Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Midodrine hydrochloride
Special Order
C01CA17
Midodrine hydrochloride
5mg
Oral tablet
No Controlled Drug Status
Valid as a prescribable product
BNF: 02070200
BLACK
ZINC Ref:
EAS3827A LEA MIDODRINE 5MG TABS TUK
Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midodrine Hydrochloride 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of midodrine hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Spotted orange, round, flat, 7.0 mm diameter tablet with a score line on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midodrine Hydrochloride is indicated in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Initial dose: 2.5 mg three times a day (Midodrine Hydrochloride 2.5 mg tablets are also available). Depending on the results of supine and standing blood pressure recordings, this dose may be increased weekly up to a dose of 10 mg three times a day. This is the usual maintenance dosage. A careful evaluation of the response to treatment and of the overall balance of the expected benefits and risks needs to be undertaken before any dose increase and advice to continue therapy for long periods. The last daily dose should be taken at least 4 hours before bedtime in order to prevent supine hypertension (see also section 4.4). Midodrine Hydrochloride 5 mg tablets may be taken with food (see section 5.2). _Paediatric population_ The safety and efficacy of midodrine in children have not been established. No data are available. _Elderly population_ There is limited data on dosing in the elderly and there are no specific studies which have focused on a possible dose reduction in the elderly population. Cautious dose titration is recommended. _Patients with renal impairment_ There are no specific studies that have focused on a possible dose reduction in patients with renal impairment. Typically, midodrine is contraindicated in patients with acute renal impairment and severe renal impairment (see section 4.3). _P Prečítajte si celý dokument