SUCRALFATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Zydus Lifesciences Limited

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Sucralfate tablets USP, 1g are supplied as follows: NDC 70771-1833-3 in bottles of 30 tablets with child-resistant closure NDC 70771-1833-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1833-5 in bottles of 500 tablets White to off-white, capsule shaped, biconvex, scored, uncoated tablets, debossed with "6" and "75" on either side of score and plain on other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India             Rev.: 03/2024

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SUCRALFATE- SUCRALFATE TABLET
ZYDUS LIFESCIENCES LIMITED
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SUCRALFATE TABLETS USP, 1G
DESCRIPTION
Sucralfate tablets, USP contain sucralfate USP and sucralfate is an
α-D-glucopyranoside,
β-D fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
Tablets for oral administration contain 1 g of sucralfate, USP.
Also contain: magnesium stearate, microcrystalline cellulose, and corn
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 GROUPS
ULCER HEALING/ NO. PATIENTS
2 WK
4 WK (OVERALL)
Sucralfate
Placebo
37/105 (35.2%)
26/106 (24.5%)
82/109 (75.2%)
68/107 (6