FENOFIBRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FENOFIBRATE (UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS)

Available from:

NORTHWIND PHARMACEUTICALS

INN (International Name):

FENOFIBRATE

Composition:

FENOFIBRATE 145 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate tablets for oral use 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. 1.2 Severe Hypertriglyceridemia Fenofibrate tablets for oral use 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. 1.3 Important Limitations of Use Fenofibrate at a dose equivalent to 145 mg of Fenofibrat

Product summary:

Fenofibrate tablets for oral use are available in two strengths: 48 mg yellow tablets, imprinted with the “a” logo and the code identification letters "FI", available in bottles of 90 (NDC 68382-228-16). 145 mg white tablets, imprinted with the “a” logo and the code identification letters "FO", available in bottles of 90 (NDC 68382-230-16). Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Please see full information on Fenofibrate 145mg Zydus Pharmaceuticals at Permanent Link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1c3696b1-23c1-2992-86a0-c0882b81048d

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

FENOFIBRATE- FENOFIBRATE TABLET
NORTHWIND PHARMACEUTICALS
----------
FENOFIBRATE 145MG 51655-902
INDICATIONS AND USAGE
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets for oral use 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.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets for oral use 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.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of Fenofibrate tablets for
oral use was not shown to reduce
coronary heart disease morbidity and mortality in a large, randomized
controlled trial of patients with
type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
Please see full information on Fenofibrate 145mg Zydus Pharmaceuticals
at Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1c3696b1-23c1-2992-86a0-c0882b81048d
DOSAGE AND ADMINISTRATION
2.1 General Considerations
Patients should be placed on an appropriate lipid-lowering diet before
receiving Fenofibrate tablets for
oral use, and should continue this diet during treatment with
Fenofibrate tablets for oral use. Fenofibrate
tablets for oral use can be given without regard to meals.
The initial treatment for dyslipidemia is dietary therapy specific for
the type of lipoprotein abnormality.
Excess body weight and excess alcoholic intake may be important
factors in