Sonizin capsules 400mg №30

Dosage form

Capsules

Composition

1 modified release capsule contains: Tamsulosin hydrochloride 400 μg

Excipients: Calcium stearate, triethyl citrate, talc, copolymer of methacrylic acid and ethyl acrylate (1: 1) (also containing polysorbate 80, sodium lauryl sulfate), microcrystalline cellulose

The composition of the body and the capsule caps: Iron oxide yellow (CI 77492 E172), ferric oxide black (CI 77499 E172), ferric oxide red (CI 77491 E172), titanium dioxide (CI 77891 E171), gelatin.

Packaging

In the blister 10 capsules. In packing 3 blisters.

Mechanism of action

Sonysin retard - Alpha 1 adrenergic blocker. Does Tamsulosin selectively and competitively block postsynaptic? 1A - adrenoreceptors that are in the smooth muscles of the prostate gland, bladder neck and prostatic urethra, as well as? 1D -adrenoretseptory, mainly located in the body of the bladder. This leads to a decrease in the tone of the smooth muscles of the prostate gland, the bladder neck and the prostatic part of the urethra and the improvement of the function of the detrusor. Due to this, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia are reduced.

As a rule, the therapeutic effect develops 2 weeks after the start of the drug, although in a number of patients a decrease in the severity of symptoms occurs after taking the first dose.

The ability of tamsulosin to affect? 1A -adrenoreceptors are 20 times greater than its ability to interact with? 1B -adrenoreceptors, which are located in the smooth muscles of blood vessels. Due to such high selectivity, the drug does not cause any clinically significant reduction in blood pressure in patients with arterial hypertension, and in patients with normal baseline blood pressure.

Indications and usage

Treatment of dysuria due to benign prostatic hyperplasia.

Contraindications

- Hypersensitivity to the drug.

With caution should use the drug for:

- Chronic renal failure (with CC less than 10 ml / min).
- Arterial hypotension (including orthostatic).
- Severe liver failure.

Dosage and administration

Assign inside, after eating, 400 mcg (1 caps.) / Day., At the same time of day, drinking plenty of water.

The capsule should not be torn apart or chewed, because this disrupts the prolonged release of the active substance.

Like other alpha 1 -adrenergic blockers, tamsulosin can cause a decrease in blood pressure, which in rare cases is accompanied by fainting. At the first signs of orthostatic hypotension (dizziness, weakness), it is necessary to seat or bed the patient until the symptoms disappear. Before starting treatment with Sonizin&№174;, it is necessary to conduct a preliminary examination of the patient in order to rule out any other disease occurring with the same symptoms as benign prostatic hyperplasia. Before treatment, rectal digital examination of the prostate and measurement of the level of prostate specific antigen (PSA) are performed, which later, during treatment, are regularly repeated.

Application for violations of liver function: With caution should use the drug in severe liver failure.

Application for violations of renal function: With caution should use the drug for chronic renal failure (with CC less than 10 ml / min).

Impact on the ability to drive motor vehicles and control mechanisms: During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug Interactions

Cimetidine increases the concentration of tamsulosin in plasma, reduces Furosemide (does not have significant clinical significance, dose change is not required).

Diclofenac and indirect anticoagulants enhance the elimination of tamsulosin.

Diazepam, propranolol, trichloromethiazide, chlormadinone, Amitriptyline, Diclofenac, glibenclamide, Simvastatin and Warfarin do not alter the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin does not change the free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone.

In in vitro studies, no interaction at the level of hepatic metabolism with amitriptyline, Salbutamol, glibenclamide, and Finasteride was detected.Other alpha 1 -blockers, acetylcholinesterase inhibitors, alprostadil, anesthetics, diuretics, levodopa, antidepressants, beta-blockers, slow calcium channel blockers, nitrates and ethanol can increase the intensity of the hypotensive effect of tamsulosin.

Overdosage

Cases of acute overdose are not described.

Symptoms: theoretically, the occurrence of acute arterial hypotension, compensatory tachycardia.
Treatment: the patient should be laid to restore blood pressure and normalize heart rate. Cardiotropic therapy is carried out. Renal function should be monitored and general supportive therapy should be performed. If the symptoms persist, you should enter the volume-substituting solutions, vasoconstrictor drugs. To prevent further absorption of tamsulosin, gastric lavage, taking Activated carbon or osmotic laxative is possible. Dialysis is not effective because tamsulosin binds strongly to plasma proteins.

In original packaging, at a temperature of from 15 ° to 30 ° C.

3 years.