Tamsulosin Verte capsules with prolonged action 0.4mg N30
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Active ingredients
Tamsulosin
Release form
Capsules
Composition
100 g ointment contains: active substance: acyclovir - 5 g; excipients: polyethylene oxide 400, polyethylene oxide 1500.
Pharmacological effect
Tamsulosin is a specific blocker of postsynaptic α1-adrenergic receptors that are in the smooth muscles of the prostate gland, bladder neck and prostatic part of the urethra. The blockade of α1-adrenoreceptors with tamsulosin leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck and the prostatic part of the urethra and the improvement of urine flow. At the same time, the severity of symptoms of filling and emptying due to increased smooth muscle tone and detrusor hyperactivity in benign prostatic hyperplasia decreases. The ability of tamsulosin to affect the α1A subtype of adrenergic receptors is 20 times greater than its ability to interact with the α1B subtype of adrenoreceptors, which are located in vascular smooth muscle. Due to its high selectivity, tamsulosin does not cause a clinically significant reduction in systemic arterial pressure (BP) in patients with arterial hypertension, or in patients with normal baseline blood pressure.
Pharmacokinetics
Tamsulosin is well absorbed in the intestine and has almost 100% bioavailability. Tamsulosin absorption slows down somewhat after eating. The same level of absorption can be achieved if the patient takes the drug each time after a normal breakfast. Tamsulosin is characterized by linear kinetics. After a single dose of the drug inside the dose of 0.4 mg, its maximum concentration in the blood plasma is achieved after 6 hours. After repeated ingestion of the drug in a daily dose of 0.4 mg, the equilibrium concentration is reached by the 5th day, while its value is 2/3 higher than the value of this parameter after a single dose of the drug. Distribution Binding to plasma proteins is 99%, the volume of distribution is small (about 0.2 l / kg). Metabolism Tamsulosin is slowly metabolized in the liver to form less active metabolites. Most tamsulosin is present in plasma in unchanged form.In experimental studies revealed the ability of tamsulosin to slightly induce the activity of microsomal liver enzymes. With an insignificant and moderate degree of liver failure, no correction of the dosing regimen is required. Withdrawal Tamsulosin and its metabolites are excreted mainly by the kidneys, with approximately 9% of the dose of the drug excreted unchanged. The half-life with a single dose of 0.4 mg of tamsulosin after a meal is 10 hours, after repeated intake of 13 hours. In renal failure, no dose reduction is required. If the patient has severe renal failure (creatinine clearance less than 10 ml / min), the administration of tamsulosin should be carried out with caution.
Indications
Treatment of dysuric disorders in benign prostatic hyperplasia.
Contraindications
hypersensitivity to tamsulosin or other components of the drug; orthostatic hypotension (including a history); severe liver failure; glucose-galactose malabsorption; sucrose / isomaltose deficiency; fructose intolerance; children's age up to 18 years.
Precautionary measures
severe renal failure (creatinine clearance less than 10 ml / min), arterial hypotension.
Use during pregnancy and lactation
The drug is intended for use only in males.
Dosage and administration
Inside Tamsulosin capsules should be taken after breakfast without chewing, drinking plenty of water. The drug is taken in 1 capsule (0.4 mg) 1 time per day.
Side effects
The incidence of side effects is classified according to the recommendations of the World Health Organization: very often:> 1/10 (˃ 10%); often: from 1/100 to 1/10 (˃ 1% and ˂ 10%); infrequently: from 1/1000 to 1/100 (˃ 0.1% and 1%); rarely: from 1/10000 to 1/1000 (˃ 0.01% and 0.1%); very rarely: ˂ 1/10000 (˂ 0.01%), including individual events; frequency unknown. Since the cardiovascular system: infrequently - a feeling of heartbeat, orthostatic hypotension; frequency is unknown - atrial fibrillation, arrhythmia, tachycardia, shortness of breath. From the gastrointestinal tract: infrequently - constipation, diarrhea, nausea, vomiting. On the part of the nervous system: often - dizziness; infrequently - headache; rarely - fainting.Reproductive system: often - ejaculatory disorders; very rarely - priapism. On the part of the respiratory system, chest and mediastinum: infrequently - rhinitis. From the skin and subcutaneous tissue: infrequently - rash, itching, urticaria; rarely, angioedema; very rarely - Stevens-Johnson syndrome; frequency is unknown - erythema multiforme, exfoliative edema. General condition disorders: infrequently - asthenia. Other: infrequently - asthenia; frequency is unknown - intraoperative instability of the iris of the eye (narrow pupil syndrome) during surgery for cataract and glaucoma, epistaxis.
