SUCRALFATE suspension

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

PAI Holdings, LLC dba PAI Pharma

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

Sucralfate Oral Suspension, 1 g/10 mL is a pink suspension with cherry flavor supplied in the following dosage forms: NDC 0121-0974-10: 10 mL unit dose cup. Case contains 30 unit-dose cups of 10 mL (NDC 0121-0974-94), packaged in 3 trays of 10 unit-dose cups each, 40 unit-dose cups of 10 mL (NDC 0121-0974-40), packaged in 4 trays of 10 unit-dose cups each, 50 unit-dose cups of 10 mL (NDC 0121-0974-50), packaged in 5 trays of 10 unit-dose cups each and 100 unit-dose cups of 10 mL (NDC 0121-0974-00), packaged in 10 trays of 10 unit-dose cups each. 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 Packaged by: Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R05/22

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

SUCRALFATE- SUCRALFATE SUSPENSION
PAI HOLDINGS, LLC DBA PAI PHARMA
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SUCRALFATE ORAL SUSPENSION
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 1 g of
sucralfate per 10 mL.
Sucralfate Oral Suspension also contains: colloidal silicon dioxide,
FD&C Red No. 40, wild
cherry flavor (contains propylene glycol, artificial flavors, natural
flavors, ethyl alcohol),
glycerin, methylcellulose, methylparaben, microcrystalline cellulose,
purified water,
simethicone emulsion, sorbitol solution.
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