Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
PROBENECID (UNII: PO572Z7917) (PROBENECID - UNII:PO572Z7917)
Actavis Pharma, Inc.
ORAL
PRESCRIPTION DRUG
For treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given. Hypersensitivity to probenecid. Children under 2 years of age. Not recommended in persons with known blood dyscrasias or uric acid kidney stones. Therapy with probenecid should not be started until an acute gouty attack has subsided.
Probenecid Tablets USP 500 mg are bisected, capsule-shaped, yellow, film-coated tablets imprinted DAN DAN and 5347 supplied in bottles of 100 and 1000. Dispense in well-closed container with child-resistant closure. Store at 20°-25° (68°-77°F). [See USP controlled room temperature.] Manufactured by: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 190811-1
Abbreviated New Drug Application
PROBENECID- PROBENECID TABLET, FILM COATED ACTAVIS PHARMA, INC. ---------- PROBENECID TABLETS USP REVISED: DECEMBER 2016 RX ONLY 190811-1 DESCRIPTION Probenecid is a uricosuric and renal tubular transport blocking agent. Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula: C H NO S M.W. 285.36 Probenecid is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Probenecid Tablets USP 500 mg contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. CLINICAL PHARMACOLOGY Probenecid is a uricosuric and renal tubular blocking agent. It inhibits the tubular reabsorption of urate, thus increasing the urinary excretion of uric acid and decreasing serum urate levels. Effective uricosuria reduces the miscible urate pool, retards urate deposition, and promotes resorption of urate deposits. Probenecid inhibits the tubular secretion of penicillin and usually increases penicillin plasma levels by any route the antibiotic is given. A 2-fold to 4-fold elevation has been demonstrated for various penicillins. Probenecid has also been reported to inhibit the renal transport of many other compounds including aminohippuric acid (PAH), aminosalicylic acid (PAS), indomethacin, sodium iodomethamate and related iodinated organic acids, 17-ketosteroids, pantothenic acid, phenolsulfonphthalein (PSP), sulfonamides, and sulfonylureas. See also DRUG INTERACTIONS. Probenecid decreases both hepatic and renal excretion of sulfobromophthalein (BSP). The tubular reabsorption of phosphorus is inhibited in hypoparathyroid but not in euparathyroid individuals. Probenecid does not influence plasma concentrations of sali Lugege kogu dokumenti