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HSA Approval

CARDURA TABLET 2 mg

SIN05014P

CARDURA TABLET 2 mg

CARDURA TABLET 2 mg

August 16, 1990

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Regulatory Information

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

TABLET

**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.

ORAL

Medical Information

**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.

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

C02CA04

doxazosin

Manufacturer Information

VIATRIS PRIVATE LIMITED

Pfizer Manufacturing Deutschland GmbH

Active Ingredients

DOXAZOSIN MESYLATE 2.43MG EQV DOXAZOSIN

2 mg

Doxazosin

Documents

Package Inserts

Cardura 2mg PI.pdf

Approved: June 15, 2021

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