CARAFATE- sucralfate suspension

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Allergan, Inc.

INN (Mezinárodní Name):

Sucralfate

Složení:

Sucralfate 1 g in 10 mL

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

CARAFATE (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. CARAFATE Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Stav Autorizace:

New Drug Application

Charakteristika produktu

CARAFATE- SUCRALFATE SUSPENSION
ALLERGAN, INC.
----------
CARAFATE
(SUCRALFATE)
ORAL SUSPENSION
DESCRIPTION
CARAFATE Oral Suspension contains sucralfate and sucralfate is an
α-D-
glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate),
aluminum complex.
CARAFATE Oral Suspension for oral administration contains 1 g of
sucralfate per 10 mL.
CARAFATE 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 emulsion 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 CARAFATE
Oral Suspension, a
®
dosage regimen of 1 gram (10 mL) four times daily was demonstrated to
be superior to
placebo in ulcer