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Antara

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Antara

Indications
Dosage
How Supplied

INDICATIONS

Primary Hypercholesterolemia and Mixed Dyslipidemia

Antara is 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 adult patients with primary hyperlipidemia or mixed dyslipidemia.

Severe Hypertriglyceridemia

Antara is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

Important Limitations of Use

Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

General Considerations

Patients should be placed on an appropriate lipid-lowering diet before receiving Antara, and should continue this diet during treatment with Antara. Antara capsules can be given without regard to meals.

Patients should be advised to swallow Antara capsules whole. Do not open, crush, dissolve or chew capsules.

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Antara if lipid levels fall significantly below the targeted range.

Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 90 mg once daily.

Primary Hypercholesterolemia and Mixed Dyslipidemia

The initial dose of Antara is 90 mg per day.

Severe Hypertriglyceridemia

The initial dose is 30 to 90 mg per day. 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 90 mg per day.

Impaired Renal Function

Treatment with Antara should be initiated at a dose of 30 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Antara should be avoided in patients with severe renal impairment [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Geriatric Patients

Dose selection for the elderly should be made on the basis of renal function [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

  • ANTARA® (fenofibrate) capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “ANTARA” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.
  • ANTARA® (fenofibrate) capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “ANTARA” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.

Storage And Handling

ANTARA® (fenofibrate) Capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “ANTARA” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.

NDC 27437 -107 -06 30's Bottle

ANTARA® (fenofibrate) Capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “ANTARA” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.

NDC 27437 -108 -06 30's Bottle
NDC 27437 -108 -09 90's Bottle
NDC 27437 -108 -01 100's Bottle

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59°to 86°F) [see USP Controlled Room Temperature] in a tightly closed container.

Manufactured for: Lupin Pharma, Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited, Goa -403 722 INDIA. Address Medical Inquiries to: Lupin Pharma Medical Inquiries 111 South Calvert Street, 21st Floor Baltimore, MD 21202 or Call: 1-800-399-2561. October 2013

Last reviewed on RxList: 11/4/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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