SONIZIN

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: GEDEON RICHTER Ltd. (Hungary)

Pharmaceutical form, composition and packaging

Modified release capsule hard gelatin, size №2, opaque, with brown cap and brown-yellow body; contents of capsules – pellets of white or nearly white.

Excipients: calcium stearate, triэtiltsitrat, talc, a copolymer of methacrylic acid and ethyl acrylate (1:1) (also containing polysorbate 80, sodium lauryl), microcrystalline cellulose.

The composition of the body and cap of the capsule: iron oxide yellow (C.I. 77492 E172), iron oxide black (C.I. 77499 E172), iron oxide red (C.I. 77491 E172), Titanium dioxide (C.I. 77891 E171), gelatin.

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.

Pharmacological action

Alpha₁-adrenoblokator. Tamsulosin selectively and competitively blocks postsynaptic α_1A-adrenoreceptory, located in the smooth muscle of the prostate, bladder neck and prostatic urethra, and α_1D-adrenoreceptory, predominantly located in the body of the bladder. 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. 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 tamsulosin_1A-adrenergic receptors in the 20 times greater than its ability to interact with the α_1B-adrenoreceptor, which are located in vascular smooth muscle. With such a high selectivity drug does not cause any clinically significant reduction in blood pressure in patients with hypertension, and in patients with normal baseline BP.

Pharmacokinetics

Absorption

After oral tamsulosin rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability is about 100%. After receiving a single oral dose of the drug 400 µg C_max tamsulosin in plasma achieved through 6 no.

Distribution

In the equilibrium state (through 5 day course taking) C values_max tamsulosin in blood plasma 60-70% higher, than C_max after a single dose of the drug.

Plasma protein binding – 99%. Tamsulosin has a slight V_d (about 0.2 l / kg).

Metabolism

Tamsulosin is not exposed to the effect of “first pass” and slowly biotransformed in the liver to pharmacologically active metabolites, maintain a high selectivity for the α_1A-adrenoceptor. Most of the active substance present in the blood in an unmodified form.

Deduction

Tamsulosin excreted by the kidneys, 9% the dose is excreted unchanged in.

T_1/2 tamsulosin in single dose -10 no, after multiple dose – 13 no, final T_1/2 – 22 no.

Testimony

- Treatment of dysuria, due to benign prostatic hyperplasia.

Dosage regimen

Assign inside, after meal, by 400 g (1 caps.)/d, at the same time of the day, drinking plenty of water. The capsule should not be broken into parts or, Our razzhevыvaty, tk. this breaks sustained release of the active substance.

Side effect

CNS: rarely – headache, dizziness, asthenia, sleep disorders (drowsiness or insomnia).

On the part of the reproductive system: rarely – retrograde ejaculation, decreased libido.

Cardio-vascular system: in a few cases – orthostatic hypotension, tachycardia, heartbeat.

From the digestive system: in some cases – nausea, vomiting, constipation or diarrhea.

Allergic reactions: in some cases – skin rash, itch, angioedema.

Other: rarely – backache, rhinitis; in a few cases – chest pain.

Contraindications

- Hypersensitivity to the drug.

FROM caution use in patients with chronic renal failure (at least QC 10 ml / min), hypotension (in t. no. orthostatic), severe hepatic insufficiency.

Cautions

Like other alpha₁-blockers tamsulosin may cause a decrease in blood pressure, in rare cases followed by fainting. At the first signs of orthostatic hypotension (dizziness, weakness) you need to sit down and put the patient until symptoms.

Before treatment Sonizinom^® you must carry out a preliminary examination of the patient in order to eliminate any other disease, proceeding with the same symptoms, as well as benign prostatic hyperplasia. Before treatment is performed digital rectal examination of the prostate and measuring the level of prostate specific antigen (PSA), which later, in the course of treatment is repeated regularly.

Effects on ability to drive vehicles and management mechanisms

In the period of treatment should refrain from activities potentially hazardous activities, require high concentration and speed of psychomotor reactions.

Overdose

Cases of acute overdose have not been described.

Symptoms: theoretically possible occurrence of acute hypotension, compensatory tachycardia.

Treatment: the patient should be put, to restore blood pressure and normalize heart rate. Spend cardiotropic therapy. It should monitor renal function and to conduct general maintenance therapy. If symptoms persist, enter obemozameschayuschie solutions, vasoconstrictor drugs. To prevent further absorption of tamsulosin possible gastric lavage, administration of activated charcoal or osmotic laxative. Dialysis is not effective, as tamsulosin binds strongly to plasma proteins.

Drug Interactions

Cimetidine increases the concentration of tamsulosin in plasma, furosemide reduces (significant clinical value has, dose modification is not required).

Diclofenac and indirect anticoagulants increase the excretion of tamsulosin.

Diazepam, propranolol, trixlormetiazid, xlormadinon, Amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change tamsulosin free fraction in human plasma in vitro. In turn, tamsulosin does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.

In in vitro studies have not been found at the level of interaction with the hepatic metabolism of amitriptyline, salbutamol, glibenclamide and finasteride.

Other alpha₁-adrenoblokatorы, acetylcholinesterase inhibitors, alprostadil, Anesthetic, Diuretic, levodopa, antidepressants, beta-blockers, blockers slow calcium channels, nitrates and ethanol may increase the intensity of the hypotensive effect of tamsulosin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of the reach of children, in its original packaging, at a temperature from 15 ° to 30 ° C.. Shelf life – 3 year.