SUCRALFATE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sucralfate (UNII: XX73205DH5) (Sucralfate - UNII:XX73205DH5)

Available from:

Precision Dose, Inc.

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 NDC 68094-043-61 10 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-043-62 10 mL per unit dose cup Thirty (30) cups per shipper SHAKE WELL BEFORE USING. AVOID FREEZING. Store at Controlled Room Temperature 20-25° C (68-77° F) [see USP]

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

SUCRALFATE- SUCRALFATE SUSPENSION
PRECISION DOSE, INC.
----------
SUCRALFATE ORAL SUSPENSION
1G/10ML
RX ONLY
DESCRIPTION
Sucralfate Oral Suspension contains sucralfate and sucralfate is an
α-D-
glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate),
aluminum complex.
[Al(OH)
] x [H O]y
(x=8 to 10 and y= 22 to 31)
R= SO Al(OH)
Sucralfate Oral Suspension for oral administration contains 1g of
sucralfate per 10 mL.
Sucralfate Oral 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 ulceradherent 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.
3
2
3
2
CLINICAL TRIALS
In a multicenter, double-blind, placebo-controlled study of Sucralfate
Oral Suspension, a
dosage regimen of 1 gram (10 mL) four