SULFASALAZINE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Chartwell RX, LLC.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

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).

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

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