Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
SULFASALAZINE (UNII: 3XC8GUZ6CB) (SULFASALAZINE - UNII:3XC8GUZ6CB)
Par Pharmaceutical
SULFASALAZINE
SULFASALAZINE 500 mg
ORAL
PRESCRIPTION DRUG
Sulfasalazine tablets, USP are indicated: - in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and - for the prolongation of the remission period between acute attacks of ulcerative colitis. Sulfasalazine tablets are contraindicated in: - Patients with intestinal or urinary obstruction, - Patients with porphyria as sulfonamides have been reported to precipitate an acute attack, - Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates. None reported.
Sulfasalazine Tablets USP, 500 mg are round, gold-colored, scored tablets, debossed "5904" and "V" on one side and plain on the reverse side. They are available in the following package sizes: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
SULFASALAZINE- SULFASALAZINE TABLET PAR PHARMACEUTICAL ---------- SULFASALAZINE TABLETS, USP RX ONLY DESCRIPTION Sulfasalazine Tablets USP, 500 mg for oral administration. THERAPEUTIC CLASSIFICATION: Anti-inflammatory agent. CHEMICAL DESIGNATION: 5-([_p_-(2-Pyridylsulfamoyl)phenyl]azo) salicylic acid. STRUCTURAL FORMULA: INACTIVE INGREDIENTS: corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc. CLINICAL PHARMACOLOGY PHARMACODYNAMICS The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), is still under investigation, but may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and _in vitro _models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of SSZ, SP, and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety. PHARMACOKINETICS _In vivo _studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. In the intestine, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Of the two species, SP is relatively well absorbed from the intestine and highly metabolized, while 5-ASA is much less well absorbed. _Absorption:_ Following oral administration of 1 g of SSZ to 9 healthy males, less than 15% of a dose of SSZ is absorbed as parent drug. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. Maximum concentrations of SSZ occur between 3 and 12 hours post-ingestion, with the mean peak concentration (6 mcg/mL) occurring at 6 hours. In comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. This longer time to peak is indica Lestu allt skjalið