FENOFIBRIC ACID capsule delayed release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Actavis Pharma, Inc.

ІПН (Міжнародна Ім'я):

FENOFIBRIC ACID

Склад:

FENOFIBRIC ACID 45 mg

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

FENOFIBRIC ACID- FENOFIBRIC ACID CAPSULE, DELAYED RELEASE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRIC ACID DELAYED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FENOFIBRIC ACID DELAYED-RELEASE
CAPSULES.
FENOFIBRIC ACID DELAYED-RELEASE CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Indications and Usage,
Combination With a Statin – removal (1) 4/2015
Dosage and Administration, Combination With a Statin – removal (2)
4/2015
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 did not reduce coronary heart disease
morbidity and mortality in patients with type 2 diabetes mellitus
(5.1).
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).
DOSAGE FORMS AND STRENGTHS
Oral Delayed Release Capsules: 45 mg and 135 mg (3).
CONTRAINDICATIONS
Severe renal dysfunction, including patients receiving dialysis (4,
12.3).
Active liver disease (4, 5.3).
Gallbladder disease (4, 5.5).
Nursing mothers (4, 8.3).
Known hypersensitivity to fenofibric acid or fenofibrate (4, 5.9)
WARNINGS AND PRECAUTIONS
Myopathy and rhabdomyolysis have been reported in patients taking
fenofibrate. The risks for myopathy and
rhabdomyolysis are increased in elderly patients; patients with
diabetes, renal failure, or hypothyroidism; and patients
being treated wit