SUCRALFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Sucralfate 1 g tablets, USP are supplied in bottles of 100, and 500. White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. Bottles of 100...........NDC 29033-003-01 Bottles of 500...........NDC 29033-003-05

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCRALFATE- SUCRALFATE TABLET
DIRECT_RX
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SUCRALFATE
Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis-(hydrogen sulfate),
aluminum complex. It has the following structural formula:
[Sucralfate 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, USP.
Also contain: povidone, magnesium stearate, and colloidal silicon
dioxide.
Therapeutic category: antiulcer.
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 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.
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%)