- Approval Id
- 6deb4a9e48b909e5
- Drug Name
- CARDURA TABLET 2 mg
- Product Name
- CARDURA TABLET 2 mg
- Approval Number
- SIN05014P
- Approval Date
- 1990-08-16
- Registrant
- VIATRIS PRIVATE LIMITED
- Licence Holder
- VIATRIS PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **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.
- Route Of Administration
- ORAL
- Indication Info
- **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.
- Contraindications
- **4.3 Contraindications**
Doxazosin is contraindicated in patients with a known hypersensitivity to quinazolines, doxazosin, or any of the inert ingredients.
- Atc Code
- C02CA04
- Atc Item Name
- doxazosin
- Pharma Manufacturer Name
- VIATRIS PRIVATE LIMITED
- Company Detail Path
- /organization/viatris-private-limited
