SUCRALFATE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Nostrum Laboratories, Inc.

INN (mednarodno ime):

Sucralfate

Sestava:

Sucralfate 1 g

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 1 g tablets, USP are supplied in bottles of 100, and 500. White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. Bottles of 100...........NDC 29033-003-01 Bottles of 500...........NDC 29033-003-05 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufacture by: Nostrum Laboratories, Inc. Kansas City, MO 64120 November 2019 Rx Only

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SUCRALFATE- SUCRALFATE TABLET
NOSTRUM LABORATORIES, INC.
----------
SUCRALFATE TABLETS, USP1 GRAM
DESCRIPTION
Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis-(hydrogen sulfate), aluminum
complex. It has the following structural formula:
Tablets for oral administration contain 1 g of sucralfate, USP.
Also contain: povidone, magnesium stearate, and colloidal silicon
dioxide.
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
ulceradherent 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%)
82/109 (75.2%)
Placebo
26/106 (24.5%)
68/107 (63.6