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:

ATLANTIC BIOLOGICALS CORP.

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 65162-062-05). SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only DISTRIBUTED BY:  ATLANTIC BIOLOGICALS CORP. 20101 N.E 16TH PLACE MIAMI, FL 33179 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCRALFATE- SUCRALFATE ORAL SUSPENSION
ATLANTIC BIOLOGICALS CORP.
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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 hea