Sucralfate (Monograph)

Brand name: Carafate
Drug class: Protectants
- Antiulcer Agents
ATC class: A02BX02
VA class: GA302
CAS number: 54182-58-0

Introduction

Antiulcer agent; anionic sulfated disaccharide.^a ^b ^c

Uses for Sucralfate

Duodenal Ulcer

Short-term (up to 8 weeks) treatment of active duodenal ulcer.^a ^b ^c

Maintenance of healing and reduction in recurrence of duodenal ulcer.^a ^c

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.¹⁰⁰ ¹³² ¹³⁶ ¹⁴⁰ ¹⁴⁴ ¹⁴⁶ ¹⁵⁴ All such patients should receive anti-infective therapy for treatment of the infection;¹²⁸ ¹³² ¹⁴⁴ ¹⁴⁵ ¹⁴⁶ choice of a particular regimen should be based on current data on optimal therapy.¹²⁸ ¹³² ¹⁴⁰ ¹⁴⁵ ¹⁶⁵ ¹⁶⁶

Efficacy of short-term sucralfate similar to that of cimetidine in adults with duodenal ulcer.^a

Gastric Ulcer

Short-term treatment of gastric ulcer^{† [off-label]}.^a

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.¹⁰⁰ ¹³² ¹³⁶ ¹⁴⁰ ¹⁴⁴ ¹⁴⁶ ¹⁵⁴ All such patients should receive anti-infective therapy for treatment of the infection;¹²⁸ ¹³² ¹⁴⁴ ¹⁴⁵ ¹⁴⁶ choice of a particular regimen should be based on current data on optimal therapy.¹²⁸ ¹³² ¹⁴⁰ ¹⁴⁵ ¹⁶⁵ ¹⁶⁶

Chemotherapy-induced Mucositis

Has been used as an oral suspension^{† [off-label]} for prevention and treatment of chemotherapy-induced mucositis^{† [off-label]}.¹⁰⁰ ¹⁰¹ ¹⁰² ¹⁰³ ¹⁰⁴ ¹⁰⁸ Results have been conflicting;¹⁰¹ additional study necessary.¹⁰⁰ ¹⁰⁴ ¹⁰⁶ ¹⁰⁷

Sucralfate Dosage and Administration

General

Equivalence of sucralfate suspension and tablets not demonstrated.^b

Administration

Oral Administration

Administer orally on an empty stomach, 1 hour before each meal and at bedtime.^a ^b ^c

Agitate suspension well prior to administration of each dose.^b

Antacids may be given as necessary for pain relief but should not be taken within 30 minutes before or after sucralfate.^a ^b ^c (See Specific Drugs under Interactions.)

NG Tube

Bezoars may form with concomitant use of sucralfate and enteral tube feedings.^a ^b ^c (See Bezoars under Cautions.)

Dosage

Adults

Duodenal Ulcer

Treatment

Oral

1 g 4 times daily for 4–8 weeks.^a ^b ^c

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.^a ^b ^c

Maintenance of Healing

Oral

1 g twice daily.^a ^c

Gastric Ulcer† [off-label]

Oral

1 g 4 times daily.^a

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.^a ^b ^c

Renal Impairment

No specific dosage recommendations at this time.^a ^b ^c (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.^b

Cautions for Sucralfate

Contraindications

Manufacturer states that there are no known contraindications to use of sucralfate.^b ^c

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.^a ^b ^c

Administration Precautions

Do not administer IV; may cause fatal complications, including pulmonary and cerebral emboli.^a ^b ^c

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.^a ^b ^c

Specific Populations

Pregnancy

Category B.^b ^c

Lactation

Not known whether sucralfate is distributed into milk.^a ^b ^c Caution if used in nursing women.^a ^b ^c

Pediatric Use

Safety and efficacy not established.^a ^b ^c

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.^b

Substantially eliminated by kidneys; assess renal function periodically since geriatric patients are more likely to have decreased renal function.^b

Renal Impairment

Use with caution in patients with chronic renal failure or those undergoing dialysis; possible impaired excretion of absorbed aluminum.¹⁰⁹ ^a ^b ^c

Possible aluminum accumulation and toxicity (e.g., aluminum osteodystrophy, osteomalacia, encephalopathy) in patients with renal impairment.^a ^b ^c

