CARAFATE- sucralfate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

Sucralfate

Composition:

Sucralfate 1 g in 10 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CARAFATE® (sucralfate) Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. There are no known contraindications to the use of sucralfate.

Product summary:

CARAFATE® (sucralfate) Suspension 1 g/10 mL is a pink suspension supplied in bottles of 14 fl oz (NDC 54868-3735-0). Dispense as is. SHAKE WELL BEFORE USING. AVOID FREEZING. Store at controlled room temperature 20-25°C (68-77°F)[see USP]. Rx Only Prescribing Information as of December 2010 Aptalis Pharma US, Inc. 100 Somerset Corporate Boulevard Bridgewater, NJ 08807 www.aptalispharma.com Carafate® is a registered trademark of Aptalis Pharma Canada Inc. Distributed by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

New Drug Application

Summary of Product characteristics

CARAFATE - SUCRALFATE SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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CARAFATE (SUCRALFATE) SUSPENSION
DESCRIPTION
CARAFATE Suspension contains sucralfate and sucralfate is an
α-D-glucopyranoside, β-D-
fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
CARAFATE Suspension for oral administration contains 1 g of sucralfate
per 10 mL.
CARAFATE 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.
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CLINICAL TRIALS
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INDICATIONS AND USAGE
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