Name:
Omnic OKAS No. 30
Description:
Controlled release tablets, coated from yellow to brownish-yellow, round, biconvex, “04” is extruded on one side. The main active ingredient Tamsulosin Form releaseControlled release tablets, coated from yellow to brownish-yellow, round, biconvex, “04” is squeezed out on one side. 1 tab. tamsulosin hydrochloride 400 mcg Excipients: macrogol 8000 – 40 mg, macrogol 7,000,000 – 200 mg, magnesium stearate – 1.2 mg. Shell composition: yellow opadry 03F22733 – 7.25 mg (hypromellose – 69.536%, macrogol 8000 – 13.024%, iron dye yellow oxide – 17.44%). 10 pieces. – blisters (1) – packs of cardboard. 10 pieces. – blisters (3) – packs of cardboard. Dosage Inside – 400 mcg 1 time / day (after breakfast). Precautions Use with caution in patients prone to arterial hypotension, with severe liver dysfunction. Before starting therapy with tamsulosin, the patient should be evaluated for the presence of other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination and, if required, determination of prostate specific antigen should be performed. In patients with impaired renal function, changes in the dosing regimen are not required. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions. Pharmacological action Blocker? 1-adrenergic receptors; remedy for the symptomatic treatment of benign prostatic hyperplasia. Selectively blocks postsynaptic ?1A-adrenergic receptors of the smooth muscles of the prostate, bladder neck, and prostatic urethra. As a result, the tone of the smooth muscles of these formations decreases, and the outflow of urine is facilitated. At the same time, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia are reduced. The therapeutic effect appears approximately 2 weeks after the start of treatment. Significantly less pronounced in tamsulosin is the ability to block ?1B-adrenergic receptors of vascular smooth muscles, so the effect on systemic blood pressure is insignificant. Pharmacokinetics After oral administration, tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract. After a single oral administration of 400 μg Cmax of the active substance in plasma is achieved after 6 hours. Plasma protein binding is 99%. Vd is insignificant and amounts to 0.2 l / kg. Tamsulosin is slowly metabolized in the liver with the formation of pharmacologically active metabolites that retain high selectivity for α1A-adrenergic receptors. Most of the active substance is present in the blood unchanged. T1 / 2 tamsulosin with a single dose is 10 hours, the terminal T1 / 2 is 22 hours. Excreted by the kidneys, 9% – unchanged. Indications for use Benign prostatic hyperplasia. Dosage and administration Inside – 400 mcg 1 time / day (after breakfast). Precautions Use with caution in patients with severe hepatic impairment. In patients with impaired renal function, changes in the dosing regimen are not required. Interaction with other drugs With the simultaneous use of tamsulosin with cimetidine, there was a slight increase in the concentration of tamsulosin in the blood plasma, and with furosemide – a decrease in concentration; with other α1-adrenergic blockers, a pronounced increase in the hypotensive effect is possible. Diclofenac and indirect anticoagulants slightly increase the rate of elimination of tamsulosin. Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin do not alter the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. In vitro studies showed no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride. Other ?1-blockers, acetylcholinesterase inhibitors, alprostadil, anesthetics, diuretics, levodopa, antidepressants, beta-blockers, slow calcium channel blockers, muscle relaxants, nitrates and ethanol may increase the severity of the hypotensive effect. Contraindications Hypersensitivity to tamsulosin. Composition of tamsulosin hydrochloride 400 mcg Excipients: macrogol 8000 – 40 mg, macrogol 7,000,000 – 200 mg, magnesium stearate – 1.2 mg. Shell composition: yellow opadry 03F22733 – 7.25 mg (hypromellose – 69.536%, macrogol 8000 – 13.024%, iron dye yellow oxide – 17.44%). Overdose Symptoms: lowering blood pressure, compensatory tachycardia. Treatment: symptomatic. Blood pressure and heart rate can recover when the patient takes a horizontal position. If there is no effect, you can use agents that increase the BCC, and, if necessary, vasoconstrictors. It is necessary to monitor kidney function. It is unlikely that dialysis will be effective because tamsulosin is extensively bound to plasma proteins. To prevent further absorption of the drug, it is advisable to wash the stomach, take activated charcoal and osmotic laxatives. Side effects From the side of the cardiovascular system: rarely – dizziness, orthostatic hypotension, palpitations. From the side of the central nervous system: headache, asthenia are possible. From the reproductive system: rarely – retrograde ejaculation. Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. Buy Omnic OKAS controlled release tablets p/o 0.4mg No. 10×3 Price for Omnic OKAS controlled release tablets p/o 0.4mg No. 10×3
INN | TAMSULOZIN |
---|---|
The code | 118 013 |
Barcode | 4 607 098 450 999 |
Dosage | 0.4 mg |
Active substance | Tamsulosin hydrochloride |
Manufacturer | Astellas Pharma Europ B.V., The Netherlands |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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