Tamsulosin tablets of prolonged action 0.4 mg №10×3

Name:
Tamsulosin prolong tablets 0.4 mg in a cell. pack No. 10×3
Description:
Tablets are white, round, with a biconvex surface. Each tablet is labeled “T9SL” on one side and “0.4” on the other side. The main active ingredient Tamsulosin Release form tablets Dosage 0.4 mg Pharmacological action Pharmacodynamics Tamsulosin selectively and competitively binds to postsynaptic ?1A and ?1D – adrenoreceptors, which contribute to the contraction of smooth muscles, and blocks them, causing relaxation of the smooth muscles of the prostate gland, bladder neck and prostatic part of the urethra . Tamsulosin increases the rate of urine output to a maximum by relaxing the smooth muscles of the prostate and urethra, thus facilitating urination. Tamsulosin reduces both bladder emptying symptoms and bladder filling symptoms, which are strongly influenced by smooth muscle contraction. By reducing peripheral resistance, alpha-blockers may help lower blood pressure. During the study of the effect of tamsulosin on patients with normal pressure, a clinically significant decrease in blood pressure was not observed, since its ability to bind to the ?1A receptor subtype is 20 times greater than its ability to interact with the ?1B receptor subtype in the vessels. PharmacokineticsAbsorption Tamsulosin is rapidly absorbed from the intestine, and its bioavailability is almost complete (100%). The rate of absorption decreases with meals before taking the drug. The absorption rate can be maintained constant if tamsulosin is taken after breakfast. The kinetics of tamsulosin are linear. Peak plasma levels are determined approximately 6 hours after taking a single dose of tamsulosin after a full meal. At a stable level, the concentration is established on the fifth day of daily intake. Cmax in blood plasma is reached after 4-6 hours both when taken on an empty stomach and after a meal. Cmax in blood plasma is 6 ng / ml at a single dose of 0.4 mg and 11 ng / l at steady state, with the introduction of the same dose. The concentration of tamsulosin in plasma before the next dose after 24 hours is 40% of the Cmax of tamsulosin in plasma when taken on an empty stomach and after a meal. Plasma levels of tamsulosin vary greatly from patient to patient, both after a single dose and after multiple doses. Distribution and elimination More than 99% of tamsulosin binds to plasma proteins, the volume of distribution is low (about 0.2 l / kg). Slowly metabolized in the liver with the formation of inactive metabolites. Tamsulosin and drugs of its metabolism are excreted mainly in the urine, with about 4% – 6% of the dose received in an unchanged form of elimination. The elimination half-life of tamsulosin is approximately 10 hours (when taken after a meal) and 13 hours at steady state. Indications for use Symptoms of urination disorders caused by benign prostatic hyperplasia (BPH). Dosage and administration Adults over 18 years of age and the elderly: one tablet daily, regardless of food intake. The tablet is swallowed whole, without breaking or chewing, which is associated with the action of the active substance. In renal failure, as well as mild and moderate hepatic insufficiency, dose adjustment is not required. Use during pregnancy and lactation Tamsulosin is intended for use only by men. Precautions Taking tamsulosin can help lower blood pressure, in rare cases accompanied by loss of consciousness. If the first signs of the development of orthostatic hypotension (dizziness, weakness) appear, the patient should be seated or laid down until these symptoms disappear. The patient should be examined before prescribing tamsulosin to exclude the presence of other diseases that may be accompanied by symptoms similar to those of benign prostatic hyperplasia. The prostate gland should be examined through the anus and, if necessary, a prostate specific antigen test should be ordered before starting treatment and then performed at regular intervals thereafter. The treatment of patients with severely impaired renal function (creatinine clearance less than 10 ml / min) should be approached with caution, since the use of the drug in this category of patients has not been studied. The development of angioedema after taking tamsulosin is rare. In such a case, the drug should be stopped immediately, and