Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: KRKA, d.d., Novo mesto, ล marjeลกka cesta 6, 8501 Novo mesto, Slovenia
Kamiren 4 mg prolonged-release tablets are indicated for the treatment of hypertension and can be used as a sole agent to control blood pressure in hypertensive patients.
In patients inadequately controlled on single antihypertensive therapy, Kamiren prolonged-release tablets may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor.
The initial dose of Kamiren prolonged-release tablets is 4 mg once daily. A significant number of patients will be controlled on this dose. If necessary, the dosage may be increased to 8 mg once daily according to patient response. The maximum recommended dose is 8 mg once daily.
In common with other drugs of this class, the dosage should be kept as low as possible and increments made under close supervision.
Since the pharmacokinetics of doxazosin are unchanged in patients with renal insufficiency, and there is no evidence that doxazosin aggravates existing renal dysfunction, the usual dosages may be used in these patients. Kamiren prolonged-release tablets are not dialysable.
There are only limited data in patients with liver impairment and on the effects of drugs known to influence hepatic metabolism (e.g. cimetidine). As with any drug metabolised wholly by the liver, Kamiren prolonged-release tablets should be used with care in patients with significant existing hepatic dysfunction. (see section 4.4 and section 5.2).
The safety and efficacy of Kamiren in children and adolescents have not been established.
Kamiren prolonged-release tablets can be taken with or without food. The tablets should be swallowed whole with a sufficient amount of liquid. They should not be cut, crushed or chewed (see section 4.4).
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. Since doxazosin is highly protein bound, dialysis is not indicated.
5 years.
This medicinal product does not require any special storage conditions.
Kamiren 4 mg prolonged-release tablets are available as pack of 28 tablets.
OPA/Alu/PVC film with Alu foil blister strips in a carton box.
No special requirements for disposal.
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