SUCRALFATE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Chartwell RX, LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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. Safety and effectiveness in pediatric patients have not been established. Clinical studies of sucralfate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, r

Produktu pārskats:

Sucralfate 1 g tablets, USP are supplied in bottles of 90 and 100. White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. Bottles of 90...........NDC 62135-436-90 Bottles of 100...........NDC 62135-436-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71148 Rev. 11/2022 Rx Only

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

SUCRALFATE- SUCRALFATE TABLET
CHARTWELL RX, LLC
----------
SUCRALFATE TABLETS, USP 1 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 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%)
STU