SUCRALFATE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Proficient Rx LP

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Sucralfate tablets, USP are indicated in: Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Каталог на резюме:

Sucralfate tablets, USP are available as white, capsule-shaped, biconvex, scored tablets, debossed “TEVA” on one side, and “22” and “10” on the scored side, containing 1 gram of sucralfate USP, packaged in bottles of 30 (NDC 82804-063-30), 60 (NDC 82804-063-60), and 90 (NDC 82804-063-90) tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Repackaged By: PROFICIENT RX LP Thousand Oaks, CA 91320 Rev. L 9/2015

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

SUCRALFATE- SUCRALFATE TABLET
PROFICIENT RX LP
----------
SUCRALFATE TABLETS, USP
RX ONLY
DESCRIPTION
Sucralfate, USP is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis(hydrogen
sulfate), aluminum complex.
R = SO Al(OH)
Tablets for oral administration contain 1 g of sucralfate, USP and the
following inactive
ingredients: corn starch, magnesium stearate, and microcrystalline
cellulose.
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.
2.
3.
3
2
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.
_In vitro_, a sucralfate-albumin film provides a barrier to diffusion
of hydrogen ions.
In human subjects, sucralfate given in doses recommended for ulcer
therapy
inhibits pepsin activity in gastric juice by 32%.
4.
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%)
82/109 (75.2%)
Placebo
26/106 (24.5%)
68/107 (63.6%)
STUDY 2
TREATMENT GROUPS
ULCER HEALING/NO