Carafate

Pronunciation

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

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

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

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.

* 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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Carafate 1GM/10ML Suspension (AXCAN PHARMA US): 420/$99.99 or 1260/$285.96

Carafate 1GM Tablets (AXCAN PHARMA US): 30/$53.99 or 90/$142.98

Sucralfate 1GM/10ML Suspension (PHARMACEUTICAL ASSOCIATES): 10/$13.99 or 50/$39.97

Sucralfate 1GM Tablets (WATSON LABS): 90/$41.99 or 270/$108.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

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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.

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