Index of drugs

Treatment of functional symptoms of moderate to severe benign prostatic hyperplasia. Supportive treatment of acute urinary retention associated with benign prostatic hyperplasia combined with catheter placement.

1 tabl sustained release contains 10 mg of alfuzosin hydrochloride and lactose.

A selective antagonist of α receptors₁-adrenergic located in the triangle of the bladder, the urethra and the prostate gland. It has a relaxant effect on the smooth muscles of the lower urinary tract, reducing the urinary flow resistance during micturition. Facilitates emptying of the bladder. The preparation increases the maximum flow of urine, reduces the detrusor's tension and increases the volume of urine, which causes the need to urinate and reduces the volume of residual urine. The drug may have moderate hypotensive effects. The mean maximum plasma concentration is obtained after about 6.69 h after a single dose after a meal. Alfuzosin binds 90% of plasma proteins. It is the main metabolized in the liver (several pathways), and metabolites are excreted via the kidney and probably also via bile. After administration, 75-91% of the oral dose is excreted in the faeces, 35% in unchanged form, and the rest in the form of metabolites, which indicates a certain degree of biliary excretion. Approx. 10% excreted unchanged in the urine. None of the metabolites are pharmacologically active. T_0,5 is approximately 8 hours. In patients with impaired renal function the volume of distribution and clearance are increased, T_0,5 remains unchanged. In patients with severe hepatic impairment T_0,5 it is prolonged, increased bioavailability, and a two-fold increase in C is also observed_max. In elderly patients, after administration of alfuzosin in the form of tablets. prolonged release C_max, bioavailability and T_0,5 they remain unchanged.

Hypersensitivity to the active substance, other quinazolines (eg terazosin, doxazosin) or to any of the excipients. Orthostatic hypotension. Liver failure. Concomitant use of other type α adrenergic receptor antagonists₁.

The preparation should not be administered to patients with severe renal impairment (creatinine clearance <30 ml / min) - no studies. The drug should be used with caution in patients receiving antihypertensive drugs or nitrates - the blood pressure should be monitored regularly, especially at the beginning of treatment. Some patients may develop orthostatic hypotension with or without symptoms after a few hours after dosing - patients should be warned about the possibility of these symptoms and recommend a lying position until they disappear completely. After the introduction of alfuzosin, there has been a significant reduction in blood pressure in patients with risk factors (ie heart disease and / or concomitant administration of an antihypertensive agent). Caution should be used when administering alfuzosin in patients who have experienced significant hypotension in response to other alpha-blocking agents₁-Adrenergic. Treatment of patients with hypersensitivity to other α-blocking drugs₁-adrenergic should be started gradually. Afuzosin should be used with caution in patients with acute heart failure. In patients with heart disease, coronary insufficiency should be continued, given that the concomitant administration of nitrates and alfuzosin may increase the risk of hypotension. In case of recurrence or worsening of angina, treatment with alfuzosin should be discontinued. Patients should be examined prior to initiating therapy with alfuzosin to rule out the presence of other diseases that may cause similar symptoms to benign prostatic hyperplasia. Due to the risk of intraoperative flaccid iris syndrome (IFIS) during surgical treatment of cataracts, the ophthalmologist should be informed about the past or current treatment with α prior to surgery_1-adrenolytic, because IFIS can lead to worsening of complications associated with the surgery.Patients with congenital QTc prolongation with a history of QTc prolongation and those taking QTc prolongation medication should be monitored prior to and during the administration of alfuzosin. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

Not applicable - preparation for men.

Most often: dizziness, occurring in about 5% of patients. Common: fainting, pain and dizziness, nausea, abdominal pain, indigestion, weakness. Uncommon: diarrhoeas, drowsiness, visual disturbances, tachycardia, palpitations, chest pain, orthostatic hypotension and syncope (especially at the beginning of treatment, when taking too much, or if resumption of treatment after a short break), nasal mucous membrane, vomiting, diarrhea, dry mouth, rash, pruritus, rash, urticaria, incontinence, edema, generalized malaise, hot flushes. Very rare: angioneurotic edema, angina pectoris in patients with coronary artery disease, hepatotoxicity. Not known: neutropenia, intraoperative flaccid syndrome, atrial fibrillation, liver cell damage, hepatic cholestasis, priapism.

Orally. Adults: 10 mg once a day. In patients with acute urinary retention from the day the catheter was inserted. Efficacy in the long-term treatment of acute urinary retention has not been established.Special groups of patients. In elderly patients (over 65 years) and in patients with mild or moderate renal impairment (creatinine clearance ≥30 ml / min), no dose reduction is necessary. Patients with mild to moderate hepatic impairment may be treated with low alphuzosin hydrochloride (according to the appropriate dosing recommendations for this group). The effectiveness of alfuzosin in children aged 2-16 has not been demonstrated, therefore its use in children and adolescents is not recommended.Way of giving. The first dose of the drug should be taken at bedtime, the Next dose should be taken daily immediately after the same meal. Table. should be swallowed whole with liquid. Avoid any other way of taking the medicine, such as crushing, chewing or chewing the tablet, because it can lead to unwanted release and absorption of the active substance, and consequently to the risk of early side effects.