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 g/kg body weight, could not find a lethal dose. Risks associated with overdose, should, therefore, be minimal.
Not applicable
Tabulated list of adverse reactions
| Immune system disorders | Not known (cannot be estimated from the available data) | Anaphylactic reaction including pruritus, urticaria, oedema, dyspnoea |
| Nervous system disorders | Not known (cannot be estimated from the available data) | Dizziness, headache, drowsiness |
| Ear and labyrinth disorders | Not known (cannot be estimated from the available data) | Vertigo |
| Gastrointestinal disorders | Common (> 1% and < 10%); | Constipation |
| Uncommon (> 0.1% and <1%) | Dry mouth, nausea, | |
| Rare (> 0.01% and <0.1%) | Bezoar formation1 | |
| Not known (cannot be estimated from the available data) | Diarrhoea, vomiting, gastric discomfort, indigestion, flatulence | |
| Skin and subcutaneous tissue disorders | Rare (> 0.01% and <0.1%) | Rash |
| Musculoskeletal and connective tissue disorders | Not known (cannot be estimated from the available data) | Back pain |
| Injury, poisoning and procedural complications | Not known (cannot be estimated from the available data) | Osteodystrophy², osteomalacia², encephalopathy², anaemia² |
¹Reported in patients with impaired gastric emptying, patients with enteral tube feeding or low birth weight infants
²Reported in patients with chronic renal impairment
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
There was no evidence of carcinogenesis in mice and rats receiving oral sucralfate in dosages of up to 1 g/kg daily (12 times the usual human dosage) for 2 years. In animal studies there was no effect evidence of impaired fertility. The effect of sucralfate on human fertility is not known.
Sucralfato Denver is indicated in adults and adolescents over 14 years old for treatment of duodenal ulcer, gastric ulcer, chronic gastritis, and the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients.
Pharmacotherapeutic group: Alimentary tract and metabolism, ATC code: A02B X02
Mechanism of action
The action of Sucralfato Denver is non-systemic as the drug is only minimally absorbed from the gastro-intestinal tract. The small amounts that are absorbed are excreted primarily in the urine. Sucralfato Denver exerts a generalised cytoprotective effect by preventing gastro-intestinal mucosal injury.
Studies in humans and animal models show that Sucralfato Denver forms an ulcer adherent complex with the proteinaceous exudate of the ulcer site. This property enables Sucralfato Denver to form a protective barrier over the ulcer lesion giving sustained protection against the penetration and action of gastric acid, pepsin and bile.
Studies both in humans and animals demonstrate that Sucralfato Denver protects the gastric mucosa against various irritants such as alcohol, acetylsalicyclic acid and sodium taurocholate.
Sucralfato Denver also directly inhibits pepsin activity and absorbs bile salts. It has only weak antacid activity. It does not alter gastric emptying time, nor normal digestive function. Sucralfato Denver has no demonstrated pharmacological effect on the cardiovascular or central nervous systems.
Paediatric population
In the literature, there are limited clinical data on the use of sucralfate in children, mainly for stress ulcer prophylaxis, reflux oesophagitis, and mucositis. The dose used in these studies was 0.5 - 1 g four times a day, depending on the children's age and the severity of the underlying disease, and was applied without major safety concerns. In view of the limited data, use of sucralfate in children under 14 years of age is currently not recommended.
Absorption
Sucralfate is only minimally absorbed from the gastro-intestinal tract. The small amounts that are absorbed are excreted primarily in the urine. Absorption of aluminium from sucralfate may be increased in patients on dialysis or with renal dysfunction (see also “other special warnings and precautionsâ€).
Sucralfato Denver must not be administered intravenously. Inadvertent intravenous administration of insoluble sucralfate and its insoluble excipients may induce fatal complications, including pulmonary and cerebral emboli. Other severe complications including aluminium intoxication are reported after intravenous administration.
The product 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, Sucralfato Denver 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.
Contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).
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 medical 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.
Paediatric Population
Sucralfato Denver is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.
Do not drive if you feel dizzy or drowsy.
For oral administration.
Sucralfato Denver must not be administered intravenously.
Duodenal ulcer, gastric ulcer, chronic gastritis:
Adults: The usual dose is 2 grams twice daily to be taken on rising and at bedtime, or 1 gram 4 times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose: 8 grams.
Four to six weeks' treatment is usually needed for ulcer healing, but up to twelve weeks may be necessary in resistant cases.
Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Sucralfato Denver.
Paediatric population: The safety and efficacy of Sucralfato Denver in children under 14 years of age has not been established.
Elderly: see below
Prophylaxis of gastrointestinal haemorrhage from stress ulceration:
Adults: The usual dose is 1 gram six times a day.
No special requirements.
