Schedule H

Oral

• Tablets: 500 mg, 1 g

• Oral suspension: 500 mg/5 mL, 1 g/10 mL

• Oral gel: 1 g/5 mL (limited availability)

Note: Topical use for mucositis is off-label and limited to specialist oncology/radiation therapy settings.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Peptic Ulcer Disease (Gastric and Duodenal Ulcer)

Parameter Recommendation

Starting dose 1 g orally, four times daily (1 hour before meals and at bedtime)

Titration Not applicable

Usual maintenance dose 1 g twice daily (after ulcer healing, for maintenance)

Maximum dose 4 g/day

Clinical Notes:

• Administer on empty stomach for optimal mucosal binding

• Treatment duration: 4–8 weeks for active ulcer healing

• Maintenance therapy: 1 g BD for up to 12 months to prevent recurrence

• Avoid antacids within 30 minutes before or after sucralfate dose

• Continue H. pylori eradication if indicated concurrently

1. Gastro-oesophageal Reflux Disease (GORD) — Adjunctive Therapy

Parameter Recommendation

Starting dose 1 g orally, four times daily (before meals and at bedtime)

Titration Not applicable

Usual maintenance dose 1 g four times daily

Maximum dose 4 g/day

Clinical Notes:

• Used as adjunct to PPI or H2RA for mucosal protection

• Particularly useful in erosive oesophagitis

• Duration: 4–8 weeks depending on clinical response

• Not first-line monotherapy for GORD

1. Stress Ulcer Prophylaxis in High-Risk Hospitalised Patients

Parameter Recommendation

Starting dose 1 g orally or via nasogastric tube, every 6 hours

Titration Not applicable

Usual maintenance dose 1 g every 6 hours

Maximum dose 4 g/day

Clinical Notes:

• Used in ICU/critical care settings

• Alternative when PPI/H2RA contraindicated or not preferred

• May have lower risk of nosocomial pneumonia compared to acid-suppressive agents

• Specialist/intensivist discretion required

• Flush nasogastric tube before and after administration

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Radiation-induced mucositis (oral)— OFF-LABEL 1 g/10 mL suspension: swish in mouth for 1–2 minutes, then spit or swallow; 4 times daily During radiation therapy and 2 weeks post-completion Specialist only (Radiation Oncology). Based on institutional protocols and supportive RCTs. Provides mucosal coating and symptomatic relief.

Chemotherapy-induced mucositis — OFF-LABEL 1 g/10 mL suspension: swish and swallow or spit; 4 times daily During chemotherapy cycles Specialist only (Medical Oncology). Limited evidence; used in Indian tertiary cancer centres.

Bile reflux gastritis — OFF-LABEL 1 g orally QID before meals 4–8 weeks Specialist gastroenterology supervision. May bind bile acids and protect mucosa.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Peptic Ulcer Disease (Gastric/Duodenal Ulcer)

Weight-based Dosing:

Weight/Age Dose Frequency Maximum Daily Dose

Children >1 year 40–80 mg/kg/day Divided into 4 doses (before meals and bedtime) 4 g/day

Adolescents (>12 years) 1 g per dose 4 times daily 4 g/day

Dosing Structure:

Parameter Recommendation

Starting dose 40 mg/kg/day orally, divided into 4 doses

Titration May increase to 80 mg/kg/day if inadequate response

Usual maintenance dose 40–80 mg/kg/day in 4 divided doses

Maximum dose 80 mg/kg/day or 4 g/day, whichever is lower

Administration:

• Give 1 hour before meals and at bedtime

• Use oral suspension for accurate dosing in younger children

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Duration Notes

GORD with erosive oesophagitis — OFF-LABEL >1 year 40–80 mg/kg/day in 4 divided doses 4–8 weeks Paediatric gastroenterologist only. Use in combination with acid suppression (PPI). Short-term use for severe erosive disease. Based on IAP recommendations and specialist practice.

NSAID-induced gastropathy prophylaxis — OFF-LABEL >6 years 40 mg/kg/day in 4 doses Duration of NSAID therapy Specialist supervision. Limited paediatric data.

Age Restrictions:

• Not recommended below 1 year of age due to insufficient safety and efficacy data

• Neonates and infants: Avoid use except under specialist paediatric gastroenterology supervision

Safety Monitoring in Children:

• Monitor for constipation (most common adverse effect)

• Assess growth parameters if prolonged use planned

• Check renal function if therapy exceeds 8 weeks

• Ensure adequate hydration

50 No dose adjustment required

30–50 Use with caution; avoid prolonged therapy (>4 weeks). Monitor for aluminium accumulation.

10–30 Avoid unless benefit clearly outweighs risk. If used, limit to short course (<2 weeks). Monitor aluminium levels if available.

<10 Avoid use. High risk of aluminium accumulation and toxicity.

Haemodialysis Avoid. Aluminium is poorly dialysable and accumulates.

Peritoneal dialysis Avoid. Same accumulation risk.

Note: Sucralfate contains aluminium hydroxide. Chronic use in renal impairment can lead to aluminium toxicity (encephalopathy, osteomalacia, microcytic anaemia). If use is unavoidable, monitor serum aluminium levels.

• Known hypersensitivity to sucralfate or any component of the formulation

• Known or suspected gastrointestinal obstruction

• Dysphagia with high aspiration risk (for oral suspension — relative contraindication)

• Chronic kidney disease (eGFR <30 mL/min) — aluminium accumulation risk

• Concurrent use with aluminium-containing antacids — additive aluminium load

• Diabetes mellitus — oral suspension contains sucrose; monitor blood glucose

• Patients with impaired swallowing or reduced consciousness — aspiration risk with suspension

• Patients on multiple oral medications — drug absorption interference

• Gastroparesis or delayed gastric emptying — bezoar formation risk

• Chronic use (>8 weeks) — monitor for phosphate depletion

Parameter Information

Overall safety Generally considered safe; minimal systemic absorption (<5%)

Risk assessment No evidence of teratogenicity in animal or limited human studies

Preferred alternatives PPIs (omeprazole, pantoprazole) are first-line for peptic ulcer in pregnancy; sucralfate is acceptable alternative

When to use May be used when acid suppression agents are not preferred or as adjunct therapy

Monitoring Maternal nutritional status; avoid prolonged use due to theoretical phosphate depletion

Parameter Information

Compatibility Compatible with breastfeeding

Milk levels Negligible (minimal systemic absorption)

Preferred alternatives None required; sucralfate is acceptable during lactation

Infant monitoring Routine observation for feeding and bowel patterns

Parameter Recommendation

Starting dose 1 g four times daily (same as adults)

Titration Not applicable

Special considerations Higher risk of constipation; ensure adequate hydration and fibre intake

Renal function Assess baseline renal function before initiating; avoid prolonged use if eGFR <30

Polypharmacy Multiple drug interactions due to binding; ensure appropriate spacing of medications

Monitoring Bowel function; signs of aluminium toxicity if prolonged use in those with reduced renal reserve

Drug/Class Interaction Mechanism Management

Fluoroquinolones(ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) Significantly reduced fluoroquinolone absorption and efficacy Chelation with aluminium in sucralfate Administer fluoroquinolone 2 hours before or 6 hours aftersucralfate

Tetracyclines (doxycycline, tetracycline) Markedly reduced tetracycline absorption Chelation Give tetracycline 2 hours before sucralfate

Levothyroxine Reduced thyroid hormone absorption Binding in GI tract Administer levothyroxine 4 hours before sucralfate; monitor TSH

Phenytoin Reduced phenytoin absorption; risk of seizure breakthrough GI binding Give phenytoin 2 hours beforesucralfate; monitor phenytoin levels

Digoxin Reduced digoxin bioavailability GI binding Administer digoxin 2 hours before sucralfate

Ketoconazole, Itraconazole Reduced antifungal absorption (require acidic environment) Reduced gastric acidity from aluminium; binding Avoid combination if possible; if needed, give antifungal 2 hours before

