SUCRALFATE suspension

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

American Health Packaging

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

Sucralfate Oral Suspension 1 g/10 mL is a pink suspension with cherry flavor supplied in the following dosage forms: 10 ml unit dose cups: 30 cups (3 x 10) NDC 60687‐738‐08 10 ml unit dose cups: 40 cups (4 x 10) NDC 60687‐738‐23 10 ml unit dose cups: 100 cups (10 x 10) NDC 60687‐738‐56 SHAKE WELL BEFORE USING. AVOID FREEZING. 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 DO NOT USE IF SEAL IS BROKEN. Distributed by: American Health Packaging Columbus, OH 43217 R02/23

授权状态:

Abbreviated New Drug Application

产品特点

SUCRALFATE- SUCRALFATE SUSPENSION
AMERICAN HEALTH PACKAGING
----------
SUCRALFATE ORAL SUSPENSION
RX ONLY
I0974C0223
R02/23
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 #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:
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