SUCRALFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northwind Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Sucralfate 1 g tablets are supplied in bottles of 30 (NDC 51655-475-52) tablets. Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other. Rx Only Prescribing Information rev. June 2018

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

SUCRALFATE- SUCRALFATE TABLET
NORTHWIND PHARMACEUTICALS, LLC
----------
SUCRALFATE TABLETS
DESCRIPTION
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.
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
GROUPS
ULCER HEALING/NO. PATIENTS
2 WK
4 WK (OVERALL)
Sucralfate
37/105 (35.2%)
82/109 (75.2%)
Placebo
26/1