GEMFIBROZIL tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Διεθνής Όνομα):

GEMFIBROZIL

Σύνθεση:

GEMFIBROZIL 600 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Gemfibrozil tablets USP, 600 mg are available as white to off-white, oval, film-coated tablets scored on one side, debossed “93”-“670” on the scored side. Packaged in blistercards of 30, 31 tablets and unit dose boxes of 30 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and humidity. Dispense contents in a tight container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. O 2/2011

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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GEMFIBROZIL TABLETS USP, 600 MG
0670
RX ONLY
DESCRIPTION
Gemfibrozil is a lipid regulating agent. It is available as tablets
for oral administration. Each tablet
contains 600 mg gemfibrozil. In addition, each tablet contains the
following inactive ingredients:
calcium stearate, colloidal silicon dioxide, hydroxypropyl cellulose,
hypromellose, microcrystalline
cellulose, polydextrose K, polyethylene glycol 4000, polysorbate 80,
pregelatinized starch and
titanium dioxide. The chemical name is
5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the
following structural formula:
C
H O M.W. 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° to 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-bli