Overdose
No reports of acute overdose of the drug. The most likely symptoms. A pronounced decrease in blood pressure and compensatory tachycardia.
Interaction with other drugs
When prescribing tamsulosin together with atenolol, enalapril, nifedipine and theophylline, no drug interaction was found. With simultaneous use of tamsulosin with cimetidine, a slight increase in plasma concentration of tamsulosin, with furosemide decreased concentration was noted, but this does not require dose adjustment, since the concentration of tamsulosin remains within the normal range. Diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not alter the free fraction of tamsulosin in human blood plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone. Diclofenac and warfarin may increase the rate of elimination of tamsulosin. In in vitro studies, no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, and finasteride was detected. The simultaneous administration of tamsulosin with strong inhibitors of the CYP3A4 isoenzyme may lead to an increase in the concentration of tamsulosin. Simultaneous administration with ketoconazole (a strong inhibitor of the CYP3A4 isoenzyme) resulted in an increase in the area under the pharmacokinetic curve (AUC) and the maximum concentration (Cmax) of tamsulosin by 2.8 and 2.2 times, respectively. Tamsulosin should not be prescribed in combination with strong inhibitors of the CYP3A4 isoenzyme in patients with metabolic imbalances of the CYP2D6 isoenzyme.The drug should be used with caution in combination with strong and moderate inhibitors of the CYP3A4 isoenzyme. The simultaneous administration of tamsulosin and paroxetine, a strong inhibitor of the CYP2D6 isoenzyme, led to an increase in Cmax and AUC of tamsulosin by 1.3 and 1.6 times, respectively, but this increase was considered clinically insignificant. The simultaneous use of tamsulosin with other α1-blockers may lead to a decrease in blood pressure.
special instructions
As with other α1-adrenergic blockers, with tamsulosin treatment, in some cases, a decrease in blood pressure may be observed, which can sometimes lead to fainting. At the first sign of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until the signs disappear. Before the appointment of tamsulosin therapy, it is necessary to exclude the presence of other diseases in the patient, which can cause the same symptoms as benign prostatic hyperplasia. Before treatment, and regularly during therapy, a digital rectal examination and, if necessary, the determination of prostate specific antigen (PSA) should be performed. Treatment with tamsulosin in patients with severe renal insufficiency (creatinine clearance less than 10 ml / min) requires caution, because studies in this category of patients was not conducted. In some patients taking or previously taking tamsulosin, during surgery for cataracts or glaucoma, the syndrome of intraoperative instability of the iris of the eye (narrow pupillary syndrome) may develop, which can lead to complications during surgery or in the postoperative period. The feasibility of discontinuing therapy with tamsulosin 1-2 weeks before surgery for cataracts or glaucoma has not been proven. Cases of intraoperative instability of the iris occurred in patients who stopped taking the drug and earlier in the operation. It is not recommended to start therapy with tamsulosin in patients who are scheduled for cataract or glaucoma surgery. During the preoperative examination of patients, the surgeon and the ophthalmologist should consider whether the patient accepts or takes tamsulosin. This is necessary to prepare for the development of the syndrome of intraoperative instability of the iris.In the case of the development of angioedema should immediately discontinue drug therapy. Re-appointment of tamsulosin is contraindicated. In renal failure, as well as in mild and moderate liver failure, no dosage regimen is required. Impact on the ability to drive vehicles and mechanisms Studies on the effect of tamsulosin on the ability to drive vehicles and mechanisms have not been conducted. But, given the possibility of dizziness, it is necessary to be careful when driving a car and doing other potentially dangerous activities that require increased concentration of attention and quickness of psychomotor reactions. Form release capsules with a slow release of 0.4 mg. 10, 15, 18 or 20 capsules in a blister strip of polyvinyl chloride film and aluminum foil. 30, 60 or 90 capsules in a high density polyethylene can. 1, 3 or 6 blister packs of 10 capsules, 2, 4 or 6 blister packs of 15 capsules, 5 blister packs of 18 capsules, 3 blister packs of 20 capsules or one can with the application instructions in a pack of cardboard.