OMNIK TOKAS table. 0.4 mg. 30 tablets
OMNIK TOKAS table. 0.4 mg. 30 tablets
Qualitative and quantitative composition
1 tablet contains Akiva ingredient Tamsulosin hydrochloride 0.4 mg
Omnik Tokas 0.4 tablets are approximately 9 mm, round, biconvex, yellow, film-coated and marked code "04"
Symptoms of lower urinary tract / ISPA / associated with benign prostatic hyperplasia / DPX /
Posology and method of administration
1 tablet per day, independent of meals.
Omnik Tokas 0.4 should be swallowed whole without chewing or crushed, not to interfere with the prolonged release of the active ingredient
Hypersensitivity to Tamsulosin hydrochloride or any of the other sastavki.Danni orthostatic hypotension in history.
Severe hepatic insufficiency.
Special warnings and precautions for use
As with other a-1 adrenoceptor antagonists in some cases may appear blood pressure during treatment with 0.4 Omnik Tokas, resulting in even more rarely syncope. At the first signs of orthostatic hypotension / dizziness, weakness / patient should sit or lie down until the symptoms have resolved. Before starting treatment with 0.4 Omnik Tokas, the patient should be examined to rule out other conditions that cause the same symptoms as benign prostatic hyperplasia. Before treatment and at regular intervals thereafter to be held digital rectal examination and, if necessary, determination of prostate specific antigen / SAP /.
Patients with severe renal failure / creatinine clearance <10 ml / min / should be careful as there is no testing in such patients.
Drug interactions and other interactions
When tamsulosin hydrochloride are coadministered with atenolol, enalapril, nifedipine or theophylline were not observed interactions.
Concomitant cimetidine increases the plasma concentration of tamsulosin, and furosemide - a fall, but as levels remain within normal range, no adjustment of dosage.
In vitro diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. Tamsulosin also change the free fractions of diazepam, propranolol, and chlormadinone trichlormethiazide. No interactions were observed in the level of hepatic metabolism studies "in vitro" with liver microsomal fractions / representative associated with cytochrome P450 enzymes metabolizing drugs / including amitriptyline, glibenclamide and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin. Combined with other A-1-adrenoceptor antagonists can lead to low blood pressure.
Pregnancy and lactation
Do not be used by women as Omnik Tokas 0.4 is only for men.
Vliyanie on ability to drive and use machines
No evidence of the influence of Omnik Tokas 0.4 on ability to drive and use machines. However, patients should know that may occur dizziness.
In case of acute hypotension occurring after overdosage to maintain the cardiovascular system. By placing the patient in the supine position can restore blood pressure and pulse return to normal. If this does not help, you should use solutions that increase plasma exchange, if necessary, vasopressors. Renal function should be monitored and general supportive measures. Haemodialysis would not help as tamsulosin is largely bound to plasma proteins. You can induce vomiting to avoid absorption. When ingested large quantities, can perform gastric lavage and use of activated charcoal and an osmotic drug, eg. sodium sulfate.
Pharmacotherapeutic Group A-1-adrenoceptor antagonists
ATC code: G04C A02.Sredstva exclusively for the treatment of prostate disease
Mechanism of Action
Tamsulosin binds selectively and competitively to postsynaptic aradrenoretseptori, in particular a1A subtype and a1D. This leads to relaxation of smooth muscle in the prostate and urethra.
Omnik Tokas increase the maximum speed of urination. It relieves obstruction by relaxing smooth muscle in the prostate and urethra, thereby improving bladder emptying mehur.Toy also improves the symptoms of a full bladder, where the bladder instability plays rolya.Efektite on these symptoms are maintained by continuous treatment . The need for surgery or catheterization significantly delayed.
Ai-adrenoceptor antagonists can reduce blood pressure by lowering peripheral resistance. During the tests Omnik 0.4 Tokas no reductions in blood pressure with clinical relevance.
Omnik Tokas 0.4 are prolonged release type of nonionic gelna matrix. In this formulation, tamsulosin is released slowly and continuously, providing a concentration of small deviations for 24 hours. Tamsulosin administered as Omnik Tokas 0.4, absorbed in chervata.Okolo 57% of the dose is absorbed. The rate and extent of absorption of tamsulosin is not affected by food. Tamsulosin shows linear pharmacokinetics.
After a single dose of 0.4 Omnik Tokas fasting, peak plasma concentration is reached on average 6 hours. At steady state, which is reached after 4-day administration, the maximum plasma concentration is reached 4-6 hours of fasting and after meals. Peak plasma concentrations increase from 6 ng / ml after the first dose to 11 ng / ml at steady state. As a result of the prolonged release properties of Omnik Tokas 0.4, the concentration of tamsulosin to 40% of the maximum plasma concentration of fasting and postprandial. In individual patients, there are significant differences in plasma concentrations, both single and repeated dosing.
Tamsulosin binds to plasma proteins, about 99%. The volume of distribution is small / about 0.21/kg /.
Tamsulosin has a low first pass effect, as it is metabolized slowly. The majority settled unchanged in plasma. Metabolism in rat liver drob.Pli tamsulosin does not induce hepatic microsomal induction of hepatic failure enzimi.Pri no dose adjustment is required. None of the metabolites are more active than the original compound.
Tamsulosin and its metabolites are primarily excreted in the urine. The amount excreted unchanged is about 4-6% of the administered dose Omnik Tokas 0.4.Sled single dose Omnik Tokas 0.4 and at steady state, the half-life is about 19 and 15 hours respectively.
There is no need for dose adjustment in renal failure.
Preclinical safety data
Were conducted toxicity tests with single and multiple doses in mice, rats and dogs. Were examined in addition pli reproductive toxicity in rats, carcinogenicity in mice and rats, and genotoxicity "in vivo" and "in vitro". Toxicity profile, as seen with high doses of tamsulosin, is similar to the known pharmacological effects of al-adrenoceptor antagonists.
At very high doses in dogs with changes in ECG. This finding was not clinically znachenie.Tamsulozin showed no relevant genotoxic properties. Reported an increased incidence of proliferative changes in the mammary glands of female rats and mice. These findings, which are probably mediated by hyperprolactinaemia and only occur at high doses are not considered important.
List of excipients
Macrogol 7.000.000 Macrogol 8.000 Magnesium stearate / E470 / / Butylhydroxytoluene / E321 / Colloidal silica anhydrous / E551 / Hypromellose / E464 / Iron oxide yellow / E172 /
There are no known
Special precautions for storage
Nature and contents of container
Aluminium foil blisters containing 30 tablets