Universal reference book for medicines
Product name: TANIZ ® -K (TANYZ ® -K)

Active substance: tamsulosin

Type: A drug used for urination disorders associated with benign prostatic hyperplasia.
Alpha 1- adrenoblocker
Manufacturer: KRKA (Slovenia) manufactured by SYNTHON (The Netherlands) packing and packaging KRKA (Slovenia)
Composition, form of production and packaging
Capsules of prolonged action hard gelatinous, size 2, with an orange-colored body and an olive-green lid with the inscription "TSL 0.4", the body and cap at the top are marked with a black stripe; the contents of the capsules are pellets of white or almost white color.
1 caps.
tamsulosin hydrochloride 400 μg
[PRING] Pellet core: microcrystalline cellulose - 276.9 mg, methacrylic and ethacrylic acid copolymer (1: 1) (dispersion 30% with emulsifiers: polysorbate-80, sodium lauryl sulfate) - 16.5 mg, triethyl citrate - 1.65 mg, talc - 16.5 mg, purified water - 12.48 mg; pellet shell: methacrylic and ethacrylic acid copolymer (1: 1) (dispersion 30% with emulsifiers: polysorbate-80, sodium lauryl sulfate) - 21.63 mg, talc - 8.65 mg, triethyl citrate - 2.16 mg.
The composition of the capsule body: iron oxide red oxide (E172) - 0.0239 mg, titanium dioxide (E171) - 0.53 mg, iron oxide oxide yellow (E172) 0.258 mg, gelatin 38.938 mg.
Composition of the capsule capsule: indigo carmine FD & C blue 2 (E132) 0.00152 mg, iron dye oxide black (E172) 0.0107 mg, titanium dioxide (E171) 0.356 mg, iron oxide yellow oxide (E172) 0.114 mg, gelatin 23.268 mg .
Ink composition: Shellac icing 45% (22% esterified in ethanol) - 59.42%, iron dye oxide black (E172) - 24.65%, butanol - 9.75%, purified water - 3.249%, propylene glycol - 1.3%, ethanol anhydrous - 1.08% , isopropyl alcohol - 0.55%, ammonium hydroxide 28% - 0.001%.
10 pieces. - Blisters (1, 2, 3, 6, 9, 20) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
The drug used in cases of urination disorders associated with benign prostatic hyperplasia. Alpha 1- adrenoblocker.
Does Tamsulosin selectively and competitively block postsynaptic? 1A- adrenoreceptors, located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra. This leads to a decrease in the tone of the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra and improve detrusor function. This reduces the symptoms of obstruction and irritation associated with benign prostatic hyperplasia (BPH). Typically, the therapeutic effect develops 2 weeks after the start of the drug, although in a number of patients, the decrease in the severity of symptoms is noted after the first dose. Is the ability of tamsulosin to affect? 1A- adrenoreceptors are 20 times greater than its ability to interact with? 1B- adrenoreceptors, which are located in the smooth muscles of the vessels. Due to this high selectivity, the drug does not cause any clinically significant reduction in systemic BP in both patients with arterial hypertension and in patients with normal initial BP.
PHARMACOKINETICS
Suction
After ingestion, tamsulosin is rapidly and almost completely absorbed from the digestive tract. This dosage form provides a sustained and slow release of tamsulosin. Bioavailability of the drug is about 100%.
Immediately after eating, the absorption of tamsulosin decreases. Uniformity of absorption increases if the patient takes the drug every day after the same meal.
After a single dose of the drug inside at a dose of 400 mcg (after a tight meal), the max of tamsulosin in plasma is reached after 6 hours. In the equilibrium state (after 5 days of course intake), the C max of tamsulosin in blood plasma is 60-70% higher than C max after a single dose.
Distribution
Binding to plasma proteins - 90%. Tamsulosin has a slight V d (approximately 0.2 l / kg).
