Sucralfate Oral Suspension

Generic Name: sucralfate oral suspension

Aluminum Complex [EPC]Over-the-Counter (OTC)

Brand Names:

Sucralfate

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.

Overview

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.

Uses

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

Dosage

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 ).

Side Effects

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, p...

Warnings

WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Sucralfate Oral Suspension. Administer Sucralfate Oral Suspension only by the oral route. Do not administer intravenously. CONTRAINDICATIONS Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Pregnancy

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.

Storage

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.

Frequently Asked Questions

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.

What are the side effects of Sucralfate Oral Suspension?

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, p...

Can I take Sucralfate Oral Suspension during pregnancy?

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.

What are the important warnings for Sucralfate Oral Suspension?

WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Sucralfate Oral Suspension. Administer Sucralfate Oral Suspension only by the oral route. Do not administer intravenously. CONTRAINDICATIONS Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.