Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
SULFASALAZINE (UNII: 3XC8GUZ6CB) (SULFASALAZINE - UNII:3XC8GUZ6CB)
Chartwell RX, LLC.
ORAL
PRESCRIPTION DRUG
Sulfasalazine Tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) 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, scored, light brown tablets, debossed with “CE” above the functional score and “33” below the functional score on one side and plain on the other side, supplied as : Bottles of 100 NDC 62135-960-01 Bottles of 300 NDC 62135-960-31 Bottles of 500 NDC 62135-960-05 Bottles of 1000 NDC 62135-960-10 Store at controlled room temperature 15–30° C (59–86° F).
Abbreviated New Drug Application
SULFASALAZINE- SULFASALAZINE TABLET CHARTWELL RX, LLC. ---------- SULFASALAZINE TABLETS SULFASALAZINE TABLETS, USP DESCRIPTION Sulfasalazine Tablets contain sulfasalazine, 500 mg, for oral administration. THERAPEUTIC CLASSIFICATION: Anti-inflammatory agent. CHEMICAL DESIGNATION: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. CHEMICAL STRUCTURE: MOLECULAR FORMULA: C H N O S INACTIVE INGREDIENTS: Corn starch, magnesium stearate, pregelatinized starch, stearic acid. CLINICAL PHARMACOLOGY PHARMACODYNAMICS The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5- ASA) and sulfapyridine (SP), 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 18 14 4 5 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 μg/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 indicative of gastrointestinal t Preberite celoten dokument