ალიმენტური ტრაქტი და მეტაბოლიზმი
სისტემური გამოყენების ინფექციის საწინააღმდეგო
სისხლი და სისხლ-წარმომქმნელი ორგანოები
სამომავლოდ დაგეგმილი პროდუქტები
Tamsaprost (MR Capsules)
Capsules. Capsule contains tamsulosin hydrochloride 0.4 mg.
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.
- Treatment of dysuric symptoms of lower urinary tract inflicted by benign
- Proven hypersensitivity to the components of the drug.
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
Treatment duration is set individually.
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
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.
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.
10 capsules in a blister.
3 blisters with a leaflet in a carton box.