DOXAZOSIN

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

Hypertension:

Doxazosin is used in a once daily regimen: the initial dose is 1mg to minimize the potential for postural hypotension and/or syncope (see section

Hypertension:

In clinical trials involving patients with hypertension, the most common reaction associated with doxazosin therapy were of a postural type (rarely associated with fainting) or non-specific and include: Ear and Labyrinth Disorders: vertigo Gastrointestinal Disorders: nausea General Disorders and Administration Site Conditions: asthenia, oedema, fatigue, malaise Nervous System Disorders: dizziness, headache, postural dizziness, somnolence, syncope Respiratory, Thoraic and Mediastinal Disorders: rhinitis Benign prostatic hyperplasia: Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.

In post marketing experience, the following additional adverse events have been reported: Blood and Lymphatic Disorders: leucopenia, thrombocytopenia Ear and Labyrinth Disorders: tinnitus Eye Disorders: blurred vision Gastrointestinal Disorders: abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, dry mouth, vomiting General Disorders and Administration Site Conditions: pain Hepatobiliary Disorders: cholestasis, hepatitis, jaundice Immune System Disorders: allergic reaction Investigations: abnormal liver function tests, weight increase Metabolism and Nutrition: anorexia Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain, muscle cramps, muscle weakness, myalgia Nervous System Disorders: hypoaesthesia, paraesthesia, tremor Psychiatric Disorders: agitation, anxiety, depression, insomnia, nervousness Renal and Urinary System Disorders: dysuria, haematuria, micturition disorder, micturition frequency, nocturia, polyuria, urinary incontinence Reproductive System and Breast Disorders: gynaecomastia, impotence, priapism, retrograde ejaculation Respiratory, Thoraic and Mediastinal Disorders: aggravated bronchospasm, coughing, dyspnoea, epistaxis Skin and Subcutaneous Tissue Disorders: alopecia, pruritus, purpura, skin rash, urticaria Vascular Disorders: hot flushes, hypotension, postural hypotension The following additional adverse events have been reported in marketing experience among patients treated for hypotension.

). Dosage may be increased after one or two weeks of therapy to 2 mg and thereafter, if necessary, to 4 mg. Dosage can be further increased, if necessary to 8 mg or the maximum recommended dose of 16 mg. 4 Special Warnings and Precautions for Use).

Depending on the individual patients urodynamics and BPH symptomatology dosage may 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 1-2 weeks. The recommended dose is 2-4mg daily.

Children:

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

Elderly:

Normal adult dose.

Patients with renal impairment:

Since there is no change in pharmacokinetics in patients with impaired renal function, the usual adult dose of doxazosin is recommended. Doxazosin is not dialysable. g. cimetidine). 2 Pharmacokinetic properties). g. doxazosin), or any of the inert ingredients.

Use during lactation:

Animal studies have shown that doxazosin accumulates in breast milk. The clinical safety of doxazosin during lactation has not been established, consequently doxazosin is contraindicated in nursing mothers. 2 Posology and method of administration).

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 doxazosin therapy.

g. sildenafil, tadalafil, vardenafil) and doxazosin may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phosphodiesterase-5-inhibitors.

g. doxazosin), or any of the inert ingredients.

Use during lactation:

Animal studies have shown that doxazosin accumulates in breast milk. The clinical safety of doxazosin during lactation has not been established, consequently doxazosin is contraindicated in nursing mothers.