SUCRALFATE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Amneal Pharmaceuticals NY LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Sucralfate tablets are indicated in:  - Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.  Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Povzetek izdelek:

Sucralfate tablets USP, 1 g  are supplied as light pink, oblong tablets debossed with “A56” on one side and plain on the other side with a score line. They are available as follows: Bottles of 100 with child-resistant closure:                            NDC 60219-1656-1 Bottles of 500:                                                                       NDC 60219-1656-5 Store at 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  Manufactured by: Amneal Pharmaceuticals Private Limited Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2023-00

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SUCRALFATE- SUCRALFATE TABLET
AMNEAL PHARMACEUTICALS NY LLC
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SUCRALFATE TABLETS, USP
DESCRIPTION
Sucralfate tablets, USP contain sucralfate, USP and sucralfate, USP is
an α-D-
glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate),
aluminum complex.
Tablets for oral administration contain 1 g of sucralfate, USP.
Also contain: D&C Red #30 Lake, FD&C Blue #1 Lake, magnesium stearate,
microcrystalline cellulose, and starch.
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 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
ACUTE DUODENAL ULCER
Over 600 patients have participated in well-controlled clinical trials
worldwide. Multicenter
trials conducted in the United States, both of them placebo-controlled
studies with
endoscopic evaluation at 2 and 4 weeks, showed:
STUDY 1
TREATMENT
GROUPS
ULCER HEALING/ NO. PATIENTS
2 WK
4 WK (OVERALL)
Sucralfate
37/105
(35.2%)