SUCRALFATE suspension

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Cardinal Health 107, LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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.

Product samenvatting:

Sucralfate Oral Suspension, 1 g/10 mL is a pink suspension with cherry flavor supplied: Overbagged with 5 x 10 mL cups per bag, NDC 55154-5790-5 Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Rx Only Packaged by: Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com Distributed By: Cardinal Health Dublin, OH 43017 L58112370324 R05/22

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

SUCRALFATE- SUCRALFATE SUSPENSION
CARDINAL HEALTH 107, LLC
----------
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,
FD&C Red No. 40, wild
cherry flavor (contains propylene glycol, artificial flavors, natural
flavors, ethyl alcohol),
glycerin, methylcellulose, methylparaben, microcrystalline cellulose,
purified water,
simethicone emulsion, 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:
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_, 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 healing.
RESULTS FROM CLINICAL TRIALS HEALING RATES FOR ACUTE DUODENAL ULCER
TREATMENT
N
WEEK 2
HEALING RATES
WEEK 4
HEALING RATES
WEEK 8
HEALING RATES
Sucralfa