Sucralfate Oral Suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VistaPharm, LLC

INN (International Name):

SUCRALFATE

Composition:

SUCRALFATE 1 g in 10 mL

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 a pink suspension supplied as follows: NDC 66689-790-01: 10 mL unit-dose cup NDC 66689-790-30: Case contains 30 unit-dose cups of 10 mL (NDC 66689-790-01), packaged in 3 trays of 10 unit-dose cups each. NDC 66689-790-40: Case contains 40 unit-dose cups of 10 mL (NDC 66689-790-01), packaged in 4 trays of 10 unit-dose cups each. NDC 66689-790-50: Case contains 50 unit-dose cups of 10 mL (NDC 66689-790-01), packaged in 5 trays of 10 unit-dose cups each. NDC 66689-790-99: Case contains 100 unit-dose cups of 10 mL (NDC 66689-790-01), packaged in 10 trays of 10 unit-dose cups each. 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 Distributed by: VistaPharm, Inc. Largo, FL 33771, USA VP1059R10 02/2020

Authorization status:

New Drug Application

Summary of Product characteristics

SUCRALFATE- SUCRALFATE SUSPENSION
VISTAPHARM, LLC
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SUCRALFATE ORAL SUSPENSION
Rx only
DESCRIPTION
Sucralfate Oral Suspension contains sucralfate and sucralfate is an
α-D-
glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate),
aluminum complex.
SucralfateOral Suspension for oral administration contains 1 g of
sucralfate per 10 mL.
SucralfateOral Suspension also contains: colloidal silicon dioxide NF,
FD&C Red #40,
flavor, glycerin USP, methylcellulose USP, methylparaben NF,
microcrystalline cellulose
NF, purified water USP, simethicone USP, and sorbitol solution USP.
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 gram (10 mL) four times daily was demonstrated to
be superior to
placebo in ulcer healing.
RE