SUCRALFATE suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Mylan Pharmaceuticals Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

Sucralfate Oral Suspension is a pink oral suspension containing 1 g of sucralfate, USP per 10 mL. It is available as follows: NDC 0378-9205-35 bottle containing 420 mL of liquid suspension SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Halo Pharmaceutical Canada, Inc. 17 800 Lapointe Mirabel, QC J7J 0W8 Canada C-11240-3 Revised: 1/2020 HLC:SUCROS:R2

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SUCRALFATE- SUCRALFATE SUSPENSION
MYLAN PHARMACEUTICALS INC.
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SUCRALFATE ORAL SUSPENSION
DESCRIPTION
Sucralfate oral suspension contains sucralfate and sucralfate is an
α-D-Glucopyranoside,
ß-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex.
x = 8 to 10, and y = 22 to 31
Sucralfate oral suspension for oral administration contains 1 g of
sucralfate per 10 mL.
Sucralfate oral suspension also contains: artificial cherry flavor,
colloidal silicon dioxide,
FD&C Red No. 40, glycerin, methylcellulose, methylparaben,
microcrystalline cellulose,
purified water, simethicone (which contains polydimethylsiloxane and
silicon dioxide) and
sorbitol solution. 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.
2.
3.
_In vitro_, sucralfate adsorbs bile salts.
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%.
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