FENOFIBRATE capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Glenmark Pharmaceuticals Inc., USA

ІПН (Міжнародна Ім'я):

FENOFIBRATE

Склад:

FENOFIBRATE 67 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating 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. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2 . 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 hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see Error! Hyperlink reference not valid. and Error! Hyperlink reference not valid. ). Fredrickson Classification of Hyperlipoproteinemias Lipid Elevation Type Lipoprotein Elevated Major Minor I (rare) Chylomicrons TG ↑↔C IIa LDL C - IIb LDL, VLDL C TG III (rare) IDL C, TG - IV VLDL TG ↑↔C V (rare) Chylomicrons, VLDL TG ↑↔ LDL-Cholesterol mg/dL (mmol/L) Definite Atherosclerotic Disease1 Two or More Other Risk Factors2 Initiation Level Goal No No ≥ 190 (≥ 4.9) < 160 (< 4.1) No Yes ≥ 160 (≥ 4.1) < 130 (< 3.4) Yes Yes or No ≥ 1303 (≥ 3.4) < 100 (< 2.6) 1 Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). 2 Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C < 35 mg/dL (< 0.91 mmol/L); and diabetes mellitus. Subtract 1 risk factor if HDL-C is ≥ 60 mg/dL (≥ 1.6 mmol/L). 3 In CHD patients with LDL-C levels 100 to 129 mg/dL, the physician should exercise clinical judgment in deciding whether to initiate drug treatment. Fenofibrate capsules are contraindicated in patients who exhibit hypersensitivity to fenofibrate. Fenofibrate capsules are contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality. Fenofibrate capsules are contraindicated in patients with preexisting gallbladder disease (see WARNINGS ).

Огляд продуктів:

Fenofibrate Capsules, USP (micronized) 67 mg are size ‘4’ hard gelatin capsules with an opaque pink cap and body, imprinted in black ink with a Glenmark logo “G” and “580” on opposing cap and body portions of the capsule, filled with white to off-white granular powder. They are supplied as follows: NDC 68462-580-01 Bottles of 100 capsules Fenofibrate Capsules, USP (micronized) 134 mg are size ‘2’ hard gelatin capsules with an opaque light blue cap and body, imprinted in black ink with a Glenmark logo “G” and “581” on opposing cap and body portions of the capsule, filled with white to off-white granular powder. They are supplied as follows: NDC 68462-581-01 Bottles of 100 capsules Fenofibrate Capsules, USP (micronized) 200 mg are size ‘1’ hard gelatin capsules with an opaque orange cap and body, imprinted in black ink with a Glenmark logo “G” and “582” on opposing cap and body portions of the capsule, filled with white to off-white granular powder. They are supplied as follows: NDC 68462-582-01 Bottles of 100 capsules Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as defined in USP with a child-resistant closure (as required).

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

FENOFIBRATE- FENOFIBRATE CAPSULE
GLENMARK PHARMACEUTICALS INC., USA
----------
FENOFIBRATE CAPSULES, USP
RX ONLY
DESCRIPTION
Fenofibrate, USP (micronized), is a lipid regulating agent available
as capsules for oral
administration. Each capsule contains 67 mg, 134 mg or 200 mg of
micronized
fenofibrate, USP. The chemical name for fenofibrate, USP is Isopropyl
2-[_p_-(_p_-
chlorobenzoyl)phenoxy]-2-methylpropanoate with the following
structural formula:
The molecular formula is C
H
Cl O and the molecular weight is 360.83 g/mol.
Fenofibrate, USP is practically insoluble in water, very soluble in
methylene chloride and
slightly soluble in alcohol. The melting point is 79°C to 82°C.
Fenofibrate, USP is a white
or almost white, crystalline powder which is stable under ordinary
conditions.
Each 67 mg fenofibrate capsule, USP (micronized) contains the
following inactive
ingredients: black iron oxide, colloidal silicon dioxide,
crospovidone, D&C Red #28, FD&C
Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium
stearate, potassium
hydroxide, povidone, pregelatinized starch, shellac, sodium lauryl
sulfate, talc and
titanium dioxide.
Each 134 mg fenofibrate capsule, USP (micronized) contains the
following inactive
ingredients: black iron oxide, colloidal silicon dioxide,
crospovidone, D&C Red #28, FD&C
Blue #1, gelatin, lactose monohydrate, magnesium stearate, potassium
hydroxide,
povidone, pregelatinized starch, shellac, sodium lauryl sulfate, talc
and titanium dioxide.
Each 200 mg fenofibrate capsule, USP (micronized) contains the
following inactive
ingredients: black iron oxide, colloidal silicon dioxide,
crospovidone, D&C Red #28, FD&C
Red #40, gelatin, iron oxide yellow, lactose monohydrate, magnesium
stearate,
potassium hydroxide, povidone, pregelatinized starch, shellac, sodium
lauryl sulfate, talc
and titanium dioxide.
FDA approved dissolution test specifications differ from USP.
20
21
4
CLINICAL PHARMACOLOGY
A variety of clinical studies have demonstrated that elevated levels
of total cholesterol
(total-