Professional Documents
Culture Documents
Introduction
Antiulcer agent; anionic sulfated disaccharide.
Duodenal Ulcer
Short-term (up to 8 weeks) treatment of active duodenal ulcer.
Conventional antiulcer therapy, including sucralfate therapy, is associated with a high rate of ulcer
recurrence (e.g., 60–100% per year) in patients with initial or recurrent duodenal ulcer and documented
Helicobacter pylori infection. All such patients should receive anti-infective therapy for treatment of the
infection; choice of a particular regimen should be based on current data on optimal therapy.
Efficacy of short-term sucralfate similar to that of cimetidine in adults with duodenal ulcer.
Gastric Ulcer
Short-term treatment of gastric ulcer† [off-label].
Conventional antiulcer therapy, including sucralfate therapy, is associated with a high rate of ulcer
recurrence (e.g., 60–100% per year) in patients with initial or recurrent gastric ulcer and documented H.
pylori infection. All such patients should receive anti-infective therapy for treatment of the infection;
choice of a particular regimen should be based on current data on optimal therapy.
Chemotherapy-induced Mucositis
†
Has been used as an oral suspension† [off-label] for prevention and treatment of chemotherapy-induced
mucositis† [off-label]. Results have been conflicting; additional study necessary.
General
Equivalence of sucralfate suspension and tablets not demonstrated.
Administration
Oral Administration
Administer orally on an empty stomach, 1 hour before each meal and at bedtime.
Antacids may be given as necessary for pain relief but should not be taken within 30 minutes before or
after sucralfate. (See Specific Drugs under Interactions.)
NG Tube
Bezoars may form with concomitant use of sucralfate and enteral tube feedings. (See Bezoars under
Cautions.)
Dosage
Adults
Duodenal Ulcer
Treatment
Oral
Although healing may occur during first 2 weeks of therapy, continue treatment for full 4–8 weeks unless
healing is confirmed by radiographic or endoscopic examination.
Maintenance of Healing
Oral
1 g twice daily.
Oral
1 g 4 times daily.
Special Populations
Hepatic Impairment
Renal Impairment
No specific dosage recommendations at this time. (See Renal Impairment under Cautions.)
Geriatric Patients
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function
and concomitant disease and drug therapy.
Contraindications
Manufacturer states that there are no known contraindications to use of sucralfate.
Warnings/Precautions
General Precautions
Although sucralfate may result in complete ulcer healing, it does not alter the post-healing frequency or
severity of duodenal ulceration; duodenal ulcer is a chronic, recurrent disease.
Administration Precautions
Do not administer IV; may cause fatal complications, including pulmonary and cerebral emboli.
Bezoars
Formation of bezoars reported, primarily in patients with underlying predisposing medical conditions
(e.g., delayed gastric emptying) or those receiving concomitant enteral tube feedings.
Specific Populations
Pregnancy
Category B.
Lactation
Not known whether sucralfate is distributed into milk. Caution if used in nursing women.
Pediatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond
differently than younger adults; select dosage with caution.
Substantially eliminated by kidneys; assess renal function periodically since geriatric patients are more
likely to have decreased renal function.
Renal Impairment
Use with caution in patients with chronic renal failure or those undergoing dialysis; possible impaired
excretion of absorbed aluminum.
Specific Drugs
Fluoroquinolone antibiotics Possible decreased absorption of fluoroquinolone Take fluoroquinolones 2 hours before
(e.g., ciprofloxacin, sucralfate
norfloxacin, ofloxacin)
Warfarin Possible decreased absorption of warfarin; may Take warfarin 2 hours before
result in subtherapeutic PT sucralfate
Sucralfate Pharmacokinetics
Absorption
Bioavailability
Minimally absorbed following oral administration.
Duration
Binding to ulcer site persists for up to 6 hours.
Distribution
Extent
Minimally distributed into tissues.
Not known whether sucralfate crosses the placenta or is distributed into milk.
Elimination
Metabolism
Reacts with hydrochloric acid in the stomach to form sucrose sulfate, which is not metabolized.
Elimination Route
Excreted principally in feces (>90%) and urine (3–5%) as sucrose sulfate within 48 hours.
Stability
Storage
Oral
Tablets
Suspension
Actions
Anionic sulfated disaccharide; pepsin inhibitor.
Exact mechanism(s) of action unclear; therapeutic effects result from local (i.e., at the ulcer site)
rather than systemic activity.
Does not affect gastric acid output or concentration; does not neutralize acidity of gastric contents.
Reacts with hydrochloric acid in the stomach; forms highly condensed, viscous, adhesive, paste-like
substance that buffers acid (14–16 mEq of in vitro acid-neutralizing capacity per 1-g dose).
Binds to surface of gastric and duodenal ulcers with greater affinity for ulcer site than normal GI
mucosa; also binds to acute gastric erosions produced by alcohol or other drugs (e.g., aspirin).
Binds electrostatically to positively charged protein molecules in damaged mucosa of the GI tract,
forming insoluble, stable complexes which form an adherent, protective barrier at the ulcer site.
Allows ulcer to heal by protecting ulcer site from ulcerogenic properties of pepsin, acid, and bile;
prevents back diffusion of hydrogen ions and adsorbs pepsin and bile acids.
Advice to Patients
Importance of taking sucralfate on an empty stomach.
Importance of women informing their clinician if they are or plan to become pregnant or plan to
breast-feed.
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some
individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of
these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary)
name
Sucralfate
AHFS DI Essentials™. © Copyright 2023, Selected Revisions June 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway,
Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.