Index of drugs

Symptoms of the lower urinary tract associated with benign prostatic hyperplasia.

1 capsules with modified release or 1 tabl. powl. sustained release contains 0.4 mg Tamsulosin hydrochloride.

Selective and competitive antagonist of α-type adrenergic α-adrenergic receptors₁, especially the α subtypes_1A and α_1D. Tamsulosin relaxes the smooth muscles of the prostate and urethra. Increases the maximum urinary flow rate. It reduces the narrowing of the urinary outflow path due to the relaxation of the smooth muscle of the prostate and urethra, reducing the symptoms of emptying. It also reduces the symptoms from filling. The reduction of symptoms from filling and emptying is maintained during long-term treatment. After oral administration of tamsulosin capsules, the bioavailability is almost 100% (absorption is reduced by administering the drug after a meal). Administration of tamsulosin in the form of a sustained release tablet, which is an oral controlled release system (OCAS), provides an even, slow release of tamsulosin for 24 h, absorption is 57%. Low-fat food has no effect on the rate of absorption and the amount of tamsulosin absorbed, after its adoption in the form of a tabl. powl. prolonged release. Absorption is increased by 64% and 149% (for AUC and Cmax, respectively) after eating a fatty meal compared to fasting. After a single dose, the maximum plasma concentration occurs after about 6 hours. Tamsulosin is approximately 99% bound to plasma proteins. Tamsulosin is metabolised in the liver and excreted mainly in the urine. After administration of the preparation in the form of a capsule about modifying about 9% of the administered dose is eliminated unchanged, T_0,5 is about 10 hours (after a meal), at steady state, about 13 hours. After administration of the preparation in the form of powl. about CAREFULLY. 4-6% of the administered dose is excreted unchanged, T_0,5 is 19 h, at steady state, about 15 hours.

Hypersensitivity to tamsulosin hydrochloride or other ingredients of the preparation. Angioneurotic edema related to previous tamsulosin use. Orthostatic hypotension. Severe hepatic failure.

Before starting treatment with Tamsulosin, the patient should be examined to exclude other conditions that may cause symptoms similar to those of BPH. It is advisable to carry out the testper rectum and if necessary, determination of prostate specific antigen (PSA) before treatment and systematically during its course. Due to the lack of clinical trials, caution should be used in patients with severe renal impairment (creatinine clearance <10 ml / min). It is not recommended to start treatment with tamsulosin in patients who are scheduled to undergo cataract surgery (risk of intraoperative flaccid iris syndrome - IFIS - during cataract surgery). Discontinuation of the drug 1-2 weeks before cataract surgery seems to be helpful, but the benefits and required withdrawal period of tamsulosin have not been established. During pre-operative assessment, it should be determined whether the patient is or has been treated with tamsulosin to provide adequate precautions in the event of IFIS occurring during surgery. In the case of angioedema, the drug should be stopped immediately and the patient should be monitored until the edema subsides; do not re-administer tamsulosin. Due to the risk of hypotension, which may cause fainting, after finding the initial symptoms of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms disappear. The safety and efficacy of tamsulosin in children and adolescents has not been established - there is no indication for use in this group of patients. Patients with a CYP2D6-slow metabolic phenotype may experience interactions when using tamsulosin with strong CYP3A4 inhibitors - use is not recommended.

Not applicable - preparation intended for use in men.

Common: dizziness, ejaculation problems, ejaculation, no ejaculation. Uncommon: headache, palpitations, orthostatic hypotension, rhinitis, constipation, diarrhea, nausea, vomiting, rash, pruritus, urticaria, asthenia. Rare: fainting, angioneurotic edema. Very rare: Stevens-Johnson syndrome, priapism. Not known: blurred vision, blurred vision, epistaxis, erythema multiforme, exfoliative dermatitis, dry mouth. In addition, after the introduction of the preparation, a small pupil syndrome (intraoperative flaccid syndrome) was observed during cataract surgery, atrial fibrillation, arrhythmia, tachycardia, dyspnea.

Orally.Kaps. about modifications. release. Adults: 1 capsule per day, after breakfast or after the first meal. The capsule should be swallowed whole with a glass of water, taken in a sitting or standing position. The capsules should not be broken or torn apart.Table. about release. Adults: 1 tabl. daily, regardless of the meal. The tablet should be swallowed whole, it should not be chewed or chewed.