Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
GEMFIBROZIL (UNII: Q8X02027X3) (GEMFIBROZIL - UNII:Q8X02027X3)
Med-Health Pharma, LLC
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 film-coated tablets, capsule-shaped, biconvex tablets; Debossed with "I" on the left side of the bisect and "G" on the right side of the bisect on one side and "225" on the other, and available as follows: NDC 51138-588-30 Bottles of 30 Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP]. Protect from light and humidity. Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Distributed by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised: 12/10 Repackage By: Med-Health Pharma, LLC North Las Vegas, NV 89032 SP-60186 Rev02
Abbreviated New Drug Application
GEMFIBROZIL - GEMFIBROZIL TABLET, FILM COATED MED-HEALTH PHARMA, LLC ---------- GEMFIBROZIL TABLETS, USP REV. 12/10 DESCRIPTION Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP, for oral administration, contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide,NF; croscarmellose sodium, NF; calcium stearate,NF; microcrystalline cellulose,NF; methylcellulose, USP and opadry white. 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, gemfibrozil therapy was associated w Soma hati kamili