DOXAZOSIN

Posology Doxazosin may be administered in the morning or evening.

Adults and the elderly:

Hypertension: Doxazosin Tablets should be taken once a day. 4). This may be increased after 1-2 weeks to 2mg daily, and thereafter to 4mg daily, if necessary. The majority of patients who respond to doxazosin will do so at a dose of 4mg or less.

Dosage can be further increased if necessary to 8mg or to a maximum daily dose of 16mg. 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 doxazosin mesilate (Doxazosin Tablets) in children and adolescents have not been established.

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 dialyzable. g. cimetidine). 2).

Method of administration:

Oral administration.

Hypertension:

In clinical trials involving patients with hypertension, the most common reactions associated with doxazosin therapy were of a postural type (rarely associated with fainting) or non-specific.

Benign prostatic hyperplasia:

Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension. The following undesirable effects have been observed and reported during treatment with Doxazosin with the following frequencies.

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 4) Common VertigoEar and labyrinth disorders Uncommon Tinnitus Common Palpitations, tachycardia Uncommon Angina pectoris, myocardial infarction Cardiac disorders Very rare Bradycardia, cardiac arrythmias Common Hypotension, postural hypotensionVascular disorders Very rare Hot flushes Common Bronchitis, cough, dyspnoea, rhinitis Uncommon Epistaxis Respiratory, thoracic and mediastinal disorders Very rare Bronchospasm Common Abdominal pain, dyspepsia, dry mouth, nausea Gastrointestinal disorders Uncommon Constipation, flatulence, vomiting, gastroenteritis, diarrhoea Uncommon Abnormal liver function testsHepatobiliary disorders Very rare Cholestasis, hepatitis, jaundice Common Pruritus Uncommon Skin rash Skin and subcutaneous tissue disorders Very rare Urticaria, alopecia, purpura Common Back pain, myalgia Uncommon Arthralgia Musculoskeletal and connective tissue disorders Rare Muscle cramps, muscle weakness Common Cystitis, urinary incontinence Uncommon Dysuria, micturition frequency, haematuria Rare Polyuria Renal and urinary disorders Very rare Increased diuresis, micturition disorder, nocturia Uncommon Impotence Very rare Gynecomastia, priapism Reproductive system and breast disorders Not known Retrograde ejaculation Common Asthenia, chest pain, influenza-like symptoms, peripheral oedema Uncommon Pain, facial oedema General disorders and administration site conditions Very rare Fatigue, malaise Investigations Uncommon Weight increase Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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 doxazosin therapy. Patients on a low sodium diet or treated with diuretics seem more sensitive for the potential for postural effects.

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 • heart failure at high output • right-sided heart failure due to pulmonary embolism or pericardial effusion • left ventricular heart failure with low filling pressure.

In patients with severe ischemic heart suffering, a too fast or marked decrease in blood pressure can result in a worsening of anginal complaints. 2). Since there is no clinical experiences in patients with severe hepatic impairment, use in these patients is not recommended.

g. sildenafil, tadalafil and 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 (doxazosin) before initiating use of phosphodiesterase-5-inhibitors.

Furthermore, it is recommended to initiate phosphodiesterase-5-inhibitor treatment with the lowest possible dose and to respect a 6-hour time interval from intake of doxazosin. No studies have been conducted with doxazosin prolonged release formulations.

g. 1. • Patients with a history of orthostatic hypotension. • Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones. 6). • Patients with hypotension (for the benign prostatic hyperplasia indication only).

Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.