Sonizin - instructions for use, dose, side effects, contraindications

Contents of the capsule: calcium stearate; triethylcurate; talc; copolymer of methacrylic acid and ethyl acrylate (1: 1), also containing polysorbate 80 and sodium lauryl sulfate; microcrystalline cellulose.

Hard gelatin capsule:

Top part:

iron oxide yellow (C.I. 77492 E172); titanium dioxide (C.I. 77891 E171); iron oxide black (C.I. 77499 E172); iron oxide red (C.I. 77491 E172); gelatin.

Bottom part:

iron oxide red (C.I. 77491 E172); iron oxide black (C.I. 77499 E172); iron oxide yellow (C.I. 77492 E172); titanium dioxide (C.I. 77891 E171); gelatin.

Description:

Hard gelatin capsules size no. 2; lid: opaque, brown; body: opaque, brownish-yellow.

The contents of the capsule are pellets of white or almost white color.

Pharmacotherapeutic group:alpha1-blocker

ATX: & nbsp

G.04.C.A.02 Tamsulosin

Pharmacodynamics:

Tamsulosin selectively and competitively blocks postsynaptic α1A- adrenoreceptors, located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra,and α1 D-adrenoreceptors, 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 neck of the bladder and the prostatic part of the urethra and improve detrusor function. This reduces the symptoms of obstruction and irritation associated with benign prostatic hyperplasia. how Normally, the therapeutic effect develops 2 weeks after the start of the drug, although in a number of patients, the decrease in the severity of symptoms is noted after the first dose.

The ability of tamsulosin to affect α1 A-Adrenoceptors are 20 times greater than its ability to interact α1 B-adrenoceptors, which are located in the smooth muscles of the vessels. Due to this high selectivity, the drug does not cause any clinically significant decrease in systemic blood pressure (BP) in both patients with arterial hypertension and in patients with normal initial BP.

Pharmacokinetics:

Suction

After oral administration tamsulosin quickly and almost completely absorbed from the gastrointestinal tract. Bioavailability of the drug is about 100%.

After a single dose of the drug inside at a dose of 400 mcg C_max the active substance in the plasma is reached after 6 hours.

Distribution

In the equilibrium state (after 5 days of course intake), the Cmax value of the active substance in blood plasma is 60-70% higher than Cmax after a single dose of the drug.

Binding to plasma proteins - 99%. Tamsulosin has a small volume of distribution (approximately 0.2 l / kg).

Metabolism

Tamsulosin does not undergo the "first pass" effect and is slowly biotransformed in the liver to form pharmacologically active metabolites that retain high selectivity to α 1A-adrenergic receptors. Most of the active substance is present in the blood in unchanged form.

Excretion

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

T1 / 2 tamsulosin with a single intake of -10 hours, after repeated intake of -13 hours, the final half-life is 22 hours.

Indications:Treatment of dysuric disorders due to benign prostatic hyperplasia.

Contraindications:

Hypersensitivity to tamsulosin hydrochloride or any other component of the drug.

Carefully:chronic renal failure (lower creatinine clearance below 10 ml / min), arterial hypotension (including orthostatic), severe hepatic impairment.

Dosing and Administration:Inside, after eating, 1 capsule per day, at the same time of the day, with plenty of water. Capsule should not be broken up into parts, or chewed, because while the sustained release of the active substance is impaired.

Side effects:

Rarely - headache, dizziness, asthenia, sleep disturbances (drowsiness or insomnia), retrograde ejaculation, decreased libido, back pain, rhinitis; in isolated cases - orthostatic hypotension, tachycardia, palpitations, pain in the chest.

On the part of the digestive system: in rare cases - nausea, vomiting, constipation or diarrhea. In extremely rare cases, hypersensitivity reactions - skin rash, itching, angioedema.

Overdose:

Cases of acute overdose are not described.

Symptoms: it is theoretically possible the emergence of acute hypotension, compensatory tachycardia.

Treatment: the patient should be laid to restore blood pressure and normalize the heart rate.Carried out cardiotropic therapy. It is necessary to monitor the function of the kidneys and apply general supportive therapy.

If the symptoms persist, you should introduce volume-substituting solutions, vasoconstrictor drugs. To prevent further absorption of tamsulosin, it is possible to wash the stomach, taking activated charcoal or osmotic laxative. Dialysis is not effective, because tamsulosin strongly binds to blood plasma proteins.

Interaction:

Cimetidine increases the concentration of tamsulosin in plasma, furosemide reduces (no significant clinical significance, no dosage changes are required). Diclofenac and indirect anticoagulants increase the excretion of tamsulosin.

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

In studies in vitro no interaction was found at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, and finasteride.

Other alpha 1-adrenoblockers, acetylcholinesterase inhibitors, alprostadil, anesthetics, diuretics, levodopa, antidepressants, beta-adrenoblockers, blockers of "slow" calcium channels, nitrates and ethanol can increase the severity of the hypotensive effect of tamsulosin.

Special instructions:

Like other α1-blockers tamsulosin can cause a decrease in blood pressure, in rare cases, causing syncope. At the first signs of orthostatic hypotension (dizziness, weakness) it is necessary to sit or lay the patient until the symptoms disappear.

Treatment with tamsulosin should be preceded by a preliminary examination of the patient to exclude any other disease that occurs with the same symptoms as benign prostatic hyperplasia. Treatment should be preceded by a preliminary rectal finger examination of the prostate and measurement of the level of specific antigen of the prostate (PSA), which later, during the treatment are regularly repeated.

Effect on the ability to drive transp. cf. and fur:During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules with a modified release of 0.4 mg.

10 capsules in a blister of PVC / PVDC film and aluminum foil. 1 (one) or 3 (three) blisters in a cardboard box with instructions for use.

Packaging:(10) - packings, cellular, outline (1) - packs, cardboard
(10) - packings, cellular, outline (3) - packs, cardboard

Storage conditions:

Store in the original packaging at a temperature of 15 - 30 ° C, out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002155/07

Date of registration:13.08.2007

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER ROMANIA, S.A. Romania

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp30.08.2015

Illustrated instructions

Instructions

Sonizin® (Sonizin®)