CARDURA TABLET 2 MG [SIN05014P]

Product Info

CARDURA TABLET 2 MG

[SIN05014P]

4.1 Therapeutic indications

Hypertension

Doxazosin is indicated for the treatment of hypertension and can be used as the initial agent to control blood pressure in the majority of patients. In patients not adequately controlled on a single antihypertensive agent, doxazosin may be used in combination with another agent, such as a thiazide diuretic, a beta-blocker, a calcium antagonist or an angiotensin-converting enzyme inhibitor.

Benign Prostatic Hyperplasia

Doxazosin is also indicated for the treatment of the urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). Doxazosin may be used in BPH patients who are either hypertensive or normotensive. While the blood pressure changes in normotensive patients with BPH are clinically insignificant, patients with hypertension and BPH have had both conditions effectively treated with doxazosin monotherapy.

4.2 Posology and method of administration

Doxazosin may be administered either in the morning or in the evening.

Hypertension

The full dosage range of doxazosin is 1 mg to 16 mg daily. It is recommended that therapy be initiated at 1 mg once daily for 1 or 2 weeks to minimize the potential for postural hypotension and/or syncope (see section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The dosage may then be increased to 2 mg once daily for an additional 1 or 2 weeks. If necessary, the daily dosage should then be increased gradually at similar intervals to 4 mg, 8 mg, and 16 mg, as determined by patient response, to achieve the desired reduction in blood pressure. The usual dose is 2 mg to 4 mg once daily.

Benign Prostatic Hyperplasia

The recommended initial dosage of doxazosin is 1 mg once daily to minimize the potential for postural hypotension and/or syncope (see section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Depending on the individual patient's urodynamics and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and up to the maximum recommended dose of 8 mg. The recommended titration interval is 1 to 2 weeks. The usual recommended dose is 2 to 4 mg once daily.

Use in Elderly

Normal adult dosage is recommended.

Use in Renally Impaired Patients

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.

Use in Hepatically Impaired Patients

See section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Use in Children

The safety and efficacy of doxazosin in children have not been established.

4.3 Contraindications

Doxazosin is contraindicated in patients with a known hypersensitivity to quinazolines, doxazosin, or any of the inert ingredients.