Product Elements:
Sucralfate sucralfate silicon dioxide fd&c red no. 40 glycerin methylparaben microcrystalline cellulose dimethicone sorbic acid benzoic acid sorbitol water sucralfate sucralfate
Drug Interactions:
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...liminated the interaction. due to sucralfate oral suspension's potential to alter the absorption of some drugs, sucralfate oral suspension should be administered separately from other drugs when alterations in bioavailability are felt to be critical. in these cases, patients should be monitored appropriately.
Indications and Usage:
Indications and usage sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
Warnings:
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:
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 pharmaceutical associates, inc. at 1-800-845-8210 or fda at 1-800-fda
Read more...-1088 or www.fda.gov/medwatch .
Contraindications:
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 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 sucralfa
Read more...te. 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.
Drug Interactions:
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...liminated the interaction. due to sucralfate oral suspension's potential to alter the absorption of some drugs, sucralfate oral suspension should be administered separately from other drugs when alterations in bioavailability are felt to be critical. in these cases, patients should be monitored appropriately.
Use in Pregnancy:
Pregnancy 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 Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Overdosage:
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:
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 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. structure
Clinical Pharmacology:
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 cov
Read more...ers 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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
How Supplied:
How supplied sucralfate oral suspension, 1 g/10 ml is a pink suspension with cherry flavor supplied in the following dosage forms: ndc 0904-7269-66: 10 ml unit dose cup. case contains 40 unit-dose cups of 10 ml (ndc 0904-7269-18), packaged in 4 trays of 10 unit-dose cups each. rx only shake well before using. avoid freezing. store at controlled room temperature 20° to 25°c (68° to 77°f); excursions permitted between 15° to 30°c (59° to 86°f). [see usp controlled room temperature]. rx only packaged and distributed by: major ® pharmaceuticals indianapolis, in 46268
Package Label Principal Display Panel:
Principal display panel- 10 ml cup label major ® ndc 0904-7269-66 sucralfate oral suspension 1 g/ml shake well delivers 10 ml see insert for institutional use only rx only major ® pharmaceuticals indianapolis, in 46268 a0974c100622 bottle label