Sucralfate

ADVERSE REACTIONS Adverse reactions to sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate tablets, 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, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth 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 tablets, including dyspnea, lip swelling, pruritus, rash, and urticaria. Cases of anaphylactic reactions, bronchospasm, laryngeal edema, edema of the mouth, pharyngeal edema, respiratory tract edema and swelling of the face have been reported with an unknown oral formulation of 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. Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.

CONTRAINDICATIONS Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

DESCRIPTION Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. It has the following structural formula: Tablets for oral administration contain 1 g of sucralfate, USP. Also contain: povidone, magnesium stearate, and colloidal silicon dioxide. Therapeutic category: antiulcer. image description

DOSAGE AND ADMINISTRATION Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 g four times per day 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. Maintenance Therapy: The recommended adult oral dosage is 1 g twice a day. 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 Chartwell RX, LLC. at 845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS AND USAGE Sucralfate tablets are indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. 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. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

OVERDOSAGE Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral toxicity 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.

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.

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2

Sucralfate Sucralfate POVIDONE MAGNESIUM STEARATE SILICON DIOXIDE SUCRALFATE SUCRALFATE oblong N;S1

ANDA074415

Sucralfate

Sucralfate

62135-436

HUMAN PRESCRIPTION DRUG

ORAL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Sucralfate Tablet, USP 1 Gram - NDC-62135-436-90 - 90's-Bottle Label Sucralfate Tablet, USP 1 Gram - NDC-62135-436-01 - 100's-Bottle Label Sucralfate Tablet, USP 1 Gram - NDC-62135-436-90 - 90's-Bottle Label image description

Clinical Trials Acute Duodenal Ulcer Over 600 patients have participated in well-controlled clinical trials worldwide. Multicenter trials conducted in the United States, both of them placebo-controlled studies with endoscopic evaluation at 2 and 4 weeks, showed: STUDY 1 Treatment Groups Ulcer Healing/ No. Patients 2 wk 4 wk (Overall) Sucralfate 37/105 (35.2%) 82/109 (75.2%) Placebo 26/106 (24.5%) 68/107 (63.6%) STUDY 2 Treatment Groups Ulcer Healing/ No. Patients 2 wk 4 wk (Overall) Sucralfate 8/24 (33%) 22/24 (92%) Placebo 4/31 (13%) 18/31 (58%) The sucralfate-placebo differences were statistically significant in both studies at 4 weeks but not at 2 weeks. The poorer result in the first study may have occurred because sucralfate was given 2 hours after meals and at bedtime rather than 1 hour before meals and at bedtime, the regimen used in international studies and in the second United States study. In addition, in the first study liquid antacid was utilized as needed, whereas in the second study antacid tablets were used. Maintenance Therapy After Healing of Duodenal Ulcer Two double-blind randomized placebo-controlled U.S. multicenter trials have demonstrated that sucralfate (1 g bid) is effective as maintenance therapy following healing of duodenal ulcers. In one study, endoscopies were performed monthly for 4 months. Of the 254 patients who enrolled, 239 were analyzed in the intention-to-treat life table analysis presented below. Duodenal Ulcer Recurrence Rate (%) Drug Months of Therapy n 1 2 3 4 Sucralfate 122 20 * 30 * 38 † 42 † Placebo 117 33 46 55 63 * P <0.05, † P <0.01 In this study, prn antacids were not permitted. In the other study, scheduled endoscopies were performed at 6 and 12 months, but for-cause endoscopies were permitted as symptoms dictated. Median symptom scores between the sucralfate and placebo groups were not significantly different. A life table intention-to-treat analysis for the 94 patients enrolled in the trial had the following results: Duodenal Ulcer Recurrence Rate (%) Drug n 6 months 12 months Sucralfate 48 19* 27* Placebo 46 54 65 * P <0.002 In this study, prn antacids were permitted. Data from placebo-controlled studies longer than 1 year are not available.

HOW SUPPLIED Sucralfate 1 g tablets, USP are supplied in bottles of 90 and 100. White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. Bottles of 90...........NDC 62135-436-90 Bottles of 100...........NDC 62135-436-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71148 Rev. 11/2022 Rx Only

PRECAUTIONS The physician should read the "PRECAUTIONS" section when considering the use of this drug in pregnant or pediatric patients, or patients of childbearing potential. Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the post healing frequency or severity of duodenal ulceration. Isolated reports of sucralfate tablet aspiration with accompanying respiratory complications have been received. Therefore, sucralfate tablets should be used with caution by patients who have known conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or diminish oropharyngeal coordination or motility.