国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sucralfate
Chugai Pharma UK Ltd
A02BX02
Sucralfate
200mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030300; GTIN: 5010981059008
OBJECT 1 ANTEPSIN 1G/5ML ORAL SUSPENSION Summary of Product Characteristics Updated 13-Nov-2013 | Chugai Pharma UK Limited 1. Name of the medicinal product Antepsin 1g/5ml Oral Suspension 2. Qualitative and quantitative composition Each 5 mL dose contains 1 gram sucralfate. For the full list of excipients, see section 6.1 3. Pharmaceutical form Oral Suspension White to off-white viscous suspension with an odour of aniseed/caramel. 4. Clinical particulars 4.1 Therapeutic indications Antepsin 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. 4.2 Posology and method of administration For oral administration. Antepsin 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 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 阅读完整的文件