DOXAZOSIN

Doxazosin may be administered in the morning or the evening. 4). Dosage may then be increased after one or two weeks of therapy to 2mg and thereafter, if necessary to 4mg. The majority of patients who respond to Doxazosin tablets will do so at a dose of 4mg or less.

Dosage can be further increased if necessary to 8mg or the maximum recommended dose of 16mg. 4). The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4mg daily.

Children:

The safety and efficacy of Doxazosin tablets in children and adolescents have not been established Elderly: Normal adult dosage.

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). 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 tablets 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).

4) Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Palpitation, tachycardia Angina pectoris, myocardial infarction Bradycardia, cardiac arrhythmias Vascular disorders Hypotension , postural Hot flushes hypotension Respiratory, thoracic and mediastinal disorders Bronchitis, cough, dyspnea, rhinitis Epistaxis, Bronchospas m Gastrointesti nal disorders Abdominal pain, dyspepsia, dry mouth, nausea Constipation, flatulence, vomiting, gastroenteritis diarrhoea Hepato- biliary disorders Abnormal liver function tests Cholestasis, hepatitis, jaundice, Skin and subcutaneous tissue disorders Pruritus Skin rash, Urticaria, alopecia, purpura Musculoskele tal, connective tissue and bone disorders Back pain, myalgia Arthralgia Muscle cramps, muscle weaknes s Renal and urinary disorders Cystitis, urinary incontinence Dysuria, micturition frequency, hematuria, Polyuria Increased diuresis, micturition disorder, nocturia Reproductive system and breast disorders Impotence Gynecomasti a, priapism Retrograde ejaculation General disorders and administratio n site conditions Asthenia, chest pain, influenza- like symptoms, peripheral oedema Pain, facial oedema Fatigue, malaise Investigations Weight increase Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse.

). 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.

Use in patients with Acute Cardiac Conditions:

As with any other vasodilatory anti-hypertensive agent it is prudent medical practice to advice 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.

2). Since there is no clinical experience in patients with severe hepatic impairment use in these patients is not recommended.

Use with PDE-5 inhibitors:

Concomitant administration of doxazosin with phosphodiestearase-5-inhibitors (eg sildenafil, tadalafil, and vardenafil) should be done with caution as both drugs have vasodilating effects and may lead to symptomatic hypotension in some patients.

To reduce the risk of orthostatic hypotension it is recommended to initiate the treatment with phosphodiesterase-5-inhibitors only if the patient is hemodynamically stabilized on alpha-blocker therapy. 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 (2) Patients with a history of orthostatic hypotension (3) Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones. 6) (5) Patient with hypotension (for benign prostatic hyperplasia indication only).

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