Carafate also known as Sucralfate is a human prescription drug labeled by 'Allergan, Inc.'. National Drug Code (NDC) number for Carafate is 58914-170. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Carafate drug includes Sucralfate - 1 g/10mL . The currest status of Carafate drug is Active.

Carafate sucralfate sucralfate sucralfate silicon dioxide fd&c red no. 40 glycerin methylcellulose, unspecified methylparaben microcrystalline cellulose water sorbitol solution maraschino cherry artificial flavor #2359

Drug intera c tions 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. in all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate Read more...

Indications and usage carafate (sucralfate) oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

Warnings fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of carafate oral suspension. administer carafate oral suspension only by the oral route. do not administer intravenously.

Dos a ge an d a dminis t rat i on acti v e duodenal ulcer : the recommended adult oral dosage for duodenal ulcer is 1 gram (10 ml) four times per day. carafate 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 carafate 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, 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 allergan usa, inc. at 1-800-678-1605 or fda at 1-800-fda-10 Read more...

Contraindications carafate oral suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Adv e rse r eacti o ns adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. in studies involving over 2700 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 derm a tolog i cal: pruritus, rash ner v ous s y s tem: dizziness, insomnia, sleepiness, vertigo oth e r: back pain, headache post- ma rk e ting 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 formula Read more...

Drug intera c tions 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. in all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate Read more...

Pregna n c y 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.

Pediatric u s e safety and effectiveness in pediatric patients have not been established.

Geriatric use clinical studies of carafate oral suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 dosage and administration ). this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see precautions special populations: chronic renal failure and dialysis patients ). because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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.

Description carafate oral suspension contains sucralfate and sucralfate is an α-d-glucopyranoside, β-d- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. carafate oral suspension for oral administration contains 1 g of sucralfate per 10 ml. carafate oral suspension also contains: colloidal silicon dioxide nf, fd&c red #40, flavor, glycerin usp, methylcellulose usp, methylparaben nf, microcrystalline cellulose nf, purified water usp, simethicone emulsion usp, and sorbitol solution usp. therapeutic category: antiulcer. carafate oral suspension contains sucralfate and sucralfate is an α-d-glucopyranoside, β-d- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.

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 compl Read more...

Carci n oge ne sis, mutag en esis, impairment of f e rt i li t y chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose). there was no evidence of drug-related tumorigenicity. a reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. mutagenicity studies were not conducted.

Clinical trials in a multicenter, double-blind, placebo-controlled study of carafate oral suspension, a dosage regimen of 1 gram (10 ml) four times daily was demonstrated to be superior to placebo in ulcer healing. resu l ts f r o m clinical trials healing rates f o r acute duo de nal ulcer treatment n week 2 healing rates week 4 healing rates week 8 healing rates carafate oral suspension 145 23(16%)* 66(46%) † 95(66%) ‡ 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 carafate (sucralfate) oral suspension 1 g/10 ml is a pink suspension supplied in bottles of 420 ml (ndc 58914-170-14). shake well before usin g . avoid freezi ng . store at controlled room temperature 20-25°c (68-77°f) [see usp]. rx only prescribing information rev. jan 2023 distributed by: allergan usa, inc. madison, nj 07940 carafate ® is a registered trademark of aptalis pharma canada ulc, an allergan affiliate. ® 2023 allergan. all rights reserved. allergan ® and its design are trademarks of allergan, inc. v2.0uspi0170 allergan

Principal display panel ndc 58914-170-14 carafate (sucralfate) oral suspension 1g/ 10ml principal display panel ndc 58914-170-14 carafate (sucralfate) oral suspension 1g/ 10ml