Sucralfate 100 MG/ML Oral Suspension [Carafate]
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 eliminated the interaction.
Because of the potential of CARAFATE to alter the absorption of some drugs, CARAFATE should be administered separately from other drugs when alterations in bioavailability are felt to be critical.
In these cases, patients should be monitored appropriately.
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 ® Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
CARAFATE ® Suspension for oral administration contains 1 g of sucralfate per 10 mL.
CARAFATE ® 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.
Carafate suspension structure
CLINICAL STUDIES
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HOW SUPPLIED
CARAFATE ® (sucralfate) Suspension 1 g/10 mL is a pink suspension supplied in bottles of 14 fl oz (NDC 54868-3735-0).
Dispense as is.
SHAKE WELL BEFORE USING.
AVOID FREEZING.
Store at controlled room temperature 20-25°C (68-77°F)[see USP].
Rx Only Prescribing Information as of December 2010 Aptalis Pharma US, Inc.
100 Somerset Corporate Boulevard Bridgewater, NJ 08807 www.aptalispharma.com Carafate ® is a reg istered trademark of Aptalis Pharma Canada Inc.
Distributed by: Physicians Total Care, Inc.
Tulsa, OK 74146
GERIATRIC USE
Geriatric Use Clinical studies of CARAFATE ® 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.
INDICATIONS AND USAGE
CARAFATE ® (sucralfate) Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
PREGNANCY
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.
NUSRING MOTHERS
Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.
DOSAGE AND ADMINISTRATION
Active Duodenal Ulcer.
The recommended adult oral dosage for duodenal ulcer is 1 g (10 mL/2 teaspoonfuls) four times per day.
CARAFATE ® 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.
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 FDA at 1-800-FDA-1088.