Sucralfate is a human prescription drug labeled by 'Par Pharmaceutical Inc.'. National Drug Code (NDC) number for Sucralfate is 0254-1011. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Sucralfate drug includes Sucralfate - 1 g/10mL . The currest status of Sucralfate drug is Active.

Sucralfate sucralfate sucralfate sucralfate silicon dioxide fd&c red no. 40 glycerin microcrystalline cellulose 105 methylparaben methylcellulose, unspecified water sorbitol maraschino cherry artificial flavor #2359

Drug interactions 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 e Read more...

Indications and usage 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 sucralfate oral suspension. administer sucralfate oral suspension only by the oral route. do not administer intravenously.

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, 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 par pharmaceutical at 1-800-828-9393 or fda at 1-800-fda-1088 or ww Read more...

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 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 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 Read more...

Drug interactions 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 e Read more...

Pregnancy teratogenic effects. pregnancy category b. 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 use safety and effectiveness in pediatric patients have not been established.

Geriatric use clinical studies of sucralfate 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 sucralfate oral suspension contains sucralfate and sucralfate is an α-d-glucopyranoside, β-d-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. sucralfate oral suspension for oral administration contains 1g of sucralfate per 10ml. sucralfate 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 usp, and sorbitol solution usp. therapeutic category: antiulcer. sucralfate 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 complex Read more...

Carcinogenesis, mutagenesis, impairment of fertility 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 sucralfate oral suspension, a dosage regimen of 1g (10 ml) four times daily was demonstrated to be superior to placebo in ulcer healing. results f rom clinical trials healing rates for acute duodenal ulcer treatment n week 2 healing rates week 4 healing rates week 8 healing rates sucralfate 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 sucralfate oral suspension 1 g/10 ml is a pink suspension supplied in bottles of 420 ml (ndc 0254-1011-96). shake well before using . avoid freezing. store at controlled room temperature 20-25°c (68-77°f) [see usp]. rx only prescribing information rev. - june 2018 distributed by: par pharmaceutical chestnut ridge, ny 10977 ® 2018 allergan. all rights reserved.

Principal display panel ndc 0254- 1011 -96 96363 sucralfate oral suspension 1g/10ml one 420 ml bottle shake well before using avoid freezing r x only ndc 0254-1011-96 96363 sucralfate oral suspension 1g/10ml one 420 ml bottle shake well before using avoid freezing rx only