Drug/Class Interaction Management

Aluminium-containing antacids Additive aluminium load; increased toxicity risk Avoid concurrent use, especially in renal impairment

Warfarin Possible reduced warfarin absorption Monitor INR when initiating or stopping sucralfate; give warfarin 2 hours before

Iron supplements Reduced iron absorption Give iron supplements 2 hours before sucralfate

PPIs and H2RAs May reduce sucralfate efficacy (requires acidic environment for optimal binding) Clinically used together; give sucralfate separately from PPI

Theophylline Possible reduced theophylline absorption Monitor theophylline levels; give 2 hours apart

Ranitidine/Famotidine Reduced H2RA absorption if given together Separate administration by 2 hours

Antiepileptics(carbamazepine, valproate) Potential reduced absorption Separate by 2 hours; monitor clinical response

• Constipation (most frequent, up to 10%)

• Dry mouth

• Nausea

• Abdominal discomfort, bloating

• Flatulence

• Indigestion

• Metallic taste

• Headache

Effect Notes

Aluminium toxicity Occurs with prolonged use in chronic renal failure; presents as encephalopathy (confusion, memory impairment, myoclonus), osteomalacia (bone pain, fractures), microcytic anaemia. Discontinue and refer if suspected.

Bezoar formation Rare; occurs in patients with gastroparesis or gastric outlet obstruction. May require endoscopic or surgical removal.

Hypophosphataemia With chronic use; aluminium binds dietary phosphate. Monitor phosphate in long-term therapy.

Anaphylaxis/Angioedema Extremely rare. Discontinue immediately if suspected.

After initiation/dose change Monitor bowel function (constipation); ensure drug spacing is maintained

Long-term use (>8 weeks) Serum phosphate levels; signs of aluminium toxicity (if renal impairment); nutritional status

In renal impairment Serum aluminium levels (if available and prolonged use); phosphate; haemoglobin (for aluminium-related anaemia)

Single Ingredient:

• Sucral (Dr. Reddy's)

• Sucrafil (Cipla)

• Ulcerfate (Sun Pharma)

• Sucralfate (Generic — multiple manufacturers)

• Hapifate (Micro Labs)

• Sucrabest (Mankind)

• Ulgel (Torrent)

• Sucralcoat (Alkem)

Fixed Dose Combinations (FDCs):

Note: Not included in NLEM 2022. Prices not NPPA-controlled; vary by brand. Available under Jan Aushadhi scheme as generic sucralfate at lower cost.

1. Empty stomach administration: Sucralfate works by binding to ulcerated mucosa — give 1 hour before meals and at bedtime for optimal effect. Food in stomach impairs binding.

1. Drug spacing is critical: Due to extensive binding of co-administered drugs, maintain 2-hour gap (or more for specific drugs like levothyroxine — 4 hours). This is the most common prescribing error with sucralfate.

1. Renal caution: Avoid prolonged use (>4 weeks) in patients with eGFR <30 mL/min due to aluminium accumulation risk. Short courses may be acceptable with monitoring.

1. Constipation management: Most common side effect. Advise adequate fluid intake and dietary fibre. Consider stool softeners if persistent.

1. Stress ulcer prophylaxis advantage: Unlike PPIs and H2RAs, sucralfate does not significantly raise gastric pH, potentially reducing nosocomial pneumonia risk in ICU patients — may be preferred in selected cases.

1. Not a substitute for H. pylori eradication: In peptic ulcer disease, always test for and treat H. pylori infection. Sucralfate provides symptomatic relief and mucosal protection but does not address underlying infection.

sucralfate; peptic ulcer; mucosal protectant; GORD; stress ulcer prophylaxis; aluminium toxicity; renal-caution; drug interactions; ICU; cytoprotective

RxIndia v1.0 — 05 Jan 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia / National Formulary of India

• NLEM 2022 (not listed)

• API Textbook of Medicine

• AIIMS Drug Formulary

• PGI Chandigarh hospital protocols

• IAP Paediatric Drug Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Select RCTs for off-label mucositis indications