Sucralfate Oral Suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Pharmaceutical Associates, Inc.

INN (International Nazwa):

SUCRALFATE

Skład:

SUCRALFATE 1 g in 10 mL

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Sucralfate Oral Suspension 1g/10 mL is a pink suspension supplied in the following dosage forms: NDC 0121-0747-10: 10 mL unit dose cup NDC 0121-0747-30: Case contains 30 unit dose cups of 10 mL (NDC 0121-0747-10). NDC 0121-0747-40: Case contains 40 unit dose cups of 10 mL (NDC 0121-0747-10). NDC 0121-0747-50: Case contains 50 unit dose cups of 10 mL (NDC 0121-0747-10). NDC 0121-0747-00: Case contains 100 unit dose cups of 10 mL (NDC 0121-0747-10). SHAKE WELL BEFORE USING. AVOID FREEZING. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Status autoryzacji:

New Drug Application

Charakterystyka produktu

SUCRALFATE- SUCRALFATE SUSPENSION
PHARMACEUTICAL ASSOCIATES, INC.
----------
SUCRALFATE ORAL SUSPENSION
I07470220
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 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 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 ulc