. Name of the medicinal product
CARDURA 1mg Tablets
2. Qualitative and quantitative composition
1.213mg equivalent to 1mg doxazosin
Excipients of known effect:
Each tablet contains 40 mg of lactose monohydrate.
Each tablet contains 0.06 mg sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
1mg white round, biconvex tablets marked CN1 on one side and 'PFIZER' on the other.
4. Clinical particulars
4.1 Therapeutic indications
Hypertension: Cardura is indicated for the treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. In patients inadequately controlled on single antihypertensive therapy, Cardura may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor.
Benign prostatic hyperplasia: Cardura is indicated for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). Cardura may be used in BPH patients who are either hypertensive or normotensive.
4.2 Posology and method of administration
Cardura may be administered in the morning or the evening.
Hypertension: Cardura 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 Cardura 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.
Benign prostatic hyperplasia: The recommended initial dosage of Cardura 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.
Paediatric population: The safety and efficacy of Cardura in children and adolescents have not been established.
Elderly patients: Normal adult dosage.
Patients with renal impairment: Since there is no change in pharmacokinetics in patients with impaired renal function, the usual adult dose of Cardura is recommended.
Cardura is not dialysable.
Patients with hepatic impairment: 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, Cardura should be administered with caution to patients with evidence of impaired liver function (see section 4.4 and section 5.2).
Method of administration
Doxazosin is contraindicated in:
1) Hypersensitivity to the active substance or other types of quinazolines (e.g. prazosin, terazosin, doxazosin), or to any of the excipients listed in section 6.1.
2) Patients with a history of orthostatic hypotension
3) Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones.
4) Patients with hypotension (for benign prostatic hyperplasia indication only)
Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.
4.4 Special warnings and precautions for use
Initiation of Therapy - In relation with the alpha-blocking properties of doxazosin, patients may experience postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness (syncope), particularly with the commencement of therapy (see section 4.2). Therefore, it is prudent medical practice to monitor blood pressure on initiation of therapy to minimise the potential for postural effects.
When instituting therapy with any effective alpha-blocker, the patient should be advised how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. The patient should be cautioned to avoid situations where injury could result, should dizziness or weakness occur during the initiation of Cardura therapy.
Use in patients with Acute Cardiac Conditions:
As with any other vasodilatory anti-hypertensive agent it is prudent medical practice to advise caution when administering doxazosin to patients with the following acute cardiac conditions:
- pulmonary oedema due to aortic or mitral stenosis
- high-output cardiac failure
- right-sided heart failure due to pulmonary embolism or pericardial effusion
- left ventricular heart failure with low filling pressure.
Use in Hepatically Impaired patients:
As with any drug wholly metabolised by the liver, Cardura should be administered with particular caution to patients with evidence of impaired hepatic function (see section 4.2). Since there is no clinical experience in patients with severe hepatic impairment use in these patients is not recommended.
Use with PDE-5 Inhibitors: