SUCRALFATE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

American Health Packaging

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Sucralfate tablets are 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. Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

產品總結:

Sucralfate 1 g tablets, USP are supplied in unit dose packages of 100 (10 x 10). White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. Unit dose packages of 100 (10 x 10) NDC 60687‐695‐01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

授权状态:

Abbreviated New Drug Application

产品特点

SUCRALFATE- SUCRALFATE TABLET
AMERICAN HEALTH PACKAGING
----------
SUCRALFATE TABLETS, USP
8469501/0622
RX ONLY
DESCRIPTION
Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis-(hydrogen sulfate),
aluminum complex. It has the following structural formula:
Tablets for oral administration contain 1 g of sucralfate, USP.
Also contain: povidone, magnesium stearate, and colloidal silicon
dioxide.
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 ulceradherent 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 GROUPS
ULCER HEALING/ NO. PATIENTS
2 wk
4 wk (Overall)
Sucralfate
37/105 (35.2%)
82/109 (75.2%)
Placebo
26/106 (24.5