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

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Golden State Medical Supply

INN（国际名称）:

CHOLINE FENOFIBRATE

组成:

FENOFIBRIC ACID 135 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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.

授权状态:

Abbreviated New Drug Application

资料单张

Golden State Medical Supply
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Revised: 3/2020
Document Id: a01ed6e6-24ba-9593-e053-2995a90a9837
34391-3
Set id: c07e21c5-7afc-4ae9-ae58-0e281a237361
Version: 5
Effective Time: 20200324
Golden State Medical Supply

产品特点

FENOFIBRIC ACID DELAYED-RELEASE- FENOFIBRIC ACID CAPSULE, DELAYED
RELEASE
GOLDEN STATE MEDICAL SUPPLY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FENOFIBRIC ACIDTHESE 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-rel