Common Adverse Effects

Constipation.^a ^b ^c

Drug Interactions

Effects on GI Absorption of Drugs

May bind to a number of drugs in the GI tract, reducing extent of absorption.^a ^b ^c Instruct patients to administer other drugs at least 2 hours before sucralfate and monitor patients appropriately if alteration in bioavailability of the other drug(s) is critical.^a ^b ^c

Specific Drugs

Drug	Interaction	Comments
Antacids	Aluminum-containing antacids: Concomitant use may increase total body burden of aluminum, possibly resulting in aluminum toxicity (see Renal Impairment under Cautions)^b ^c	Aluminum-containing antacids: Use caution in patients with chronic renal failure or those undergoing dialysis^b ^c All antacids: Take antacids at least 30 minutes before or after sucralfate^a ^b ^c
Cimetidine	Possible decreased absorption of cimetidine^a ^b ^c	Take cimetidine 2 hours before sucralfate^b ^c
Digoxin	Possible decreased absorption of digoxin^a ^b ^c	Take digoxin 2 hours before sucralfate^b ^c
Fluoroquinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)	Possible decreased absorption of fluoroquinolone¹¹⁰ ¹¹¹ ¹¹² ¹¹³ ¹¹⁴	Take fluoroquinolones 2 hours before sucralfate¹¹¹ ¹¹³ ¹¹⁴
Ketoconazole	Possible decreased absorption of ketoconazole^a ^b ^c	Take ketoconazole 2 hours before sucralfate^b ^c
Levothyroxine	Possible decreased absorption of levothyroxine^b ^c	Take levothyroxine 2 hours before sucralfate^b ^c
Phenytoin	Possible decreased absorption of phenytoin^a ^b ^c	Take phenytoin 2 hours before sucralfate^b ^c
Quinidine	Possible decreased absorption of quinidine^b ^c	Take quinidine 2 hours before sucralfate^b ^c
Ranitidine	Possible decreased absorption of ranitidine^a ^b ^c	Take ranitidine 2 hours before sucralfate^b ^c
Tetracycline	Possible decreased absorption of tetracycline^a ^b ^c	Take tetracycline 2 hours before sucralfate^b ^c
Theophylline	Possible decreased absorption of theophylline^a ^b ^c	Take theophylline 2 hours before sucralfate^b ^c
Warfarin	Possible decreased absorption of warfarin;^a ^b ^c may result in subtherapeutic PT^b	Take warfarin 2 hours before sucralfate^b ^c

Sucralfate Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following oral administration.^a ^b ^c

Duration

Binding to ulcer site persists for up to 6 hours.^a

Distribution

Extent

Minimally distributed into tissues.^a

Not known whether sucralfate crosses the placenta or is distributed into milk.^a ^b ^c

Elimination

Metabolism

Reacts with hydrochloric acid in the stomach to form sucrose sulfate, which is not metabolized.^a

Elimination Route

Excreted principally in feces (>90%) and urine (3–5%) as sucrose sulfate within 48 hours.^a

Stability

Storage

Oral

Tablets

Tight containers at room temperature.^a

Suspension

20–25°C;^b do not freeze.^a ^b

Actions

Anionic sulfated disaccharide; pepsin inhibitor.^a ^b ^c
Exact mechanism(s) of action unclear; therapeutic effects result from local (i.e., at the ulcer site) rather than systemic activity.^a ^b ^c
Does not affect gastric acid output or concentration; ^a does not neutralize acidity of gastric contents.^a
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).^a ^b ^c
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).^a
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.^a ^b ^c
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.^a ^b ^c
May decrease rate of gastric emptying.^a

Advice to Patients

Importance of taking sucralfate on an empty stomach.^a ^b ^c
Importance of shaking suspension well prior to each use.^b
Importance of not taking antacids 30 minutes before or after sucralfate dose.^a ^b ^c
Importance of completing full course of therapy, unless healing is shown on radiographic or endoscopic examination.^a ^b ^c
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., renal failure).^a ^b ^c
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^a ^b ^c
Importance of informing patients of other important precautionary information. (See Cautions.)

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
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Suspension	500 mg/5 mL	Carafate (with methylparaben)	Axcan
	Tablets	1 g*	Carafate (scored)	Axcan
			Sucralfate Tablets	Eon

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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