SUCRALFATE- sucralfate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

Sucralfate

Composition:

Sucralfate 1 g in 10 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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:

Sucralfate Suspension 1 g/10 mL is a pink suspension supplied as follows: NDC 66689-790-01: 10 mL unit dose cup NDC 66689-790-50: Case contains 50 unit dose cups of 10 mL (NDC 66689-790-01), packaged in 5 trays of 10 unit dose cups each. SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20°-25°C (68°-77°F) [See USP CONTROLLED RM TEMP]

Authorization status:

New Drug Application

Summary of Product characteristics

SUCRALFATE- SUCRALFATE SUSPENSION
CARDINAL HEALTH
----------
SUCRALFATE
SUSPENSION
1 G/ 10 ML
Rx only
DESCRIPTION
Sucralfate Suspension contains sucralfate and sucralfate is an
α-D-glucopyranoside, β-
Dfructofuranosyl-, octakis (hydrogen sulfate), aluminum complex.
Sucralfate Suspension for oral administration contains 1 gram of
sucralfate per 10 mL.
Sucralfate 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.
2.
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.
In vitro, a sucralfate-albumin film provides a barrier to diffusion of
hydrogen ions.
3.
4.
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
Suspension, a dosage regiment of
1 g (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
Suspension
145
23(