FENOFIBRATE- fenofibrate tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Graviti Pharmaceuticals Private Limited

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 145 mg of fenofibrate tablet was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 d

Product samenvatting:

Fenofibrate tablets, USP are available in two strengths: 48 mg tablets are yellow, oval shaped, biconvex, film coated tablets debossed with "158" on one side and plain on other side. Available as following. Bottles of 30 tablets with child-resistant closure, NDC 69844-012-01 Bottles of 90 tablets with child-resistant closure, NDC 69844-012-02 Bottles of 1,000 tablets, NDC 69844-012-03 145 mg tablets are white, oval shaped, biconvex, film coated tablets debossed with "159" on one side and plain on other side. Available as following. Bottles of 30 tablets with child-resistant closure, NDC 69844-013-01 Bottles of 90 tablets with child-resistant closure, NDC 69844-013-02 Bottles of 1,000 tablets, NDC 69844-013-03 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FENOFIBRATE - FENOFIBRATE TABLET
GRAVITI PHARMACEUTICALS PRIVATE LIMITED
----------
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
Warnings and Precautions, Hepatotoxicity ( 5.2) 03/2021
INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR)
alpha agonist indicated as an adjunct
to diet:
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).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart
disease morbidity and mortality in
patients with type 2 diabetes mellitus ( 5.1).
DOSAGE AND ADMINISTRATION
Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of
145 mg once daily ( 2.2).
Severe hypertriglyceridemia: Initial dose of 48 mg to 145 mg once
daily. Maximum dose is 145 mg (
2.3).
Renally impaired patients: Initial dose of 48 mg once daily ( 2.4).
Geriatric patients: Select the dose on the basis of renal function (
2.5).
May be taken without regard to meals ( 2.1).
DOSAGE FORMS AND STRENGTHS
Oral Tablets: 48 mg and 145 mg ( 3).
CONTRAINDICATIONS
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).
WARNINGS AND PRECAUTIONS
_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 duration of therapy. Discontinue
if signs or symptoms of liver injury
develop or if elevated enzyme levels persist ( 5.2).
_Myopa