Sucralfate is indicated in adults and adolescents over 14 years of age for the treatment of:

• Duodenal ulcer
• Gastric ulcer
• Chronic gastritis
• Prophylaxis of gastrointestinal bleeding due to stress ulceration in critically ill patients.

Sucralfate is a non-systemic drug with minimal absorption from the gastrointestinal tract. The small amount that is absorbed is mainly excreted through urine. It promotes healing of gastric and duodenal ulcers by forming a chemical complex that adheres to the ulcer site, creating a protective barrier. Additionally, Sucralfate inhibits the action of pepsin and bile.

Duodenal ulcer, gastric ulcer, chronic gastritis

• Adults: The usual dose is Sucralfate 2 gm twice daily to be taken on rising and at bedtime or Sucralfate 1 gm four times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose is 8 gm but up to twelve weeks may be necessary in resistant cases.
• Pediatric population: The safety and efficacy of Sucralfate in children under 14 years of age has not been established.
• Elderly: There are no special dosage requirements for elderly patients but as with all medicines the lowest effective dose should be used.

Prophylaxis of gastrointestinal hemorrhage from stress ulceration

• Adults: The usual dose is Sucralfate 1 gm orally or via a nasogastric tube 4 to 6 times a day. To prevent clogging of the nasogastric tube flush with 10 ml of water following each administration. The duration of treatment for prophylaxis of stress ulceration must be individually determined. Treatment should be continued for as long as one or more of the risk factors for stress ulceration is present but normally not for more than 14 days.

Sucralfate should be taken on an empty stomach. Antacid should not be administered within 30 minutes of Sucralfate.

Concomitant use of Sucralfate may reduce the bioavailability of several drugs, including fluoroquinolones (e.g., ciprofloxacin, norfloxacin), tetracycline, ketoconazole, sulpiride, digoxin, warfarin, phenytoin, theophylline, levothyroxine, quinidine, and H2-receptor antagonists. This effect can usually be avoided by separating administration of Sucralfate and these drugs by at least 2 hours. This interaction is non-systemic and is believed to occur due to binding of these drugs by Sucralfate in the gastrointestinal tract. Because Sucralfate may affect drug absorption, spacing its administration from other medications should be considered when precise bioavailability is important. Sucralfate should not be co-administered with citrate preparations, as this may increase aluminium absorption due to chelation. When used via nasogastric tube, Sucralfate (1 g) should be separated from enteral feeds by at least 1 hour. Rare cases of bezoar formation have been reported when administered too closely with enteral feeding.

Sucralfate is contraindicated in patients with known hypersensitivity to the drug.

The most common adverse effects include headache (3.4%), nausea (2.3%), abdominal pain (2.3%), constipation (1.1%), diarrhea (1.1%), and urticaria (1.1%). Most cases of bezoar formation occurred in patients with predisposing conditions such as delayed gastric emptying or those receiving enteral feeding. Episodes of hyperglycemia have also been reported in diabetic patients.

Safety in pregnancy has not been established. Sucralfate should be used during pregnancy only if clearly needed. It is not known whether it is excreted in human milk. Caution should be exercised in breastfeeding women.

Use with caution in patients with renal impairment due to risk of increased aluminium absorption. It is not recommended in dialysis patients. Prolonged use in severe renal dysfunction may lead to aluminium accumulation, resulting in osteodystrophy, osteomalacia, encephalopathy, and anaemia. Regular monitoring of aluminium, phosphate, calcium, and alkaline phosphatase is recommended in renal impairment. Concomitant use with other aluminium-containing products should be avoided. Bezoar formation has been reported, mainly in critically ill patients with delayed gastric emptying or those receiving enteral feeding.

Pediatric: Not recommended for children under 14 years due to lack of safety and efficacy data.

Elderly: No dose adjustment required.

Renal impairment: Use with caution.

Ability to drive: Avoid driving if dizziness or drowsiness occurs.

Overdose cases are usually asymptomatic. Some cases report abdominal pain, nausea, and vomiting. Animal studies show very high doses are not lethal. Therefore, overdose risk is considered low.

Chelating complex

Store in a cool, dry place, protected from light.