Rx Item-Sucralfate 1GM 100X10 ML Suspension by Precision Dose Pharma USA

CARAFATE - sucralfate suspension
Physicians Total Care, Inc.
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:

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.
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.
INDICATIONS AND USAGE

CARAFATE� (sucralfate) Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
ADVERSE REACTIONS

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%
DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 g (10 mL/2 teaspoonfuls) four times per day. CARAFATE� should be administered on an empty stomach.

Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.

While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.

Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See PRECAUTIONS Geriatric Use)

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rx Item-Sucralfate 1GM 100X10 ML Suspens
Item No. RX869533, 869533, NDC No.: 68094-0171-61, 68094-171-61, 6809417161, 68094017161, 0171-61, 017161 UPC No. 3-68094-17161-8, 368094-171618, 368094171618

Rx Item-Sucralfate 1GM 100X10 ML Suspens
Item No. RX869533, 869533, NDC No.: 68094-0171-61, 68094-171-61, 6809417161, 68094017161, 0171-61, 017161 UPC No. 3-68094-17161-8, 368094-171618, 368094171618

Rx Item-Sucralfate 1GM 100X10 ML Suspens
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