SULFASALAZINE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

SULFASALAZINE (UNII: 3XC8GUZ6CB) (SULFASALAZINE - UNII:3XC8GUZ6CB)

Boleh didapati daripada:

REMEDYREPACK INC.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Sulfasalazine tablets 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.

Ringkasan produk:

Sulfasalazine tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed "G500". They are available in the following package sizes: NDC: 70518-1829-00 NDC: 70518-1829-01 NDC: 70518-1829-02 NDC: 70518-1829-03 NDC: 70518-1829-04 PACKAGING: 270 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 270 in 1 BOTTLE PLASTIC Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status kebenaran:

New Drug Application Authorized Generic

Ciri produk

SULFASALAZINE- SULFASALAZINE TABLET
REMEDYREPACK INC.
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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:
INACTIVE INGREDIENTS: magnesium stearate, povidone, silica (colloidal
anhydrous), starch (pregelatinized).
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 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 transit to the
lower intestine where bacteria med