the patient should be observed until the edema disappears. Tamsulosin should not be re-administered. Pupil constriction syndrome has been observed in some patients who took tamsulosin at the time of surgery or earlier during cataract removal. The development of pupillary constriction syndrome can lead to an increased risk of complications during surgery. Tamsulosin is not recommended for patients who are scheduled for cataract removal. Interaction with other drugs When taken simultaneously with atenolol, enalapril, nifedipine and theophylline, no interactions were observed. When taken simultaneously with cimetidine, the plasma concentration of tamsulosin increases, with furosemide it decreases, but remains within the normal range. Diazepam, propranolol, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not affect the free fraction of tamsulosin, tamsulosin itself also does not change the free fraction of diazepam, propranolol and chlormadinone. It has been established that tamsulosin in in vitro studies of liver microsomal fractions (representing the system of enzyme metabolism associated with cytochrome P-450) does not interact with amitriptyline, salbutamol, glibenclamide and finasteride. Taking diclofenac and warfarin may increase the excretion of tamsulosin. Strong inhibitors of CYP3A4 (ketoconazole) slow down the metabolism of tamsulosin and increase its maximum concentration and AUC by 2.2 and 2.8 times, respectively. Taking strong inhibitors of CYP2D6 (paroxetine) also increases the maximum concentration and AUC of tamsulosin by 1.3 and 1.6 times, but this is not clinically significant. Simultaneous administration with other ?1A-adrenergic antagonists may help lower blood pressure. Contraindications Hypersensitivity to tamsulosin (including the development of drug-induced angioedema) or to any excipient. Orthostatic hypotension in history. Severe liver failure. Active ingredient: tamsulosin hydrochloride – 0.4 mg; excipients: microcrystalline cellulose, hypromellose, carbomer, iron oxide red (E172), magnesium stearate, anhydrous colloidal silicon dioxide. Overdose There are no reports of cases of acute overdose. However, acute hypotension (in which systolic blood pressure is less than 70 mm Hg), vomiting, and diarrhea are theoretically possible, which are corrected by replacing fluid loss. In the event of acute arterial hypotension against the background of an overdose, measures are shown to help stabilize the function of the cardiovascular system. Normalization of blood pressure and restoration of normal heart rate can be achieved by placing the patient in a horizontal position. In the absence of a positive effect, plasma-substituting agents are indicated and, if necessary, the appointment of vasoconstrictor drugs. Due to the ability of tamsulosin to actively bind to plasma proteins, a positive effect from the use of dialysis is unlikely. It is advisable to induce vomiting to reduce the amount of absorbed substance. If a large amount of the drug has entered the body, gastric lavage, the appointment of activated charcoal and osmotic laxatives are indicated. Side effects During cataract removal while taking tamsulosin, pupillary constriction and intraoperative instability of the iris, known as pupillary constriction syndrome (IRIS), may occur. Adverse events classified by organs and systems are listed below in descending order of frequency: common (?1/100 < 1/10), infrequent (?1/1000 <1/100), rare (?1/10000 <1/1000 ), very rare (? 1/10000). Disorders of the cardiovascular system. Uncommon: tachycardia, orthostatic hypotension. Frequency not established: atrial fibrillation, arrhythmia, shortness of breath. Nervous system disorders. Frequent: dizziness (up to 1.3%); infrequent: headache; rare: fainting. Respiratory and mediastinal disorders. Uncommon: rhinitis. Gastrointestinal disorders. Uncommon: constipation, diarrhea, nausea, vomiting. Skin and subcutaneous tissue disorders. Uncommon: rash, itching, urticaria; rare: angioedema; very rare: Stevens-Johnson syndrome. Reproductive system and mammary glands. Uncommon: violation of ejaculation; rare: priapism. General disorders and complications at the injection site. Uncommon: asthenia. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25? Keep out of the reach of children. Buy Tamsulosin tablets of prolonged action 0.4 mg No. 10x3