CARAFATE- sucralfate tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Allergan, Inc.

INN (Међународно име):

Sucralfate

Састав:

Sucralfate 1 g

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

CARAFATE®  (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. Carafate is contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Статус ауторизације:

New Drug Application

Карактеристике производа

CARAFATE- SUCRALFATE TABLET
ALLERGAN, INC.
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CARAFATE TABLETS
(SUCRALFATE)
DESCRIPTION
CARAFATE Tablets contain sucralfate and 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: D & C Red #30 Lake, 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:
1. 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.
2. In vitro, a sucralfate-albumin film provides a barrier to diffusion
of hydrogen ions.
3. In human subjects, sucralfate given in doses recommended for ulcer
therapy inhibits pepsin
activity in gastric juice by 32%.
4. 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 to
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 GROUPSULCER HEALING/ NO. PATIENTS
2 WK
4 WK (OVERALL)
Sucralfate
Placebo
37/105 (35.2%)
26/106 (24.5%)
82/109 (