País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
GEMFIBROZIL (UNII: Q8X02027X3) (GEMFIBROZIL - UNII:Q8X02027X3)
West-ward Pharmaceutical Corp
GEMFIBROZIL
GEMFIBROZIL 600 mg
ORAL
PRESCRIPTION DRUG
Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for: 1. 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 tablets, USP 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 ele
Gemfibrozil Tablets, USP are supplied as white, oval, film-coated, scored, engraved with "WW45" tablets, each containing 600 mg gemfibrozil, and available as follows: Bottles of 30 Bottles of 60 Bottles of 500 Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP]. Protect from light and humidity. Distributed by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Manufactured by: Hikma Pharmaceuticals P.O. Box 182400 Amman 11118 - Jordan Revised: October 2010
Abbreviated New Drug Application
GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED WEST-WARD PHARMACEUTICAL CORP ---------- GEMFIBROZIL TABLETS, USP REV. 10/10 DESCRIPTION Gemfibrozil tablet, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each also contains colloidal silicon dioxide, PEG 3000, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide. 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 tablet, USP 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 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 Llegiu el document complet