Company: Actavis Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Doxazosin (as mesilate) 4mg, 8mg.
Description: White, round, biconvex, prolonged release tablets marked DL or DH respectively.
Presentation: 4mg-28, €GMS to be confirmed; 8mg-28, €6.55.
Indications: Essential hypertension. Symptomatic treatment of benign prostatic hyperplasia (BPH).
Pharmacology: Administration of doxazosin in hypertensive patients causes a clinically significant reduction in blood pressure as a result of a reduction in systemic vascular resistance. This effect is thought to result from selective blockade of the alpha-1-adrenoceptors located in the vasculature. Administration of doxazosin to patients with prostatic hyperplasia results in a significant improvement in urodynamics and symptoms as a result of a selective blockade of alpha-adrenoceptors located in the prostatic muscular stroma, capsule and bladder neck.
Dosage: Adult: Usually 4mg once daily. If necessary, may be increased to maximum 8mg once daily. Swallow whole. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance, to quinazolines (e.g.prazosin, terazosin, doxazosin) or any of the excipients. History of orthostatic hypotension or of gastro-intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract. BPH and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones. Hypotension. As monotherapy in patients with BPH causing overflow bladder, anuria or progressive renal insufficiency. Lactation.
Special precautions: Not appropriate for first-line treatment for essential hypertension, may be used as a monotherapy in patients who have failed to respond to or have contraindications to other agents; alternatively, use should be limited to second or third line treatment in combination with other antihypertensives. Severe hepatic impairment (not recommended). Monitor for postural effects when initiating therapy. Caution: Acute heart conditions (pulmonary oedema due to aortic or mitral stenosis, heart failure at high output, right-sided heart failure due to pulmonary embolism or pericardiac effusion, left ventricular heart failure with low filling pressure), impaired liver function, cataract surgery. Driving/using machines. Pregnancy (only if benefit outweighs risk).
Drug interactions: Caution: Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil). Other alpha-blockers and antihypertensives.
Adverse drug reactions: Respiratory tract infection, urinary tract infection, dizziness, headache, somnolence, vertigo, palpitation, tachycardia, (postural) hypotension, bronchitis, cough, dyspnoea, rhinitis, GI upset, pruritus, back pain, myalgia, cystitis, urinary incontinence, asthenia, chest pain, influenza-like symptoms, peripheral oedema.
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: 1890 333231. Fax: (021) 4619049. E-mail: contact@actavis.ie