SUCRALFATE suspension

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Major Pharmaceuticals

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients. WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Sucralfate Oral Suspension. Administer Sucralfate Oral Suspension only by the oral route. Do not administer intravenously.

পণ্য সারাংশ:

Sucralfate Oral Suspension, 1 g/10 mL is a pink suspension with cherry flavor supplied in the following dosage forms: NDC 0904-7269-66: 10 mL unit dose cup. Case contains 40 unit-dose cups of 10 mL (NDC 0904-7269-18), packaged in 4 trays of 10 unit-dose cups each. SHAKE WELL BEFORE USING. AVOID FREEZING. Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Rx Only

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

SUCRALFATE- SUCRALFATE SUSPENSION
MAJOR PHARMACEUTICALS
----------
SUCRALFATE- SUCRALFATE SUSPENSION
MAJOR® PHARMACEUTICALS
RX ONLY
DESCRIPTION
SUCRALFATE ORAL SUSPENSION CONTAINS SUCRALFATE AND SUCRALFATE IS AN
Α-D-
GLUCOPYRANOSIDE, Β-D-FRUCTOFURANOSYL-, OCTAKIS-(HYDROGEN SULFATE),
ALUMINUM COMPLEX.
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%.
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
In a multicenter, double-blind, placebo-controlled study of Sucralfate
Oral Suspension, a
dosage regimen of 1 gram (10 mL) four times daily was demonstrated to
be superior to
placebo in ulcer healing.
Results from Clinical Trials Healing Rates for Acute Duodenal Ulcer
Treatment
n
Week 2 Healing
Rates
Week 4 Healing
Rates
Week 8 Healing
Rates
Sucralfate Oral
Suspension
14523 (16%)*
66 (46%)†
95 (66%)‡
Placebo
14710 (7%)
39 (27%)
58 (39%)
*P=0.016 †P=0.001 ‡P=0.0001
Equivalence of sucralfate oral suspension to sucralfate