Sulafate

• Approved Indications:
• Treatment of active duodenal ulcers
• Maintenance therapy for duodenal ulcer healing
• Management of gastric ulcers (adjunctive)
• Treatment and prevention of stress gastritis and stress ulcers in critically ill patients
• Mucosal protection in gastroesophageal reflux disease (GERD) refractory to acid suppression
• Off-label (Clinically Accepted) Uses:
• Management of oral and esophageal ulcerations due to radiation or chemotherapy
• Treatment of gastritis and esophagitis caused by acid or NSAIDs
• Adjunct in prevention of upper gastrointestinal bleeding in high-risk patients
• Use in management of ulcerative mucosal lesions in inflammatory bowel disease (limited evidence)

• Adults:
• Usual dose: 1 gram orally four times daily (before meals and at bedtime)
• For duodenal ulcer treatment: 1 gram four times daily for 4-8 weeks
• Maintenance: 1 gram twice or four times daily depending on ulcer recurrence risk
• Pediatrics:
• Safety and efficacy not fully established; dosing based on clinical judgment (commonly 40 mg/kg/day divided into four doses)
• Elderly:
• No specific dose adjustment needed; monitor renal function
• Special Populations:
• Renal impairment: Caution advised due to aluminum content; dose adjustment may be necessary
• Hepatic impairment: No dosage adjustment required
• Administration Route: Oral suspension or tablets
• Instructions: Administer on an empty stomach, 1 hour before meals and at bedtime; avoid antacids within 30 minutes before or after sucralfate

Sucralfate is a complex salt of sucrose sulfate and aluminum hydroxide that undergoes polymerization in an acidic environment to form a viscous, sticky gel that adheres selectively to ulcerated mucosal surfaces and erosions. This physical barrier protects the mucosa from acid, pepsin, and bile salts, promoting healing by preventing further injury and allowing regeneration. Additionally, it may stimulate local prostaglandin and bicarbonate secretion, enhancing mucosal defense and repair.

• Absorption: Minimal systemic absorption (<3%) after oral administration
• Distribution: Systemic distribution negligible due to minimal absorption
• Metabolism: Not metabolized
• Excretion: Primarily eliminated unchanged via feces; aluminum is minimally absorbed and excreted renally
• Onset of Action: Protective barrier forms within 30 minutes of administration
• Half-life: Not systemically absorbed, so half-life not applicable for the drug itself

• Pregnancy: Classified as FDA Category B; animal studies have shown no teratogenic effects; use only if clearly needed
• Lactation: Limited data available; sucralfate is poorly absorbed and unlikely to affect breastfed infants; caution advised
• Recommendation: Use during pregnancy and lactation only when benefits outweigh risks

• Primary Class: Gastrointestinal agent
• Subclass: Mucosal protective agent / Antiulcer agent

• Known hypersensitivity to sucralfate or any of its components
• Inability to swallow tablets or oral suspension safely
• Caution in patients with severe renal impairment due to aluminum accumulation risk

• Aluminum accumulation and toxicity may occur in patients with renal failure; monitor closely
• Risk of constipation; adequate hydration and fiber intake recommended
• Avoid concurrent use with other aluminum-containing products
• Administer other medications at least 2 hours before or after sucralfate to avoid absorption interference
• Watch for early signs of hypersensitivity such as rash or anaphylaxis
• Not a substitute for acid suppression in severe reflux or ulcer bleeding

• Common:
• Constipation
• Dry mouth
• Flatulence
• Nausea
• Less Common:
• Dizziness
• Sleepiness
• Skin rash
• Rare but Serious:
• Hypersensitivity reactions including anaphylaxis
• Aluminum toxicity in renal impairment (encephalopathy, osteomalacia)

• Major Interactions:
• May bind and reduce absorption of drugs such as digoxin, phenytoin, fluoroquinolones, tetracyclines, warfarin, and thyroid hormones
• Administer other drugs at least 2 hours before or after sucralfate
• Drug-Food: No significant interactions
• Drug-Alcohol: No significant interactions
• Enzyme Systems: Does not affect or is affected by CYP450 enzymes

• Current guidelines continue to recommend sucralfate as an effective mucosal protective agent for duodenal ulcers and prevention of stress ulcers
• No major recent changes in dosing or approved indications
• Cautionary statements regarding aluminum accumulation in renal impairment have been reinforced by regulatory authorities
• Increasing emphasis on administration timing relative to other drugs to avoid absorption interference

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and heat
• Keep tablets in original packaging to avoid degradation
• Oral suspension: Shake well before use; do not freeze; store at room temperature
• Keep out of reach of children