Cytoprotective Agent — GI Mucosal Protection Pregnancy: Teratogenicity studies in mice, rats and rabbits at doses up to 50 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women; because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Sucralfate (Burns — GI Mucosal Protection)

Brand names: Antepsin

Sucralfate is a sucrose-aluminium complex used in burns patients for stress-related mucosal protection of the upper gastrointestinal tract, offering a non-acid-suppressing alternative for prophylaxis against stress ulceration in the critically injured.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Active duodenal ulcer: 1 g four times per day on an empty stomach. Maintenance therapy: 1 g twice a day

Route: Oral

Frequency: Four times daily (maintenance: twice daily)

INDICATION CAVEAT — READ FIRST: no UK SPC was retrieved for this bundle, so the dose above comes from US labelling (Sucralfate tablets, NuCare Pharmaceuticals, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2ad411ea-6bf6-b3bd-e063-6394a90af2e7). That label's indication is ACTIVE DUODENAL ULCER (and maintenance therapy), not stress-ulcer prophylaxis or GI mucosal protection in burns — the clinician must confirm the indication, dose and route against the UK SPC and the local burns/critical-care protocol. DURATION: while healing may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. ADMINISTRATION: take on an empty stomach; antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate. Because sucralfate can alter the absorption of some drugs, it should be administered separately from other drugs when alterations in bioavailability are felt to be critical (dosing the concomitant medicine 2 hours before sucralfate eliminated the interaction in all case studies to date). ELDERLY: dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or drug therapy. BURNS/ICU-RELEVANT SAFETY POINTS FROM THE LABEL: bezoars have been reported in patients treated with sucralfate — the majority had underlying conditions predisposing to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications including pulmonary and cerebral emboli — this is an oral product only and must never be injected.

Dose adjustments

Renal

No numeric adjustment is stated in the fetched label. It states that sucralfate is known to be substantially excreted by the kidney and that the risk of toxic reactions may be greater in patients with impaired renal function, cross-referring to a 'Special Populations: Chronic Renal Failure and Dialysis Patients' precautions section that was NOT retrieved in this bundle — verify that section (aluminium accumulation) before use in renal impairment or dialysis.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known hypersensitivity reactions to sucralfate or to any of the excipients
Safety and effectiveness in paediatric patients have not been established

Side effects

Constipation — the most frequent complaint (2%); adverse effects were reported in 4.7% of over 2700 patients treated in clinical trials
Gastrointestinal (<0.5%): diarrhoea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth
Dermatological (<0.5%): pruritus, rash
Nervous system (<0.5%): dizziness, insomnia, sleepiness, vertigo; also back pain and headache
Post-marketing: hypersensitivity including dyspnoea, lip swelling, pruritus, rash and urticaria; anaphylactic reactions, bronchospasm, laryngeal oedema and facial swelling reported with an unknown oral formulation; bezoars (especially with delayed gastric emptying or concomitant enteral tube feeding)

Interactions

Reduced extent of absorption (bioavailability) of concomitantly administered cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline and theophylline — the mechanism appears non-systemic, from sucralfate binding the agent in the gastrointestinal tract
Warfarin — subtherapeutic prothrombin times with concomitant warfarin and sucralfate have been reported in spontaneous and published case reports, although two clinical studies showed no change in serum warfarin concentration or prothrombin time
Mitigation stated in the label: in all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction; administer sucralfate separately from other drugs when alterations in bioavailability are felt to be critical and monitor appropriately

Clinical monograph

How it works

In the acidic stomach it forms a viscous adherent barrier over ulcerated and inflamed mucosa, protecting it from acid, pepsin and bile while having minimal systemic absorption.

Prescribing in practice

Because it relies on aluminium, use caution with prolonged therapy in renal impairment owing to the risk of aluminium accumulation, which is pertinent in burns patients prone to renal injury.
It binds and reduces the absorption of many other oral drugs, so administration of interacting medicines should be separated in time.
It requires an acidic environment to work, so concurrent strong acid suppression may reduce its barrier effect.

Monitoring

Monitor for signs of gastrointestinal bleeding and, with prolonged use in renal impairment, consider aluminium accumulation.

Counselling the patient

This medicine coats and protects the stomach lining rather than reducing acid.
Separate it in time from other oral medicines and from feeds where advised.
Report any black stools, vomiting of blood or worsening constipation.

Evidence & guidelines

Sucralfate is an established option for stress ulcer prophylaxis, with critical-care guidance comparing it against acid-suppressing agents.

Reference: STRESS Trial (Cook et al.); BBA Burns GI Complication Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators