Sucralfate

• Duodenal Ulcers
• Stress Ulcer Prevention
• Peptic Ulcer Disease

Sucralfate is a unique gastrointestinal medication that forms a protective barrier over ulcerated mucosa. It is used to treat and prevent duodenal ulcers and maintain healed ulcers, working through local cytoprotective mechanisms rather than acid suppression.

Mechanism of Action

Sucralfate provides mucosal protection through multiple mechanisms:

• Barrier formation: In acidic environment, forms a viscous, adhesive paste that binds to ulcer base
• Selective binding: Adheres to ulcerated tissue with higher affinity than normal mucosa
• Protects from acid and pepsin: Physical barrier prevents further damage
• Stimulates prostaglandin synthesis: Enhances mucosal defense
• Binds bile salts: Reduces mucosal injury from refluxed bile
• Promotes growth factor binding: Concentrates EGF and FGF at ulcer site

Sucralfate is a complex of sulfated sucrose and aluminum hydroxide.

Available Formulations

Sucralfate is available as:

• Tablets: 1 g
• Oral suspension: 1 g/10 mL

Medical Uses

FDA-Approved Indications:

• Short-term treatment (up to 8 weeks) of active duodenal ulcer
• Maintenance therapy of healed duodenal ulcer

Off-Label Uses:

• Stress ulcer prophylaxis in critically ill patients
• GERD
• Radiation-induced esophagitis or proctitis
• Mucositis
• Gastric ulcers

Dosing Guidelines

Active Duodenal Ulcer:

• 1 g four times daily on an empty stomach (1 hour before meals and at bedtime)
• Treatment duration: 4-8 weeks

Maintenance Therapy:

• 1 g twice daily on an empty stomach

Administration:

• Take on empty stomach for optimal efficacy
• Do not crush or chew tablets
• Shake suspension well before use

Important Safety Information

Contraindications:

• Known hypersensitivity to sucralfate or any component

Warnings and Precautions:

• Aluminum toxicity: Use with caution in chronic renal failure (aluminum accumulation)
• Bezoar formation: Cases reported, especially in critically ill patients with tube feeding
• Duodenal ulcer is a chronic disease: Successful healing requires follow-up
• Drug binding: May interfere with absorption of many medications

Drug Interactions

Sucralfate can bind to and reduce absorption of many drugs. Separate administration by at least 2 hours:

• Fluoroquinolones (ciprofloxacin, levofloxacin): Significantly reduced absorption
• Tetracyclines: Reduced absorption
• Phenytoin: Reduced absorption
• Warfarin: May reduce absorption
• Digoxin: May reduce absorption
• Ketoconazole: May reduce absorption
• Levothyroxine: May reduce absorption
• Quinidine: Reduced serum levels

Antacids: May interfere with sucralfate binding; separate by 30 minutes

Special Populations

• Renal Impairment: Use with caution due to aluminum absorption risk; avoid in severe/dialysis patients if possible
• Hepatic Impairment: No specific adjustment
• Pregnancy: Limited data; use only if clearly needed
• Lactation: Unknown if excreted in milk; likely minimal absorption
• Elderly: Consider renal function; monitor for aluminum toxicity in long-term use
• Pediatric: Safety and efficacy not established