SULFASALAZINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenstone LLC

INN (International Name):

SULFASALAZINE

Composition:

SULFASALAZINE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sulfasalazine tablets are indicated: Sulfasalazine tablets are contraindicated in: None reported.

Product summary:

Sulfasalazine tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed "G500". They are available in the following package sizes: Bottle of 100(with carton) NDC 59762-5000-5 Bottle of 100 NDC 59762-5000-1 Bottle of 300 (with carton) NDC 59762-5000-6 Bottle of 300 NDC 59762-5000-2 Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

SULFASALAZINE- SULFASALAZINE TABLET
GREENSTONE LLC
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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:
MOLECULAR FORMULA: C18H14N4O5S
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