SUCRALFATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Cardinal Health

INN (International Name):

SUCRALFATE

Sammensetning:

SUCRALFATE 1 g

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SUCRALFATE- SUCRALFATE TABLET
CARDINAL HEALTH
----------
SUCRALFATE TABLETS, USP
2210
RX ONLY
DESCRIPTION
Sucralfate 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.
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.
3
2
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
GRO