DOXAZOSIN

Posology Doxazosin may be administered in the morning or evening. 4). Dosage may then be increased to 2 mg (5 ml) after an additional one or two weeks of therapy and thereafter, if necessary to 4 mg (10 ml). The majority of patients who respond to Doxazosin will do so at a dose of 4mg (10 ml) or less.

Dosage can be further increased if necessary to 8 mg (20 ml) or the maximum recommended dose of 16 mg (40 ml). 4). Depending on the individual patient’s urodynamics and BPH symptomatology, dosage may then be increased to 2 mg (5 ml) and thereafter to 4 mg (10 ml) and up to the maximum recommended dose of 8 mg (20 ml).

The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4 mg (5-10 ml) once daily.

Paediatric population:

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

Elderly patients:

Normal adult dosage.

Hepatic/Renal impairment 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. Shake the suspension at least 30 seconds prior to prepare the dose.

Doses of 10 ml or below should be administered using the 10ml syringe. For doses greater than 10ml, the 20 ml syringe should be used. Wash the syringe with water.

Hypotension:

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).

4) Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Palpitation, tachycardia Angina pectoris, myocardial infarction Bradycar dia, cardiac arrhythm ias Vascular disorders Hypotensio n, postural hypotension Hot flushes Respiratory, thoracic and mediastinal disorders Bronchitis, cough, dyspnoea, rhinitis Epistaxis Broncho spasm Gastrointesti nal disorders Abdominal pain, dyspepsia, dry mouth, nausea Constipation, flatulence, vomiting, gastroenteritis, diarrhoea Hepato- biliary disorders Abnormal liver function tests Cholesta sis, hepatitis, jaundice Skin and subcutaneou s tissue disorders Pruritus Skin rash Urticaria, alopecia, purpura Musculoskel etal, connective tissue and bone disorders Back pain, myalgia Arthralgia Muscle cramps, muscle weakness Renal and Urinary disorders Cystitis, Urinary incontin- ence Dysuria, micturition frequency, haematuria Polyuria Increase d diuresis, Micturiti on disorder, nocturia Reproductiv e system and breast disorders Impotence Gyneco mastia, priapism Retrogra de ejaculati on General disorders and administrati on site conditions Asthenia, chest pain, influenza- like symptoms, peripheral oedema Pain, facial oedema Fatigue, malaise Investigation s Weight increase Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple.

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.

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.

2). g. 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.

Use in patients undergoing cataract surgery:

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded.

As IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

Priapism:

Prolonged erections and priapism have been reported with alpha-1 blockers including doxazosin in post marketing experience. If priapism is not treated immediately, it could result in penile tissue damage and permanent loss of potency, therefore the patient should seek immediate medical assistance.

Screening for Prostate Cancer:

Carcinoma of the prostate causes many of the symptoms associated with BPH and the two disorders can co
exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with doxazosin for treatment of BPH symptoms.

Excipient warning:

Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per 5 ml, that is to say essentially 'sodium free'. Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216): may cause allergic reactions (possibly delayed).

011 mg/ml.

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 4) Patients with hypotension (for benign prostatic hyperplasia indication only) Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.