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Sucralfate
Overview
What is Sucralfate?
Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen
sulfate), aluminum complex.
R=SO[Al(OH)·(HO)]
Tablets for oral administration contain 1 g of sucralfate.
Corn starch, magnesium stearate, and microcrystalline
cellulose
antiulcer
What does Sucralfate look like?
What are the available doses of Sucralfate?
Sorry No records found.
What should I talk to my health care provider before I take Sucralfate?
Sorry No records found
How should I use Sucralfate?
Sucralfate is indicated in:
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.
The recommended adult oral dosage is 1 g twice a day.
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 , .)
What interacts with Sucralfate?
There are no known contraindications to the use of sucralfate.
What are the warnings of Sucralfate?
Sorry No Records found
What are the precautions of Sucralfate?
Duodenal ulcer is a chronic, recurrent disease. While short-term
treatment with sucralfate can result in complete healing of the ulcer, a
successful course of treatment with sucralfate should not be expected to alter
the posthealing frequency or severity of duodenal ulceration.
When sucralfate is administered orally, small amounts of aluminum
are absorbed from the gastrointestinal tract. Concomitant use of sucralfate with
other products that contain aluminum, such as aluminum-containing antacids, may
increase the total body burden of aluminum. Patients with normal renal function
receiving the recommended doses of sucralfate and aluminum-containing products
adequately excrete aluminum in the urine. Patients with chronic renal failure or
those receiving dialysis have impaired excretion of absorbed aluminum. In
addition, aluminum does not cross dialysis membranes because it is bound to
albumin and transferrin plasma proteins. Aluminum accumulation and toxicity
(aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in
patients with renal impairment. Sucralfate should be used with caution in
patients with chronic renal failure.
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.
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.
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.
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.
Safety and effectiveness in children have not been
established.
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
.)
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 ,
,
.) 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.
What are the side effects of Sucralfate?
Adverse reactions to sucralfate in clinical trials were minor and
only rarely led to discontinuation of the drug. In studies involving over 2700
patients treated with sucralfate tablets, 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:
diarrhea, nausea, vomiting, gastric discomfort, indigestion,
flatulence, dry mouth
pruritus, rash
dizziness, insomnia, sleepiness, vertigo
back pain, headache
Postmarketing reports of hypersensitivity reactions, including urticaria
(hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial
swelling have been reported in patients receiving sucralfate tablets. Similar
events were reported with sucralfate suspension. However, a causal relationship
has not been established.
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.
Inadvertent injection of insoluble sucralfate and its insoluble excipients
has led to fatal complications, including pulmonary and cerebral emboli.
Sucralfate is intended for intravenous
administration.
What should I look out for while using Sucralfate?
There are no known contraindications to the use of sucralfate.
What might happen if I take too much Sucralfate?
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.
How should I store and handle Sucralfate?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of:Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.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 USASellersville, PA 18960Rev. E 5/2007Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of:Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.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 USASellersville, PA 18960Rev. E 5/2007Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of:Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.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 USASellersville, PA 18960Rev. E 5/2007Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of:Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.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 USASellersville, PA 18960Rev. E 5/2007Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of:Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.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 USASellersville, PA 18960Rev. E 5/2007Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of:Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.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 USASellersville, PA 18960Rev. E 5/2007Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of:Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.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 USASellersville, PA 18960Rev. E 5/2007Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of:Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.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 USASellersville, PA 18960Rev. E 5/2007
Clinical Information
Chemical Structure
No Image foundClinical 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:
These observations suggest that sucralfate’s antiulcer activity is the result
of formation of an ulcer-adherent complex that covers the ulcer site and
protects it against further attack by acid, pepsin, and bile salts. There are
approximately 14-16 mEq of acid-neutralizing capacity per 1 g dose of
sucralfate.
Non-Clinical Toxicology
There are no known contraindications to the use of sucralfate.The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the posthealing frequency or severity of duodenal ulceration.
When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of sucralfate and aluminum-containing products adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.
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.
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.
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.
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.
Safety and effectiveness in children have not been established.
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 .)
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 , , .) 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.
Adverse reactions to sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate tablets, 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:
diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth
pruritus, rash
dizziness, insomnia, sleepiness, vertigo
back pain, headache
Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving sucralfate tablets. Similar events were reported with sucralfate suspension. However, a causal relationship has not been established.
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.
Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is intended for intravenous administration.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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