国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
PENTOXIFYLLINE (UNII: SD6QCT3TSU) (PENTOXIFYLLINE - UNII:SD6QCT3TSU)
State of Florida DOH Central Pharmacy
ORAL
PRESCRIPTION DRUG
Pentoxifylline extended-release Tablet is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release Tablet 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 extended-release Tablet 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 Tablet is available for oral administration as 400 mg white, oblong, compressed tablets, engraved with "BVF" on one side and "0117" on the other; tablets are unscored. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers with safety closures.
Abbreviated New Drug Application
PENTOXIFYLLINE - PENTOXIFYLLINE TABLET, EXTENDED RELEASE STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, 400 MG. Rx only DESCRIPTION Pentoxifylline extended-release Tablets for oral administration, contains 400 mg of the active drug and the following inactive ingredients: hydroxyethyl cellulose NF, povidone USP, talc USP, magnesium stearate NF, isopropyl alcohol USP in an extended-release formulation. Pentoxifylline extended-release Tablet is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3,7- dimethylxanthine 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 chemical structure is: Molecular weight: 278.31 Molecular formula: C H N O 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. PHARMACOKINETICS AND METABOLISM After oral administration in aqueous solution pentoxifylline is almost completely absorbed. It undergoes a first-pass effect and the various metabolites appear in plasma very soon after dosing. Peak plasma levels of the 完全なドキュメントを読む