FENOFIBRATE tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Proficient Rx LP

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Fenofibrate tablet USP is 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 tablet USP is 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 tablet USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with t

Резиме производа:

Fenofibrate tablets USP are available in two strengths: Fenofibrate tablets USP, 54 mg are yellow, round, biconvex, film coated tablets debossed with "LU" on one side and "J41" on the other side. They are available as follows: Bottles of 90                                                    NDC 68180-362-09 Bottles of 500                                                  NDC 68180-362-02 Bottles of 1000                                                NDC 68180-362-03 Carton of 100 (10 x 10) Unit-dose Tablets     NDC 68180-362-13 Fenofibrate tablets USP, 160 mg are white to off-white oval shaped, biconvex film coated tablets, debossed with "LU" on one side and "J42" on the other side. They are available as follows: Bottles of 90                                                     NDC 68180-363-09 Bottles of 500                                                   NDC 68180-363-02 Bottles of 1000                                                 NDC 68180-363-03 Carton of 100 (10 x 10) Unit-dose Tablets       NDC 68180-363-13 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

FENOFIBRATE- FENOFIBRATE TABLET
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE TABLET SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR FENOFIBRATE TABLET.
FENOFIBRATE TABLETS USP, 54 MG AND 160 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity Reactions (5.9) 05/2018
INDICATIONS AND USAGE
Fenofibrate tablet USP is a peroxisome proliferator-activated receptor
(PPAR) alpha agonist indicated as an adjunct to diet:
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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).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions > 2% and at least 1% greater than placebo: Abnormal
liver tests, increased AST, increased ALT,
increased CPK, and rhinitis (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS,
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2019
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).
Oral Tablets: 54 mg and 160 mg (3).
Severe renal dysfunction, including dialysis patients (4, 8.6, 12.3).
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