SULFASALAZINE tablet, delayed release

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 delayed release tablets are indicated: Sulfasalazine delayed release tablets are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects. In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. Unlike anti-inflammatory drugs, sulfasalazine delayed release tablets do not produce an immediate response. Concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of sulfasalazine delayed release tablets is apparent. Sulfasalazine delayed release tablets are con

Product summary:

Sulfasalazine delayed release tablets, 500 mg, are elliptical, gold-colored, film enteric-coated tablets, monogrammed "104" on one side. They are available in the following package sizes: Bottle of 100 (with carton) NDC 59762-0104-5 Bottle of 100 NDC 59762-0104-1 Bottle of 300 (with carton) NDC 59762-0104-6 Bottle of 300 NDC 59762-0104-2 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, DELAYED RELEASE
GREENSTONE LLC
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SULFASALAZINE DELAYED RELEASE TABLETS, USP
ENTERIC-COATED TABLETS
DESCRIPTION
Sulfasalazine delayed release tablets contain sulfasalazine,
formulated in a delayed
release tablet (enteric-coated), 500 mg, for oral administration.
Sulfasalazine delayed release tablets are film coated with cellulose
acetate phthalate to
retard disintegration of the tablet in the stomach and reduce
potential irritation of the
gastric mucosa.
THERAPEUTIC CLASSIFICATION: Anti-inflammatory agent and/or
immunomodulatory
agent.
CHEMICAL DESIGNATION: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic
acid.
CHEMICAL STRUCTURE:
MOLECULAR FORMULA: C
H
N O S
INACTIVE INGREDIENTS: beeswax (white), carnauba wax, cellacefate,
magnesium
stearate, polyethylene glycol, povidone, propylene glycol,
self-emulsifying glycerol
monostearate, silica (colloidal anhydrous), starch (pregelatinized),
talc.
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. The relative contribution of the parent drug and the major
metabolites in
18
14
4
5
rheumatoid arthritis is unknown.
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-A