capsules 135 mg: A blue cap and a yellow body imprinted in black ink the number “135”, available in bottles of 90 (NDC 0115-1555-10). A blue cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “135”, available in bottles of 90 (NDC 0115-1460-10). Store at 25°C (77°F); excursions permitted to 15°-30°C (59° to 86°F) [See USP controlled room temperature]. Keep out of the reach of children. Protect from moisture.
Indications & Usage
1 INDICATIONS AND USAGE Fenofibric acid delayed release capsules are a 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 Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibric acid delayed release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia. 1.3 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 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1 )] . 1.4 General Considerations for Treatment Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed release capsules therapy. Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Hypertriglyceridemia: 45 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 is 45 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 is 135 mg once daily. 2.4 Impaired Renal Function Treatment with fenofibric acid delayed release capsules should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibric acid delayed release capsules should be avoided in patients with severely impaired renal function [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] . 2.5 Geriatric Patients Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations ( 8.5 )] .