GEMFIBROZIL- gemfibrozil tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

GEMFIBROZIL (UNII: Q8X02027X3) (GEMFIBROZIL - UNII:Q8X02027X3)

Предлага се от:

NuCare Pharmaceuticals,Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: - Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompa

Каталог на резюме:

Gemfibrozil Tablets USP 600 mg: White, elliptical, film-coated, scored tablets, imprinted C17 on one side, are available as follows: NDC 68071-4421-3 BOTTLES OF 30 NDC 68071-4421-6 BOTTLES OF 60 NDC 68071-4421-8 BOTTLES OF 180 Store at controlled room temperature 20° – 25°C (68° – 77°F) [see USP]. Protect from light and humidity.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

GEMFIBROZIL- GEMFIBROZIL TABLET
NUCARE PHARMACEUTICALS,INC.
----------
GEMFIBROZIL TABLETS USP, 600 MG - GEMFIBROZIL TABLETS
NIVAGEN PHARMACEUTICALS, INC.
RX ONLY
DESCRIPTION
Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is
available as tablets for oral
administration. Each tablet contains 600 mg gemfibrozil. Each tablet
also contains calcium stearate, NF;
microcrystalline cellulose, NF; hydroxypropyl cellulose, NF;
polysorbate 80, NF; colloidal silicon
dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose
sodium, NF; Opadry white;
Opacode Blue. Opadry white contains hypromellose, titanium dioxide,
polyethylene glycol 400 and
Opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium
dioxide, propylene glycol,
isopropyl alcohol. The chemical name is
5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the
following structural formula:
The empirical formula is C
H
O
and the molecular weight is 250.35; the solubility in water and
acid is 0.0019% and in dilute base it is greater than 1%. The melting
point is 58°–61° C. Gemfibrozil is
a white solid which is stable under ordinary conditions.
CLINICAL PHARMACOLOGY
Gemfibrozil is a lipid regulating agent which decreases serum
triglycerides and very low density
lipoprotein (VLDL) cholesterol, and increases high density lipoprotein
(HDL) cholesterol. While
modest decreases in total and low density lipoprotein (LDL)
cholesterol may be observed with
gemfibrozil therapy, treatment of patients with elevated triglycerides
due to Type IV
hyperlipoproteinemia often results in a rise in LDL-cholesterol.
LDL-cholesterol levels in Type IIb
patients with elevations of both serum LDL-cholesterol and
triglycerides are, in general, minimally
affected by gemfibrozil treatment; however, gemfibrozil usually raises
HDL-cholesterol significantly
in this group. Gemfibrozil increases levels of high density
lipoprotein (HDL) subfractions HDL2 and
HDL3, as well as apolipoproteins AI and AII. Epidemiological studies
have shown that both low H