Active material: Tamsulozin
When ATH: G04CA02
CCF: Preparation, used in violation of urination, associated with benign prostatic hyperplasia. Alpha1-adrenoblokator
Codes ICD-10 (testimony): N40
When CSF: 28.01.02.01
Manufacturer: KRKA d.d. (Slovenia)
Capsules of the prolonged action hard gelatin, size №2, с корпусом оранжевого цвета и оливково-зеленой крышечкой с надписью “TSL 0.4”, body and lid on top marked stripe black; содержимое капсул – пеллеты белого или почти белого цвета.
| 1 caps. | |
| tamsulosin hydrochloride | 400 g |
Excipients: microcrystalline cellulose, Copolymer of methacrylic and ètakrilovoj acid (1:1) (variance 30% (c) emulsifiers: polysorbate-80, sodium lauryl), triэtiltsitrat, talc, Purified water.
The composition of the shell capsules: iron oxide red dye (E172), Titanium dioxide (E171), dye iron oxide yellow (E172), gelatin.
The composition of the capsule caps: Indigo Carmine FDS&C Blue 2 (E132), , dye iron oxide black (E172), Titanium dioxide (E171), dye iron oxide yellow (E172), gelatin.
Ink composition: шеллак глазурь – 47.5% (22% jeterificirovanno), dye iron oxide black (E172), propylene glycol.
10 PC. – блистеры (1) – пачки картонные.
10 PC. – блистеры (2) – пачки картонные.
10 PC. – блистеры (3) – пачки картонные.
10 PC. – блистеры (6) – пачки картонные.
10 PC. – блистеры (9) – пачки картонные.
10 PC. – блистеры (20) – пачки картонные.
Preparation, used in violation of urination, associated with benign prostatic hyperplasia. Alpha1-adrenoblokator.
Tamsulosin selectively and competitively blocks postsynaptic α1A
-adrenoreceptory, located in the smooth muscle of the prostate, bladder neck and prostatic urethra. This reduces the tone of smooth muscles of the prostate, bladder neck and prostatic urethra and improve the function of the detrusor. This reduces the symptoms of obstruction and irritation, associated with benign prostatic hyperplasia (DGPŽ). Usually, the therapeutic effect develops after 2 weeks after the start of dosing, although in some patients the decrease in symptoms is observed after the first dose. The ability to influence the α tamsulosin1A-adrenergic receptors in the 20 times greater than its ability to interact with the α1B-adrenoreceptor, which are located in vascular smooth muscle. With such a high selectivity drug does not cause any clinically significant reduction in systemic blood pressure in patients with hypertension, and in patients with normal baseline BP.
Absorption
After oral tamsulosin rapidly and almost completely absorbed from the gastrointestinal tract. This dosage form provides prolonged and slow release of tamsulosin. Биодоступность препарата – около 100%.
Immediately after ingestion decreases the absorption of tamsulosin. Uniformity of absorption increases, if a patient takes medication every day after the same meal.
After receiving a single oral dose of the drug 400 g (After a hearty meal) FROMmax tamsulosin in plasma achieved through 6 no. In the equilibrium state (through 5 day course taking) values withmax tamsulosin in blood plasma 60-70% higher, than withmax after a single dose of the drug.
Distribution
Plasma protein binding - 90%. Tamsulosin has a slight Vd (about 0.2 l / kg).
Metabolism
Тамсулозин практически не подвергается эффекту “первого прохождения” и медленно биотрансформируется в печени с образованием фармакологически активных метаболитов, maintain a high selectivity for the α1A-adrenoceptor. None of the metabolites is more active, чем исходное вещество – тамсулозин. Most of the active substance present in the blood in an unmodified form. When liver failure dose not required.
Deduction
Tamsulosin and its metabolites are primarily excreted by the kidneys, with approximately 9% the dose is excreted unchanged in.
T1/2 тамсулозина при однократном приеме – 10 no (When administered after meals), после многократного приема – 13 no, final T1/2 – 22 no.
- Benign prostatic hyperplasia (treatment of dysuric disorders).
Inside, After the first meal, drinking plenty of water. Drug taking in sitting or standing. The capsule should not crush and chew.
Assign 400 g (1 capsule)/d.
Part of the central and peripheral nervous system: often - dizziness; нечасто – головная боль; редко – обморок, asthenia, sleep disturbance (drowsiness or insomnia).
With the genitourinary system: нечасто – ретроградная эякуляция; очень редко – приапизм, decreased libido.
From the digestive system: нечасто – тошнота, vomiting, constipation or diarrhea.
Cardio-vascular system: нечасто – тахикардия, palpitation, orthostatic hypotension; очень редко – боль в грудной клетке.
Allergic reactions: нечасто – кожная сыпь, hives; очень редко – кожный зуд, angioedema.
Other: нечасто – ринит; редко – боль в спине.
-orthostatic hypotension in history;
- Severe hepatic impairment;
-hypersensitivity to tamsulozinu or to other components of the drug.
FROM caution should designate product in severe renal failure (CC less than 10 ml / min), tk. safety has not been proven.
Tamsulosin is intended only for men.
Tamsulosin should be used with caution in patients with a predisposition to orthostatic hypotension. At the first signs of orthostatic hypotension (dizziness or weakness), пациента следует посадить или перевести в положение “лежа” до исчезновения симптомов.
Before beginning drug therapy, the patient must be examined in order, to exclude the presence of other diseases, that can cause the same symptoms, as BPH. Before treatment and regularly during therapy should be performed digital rectal examination and, if necessary, determination of prostate specific antigen.
In patients with renal insufficiency (CC less than 10 ml / min) the drug should be used with caution (safety has not been proven).
Effects on ability to drive vehicles and management mechanisms
During the period of treatment must be careful when driving and occupation of other potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Cases of acute overdose have not been described.
Symptoms: marked reduction in blood pressure, sometimes accompanied by fainting, compensatory tachycardia.
Treatment: symptomatic therapy. The patient should immediately translate into horizontal position. If there is no effect, you should enter obemozameshhajushhie solutions or sossoudossoujiwate drugs. It was necessary to monitor kidney function. Dialysis nyeeffyektivyen (связывание с белками – 90%). To prevent further absorption of the drug it is advisable to gastric lavage, reception activated carbon and osmotic laxatives (sodium sulfate).
There were no interactions with the concomitant use of tamsulosin and atenolol, Enalapril, nifedipine or theophylline.
Simultaneous application of cimetidine increases the level of tamsulosin in plasma. Furosemide reduces the level of tamsulosin in plasma. In both cases, however, these levels remain within therapeutically active concentrations and dose should not be changed.
Diclofenac and indirect combined (warfarin) slightly increase the speed out tamsulosin.
In in vitro studies have not been found at the level of interaction with the hepatic metabolism of amitriptyline, salbutamol, glibenclamide and finasteride.
Concomitant use of tamsulosin with other α1-blockers and other drugs, lower blood pressure, It can lead to a marked increased hypotensive effect.
The concentration of tamsulosin in plasma did not change in the presence of diazepam, trihlormetiazida or simvastatin. Also tamsulosin did not change the concentration of diazepam, propranolol, trichlormethiazide and chlormadinone.
The drug is released under the prescription.
The drug should be stored out of reach of children at or above 25 ° C. Shelf life - 2.5 year.
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