sucralfate 1 GM Oral Tablet
Generic Name: SUCRALFATE
Brand Name: Sucralfate
- Substance Name(s):
- 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, 1-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 case studies 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 sucralfate to alter the absorption of some drugs, sucralfate 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 toxicity 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 is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex.
R=SO3[Al2(OH)5·(H2O)2] Tablets for oral administration contain 1 g of sucralfate.
Inactive Ingredients Corn starch, magnesium stearate, and microcrystalline cellulose Therapeutic Category antiulcer Molecular Formula
CLINICAL STUDIES
CLINICAL TRIALS Acute Duodenal Ulcer Over 600 patients have participated in well-controlled clinical trials worldwide.
Multicenter trials conducted in the United States, both of them placebo-controlled studies with endoscopic evaluation at 2 and 4 weeks, showed: STUDY 1 Treatment Groups Ulcer Healing/No.
Patients 2 wk 4 wk (Overall) Sucralfate 37/105 (35.2%) 82/109 (75.2%) Placebo 26/106 (24.5%) 68/107 (63.6%) STUDY 2 Treatment Groups Ulcer Healing/No.
Patients 2 wk 4 wk (Overall) Sucralfate 8/24 (33%) 22/24 (92%) Placebo 4/31 (13%) 18/31 (58%) The sucralfate-placebo differences were statistically significant in both studies at 4 weeks but not at 2 weeks.
The poorer result in the first study may have occurred because sucralfate was given 2 hours after meals and at bedtime rather than 1 hour before meals and at bedtime, the regimen used in international studies and in the second United States study.
In addition, in the first study liquid antacid was utilized as needed, whereas in the second study antacid tablets were used.
Maintenance Therapy After Healing of Duodenal Ulcer Two double-blind randomized placebo-controlled U.S.
multicenter trials have demonstrated that sucralfate (1 g bid) is effective as maintenance therapy following healing of duodenal ulcers.
In one study, endoscopies were performed monthly for 4 months.
Of the 254 patients who enrolled, 239 were analyzed in the intention-to-treat life table analysis presented below.
Duodenal Ulcer Recurrence Rate (%) * p < 0.05 † p < 0.01 Months of Therapy Drug n 1 2 3 4 Sucralfate 122 20* 30* 38† 42† Placebo 117 33 46 55 63 In this study, prn antacids were not permitted.
In the other study, scheduled endoscopies were performed at 6 and 12 months, but for-cause endoscopies were permitted as symptoms dictated.
Median symptom scores between the sucralfate and placebo groups were not significantly different.
A life table intention-to-treat analysis for the 94 patients enrolled in the trial had the following results: Duodenal Ulcer Recurrence Rate (%) * p < 0.002 Drug n 6 months 12 months Sucralfate 48 19* 27* Placebo 46 54 65 In this study, prn antacids were permitted.
Data from placebo-controlled studies longer than 1 year are not available.
HOW SUPPLIED
Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate.
Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.
They are supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod.
Code 53808-0797-1 1 g 30 Tablets in a Blister Pack WHITE 0093-2210 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Manufactured By: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States
GERIATRIC USE
Geriatric Use Clinical studies of sucralfate tablets 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
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.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in children have not been established.
PREGNANCY
Pregnancy
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 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.
Maintenance Therapy 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.
(See PRECAUTIONS, Geriatric Use.)