Alfuzosin Hydrochloride

Registered South African indications:

• Benign prostatic hyperplasia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hepatic impairment
• History of orthostatic hypotension
• Coadministration with alpha-1 adrenoceptor blocking agents

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Elderly
• Cardiovascular disease
• Congenital or acquired QTc prolongation
• Cataract surgery
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• Coadministration with potent CYP3A4 inhibitors

Forms avail. in SA and covered in this monograph: tab

Functional symptoms of benign prostatic hyperplasia

• Oral (tab): 10mg, dly after meals

Do not cut/crush/chew/dissolve

Not established for use in children

Pregnancy

• Not indicated for use in pregnant women
• No adverse events observed in animal studies

Breastfeeding

• Not indicated for use in breastfeeding women
• Alfuzosin excretion in breast milk is unknown

Renal Impairment

• CrCl ≥30 ml/min: No dose adjustment recommended
• CrCl <30 ml/min: Caution; no dose adjustment recommended

Hepatic Impairment

• Contraindicated

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Vertigo
• Drowsiness
• Asthenia
• Malaise

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Chest pains
• Angina pectoris in patient with pre-coronary artery disorders 
• Atrial fibrillation
• Postural hypotension
• Syncope
• Oedema
• Hot flushes

Respiratory Disorders

• Rhinitis

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Dyspepsia
• Diarrhoea
• Dry mouth

Hepatobiliary Disorders

• Hepatotoxicity
• Hepatocellular injury
• Cholestatic liver disease

Genitourinary Disorders

• Urine incontinence
• Priapism

Skin and Subcutaneous Tissue Disorders

• Skin rashes
• Pruritus
• Exanthema
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Neutropenia
• Thrombocytopenia
• Angioneurotic oedema

Sensory Disorders

• Abnormal vision
• Intraoperative floppy iris syndrome

• CYP3A4 inhibitors 
• Alpha blockers
• Antihypertensive agents
• Nitrates
• General anaesthetics

• Blood pressure
• Prostate-specific antigen

Alfuzosin is a selective a lpha-1 adrenoceptor antagonist. It acts in the trigone of the urine bladder, the urethra and the prostate gland. This leads to relaxation of the smooth muscles, resulting in improved urine flow.  

Tablet 10mg

• Alfuwin XL (Zentiva) originator
• Rantral MR (Ranbaxy)
• Xatral  XL (Sanofi Aventis)