FENOFIBRIC ACID DELAYED-RELEASE- fenofibric acid capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLINE FENOFIBRATE (UNII: 4BMH7IZT98) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

CHOLINE FENOFIBRATE

Composition:

FENOFIBRIC ACID 45 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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. Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease

Product summary:

Fenofibric Acid Delayed-Release Capsules are supplied in two dose strengths as follows: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FENOFIBRIC ACID DELAYED-RELEASE- FENOFIBRIC ACID CAPSULE, DELAYED
RELEASE
Par Pharmaceutical, Inc.
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MEDICATION GUIDE
Fenofibric Acid (fen'' oh fye' brik as'id) Delayed-Release Capsules
Read this Medication Guide before you start taking fenofibric acid
delayed-release capsules and each
time you get a refill. There may be new information. This information
does not take the place of talking to
your healthcare provider about your medical condition or your
treatment.
What is the most important information I should know about fenofibric
acid delayed-release capsules?
Fenofibric acid delayed-release capsules can cause muscle pain,
tenderness or weakness, which may be
symptoms of a rare but serious muscle condition called rhabdomyolysis.
In some cases rhabdomyolysis
can cause kidney damage and death. The risk of rhabdomyolysis may be
higher when fenofibric acid
delayed-release capsules are given with statins. If you take a statin,
tell your healthcare provider.
What are fenofibric acid delayed-release capsules?
Fenofibric acid delayed-release capsules are a prescription medicine
used to treat cholesterol in the blood
by lowering the total amount of triglycerides and LDL (bad)
cholesterol, and increasing the HDL (good)
cholesterol. Fenofibric acid delayed-release capsules have not been
shown to lower your risk of having
heart problems or a stroke. You should be on a low fat and low
cholesterol diet while you take fenofibric
acid delayed-release capsules.
The safety and effectiveness of fenofibric acid delayed-release
capsules in children is not known.
Who should not take fenofibric acid delayed-release capsules?
Do not take fenofibric acid delayed-release capsules if you:
•
are allergic to fenofibric acid, or any of the ingredients in
fenofibric acid delayed-release capsules.
See the end of this Medication Guide for a list of all the ingredients
in fenofibric acid delayed-
release capsules.
•
have severe kidney disease.
•
have liver disease.
•
have gallbladder disease.
•
are a nursing mother.
Talk to y

Summary of Product characteristics

FENOFIBRIC ACID DELAYED-RELEASE- FENOFIBRIC ACID CAPSULE, DELAYED
RELEASE
PAR PHARMACEUTICAL, INC.
----------
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
Warnings and Precautions, Hypersensitivity Reactions (5.9)
05/2018
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).
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. Risks are increased in elderly patients
and patients with diabetes, renal failure, hypothyroidism, or statin
coadministration (5.2).
Fenofibric acid delayed-release capsules can increase serum
transam