SUCRALFATE- sucralfate oral suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

Sucralfate Oral Suspension 1 g/10 mL is supplied as a pink colored, cherry flavored suspension available in bottles of 420 mL (NDC 42291-781-42). SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Manufactured for: AvKARE Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals LLC Branchburg, NJ 08876 Mfg. Rev. 08-2020-01 AV 01/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCRALFATE- SUCRALFATE ORAL SUSPENSION
AVKARE
----------
SUCRALFATE ORAL SUSPENSION
DESCRIPTION
Sucralfate Oral Suspension contains sucralfate, USP 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, USP per 10
mL.
Sucralfate Oral Suspension also contains: cherry flavor, colloidal
silicon dioxide, FD&C
Red #40, glycerin, methylcellulose, methylparaben, microcrystalline
cellulose, purified
water, simethicone emulsion, 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. 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 g (10 mL) four times daily was demonstrated to be
superior to
placebo in ulcer healing.
RESULTS FROM C