SUCRALFATE suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Physicians Total Care, Inc.

INN (International Nazwa):

SUCRALFATE

Skład:

SUCRALFATE 1 g in 10 mL

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Sucralfate Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. There are no known contraindications to the use of sucralfate.

Podsumowanie produktu:

Sucralfate Suspension 1 g/10 mL is a pink suspension. NDC 54868-5299-1 Ten (10) 10 mL oral liquid unit dose cups per tray. Ten (10) trays per shipper. NDC 54868-5299-0 Ten (10) 10 mL oral liquid unit dose cups per tray. Three (3) trays per shipper. SHAKE WELL BEFORE USING Store at controlled room temperature 20-25°C (68-77°F) [see USP]). Avoid freezing.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

SUCRALFATE - SUCRALFATE SUSPENSION
PHYSICIANS TOTAL CARE, INC.
----------
SUCRALFATE SUSPENSION
1 G/10 ML
R ONLY
DESCRIPTION
Sucralfate Suspension contains sucralfate and sucralfate is an
_α-_D-glucopyranoside β_-_D-fructo-
furanosyl-, octakis-(hydrogen sulfate), aluminum complex.
Sucralfate Suspension for oral administration contains 1 g of
sucralfate per 10 mL. Sucralfate
Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40,
flavor, glycerin USP, methyl-
cellulose 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%.
4. In vitro, sucralfate absorbs 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.
X
CLINICAL TRIALS
In a multicenter, double-blind, placebo-controlled study of Sucralfate
Suspension, a dosage regimen of
1 g (10 mL) four times daily was demonstrated to be superior to
placebo in ulcer healing.
R