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Carafate

Generic Name: Sucralfate
Class: Protectants
ATC Class: A02BX02
VA Class: GA302
CAS Number: 54182-58-0

Medically reviewed on Jun 1, 2018

Introduction

Antiulcer agent; anionic sulfated disaccharide.a b c

Uses for Carafate

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.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 for prevention and treatment of chemotherapy-induced mucositis.100 101 102 103 104 108 Results have been conflicting;101 additional study necessary.100 104 106 107

Carafate 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
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 Carafate

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

Interactions for Carafate

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 dialysisb c

All antacids: Take antacids at least 30 minutes before or after sucralfatea b c

Cimetidine

Possible decreased absorption of cimetidinea b c

Take cimetidine 2 hours before sucralfateb c

Digoxin

Possible decreased absorption of digoxina b c

Take digoxin 2 hours before sucralfateb 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 ketoconazolea b c

Take ketoconazole 2 hours before sucralfateb c

Levothyroxine

Possible decreased absorption of levothyroxineb c

Take levothyroxine 2 hours before sucralfateb c

Phenytoin

Possible decreased absorption of phenytoina b c

Take phenytoin 2 hours before sucralfateb c

Quinidine

Possible decreased absorption of quinidineb c

Take quinidine 2 hours before sucralfateb c

Ranitidine

Possible decreased absorption of ranitidinea b c

Take ranitidine 2 hours before sucralfateb c

Tetracycline

Possible decreased absorption of tetracyclinea b c

Take tetracycline 2 hours before sucralfateb c

Theophylline

Possible decreased absorption of theophyllinea b c

Take theophylline 2 hours before sucralfateb c

Warfarin

Possible decreased absorption of warfarin;a b c may result in subtherapeutic PTb

Take warfarin 2 hours before sucralfateb c

Carafate 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, Martec, Teva, UDL, Warrick, Watson

AHFS DI Essentials. © Copyright 2018, Selected Revisions June 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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

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a. AHFS drug information 2007. McEvoy GK, ed. Sucralfate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2983-5.

b. Axcan Scandipharm Inc. Carafate (sucralfate) suspension prescribing information. Birmingham, AL; 2004 Apr.

c. Axcan Scandipharm Inc. Carafate (sucralfate) tablets prescribing information. Birmingham, AL; 2004 Mar.

d. Konturek SJ, Kwiecien N, Obtulowicz W et al. Double blind controlled study on the effect of sucralfate on gastric prostaglandin formation and microbleeding in normal and aspirin treated man. Gut. 1986; 27:1450-6. http://www.ncbi.nlm.nih.gov/pubmed/3492413?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1433967&blobtype=pdf

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