SULFASALAZINE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Aphena Pharma Solutions - Tennessee, LLC

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

Sulfasalazine Tablets, USP, 500 mg are round, mustard-colored, biconvex, debossed "WATSON "and "796 "on one side and partial bisect on the other side. They are available in the following package sizes: Bottles of 100              NDC 0591-0796-01 Bottles of 500              NDC 0591-0796-05 Bottles of 1000            NDC 0591-0796-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SULFASALAZINE- SULFASALAZINE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
SULFASALAZINE
TABLETS, USP
RX ONLY
DESCRIPTION
Sulfasalazine Tablets, USP, 500 mg for oral administration.
THERAPEUTIC CLASSIFICATION: Anti-inflammatory agent.
CHEMICAL DESIGNATION: 5-([_p_-(2-pyridylsulfamoyl)phenyl]azo)salicylic
acid.
CHEMICAL STRUCTURE:
C
H
N O S
The molecular weight of sulfasalazine is 398.39.
INACTIVE INGREDIENTS: magnesium stearate, pregelatinized corn starch,
sodium starch
glycolate and 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
autoradio-graphic 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
18
14
4
5
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 mcg/mL) occurring at 6 hours.
In comparison, peak plasma levels of both SP and 5-ASA occur
approximately 10 hours
after dosing. This longer