Sucralfate is indicated in adults and adolescents over 14 years old for treatment of-

• Duodenal ulcer
• Gastric ulcer
• Chronic gastritis
• The prophylaxis of gastrointestinal hemorrhage from stress ulceration in seriously ill patients.

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.

Administration

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

Sucralfate tablet and suspension are contraindicated in patients with hypersensitivity to sucralfate.

The most common adverse event was headache (3.4%) followed by nausea (2.3%), abdominal pain (2.3%), constipation (1.1%), diarrhea (1.1%), and urticaria (1.1%). The majority of patients who reported bezoars, had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Episodes of hyperglycemia have been reported in diabetic patient.

Overdose Effects

In a clinical trial on healthy men of overdose with Sucralfate, most cases remained asymptomatic but symptoms of abdominal pain, nausea, and vomiting were reported in a few cases. Acute oral toxicity studies in animals using doses up to 12 gm/kg body weight could not find a lethal dose. Risks associated with overdose should therefore be minimal.

Sucralfate should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption. Sucralfate is not recommended for use in individuals on dialysis. In patients with severe or chronic renal impairment, Sucralfate should be used with extreme caution and only for short-term treatment. Small amounts of aluminium are absorbed through the gastrointestinal tract and aluminium may accumulate. Aluminium osteodystrophy, osteomalacia, encephalopathy and anaemia have been reported in patients with chronic renal impairment. For patients with impairment of renal function, laboratory testing such as aluminium, phosphate, calcium and alkaline phosphatase is recommended to be periodically performed due to excretion impairment. The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity. Bezoars have been reported after administration of sucralfate mainly to severely ill patients in intensive care units. The majority of these patients (including neonates in whom sucralfate is not recommended) had underlying conditions that may predispose to bezoar formation (such as delayed gastric emptying due to surgery, drug therapy or diseases that reduce motility) or were receiving concomitant enteral tube feeding.

Use in Special Populations

Pediatric Population: Sucralfate is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.

In elderly patients: Dose adjustments are not necessary.

Renal Impairment: Sucralfate should be used with caution in renal insufficiency patients.

Effects on ability to drive and use machines: Patients should not be drive if feel dizzy or drowsy.

Pregnancy & Lactation

Safety in pregnant women has not been established and Sucralfate should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Caution should be exercised when Sucralfate is administered to breast-feeding women.