Sucralfate Oral Suspension

Description

DESCRIPTION Sucralfate Oral Suspension contains sucralfate and sucralfate is an β-D-glucopyranoside, α-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, FD&C Red No. 40, wild cherry flavor (contains propylene glycol, artificial flavors, natural flavors, ethyl alcohol), glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion, sorbitol solution. Therapeutic category: antiulcer Sucralfate_structure

What Is Sucralfate Oral Suspension Used For?

INDICATIONS AND USAGE Sucralfate Oral Suspension is indicated in the short-term (up to 8weeks) treatment of active duodenal ulcer.

Dosage and Administration

DOSAGE AND ADMINISTRATION Active Duodenal Ulcer The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate Oral Suspension 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 Oral Suspension. 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, 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 Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Active Duodenal Ulcer The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate Oral Suspension 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 Oral Suspension. 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, 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 Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects (Adverse Reactions)

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 2,700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system: Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting Dermatological : pruritus, rash Nervous System: dizziness, insomnia, sleepiness, vertigo Other : back pain, headache Post-marketing cases of hypersensitivity have been reported with the use of sucralfate oral suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria. Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate. Cases of hyperglycemia have been reported with sucralfate. Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

Contraindications

CONTRAINDICATIONS Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Pregnancy and Breastfeeding

Teratogenic effects Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.

Overdosage

OVERDOSAGE Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

How Supplied

HOW SUPPLIED Sucralfate Oral Suspension, 1 g/10 mL is a pink suspension with cherry flavor supplied in the following dosage forms: NDC 0904-7470-66: 10 mL unit dose cup. Case contains 20 unit-dose cups of 10 mL (NDC 0904-7470-56), packaged in 2 trays of 10 unit-dose cups each, 30 unit-dose cups of 10 mL (0904-7470-01), packaged in 3 trays of 10 unit-dose cups each, 40 unit-dose cups of 10 mL (NDC 0904-7470-18), packaged in 4 trays of 10-unit-dose cups each, 50 unit-dose cups of 10 mL (NDC 0904-7470-95), packaged in 5 trays of 10 unit-dose cups each and 100 unit-dose cups of 10 mL (NDC 0904-7470-72), packaged in 10 trays of 10 unit-dose cups each. SHAKE WELL BEFORE USING. AVOID FREEZING. Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature]. Rx Only Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 R02/24