Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Magurol is indicated for the treatment of hypertension and can be used as the sole agent to control the blood pressure in the majority of patients. In patients controlled on single antihypertensive therapy, Magurol may be used in combination with a thiazide diuretic, beta-adrenoreceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor.
Magurol is indicated for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia. Magurol may be used in BPH patients who are either hypertensive or normotensive.
For oral administration. Magurol may be administered in the morning or the evening.
Magurol is used in a once daily regimen: the initial dose is 1mg, to minimise the potential for postural hypotension and/or syncope (see section 4.4). Dosage may then be increased to 2mg after an additional one or two weeks of therapy and thereafter, if necessary to 4mg. The majority of patients who respond to Magurol will do so at a dose of 4mg or less. Dosage can be further increased if necessary to 8mg or the maximum recommended dose of 16mg.
The recommended initial dosage of Magurol is 1mg given once daily to minimise the potential for postural hypotension and/or syncope (see section 4.4). Depending on the individual patient’s urodynamics and BPH symptomatology dosage may then be increased to 2mg and thereafter to 4mg and up to the maximum recommended dose of 8mg. The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4mg daily.
The safety and efficacy of doxazosin in children have not been established.
Normal adult dosage.
Since there is no change in pharmacokinetics in patients with impaired renal function, the usual adult dose of doxazosin is recommended.
Doxazosin is not dialysable.
There are only limited data in patients with liver impairment and on the effect of drugs known to influence hepatic metabolism (e.g. cimetidine). As with any drug wholly metabolised by the liver, doxazosin should be administered with caution to patients with evidence of impaired liver function (see section 4.4 and section 5.2).
Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures may be appropriate in individual cases.
If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressor should then be used. Renal function should be monitored and supported as needed.
Since doxazosin is highly protein bound, dialysis is not indicated.
5 years.
Store below 25°C, in the original package in order to protect from moisture.
Magurol 1mg, 2mg, 4mg tablets are packed in PVC/aluminium foil blisters of seven or ten tablets.
Not all pack sizes may be marketed.
None.
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