Sucralfate - Sucralfate Oral Suspension suspension prescribing information
INDICATIONS AND USAGE
Sucralfate Oral Suspension is indicated in the short-term (up to 8weeks) treatment of active duodenal ulcer.
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
CONTRAINDICATIONS
Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
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.
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
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 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.
2.000000000000000e+00 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%.
I n 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.
Clinical Trials
In a multicenter, double-blind, placebo-controlled study of Sucralfate Oral Suspension, a dosage regimen of 1 gram (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 Oral | 145 | 23 (16%) | 66 (46%)† | 95 (66%)‡ |
| Suspension | ||||
| Placebo | 147 | 10 (7%) | 39 (27%) | 58 (39%) |
•P=0.016 †P=0.001 ‡P=0.0001
Equivalence of sucralfate oral suspension to sucralfate tablets has not been demonstrated.
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