Metabolism
Tamsulosin is practically not exposed to the effect of "first passage" and is slowly biotransformed in the liver with the formation of pharmacologically active metabolites that retain high selectivity to? 1A- adrenoreceptors. None of the metabolites is more active than the original substance - tamsulosin. Most of the active substance is present in the blood in unchanged form. With hepatic failure, a dose change is not required.
Excretion
Tamsulosin and its metabolites are mainly excreted by the kidneys, with approximately 9% of the dose being excreted unchanged.
T 1/2 tamsulosin with a single admission - 10 h (after reception after meals), after repeated intake - 13 h, final T 1/2 - 22 h.
INDICATIONS
- benign prostatic hyperplasia (treatment of dysuric disorders).
DOSING MODE
Inside, after the first meal, with plenty of water. The drug is taken in a sitting or standing position. Capsule should not be broken and chewed.
Assign 400 mcg (1 capsule) / day.
SIDE EFFECT
From the central and peripheral nervous system: often - dizziness; infrequently - a headache; rarely - fainting, asthenia, sleep disturbance (drowsiness or insomnia).
From the genitourinary system: infrequently - retrograde ejaculation; very rarely - priapism, decreased libido.
From the digestive system: infrequently - nausea, vomiting, constipation or diarrhea.
From the cardiovascular system: infrequently - tachycardia, increased heart rate, orthostatic hypotension; very rarely - pain in the chest.
Allergic reactions: infrequent - skin rash, hives; very rarely - skin itching, angioedema.
Other: infrequently, rhinitis; rarely - pain in the back.
CONTRAINDICATIONS
- an orthostatic arterial hypotension in the anamnesis;
severe hepatic impairment;
- Hypersensitivity to tamsulosin or other components of the drug.
Caution should be given to the drug in severe renal failure (QC less than 10 ml / min), tk. safety is not proven.
PREGNANCY AND LACTATION
Tamsulosin is for men only.
APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with severe renal failure (CC less than 10 ml / min), the drug should be used with caution (safety not proven).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency.
SPECIAL INSTRUCTIONS
Tamsulosin should be used with caution in patients with a predisposition to orthostatic hypotension. When the first signs of orthostatic hypotension (dizziness or weakness) appear, the patient should be placed or transferred to the "lying" position 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 BPH. Before the start of treatment and regularly during therapy, a digital rectal examination and, if necessary, the determination of a specific antigen of the prostate should be performed.
In patients with severe renal failure (CC less than 10 ml / min), the drug should be used with caution (safety not proven).
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
OVERDOSE
Cases of acute overdose are not described.
Symptoms: marked decrease in blood pressure, sometimes accompanied by syncope, compensatory tachycardia.
Treatment: conduct symptomatic therapy. The patient must be immediately moved to a horizontal position. In the absence of effect, it is necessary to introduce volume-substituting solutions or vasoconstrictive drugs. It is necessary to monitor kidney function. Dialysis is ineffective (binding to proteins - 90%). To prevent further absorption of the drug, it is advisable to wash the stomach, take activated charcoal and osmotic laxatives (sodium sulfate).
DRUG INTERACTION
No interaction was found with simultaneous use of tamsulosin with atenolol, enalapril, nifedipine, or theophylline.
Simultaneous use of cimetidine increases the level of tamsulosin in blood plasma. Furosemide reduces the level of tamsulosin in the blood plasma. However, in both cases, these levels remain within the therapeutically active concentrations and the dose should not be changed.
Diclofenac and indirect anticoagulants (warfarin) slightly increase the rate of excretion of tamsulosin.
In studies in vitro, no interaction was found at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, and finasteride.
Simultaneous use of tamsulosin with others? 1- adrenoblokatorami and other drugs that reduce blood pressure, can lead to a marked increase in the hypotensive effect.
The concentration of tamsulosin in the blood plasma did not change in the presence of diazepam, trichloromethiazide or simvastatin. Also tamsulosin did not change the concentration of diazepam, propranolol, trichloromethiazide and chloromadinone.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 ° C. Shelf life - 2.5 years.
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