FENOFIBRATE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sun Pharmaceutical Industries, Inc.

INN (mednarodno ime):

FENOFIBRATE

Sestava:

FENOFIBRATE 54 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 d

Povzetek izdelek:

Fenofibrate tablets, USP are available in two strengths: Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “RX900 ” on one side and plain on the other side. They are supplied as follows. NDC 63304-900-03 Bottles of 10 NDC 63304-900-90 Bottles of 90 NDC 63304-900-10 Bottles of 1000 Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “RX901 ” on one side and plain on the other side. They are supplied as follows: NDC 63304-901-03 Bottles of 10 NDC 63304-901-90 Bottles of 90 NDC 63304-901-05 Bottles of 500 NDC 63304-901-10 Bottles of 1000 Storage Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Keep this and all medication out of the reach of children. Protect from moisture.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

FENOFIBRATE- FENOFIBRATE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR)
alpha agonist indicated as an adjunct to
diet: (1)
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Limitations of Use: Fenofibrate was not shown to reduce coronary heart
disease morbidity and mortality in
patients with type 2 diabetes mellitus (5.1). (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Oral Tablets: 54 mg and 160 mg (3). (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Warnings and Precautions, Hepatotoxicity (5.2) 02/2021
Warnings and Precautions, Myopathy and rhabdomyolysis (5.3) 02/2021
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 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 dialysis patients (4, 8.6, 12.3).
Active liver disease (4, 5.3).
Gallbladder disease (4, 5.5).
Known hypersensitivity to fenofibrate (4).
Nursing mothers (4, 8.2).
_Hepatotoxicity_: Serious drug-induced liver injury, including liver
transplantation and death, has been
reported with fenofibrate. Monitor patient’s liver function,
including serum ALT, AST, and total bilirubin,
at baseline and periodically for the