SUCRALFATE suspension

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Pacific Pharma, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Produktbesonderheiten:

Sucralfate Oral Suspension 1 g/10 mL is a pink suspension supplied in bottles of 420 mL (NDC 82182-106-14).       SHAKE   WELL   BEFORE   USIN G . AVOID FREEZI NG . Store at controlled room temperature 20-25°C (68-77°F) [see USP]. Rx Only Prescribing Information rev. Jun 2023 Product of Japan Manufactured for: Pacific Pharma North Chicago, IL 60064 © 2023 AbbVie. All rights reserved. v1.0USPI0106

Berechtigungsstatus:

New Drug Application Authorized Generic

Fachinformation

SUCRALFATE- SUCRALFATE SUSPENSION
PACIFIC PHARMA, INC.
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SUCRALFATE
ORAL SUSPENSION
DESCRIPTION
Sucralfate Oral Suspension contains sucralfate and sucralfate is an
α-D-
glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate),
aluminum complex.
Sucralfate Oral Suspension for oral administration contains 1 g of
sucralfate per 10 mL.
Sucralfate Oral Suspension also contains: colloidal silicon dioxide
NF, FD&C Red #40,
flavor, glycerin USP, methylcellulose USP, methylparaben NF,
microcrystalline cellulose
NF, purified water USP, simethicone emulsion USP, and sorbitol
solution USP.
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%.
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
In a multicenter, double-blind, placebo-
controlled study of Sucralfate Oral Suspension, a dosage
regimen of 1 gram (10 mL) four times daily was demonstrated to be
superior to placebo in ulcer h