POM: Prescription only medicine
This information is intended for use by health professionals
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 Antepsin.Paediatric population: The safety and efficacy of Antepsin in children under 14 years of age has not been established. Currently available data are described in section 5.1 but no recommendation on posology can be made. Elderly: see below
Prophylaxis of gastrointestinal haemorrhage from stress ulceration:Adults: The usual dose is 1 gram six times a day. A maximum dose of 8 grams daily should not be exceeded. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Antepsin.Elderly: There are no special dosage requirements for elderly patients but as with all medicines, the lowest effective dose should be used.Paediatric population: The safety and efficacy of Antepsin in children under 14 years of age has not been established. Currently available data are described in section 5.1.
Paediatric PopulationAntepsin is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.
PregnancyTeratogenicity studies in mice, rats and rabbits at doses up to 50 times the human dose have revealed no evidence of harm to the foetus. Safety in pregnant women has not been established and Antepsin should be used during pregnancy only if clearly needed.
LactationIt is not known whether this drug is excreted in human milk. Caution should be exercised when Antepsin is administered to breast-feeding women.
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|
Reporting of suspected adverse reactionsReporting 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.
Mechanism of actionThe action of Antepsin 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. Antepsin exerts a generalised cytoprotective effect by preventing gastro-intestinal mucosal injury.Studies in humans and animal models show that Antepsin forms an ulcer adherent complex with the proteinaceous exudate of the ulcer site. This property enables Antepsin 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 Antepsin protects the gastric mucosa against various irritants such as alcohol, acetylsalicyclic acid and sodium taurocholate.Antepsin 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. Antepsin has no demonstrated pharmacological effect on the cardiovascular or central nervous systems.
Paediatric populationIn 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.
AbsorptionSucralfate 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 precautions).