SUCRALFATE suspension

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Sucralfate (UNII: XX73205DH5) (Sucralfate - UNII:XX73205DH5)

Commercializzato da:

Precision Dose Inc.

INN (Nome Internazionale):

Sucralfate

Composizione:

Sucralfate 1 g in 10 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Sucralfate Oral Suspension 1 g/10 mL is a pink suspension. Dispense as is. NDC 68094-171-61 10 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-171-62 10 mL per unit dose cup Thirty (30) cups per shipper SHAKE WELL BEFORE USING. AVOID FREEZING. Store at Controlled Room Temperature 20-25° C (68-77° F) [see USP]

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

SUCRALFATE- SUCRALFATE SUSPENSION
PRECISION DOSE INC.
----------
SUCRALFATE ORAL SUSPENSION
1 G/10 ML
RX ONLY
DESCRIPTION
Sucralfate Oral Suspension contains sucralfate and sucralfate is an
α-D-glucopyranoside, β-D-
fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
[Al(OH) ]
[H O]
(x = 8 to 10 and y = 22 to 31)
R = SO Al(OH)
Sucralfate Oral Suspension for oral administration contains 1g of
sucralfate per 10mL. 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%.
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
In a multicenter, double-blind, placebo-controlled study of Sucralfate
Oral Suspension, a dosage
regimen of 1g (10 mL) four times