GASTROFAIT 500/MG TAB 20/TAB

Indications

Approved Uses

Short-term treatment of active duodenal ulcers, maintenance therapy for duodenal ulcer recurrence prevention, treatment of gastric ulcers

Off-Label Uses

["Stress ulcer prophylaxis in critically ill patients (less favored than PPIs/H2RAs in many protocols but used in some settings)", "GERD symptom management (adjunct/alternative when appropriate)", "Radiation-induced mucositis/proctitis (topical/oral use depending on site)", "Chemotherapy-induced mucositis (supportive care)", "NSAID-associated mucosal injury/ulcer prevention (adjunct in selected cases)"]

Dosage & Administration

Dosing by Condition

Duodenal ulcer (active treatment): 1 g orally four times daily on an empty stomach (1 hour before meals and at bedtime) for 4-8 weeks (or until healed).
Maintenance (duodenal ulcer): 1 g orally twice daily on an empty stomach.
Gastric ulcer (active treatment): 1 g orally four times daily on an empty stomach for 4-8 weeks (commonly used regimen).

Initial Dose

1g (two 500mg tablets) four times daily, 1 hour before each meal and at bedtime

Maintenance Dose

1g twice daily.

Maximum Dose

4g per day

Children's Dosage

Use and dose must be determined by your doctor.

Dose Adjustment Notes

Renal impairment: use with caution (especially severe CKD/dialysis) due to risk of aluminum accumulation/toxicity; avoid prolonged/high-dose use if possible. Hepatic impairment: no dose adjustment generally required.

How to Take

Take orally on an empty stomach (about 1 hour before meals and at bedtime). Swallow with water; if swallowing is difficult, the tablet may be crushed and mixed with a small amount of water to make a slurry and taken immediately. Separate from other oral medicines by at least 2 hours. If antacids are needed, take them at least 30 minutes before or after sucralfate.

Side Effects

Common Side Effects

Constipation, dry mouth, nausea, gastric discomfort, indigestion, flatulence, diarrhea, dizziness, headache

Side Effect Frequency

Common (≥1% to <10%): Constipation. Uncommon (<1%): Nausea, vomiting, flatulence, dry mouth, pruritus, rash, headache, dizziness, gastric discomfort/indigestion. Rare/clinically important: aluminum accumulation/toxicity with prolonged use in renal impairment.

Safety & Warnings

Contraindications

Known hypersensitivity to sucralfate or any excipients.

Warnings & Precautions

Use caution in renal impairment (risk of aluminum accumulation/toxicity), and in patients at risk of bezoars (delayed gastric emptying, severe illness, enteral tube feeding). Separate administration from other oral medications by ≥2 hours; if antacids are needed, separate by ~30 minutes.

Age Restriction

Pediatric use: safety and effectiveness have not been established; use in children only if clearly needed under specialist/medical supervision (no specific age cutoff in labeling).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Sucralfate can reduce absorption of many oral drugs (notably fluoroquinolones, tetracyclines, levothyroxine, digoxin, phenytoin, warfarin, theophylline, azole antifungals); separate other medications by at least 2 hours (some require longer, e.g., fluoroquinolones). Antacids may be used but should be separated (commonly ≥30 minutes) to avoid interference.

Interaction Severity

"Major (avoid/strict separation; clinically significant reduced absorption): ["Fluoroquinolones (e.g., ciprofloxacin, levofloxacin, norfloxacin)
Tetracyclines
Levothyroxine
Phenytoin
Integrase inhibitors susceptible to chelation/adsorption (e.g., bictegravir, dolutegravir, raltegravir) and related combination products"], "Moderate (separate doses; monitor clinical effect/levels when applicable): ["Digoxin
Warfarin
Theophylline
Azole antifungals where absorption is critical (e.g., ketoconazole)"], "Minor: ["Antacids (separate by at least 30 minutes to avoid reduced sucralfate efficacy)"]

Food Interaction

Food decreases effectiveness; administer on an empty stomach (about 1 hour before meals and at bedtime).

Special Populations

Pregnancy

Category B

Children

Use and dose must be determined by your doctor.

Elderly

Standard adult dosing; use with caution due to increased risk of constipation and potential renal impairment leading to aluminum accumulation. Monitor renal function.

Kidney Impairment

No specific dose adjustment is defined, but use with caution in renal impairment and avoid prolonged/high-dose use in severe renal failure or dialysis due to aluminum accumulation/toxicity risk.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Stopping the Medicine

May be stopped without tapering, but should be taken for the full prescribed duration unless the prescriber advises stopping earlier (e.g., intolerance/adverse effects).

Overdose

Acute overdose is usually low risk due to minimal systemic absorption; expected effects are mainly GI (e.g., constipation, nausea/abdominal discomfort). Manage with supportive care; consider aluminum accumulation/toxicity risk mainly with large/prolonged exposure, especially in renal impairment.

Patient Counseling

Take on an empty stomach 1 hour before meals and at bedtime; for a 1 g dose, take two 500 mg tablets. Swallow with water (or crush and mix with a little water if needed). Separate from other oral medicines by at least 2 hours; if using antacids, separate by at least 30 minutes. Constipation is common-maintain fluids/fiber; seek advice if severe. Complete the prescribed course (often 4-8 weeks). Tell your clinician if you have kidney disease. Store below 30°C.

Monitoring Requirements

Routine lab monitoring is not required for most patients; in severe renal impairment or prolonged/high-dose therapy, monitor clinically for aluminum toxicity (and consider aluminum levels if symptomatic) and monitor constipation.

Pharmacology

Mechanism of Action

In an acidic environment (approximately pH <4), sucralfate polymerizes/cross-links to form a viscous, ulcer-adherent protective complex that binds to exposed proteins at ulcer sites, creating a barrier against acid, pepsin, and bile salts; it also reduces pepsin activity and may enhance local prostaglandins/growth factors to support mucosal defense.

Onset of Action

Local mucosal protective action begins within 1-2 hours; symptom improvement may take days to weeks and ulcer healing typically requires 4-8 weeks.

Duration of Effect

Up to about 6 hours per dose (local mucosal protective effect).

Half-Life

Not clinically meaningful/typically not defined because systemic absorption is minimal; no reliable systemic half-life is established for oral sucralfate.

Bioavailability

Minimal systemic absorption; bioavailability is <5% (most acts locally in the GI tract).

Metabolism

Not systemically metabolized to a clinically significant extent; acts locally in the gastrointestinal tract.

Excretion

Primarily fecal; only a small absorbed fraction (as aluminum) is excreted renally.

Product Information

Available Dosage Forms

Tablet, Oral suspension.

Composition per Dose

Each tablet: 500mg sucralfate

Generic Availability

Yes

OTC Alternatives

OTC options for symptom relief include antacids (e.g., calcium carbonate; aluminum/magnesium hydroxide) and OTC acid suppressants (H2 blockers like famotidine; PPIs like omeprazole where available OTC), but there is no true OTC equivalent to sucralfate’s mucosal-adherent protective mechanism.

Gi Condition

Ulcer

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