Tulosin modified release capsules 0.4mg #10×3

Name:
Tulozin caps with mod.high. 0.4 mg in bl. in pack. №10х3
Description:
Capsules with modified release hard gelatin, self-closing, with a transparent green body and an opaque green cap; the contents of the capsules are white pellets, odorless or almost odorless. The main active ingredient Tamsulosin hydrochloride Release formModified release hard gelatin capsules, self-closing, with a transparent green body and an opaque green cap; the contents of the capsules are white pellets, odorless or almost odorless. 1 caps. tamsulosin hydrochloride 400 mcg Excipients: microcrystalline cellulose, copolymer of methacrylic acid with ethyl acrylate (1:1) (in the form of a 30% aqueous dispersion solution), calcium stearate. The composition of the pellet shell: a copolymer of methacrylic acid and ethyl acrylate (1:1) (in the form of a 30% aqueous dispersion solution), talc, triethylcitrate, tween 80 (polysorbate 80). The composition of the capsule shell: body – indigo carmine, quinoline yellow, gelatin; cap – indigo carmine, quinoline yellow, titanium dioxide, gelatin. 10 pieces. – blisters (1) – packs of cardboard. 10 pieces. – blisters (3) – packs of cardboard. Dosage 0.4 mg in bl. in pack. No. 10×3 Special instructionsTamsulosin should be used with caution in patients predisposed to orthostatic hypotension, because. and in the case of taking other alpha1-blockers, in some patients during the course of treatment, blood pressure may decrease, which sometimes leads to fainting. At the first signs of orthostatic hypotension (dizziness or weakness), the patient should be seated or laid down until the symptoms disappear. Before starting therapy with the drug, the patient should be examined to exclude 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, the determination of prostate specific antigen (PSA) should be performed. In patients with severe renal insufficiency (CC < 10 ml / min), Tulosin should be used with caution, because. the safety of the drug in this category of patients has not been studied. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Pharmacological action Alpha 1-adrenergic blocker. Tulosin selectively and competitively blocks postsynaptic ?1A-adrenergic receptors located in the smooth muscles of the prostate, bladder neck and prostatic urethra, as well as ?1D-adrenergic receptors, predominantly located in the body of the bladder. This leads to a decrease in the tone of the smooth muscles of the prostate, bladder neck and prostatic urethra and an improvement in detrusor function. This reduces the symptoms of obstruction and irritation associated with benign prostatic hyperplasia. As a rule, the therapeutic effect develops 2 weeks after the start of the drug, although in some patients a decrease in the severity of symptoms is noted after taking the first dose. Tulosin's ability to act on ?1A-adrenergic receptors is 20 times greater than its ability to interact with ?1B-adrenergic receptors, which are located in vascular smooth muscle. Due to this high selectivity, the drug does not cause any clinically significant decrease in systemic blood pressure in both patients with arterial hypertension and in patients with normal baseline blood pressure. Pharmacokinetics Absorption After oral administration, tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract. The bioavailability of the drug is about 100%. After a single oral administration of the drug, Cmax of the active substance in plasma is reached after 6 hours. Immediately after a meal, the absorption of tamsulosin decreases. The uniformity of absorption increases if the patient takes the drug every day after the same meal. In an equilibrium state (after 5 days of course administration), the values of Cmax of the active substance in blood plasma are 60-70% higher than Cmax after a single dose of the drug. Distribution Plasma protein binding - 99%. Tamsulosin has a negligible Vd of approximately 0.2 L/kg. Metabolism Tamsulosin is practically not subjected to the "first pass" effect and is slowly biotransformed in the liver with the formation of pharmacologically active metabolites that retain high selectivity for ?1A-adrenergic receptors. None of the metabolites is more active than the parent substance. Most of the active substance is present in the blood unchanged. Withdrawal Tamsulosin and its metabolites are mainly excreted by the kidneys, with approximately 9% of the dose excreted unchanged. T1 / 2 tamsulosin with a single dose - 10 hours, after multiple doses - 13 hours, final T1 / 2 - 22 hours. Pharmacokinetics in special clinical cases In liver failure, dose adjustment is not required. In case of impaired renal function, the dose of the drug is not required to be specified. Indications for use - treatment of functional symptoms of benign prostatic hyperplasia. Dosing and Administration Tulosin is taken orally at a dose of 400 mcg (1 capsule/day). Capsules are taken after the first meal with plenty of water. The capsule should not be broken or chewed. Use during pregnancy and lactation Tulosin is intended for men only. Precautions Caution should be used in severe hepatic impairment. Caution should be used in chronic renal failure (CC less than 10 ml / min). Interaction with other drugs Simultaneous use of cimetidine increases the concentration of tamsulosin in the blood plasma, furosemide reduces its concentration in the blood plasma. However, in both cases, the content of tamsulosin remains within the therapeutically active concentrations and dose adjustment is not required. Diclofenac and indirect anticoagulants slightly increase the rate of elimination of tamsulosin. Simultaneous use of tamsulosin with other alpha1-blockers and other drugs that reduce blood pressure can lead to a pronounced increase in the hypotensive effect. No interaction was found with the simultaneous use of tamsulosin with atenolol, enalapril, nifedipine or theophylline. The plasma concentration of tamsulosin did not change in the presence of diazepam, trichlormethiazide, amitriptyline, diclofenac, glibenclamide, simvastatin or warfarin. Tamsulosin did not change the concentrations of diazepam, propranolol, trichlormethiazide and chlormadinone. Contraindications - hypersensitivity to the components of the drug. Caution should be used in chronic renal failure (CC < 10 ml / min), arterial hypotension (including orthostatic), severe liver failure. Composition 1 caps. tamsulosin hydrochloride 400 mcg Excipients: microcrystalline cellulose, copolymer of methacrylic acid with ethyl acrylate (1:1) (in the form of a 30% aqueous dispersion solution), calcium stearate. The composition of the pellet shell: a copolymer of methacrylic acid and ethyl acrylate (1:1) (in the form of a 30% aqueous dispersion solution), talc, triethylcitrate, tween 80 (polysorbate 80). The composition of the capsule shell: body - indigo carmine, quinoline yellow, gelatin; cap - indigo carmine, quinoline yellow, titanium dioxide, gelatin. 10 pieces. - blisters (1) - packs of cardboard. 10 pieces. - blisters (3) - packs of cardboard. Overdose Cases of acute overdose are not described. Symptoms: theoretically possible occurrence of acute arterial hypotension. Treatment: the patient should be laid down to restore blood pressure and normalize heart rate. Carry out cardiotropic therapy. Renal function should be monitored and general supportive therapy applied. If symptoms persist, volume-replacing fluids or vasoconstrictors should be administered. To prevent further absorption of tamsulosin, gastric lavage, activated charcoal, or an osmotic laxative may be taken. Dialysis is not effective because tamsulosin is strongly bound to plasma proteins. Side effect From the side of the central nervous system: 1-10% - dizziness, drowsiness or insomnia; 0.1-1% - headache. From the digestive system: 0.1-1% - nausea, vomiting, diarrhea or constipation. From the reproductive system: 0.1-1% - retrograde ejaculation, decreased libido; < 0.01% - priapism. From the side of the cardiovascular system: 0.01-0.1% - orthostatic hypotension, tachycardia, palpitations, chest pain, fainting. Allergic reactions: 0.01-0.1% - skin rash, itching, urticaria, angioedema. Others: 0.1-1% - decreased visual acuity, rhinitis, asthenia, back pain. Storage conditions The drug should be stored out of the reach of children at temperatures below 25°C. Buy Tulosin modified release capsules 0.4mg #10x3