Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
MIDODRINE HYDROCHLORIDE
Nycomed UK Limited
5 Milligram
Tablets
2010-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midon 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg midodrine hydrochloride. Also contains the colourant E110 (Sunset Yellow FCF-Lake) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Orange, round, biplanar tablets with bevelled edge. Scored on one side with marking ‘GU’ above and ‘5.0’ below the score. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in the treatment of idiopathic orthostatic hypotension (Shy-Drager and Bradbury-Eggleston Syndromes). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and adolescents: The usual starting dose is 2.5 mg 2-3 times daily. The dose should be increased at weekly intervals in small increments until an optimal response is obtained. Most patients are controlled at or below 30 mg daily given in divided doses. The maximum daily dose is 30mg given in divided doses. Doses in excess of 30 mg daily are not recommended. The supine and standing blood pressure should be monitored regularly during initial treatment (at least two times a week) and the use of Midodrine should be stopped if suprine hypertension increases excessively. Dosing of midodrine should occur during the daytime, when the patient needs to be upright. A dosing schedule of 3-4 hour intervals is suggested. The last dose should be taken at least four hours before bedtime to reduce the risk of supine hypertension. Elderly: Although there is no evidence to suggest that dosage requirements are different in the elderly, it is recommended that the initial dose used be small and that increases in dosage be titrated against t Đọc toàn bộ tài liệu