Tamsulosin

Brand Astellas

In stock 739 Items

Available since: 2019-09-19

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Clinical Pharmacology

Omnick has an alpha-adrenolytic effect.

Pharmacodynamics

Blockade α₁-adrenoreceptors tamsulosin leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck and prostatic urethra and improve urine flow. At the same time, both emptying symptoms and filling symptoms due to increased smooth muscle tone and detrusor hyperactivity in benign prostatic hyperplasia decrease.

The ability of tamsulosin to affect α_1A- subtype of adrenoreceptors is 20 times greater than its ability to interact with α_1B-subtype of adrenoreceptors, which are located in the smooth muscles of blood vessels. Due to its high selectivity, tamsulosin does not cause a clinically significant reduction in systemic blood pressure in patients with arterial hypertension, and in patients with normal baseline blood pressure.

Pharmacokinetics

Suction

Tamsulosin is well absorbed in the intestines and has almost 100% bioavailability. Tamsulosin absorption slows down somewhat after eating. The same level of absorption can be achieved if the patient takes the drug each time after a normal breakfast. Tamsulosin is characterized by linear kinetics. After a single dose of 0.4 mg of its drug C_max in plasma is reached after 6 hours. After repeated ingestion of 0.4 mg per day, the equilibrium concentration is reached by the 5th day, while its value is about 2/3 higher than the value of this parameter after taking a single dose.

Distribution

Plasma protein binding is 99%, the volume of distribution is small (about 0.2 l / kg).

Metabolism

Tamsulosin is slowly metabolized in the liver to form less active metabolites. Most tamsulosin is unchanged in blood plasma.

The experiment revealed the ability of tamsulosin to slightly induce the activity of microsomal liver enzymes.

With an insignificant and moderate degree of liver failure, no correction of the dosing regimen is required.

Removal

Tamsulosin and its metabolites are mainly excreted in the urine, while about 9% of the drug is excreted unchanged.

T_1/2 the drug with a single dose of 0.4 mg after a meal is 10 hours, with multiple - 13 hours

In case of renal insufficiency, a dose reduction is not required if the patient has severe renal insufficiency.

Indications

Dysuric disorders in benign prostatic hyperplasia (treatment).

Composition

active substance: tamsulosin hydrochloride 0.4 mg;

Excipients: MCC; methacrylic acid copolymer (type C); polysorbate 80; sodium lauryl sulfate; triacetin; calcium stearate; talc; gelatin; indigotin; titanium dioxide; iron oxide yellow; iron oxide red

Tamsulosin is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Omnic	Astellas	Netherlands	capsules
Tamsulosin	Vertex	Russia	capsules
Tamsulosin-OBL			capsules
Proflosin	Berlin-Chemie/Menarini	Germany	capsules
Tamsulosin	Obolensky OP	Russia	pills
Tamzelin	Velpharm	Russia	capsules
Omsulozin	Ranbaxy Laboratories Ltd	India	capsules
Fokusin	Zentiva KS	Czech	capsules
Sonizin	Gedeon Richter	Hungary	capsules
Omnic Ocas	Astellas	Netherlands	pills

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Dosage and Administration

Inside After breakfast, drinking water, 1 capsule (0.4 mg) 1 time per day. Capsule is not recommended to chew, because this may affect the rate of release of the drug.

Adverse reactions

Seldom- dizziness, retrograde ejaculation; in rare cases - orthostatic hypotension, tachycardia / palpitations, asthenia, headache.

From the digestive tract: rarely - nausea, vomiting, diarrhea, constipation.

In extremely rare cases, hypersensitivity reactions (skin rash, itching, angioedema) may occur.

Carefully - severe renal failure

Drug interactions

When prescribing the drug Omnic^® no interactions were found with atenolol, enalapril or nifedipine. At simultaneous use of Omnic^® with cimetidine, there was a slight increase in the concentration of tamsulosin in the blood plasma, and with furosemide, a decrease in the concentration (this does not require changing the dose of Omnick^®because the concentration of the drug remains within the normal range).

Diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasmain vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone.

In researchin vitro no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, and finasteride was detected.

Diclofenac and warfarin may increase the rate of elimination of tamsulosin.

Simultaneous administration of other α antagonists₁-adrenoretseptorov can lead to lower blood pressure.

Special instructions

As with other α₁-blockers, in the treatment of the drug Omnic^® in some cases, there may be a decrease in blood pressure, which can sometimes lead to fainting. At the first sign of orthostatic hypotension (dizziness, weakness), the patient should sit down or lie down and remain in that position until the signs disappear. During surgery for cataracts during the administration of the drug, the syndrome of intraoperative instability of the iris of the eye (narrow pupil syndrome) may develop, which must be considered by the surgeon for the preoperative preparation of the patient and during the operation.

Before starting therapy with Omnick^®, the patient should be examined in order to exclude the presence of other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before treatment, and regularly during therapy, a digital rectal examination should be performed and, if required, the determination of prostate specific antigen (PSA).

Overdosage

Symptoms: acute hypotension.
Treatment: to prevent further absorption of the drug, it is advisable to wash the stomach, to appoint the reception of Activated charcoal and osmotic laxative, for example, sodium sulfate; Blood pressure and heart rate can recover if the patient is placed in a horizontal position. In the absence of effect, it is possible to use agents that increase the bcc and, if necessary, vasoconstrictor agents. Kidney function should be monitored. It is unlikely that dialysis will be effective, as tamsulosin is intensively bound to plasma proteins.