Sucralfate

INDI C A T I O N S A ND U S A G E CARAFATE ® (sucralfate) is 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.

D O S A G E A N D A D M INI S T R A T I O N A cti v e D u oden a l Ulc e r: 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. M ain t enance T he r ap y: 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. Call your doctor for medical advice about side effects.

C O N T R A INDI C A T I O NS Carafate is contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

P R E C A U T I O NS 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.

A D VE R S E R E A C T I O NS 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: G a s t r oin t e s t inal: diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth De r ma t olo g i c a l: pruritus, rash Ne r v ous S y s t em: dizziness, insomnia, sleepiness, vertigo Ot he r: back pain, headache P os t- ma r k e t in g: cases of hypersensitivity have been reported with the use of sucralfate tablets, including dyspnea, lip swelling, pruritus, rash, and urticaria.

Drug In t e r a c t io n s Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy. The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract.

Store at Controlled room temperature 59-86°F (15-30°C).