SUCRALFATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Physicians Total Care, Inc.

INN (International Adı):

SUCRALFATE

Kompozisyon:

SUCRALFATE 1 g

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Sucralfate is 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. There are no known contraindications to the use of sucralfate.

Ürün özeti:

Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of: Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side. 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). Manufactured By: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 5/2007

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SUCRALFATE - SUCRALFATE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
DESCRIPTION
Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis(hydrogen sulfate), aluminum
complex.
R=SO [Al
(OH) ·(H O) ]
Tablets for oral administration contain 1 g of sucralfate.
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. 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 14-16 mEq of acid-neutralizing capacity
per 1 g dose of sucralfate.
3
2
5
2
2
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 H