Омник®

General characteristics. Structure:

Active veshchestvo:tamsulozina hydrochloride of 0,4 mg, cellulose microcrystallic, copolymer of methacrylic acid, polysorbate 80, sodium lauryl sulfate, triacetin, calcium stearate, talc, gelatin firm, E132 indigotin, titanium dioxide (E171), ferrous oxide yellow (E172) and ferrous oxide red (E172).
Description: the solid gelatin capsules having orange color the case with marking 701 and the graphic representation. comrade of a sign and olive-green color a lid with marking 0,4. Capsules contain granules from color, white to white with a light yellow shade.

Pharmacological properties:

Pharmacodynamics. Tamsulozin is a specific blocker postsynaptic * 1 adrenoceptors which are in smooth muscles of a prostate, a neck of a bladder and a prostatic part of an urethra. Blockade * 1 adrenoceptors tamsuloziny leads to decrease in a tone of smooth muscles of a prostate, neck of a bladder and a prostatic part of an urethra and improvement of outflow of urine. At the same time both emptying symptoms, and the filling symptoms caused by the raised tone of smooth muscles and a detruzorny hyperactivity at a benign hyperplasia of a prostate decrease.
Ability of a tamsulozin to influence on * 1A a subtype of adrenoceptors by 20 times surpasses its ability to interact with * 1B a subtype of adrenoceptors which are located in unstriated muscles of vessels. Thanks to the high selectivity, тамсулозин does not cause clinically significant decrease in the system arterial pressure (AP) both in patients with arterial hypertension, and in patients with the normal initial ABP.

Pharmacokinetics. Absorption: Tamsulozin is well soaked up in intestines and nearly 100% have bioavailability. Absorption of a tamsulozin is a little slowed down after meal. Identical level of absorption can be reached if the patient every time accepts drug after a usual breakfast. Tamsulozin is characterized by linear kinetics. After a single dose in 0.4 mg of drug its maximum concentration in plasma is reached in 6 hours. After multiple dose in 0.4 mg a day equilibrium concentration is reached by 5th day, at the same time its value is approximately 2/3 higher than value of this parameter after reception of a single dose.
Distribution: Communication with proteins of plasma - 99%, the volume of distribution small (about 0.2 l/kg).
Metabolism: Tamsulozin is slowly metabolized in a liver with formation of less active metabolites. The most part of a tamsulozin is presented in a blood plasma in not changed form.
In an experiment ability of a tamsulozin to slightly induce activity of microsomal enzymes of a liver is revealed.
At insignificant and moderate degree of a liver failure correction of the mode of dosing is not required.
Removal: Tamsulozin and his metabolites are mainly removed with urine, at the same time about about 9% of drug are allocated in not changed look.
The drug elimination half-life at a single dose of 0.4 mg after food makes 10 hours, at repeated - 13 hours.
At a renal failure the dose decline, in the presence is not required from the patient of a heavy renal failure (clearance of creatinine less than 10 ml/min.) purpose of a tamsulozin needs to be carried out with care.

Indications to use:

Treatment of dysuric frustration at a benign hyperplasia of a prostate.

Route of administration and doses:

Inside, after a breakfast, washing down with water, accept on 1 capsule (0.4 mg) of 1 times a day. The capsule is not recommended to be chewed as it can influence drug release speed.

Features of use:

As well as when using others * 1 adrenoblockers, at treatment by the drug Omnik® decrease in the ABP which can sometimes lead to an unconscious state in some cases can be observed. At the first symptoms of orthostatic hypotension (dizziness, weakness) the patient has to sit down or lay down and remain in this situation until signs do not disappear.
Before beginning therapy with the drug Omnik®, the patient has to be inspected to exclude existence of other diseases which can cause the same symptoms, as well as a benign hyperplasia of a prostate. Before an initiation of treatment and regularly during therapy manual rectal inspection and if it is required, definition of the prostatic specific antigen (PSA) has to be carried out.
Pregnancy and lactation. There are no data.

Side effects:

Seldom - dizziness, a retrograde ejaculation; in isolated cases - orthostatic hypotension, tachycardia/heartbeat, an adynamy, a headache.
From digestive tract in rare instances - nausea, vomiting, diarrhea, a lock.
In extremely exceptional cases hypersensitivity reactions - skin rash, an itch, a Quincke's disease can be observed.

Interaction with other medicines:

At purpose of the drug Omnik® together with atenololy, enalapril or nifedipine of interactions it was revealed not. At simultaneous use of Omnik with Cimetidinum some increase in concentration of a tamsulozin in a blood plasma, and with furosemide - decrease in concentration is noted, however it does not demand change of a dose of Omnik as concentration of drug remains within normal range. Diazepam, propranolol, трихлорметиазид, хлормадинон, amitriptyline, diclofenac, glibenclamide, симвастатин and warfarin do not change free fraction of a tamsulozin in plasma of the person of in vitro. In turn, тамсулозин also does not change free fractions of diazepam, propranolol, a trikhlormetiazid and hlormadinon.
In the researches in vitro interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteridy was not revealed. Diclofenac and warfarin can increase the speed of removal of a tamsulozin.
Co-administration of other antagonists * 1 adrenoceptors can lead to decrease in the ABP.

Contraindications:

Hypersensitivity to a tamsulozin or any other component of drug.
Orthostatic hypotension (including in the anamnesis).
The expressed liver failure.

With care - a heavy renal failure (clearance of creatinine less than 10 ml/min.).

Overdose:

There are no messages on cases of acute overdose tamsuloziny. However, theoretically at overdose development of acute decrease in the ABP and compensatory tachycardia in case of which performing symptomatic therapy is necessary is possible. Arterial pressure and heart rate can be redeemed at acceptance by the person of horizontal situation. In the absence of effect it is possible to apply the means increasing the volume of the circulating blood and if it is necessary, vasoconstrictors. It is necessary to control function of kidneys. It is improbable that dialysis will be effective as it тамсулозин is strongly connected with proteins of plasma.
For prevention of further absorption of drug the gastric lavage, reception of absorbent carbon or osmotic laxative, for example sulfate sodium is reasonable.

Storage conditions:

At a temperature not above 25 °C. Period of validity. 4 years.

Issue conditions:

According to the recipe

Packaging:

Blisters on 10 capsules, on 1 or 3 blisters in a cardboard pack.