SUCRALFATE suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Natco Pharma USA LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Sucralfate Oral Suspension 1g/10mL is a pink suspension supplied in 10 mL unit dose medicine cups. NDC: 69339-148-01 (1) cup NDC: 69339-148-17 (40) cups NDC: 69339-148-19 (100) cups Distributed by: Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458, USA SHAKE WELL BEFORE USING. AVOID FREEZING. Store at Controlled Room Temperature 20-25º C (68-77º F) [see USP] Rx ONLY Prescribing Information rev. 06/2018 © 2019 Allergan. All rights reserved. DASH-DOSE TM Sucralfate Oral Suspension 1g/10mL SHAKE WELL BEFORE USING AVOID FREEZING Rx ONLY FOR ORAL ADMINISTRATION ONLY Each 10mL (2 teaspoons) Sucralfate Oral Suspension contains 1g sucralfate. Usual Dosage: Recommended adult dosage is 1g (2 teaspoons) four times a day on an empty stomach. See package insert for full prescribing information. WARNING : Keep out of reach of children. Pharmacist : Dispense as is. Store at Controlled Room Temperature 20-25ºC (68-77ºF) [see USP]. Distributed by: Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458, USA DP-UD-PI-AT-[118607] 

Status autoryzacji:

New Drug Application

Charakterystyka produktu

SUCRALFATE- SUCRALFATE SUSPENSION
NATCO PHARMA USA LLC
----------
SUCRALFATE ORAL SUSPENSION
Rx only
DESCRIPTION
Sucralfate Oral Suspension contains sucralfate and sucralfate is an
α-D-
glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate),
aluminum complex.
Sucralfate oral Suspension for oral administration contains 1 g of
sucralfate per 10 mL.
Sucralfate oral Suspension also contains: colloidal silicon dioxide
NF, FD&C Red #40,
flavor, glycerin USP, methylcellulose USP, methylparaben NF,
microcrystalline cellulose
NF, purified water USP, simethicone USP, and sorbitol solution USP.
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%.
_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 heal