FENOFIBRIC ACID capsule, delayed release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Aurobindo Pharma Limited

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 no

Toote kokkuvõte:

Fenofibric Acid Delayed-Release Capsules 45 mg are orange opaque cap/yellow opaque body size "3" hard gelatin capsules imprinted with "CFB" on cap and "45" on body with black ink and filled with white to off-white round cylindrical mini tablets. Bottles of 90                           NDC 59651-216-90 Fenofibric Acid Delayed-Release Capsules 135 mg are blue opaque cap/yellow opaque body size "0" hard gelatin capsules imprinted with "CFB" on cap and "135" on body with black ink and filled with white to off-white round cylindrical mini tablets. Bottles of 90                          NDC 59651-217-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

FENOFIBRIC ACID - FENOFIBRIC ACID CAPSULE, DELAYED RELEASE
AUROBINDO PHARMA LIMITED
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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
Warnings and Precautions, Hepatotoxicity (5.2) 03/2021
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 mg 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, 5.2).
Gallbladder disease (4, 5.5).
Nursing mothers (4, 8.2).
Known hypersensitivity to fenofibric acid or fenofibrate (4, 5.9).
WARNINGS AND PRECAUTIONS
_Hepatotoxicity:_ Serious drug-induced liver injury, including liver
transplantation and death, has been
reported with fenofibric acid delayed-release capsules. Monitor
patient’s liver function, including serum
ALT, AST, and total bilirubin, at baseline and periodically for the
duration of therapy.