FENOFIBRATE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)

Доступна з:

Aphena Pharma Solutions - Tennessee, LLC

ІПН (Міжнародна Ім'я):

FENOFIBRATE

Склад:

FENOFIBRATE 160 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate tablets are 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 obviate 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. Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2

Огляд продуктів:

Fenofibrate Tablets, USP are available containing 54 mg or 160 mg of fenofibrate, USP. The 54 mg tablets are yellow, film-coated, round, unscored tablets debossed with KLX on one side of the tablet and 170 on the other side. They are available as follows: NDC 0378-7100-77 bottles of 90 tablets The 160 mg tablets are white, film-coated, round, unscored tablets debossed with KLX on one side of the tablet and 171 on the other side. They are available as follows: NDC 0378-7101-77 bottles of 90 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Keep out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

FENOFIBRATE- FENOFIBRATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENOFIBRATE TABLETS.
FENOFIBRATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator receptor alpha (PPARα)
activator indicated as an adjunct to diet:
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Important Limitations of Use: Fenofibrate was not shown to reduce
coronary heart disease morbidity and mortality in
patients with type 2 diabetes mellitus (5.1).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Oral Tablets: 54 mg and 160 mg (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (> 2% and at least 1% greater than
placebo) are abnormal liver tests, increased AST,
increased ALT, increased CPK, and rhinitis (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C
in adult patients with primary
hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia
(1.2).
Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of
160 mg once daily (2.2).
Severe hypertriglyceridemia: Initial dose of 54 mg to 160 mg once
daily. Maximum dose is 160 mg (2.3).
Renally impaired patients: Initial dose of 54 mg once daily (2.4).
Geriatric patients: Select the dose on the basis of renal function
(2.5).
Should be given with meals (2.1).
Severe renal dysfunction, including patients receiving dialysis (4,
8.6, 12.3).
Active liver disease (4, 5.3).
Gallbladder disease (4, 5.5).
Known hypersensitivity to fenofibrate (4).
Nursing mothers (4, 8.3).
Myopathy and rhabdomyo