DOXATAN Tablets 4mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
DOXAZOSIN
Available from:
Stada Arzneimittel AG
Dosage:
4mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
2000-01-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxatan 4mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg doxazosin (as mesilate).
Excipients: Each tablet contains: 80mg lactose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White, oblong tablet, scored on one side, embossed ‘D4’ on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxatan 4mg Tablets are indicated for the treatment of essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Unless prescribed otherwise, the following dosage regimen is recommended:
Start therapy with 1mg of doxazosin once daily. Depending on the individual patient's blood pressure response, dosage
may, after 1 2 weeks, be increased to 2mg of doxazosin once daily, if necessary, then to 4mg of doxazosin once daily,
and eventually to 8mg of doxazosin once daily.
Average daily dose for maintenance therapy: 2 4mg of doxazosin once daily.
Maximum daily dose: 16mg of doxazosin.
Use in elderly people and patients with renal insufficiency:
As the pharmacokinetic properties of doxazosin are unchanged in elderly patients and those with renal insufficiency,
these patients can be treated with the usual dose.
However, dosage should be kept as low as possible and increments made under close supervision.
As doxazosin is highly protein bound, it is not removed by dialysis.
Use in patients with hepatic insufficiency:
The doxazosin dose should be titrated particularly carefully in patients with impaired liver function. No clinical practice
experience is available in patients with serious hepatic dysfunction (see section 4.4).
Doxazosin tablets can be used as monotherapy or in combination with a thiazide diuretic, b
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