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Genito-Urinary System

Tamsaprost (MR Capsules)
(Tamsulosin)



CONTENT:
Capsules. Capsule contains tamsulosin hydrochloride 0.4 mg.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Tamsulosin selectively and competitively blocks postsynaptic ?1-adrenoreceptors, particularly ?1? and ?1D subtypes in smooth muscles of prostate, neck of urinary bladder, prostatic urethra and detrusor. In conditions of decrease in the tone of smooth muscles of prostate, neck of urinary bladder and prostatic urethra improvement of outflow of urine happens. Simultaneously, intensity of the symptoms of obstruction (emptying) and excitation (filling) of urinary bladder associated with benign prostatic hyperplasia decreases. Described influence of the drug on the symptoms of obstruction and excitation retains in prolonged administration.
Due to such high selectivity the drug does not cause clinically significant decrease in systemic blood pressure (BP) both in patients with normal BP and patients with arterial hypertension.
Therapeutic effect usually develops in 2 weeks after commencement of drug administration, though a decrease of symptom intensity in a number of patients is already observed after the first dose administration.
PHARMACOKINETICS. After oral administration tamsulosin is rapidly and almost completely absorbed from GIT. After single administration of 0.4 mg maximal plasma tamsulosin concentration is achieved in 6 hours. Tamsulosin demonstrates linear pharmacokinetics with achievement of steady-state plasma levels on the 5th day of therapy.
Tamsulosin is metabolized in cytochrome CYP3A4 system. Half-life period is 9 to 15 hours. Up to 76% (mainly as metabolites) is excreted by kidney, 21% is excreted in fecal masses.
 
THERAPEUTIC INDICATIONS:
- Treatment of dysuric symptoms of lower urinary tract inflicted by benign prostatic hyperplasia.
 
CONTRAINDICATIONS:
- Proven hypersensitivity to the components of the drug.
 
SIDE EFFECTS:
Possible: headache, dizziness, asthenia, sleep disturbance (somnolence or insomnia), retrograde ejaculation, decreased libido, backache, rhinitis, nausea, vomiting, constipation or diarrhea.
 
DOSAGE AND ADMINISTRATION:
Take 1 capsule of the drug daily after meal (with the interval of 24 hours), with sufficient amount of water. A capsule should be swallowed without chewing otherwise disturbance of controlled modified release of active ingredient is possible.
Treatment duration is set individually.
 
DRUG INTERACTIONS:
It is not recommended to administer the drug with potent inhibitors of cytochrome CYP3A4 system (e.g. ketokonazole).
Tamsaprost should not be administered with other alpha-adrenoblockers.
It is necessary to exercise caution while taking the drug with erythromicine, paroxetine, cimetidine, warfarin and terbinafine.
There is no necessity of dose adjustment in concurrent administration of nifedipine, atenolol, enalaprile, digoxin, theophylline and furosemide.
 
INFLUENCE ON THE ABILITY TO DRIVE AND TO OPERATE OTHER MECHANISMS:
During the treatment one should be cautious while driving and operating potentially dangerous kinds of activity demanding the heightened attention and rate of psychomotor reactions.
 
OVERDOSE:
Cases of acute drug overdose have not been noticed.
Theoretically, after the drug overdose there is a possibility of acute hypotension development that requires commencement of cardiotropi? therapy, monitoring of the cardiovascular system function and kidney function. To prevent further absorption of the drug, gastric lavage, activated carbon or osmotic purgative administration is recommended. Dialysis is not reasonable because of significant extent of binding of tamsulosin with blood plasma proteins.
 
PACKAGING:
10 capsules in a blister.
3 blisters with a leaflet in a carton box.
 
 
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