Fenofibrate 54mg Tab, 90ct Bottle

Description

What is Fenofibrate and how is it used?

Fenofibrate is a prescription medicine used to treat the symptoms of high cholesterol and triglycerides (fatty acids) in the blood. Fenofibrate may be used alone or with other medications.

Fenofibrate belongs to a class of drugs called Fibric Acid Agents.

It is not known if Fenofibrate is safe and effective in children.

What are the possible side effects of Fenofibrate?

Fenofibrate may cause serious side effects including:

• sharp stomach pain spreading to your back or shoulder blade,
• loss of appetite,
• stomach pain just after eating a meal,
• yellowing of the skin or eyes (jaundice),
• fever,
• chills,
• weakness,
• sore throat,
• mouth sores,
• unusual bruising or bleeding,
• chest pain,
• sudden cough,
• wheezing,
• rapid breathing,
• coughing up blood, and
• swelling, warmth or redness in an arm or leg

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Fenofibrate include:

• runny nose,
• sneezing, and
• abnormal laboratory tests

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Fenofibrate. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Fenofibrate (fenofibrate) capsules, is a lipid regulating agent available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, l-methylethyl ester with the following structural formula:

The empirical formula is C₂₀H₂₁O₄Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79°-82°C. Fenofibrate is a white solid which is stable under ordinary conditions.

Inactive Ingredients: Each gelatin capsule contains sugar spheres, hypromellose, sodium lauryl sulfate, dimethicone, simethicone, and talc. The gelatin capsules also contain black iron oxide, D&C Yellow #10, Indigo carmine FD&C Blue #2, shellac, soya lecithin, sulfur dioxide, titanium dioxide and yellow iron oxide.

INDICATIONS

Primary Hypercholesterolemia And Mixed Dyslipidemia

Fenofibrate 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 hypercholesterolemia or mixed dyslipidemia.

Severe Hypertriglyceridemia

Fenofibrate is also indicated as adjunctive therapy to diet for treatment of adult patients with severe 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

DOSAGE AND ADMINISTRATION

General Considerations

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

Patients should be advised to swallow Fenofibrate 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 Fenofibrate 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 130 mg once daily.

Primary Hypercholesterolemia And Mixed Dyslipidemia

The initial dose of Fenofibrate is 130 mg per day.

Severe Hypertriglyceridemia

The initial dose is 43 to 130 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 130 mg per day.

Impaired Renal Function

Treatment with Fenofibrate should be initiated at a dose of 43 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 Fenofibrate 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

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.