GEMFIBROZIL tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

XLCare Pharmaceuticals, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Gemfibrozil Tablets 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 accompanying

leaflet_short:

Gemfibrozil Tablets, USP are supplied as: White to off white, film coated, oval tablets, debossed with “1” with two partial bisects on one side and two partial bisects on other side, each containing 600 mg gemfibrozil, USP are available as follows: NDC 72865-186-60; Bottles of 60 NDC 72865-186-18; Bottles of 180 NDC 72865-186-05; Bottles of 500 Store at controlled room temperature 20° – 25°C (68° – 77°F) [see USP]. Protect from light and humidity. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: XLCare Pharmaceuticals, Inc. 242 South Culver Street, Suite 202 Lawrenceville, GA 30046 Rev: 08/21

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

GEMFIBROZIL- GEMFIBROZIL TABLET
XLCARE PHARMACEUTICALS, INC.
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GEMFIBROZIL TABLETS, USP
DESCRIPTION
Gemfibrozil, USP is a lipid regulating agent. It is available as
tablets for oral
administration. Each tablet contains 600 mg gemfibrozil. Each tablet
also contains the
following inactive ingredients: pregelatinized starch,
microcrystalline cellulose, povidone,
colloidal silicon dioxide, polysorbate, croscarmellose sodium, calcium
stearate,
hydroxypropyl cellulose, and talc. 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 HDL and
HDL , as well as apolipoproteins AI and AII. Epidemiological studies
have shown that
both low HDL-cholesterol and high LDL-cholesterol are independent risk
factors for
coronary heart disease.
In the primary prevention component of the Helsinki Heart Study, in
which 4081 male
patients between the ages of 40 and 55 were studied in a randomized,
double-blind,
placebo-controlled fashion, gemf