SUCRALFATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)

Dostupné s:

Aphena Pharma Solutions - Tennessee, LLC

INN (Mezinárodní Name):

SUCRALFATE

Složení:

SUCRALFATE 1 g

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Sucralfate is indicated in: - Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. There are no known contraindications to the use of sucralfate.

Přehled produktů:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Sucralfate 1-g tablets are supplied in bottles of 90, 100, 360 and 500. Light blue, scored, oblong tablets are engraved WATSON 780 on one side and are blank with bisect on the other.  Prescribing Information as of June 2008A Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: sanofi-aventis U.S. LLC Kansas City, MO 64137 USA 50088983

Stav Autorizace:

New Drug Application

Charakteristika produktu

SUCRALFATE- SUCRALFATE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
PRESCRIBING INFORMATION AS OF
JUNE 2008A
SUCRALFATE
TABLETS RX ONLY
DESCRIPTION
Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis-(hydrogen sulfate), aluminum
complex.
Tablets for oral administration contain 1 g of sucralfate.
Also contain: FD&C Blue #1 Lake, magnesium stearate, microcrystalline
cellulose, and starch.
Therapeutic category: antiulcer.
CLINICAL PHARMACOLOGY
Sucralfate is only minimally absorbed from the gastrointestinal tract.
The small amounts of the sulfated
disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of sucralfate’s ability to accelerate healing
of duodenal ulcers remains to be
fully defined, it is known that it exerts its effect through a local,
rather than systemic, action. The
following observations also appear pertinent:
Studies in human subjects and with animal models of ulcer disease have
shown that sucralfate forms
an ulcer-adherent complex with proteinaceous exudate at the ulcer
site.
In vitro, a sucralfate-albumin film provides a barrier to diffusion of
hydrogen ions.
In human subjects, sucralfate given in doses recommended for ulcer
therapy inhibits pepsin activity
in gastric juice by 32%.
In vitro, sucralfate adsorbs bile salts.
These observations suggest that sucralfate’s antiulcer activity is
the result of formation of an ulcer-
adherent complex that covers the ulcer site and protects it against
further attack by acid, pepsin, and bile
salts. There are approximately 14-16 mEq of acid-neutralizing capacity
per 1-g dose of sucralfate.
CLINICAL TRIALS
ACUTE DUODENAL ULCER
Over 600 patients have participated in well-controlled clinical trials
worldwide. Multicenter trials
conducted in the United States, both of them placebo-controlled
studies with endoscopic evaluation at 2
and 4 weeks,showed:
STUDY 1
TREATMENT GROUPS
ULCER HEALING/ NO. PATIENTS
2 WK
4 WK (OVERALL)
Sucralfate
37/105 (35.2%) 82/109 (75.2%)
Placebo
26/106 (24.5%) 68/107 (