국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
Pentoxifylline (UNII: SD6QCT3TSU) (PENTOXIFYLLINE - UNII:SD6QCT3TSU)
NCS HealthCare of KY, LLC dba Vangard Labs
ORAL
PRESCRIPTION DRUG
Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease. Pentoxifylline should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.
Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in blistercards of 30 (NDC 0615-8305-39). Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mg Manufactured by Manufactured for Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: May 2016 Rev. 7
Abbreviated New Drug Application
PENTOXIFYLLINE- PENTOXIFYLLINE TABLET, EXTENDED RELEASE NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS ---------- PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 MG RX ONLY DESCRIPTION Pentoxifylline extended-release tablets, USP for oral administration contain 400 mg of the active drug and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 3,7-Dihydro-3,7-dimethyl-1-(5-oxohexyl)- 1H-purine-2,6-dione that, unlike theophylline, is a hemorrheologic agent, i.e., an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The molecular formula is C H N O and its molecular weight is 278.31. The chemical structure is: USP Dissolution Test 9 CLINICAL PHARMACOLOGY MODE OF ACTION Pentoxifylline and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of pentoxifylline and the sequence of events leading to clinical improvement are still to be defined. Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and _in_ _vitro_ human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation. Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of pentoxifylline in patients with peripheral arterial disease. 13 18 4 3 PHARMACOKINETICS AND METABOLISM After oral administration in aqueous solution pentoxifylline is almost completely absorbed. It undergoes a first-pass effect 전체 문서 읽기