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Pharmacological effect

A remedy for the treatment of benign prostatic hyperplasia Suppresses the activity of 5α-reductase 1 and 2 isoenzymes, which are responsible for the conversion of testosterone into 5α-dihydrotestosterone. Dihydrotestosterone is the main androgen responsible for hyperplasia of the glandular tissue of the prostate.
The maximum effect of Dutasteride (Avodart)on the decrease in the concentration of dihydrotestosterone is dose-dependent and is observed after 1-2 weeks. After starting treatment. After 1 and 2 weeks. Dutasteride at a dose of 0.5 mg/day reduces the average concentration of dihydrotestosterone in serum by 85% and 90%.


INTERACTIONS: Since dutasteride is metabolized by the CYP 3A4 isoenzyme, the plasma concentration of dutasteride may increase in the presence of CYP 3A4 inhibitors and the clearance of dutasteride decreases with the simultaneous application of CYP 3A4 inhibitors with verapamil (37 %) and diltiazem (44%). At the same time, the clearance of dutasteride does not decrease with the use of another calcium channel antagonist along with amlodipine. The decrease in clearance and the corresponding increase in the effect of dutasteride in the presence of CYP 3A4 inhibitors is not of great clinical significance due to the broad spectrum of safety of the drug. In vitro isoenzymes CYP 1A2, CYP 2C9, CYP2 C19 and CYP 2D6 do not participate in the metabolism of dutasteride in humans, dutasteride does not inhibit enzymes of the cytochrome P450 system in humans involved in drug metabolism.In vitro studies have established that dutasteride does not prevent warfarin, diazepam or phenytoin from binding to plasma proteins and that these components do not replace dutasteride. The interaction of dutasteride with tamsulosin, terazocin, warfarin, digoxin and colestyramine has been studied. No clinically significant interaction was detected. Although specific drug interaction studies have not been conducted, approximately 90% of all patients in clinical studies with dutasteride received another concomitant therapy. No clinically significant adverse effects have been observed during the simultaneous use of dutasteride with antihyperlipidemic drugs, ACE inhibitors, -adrenergic receptor blockers, calcium channel blockers, GCS, diuretics, NSAIDs, phosphodiesterase type V inhibitors and quinolone antibiotics. According to a study to investigate the interaction of tamsulosin or terazocin in combination with Avodart for 2 weeks, no signs of pharmacokinetic or pharmacodynamic interaction were detected.


OVERDOSAGE: According to clinical studies, in volunteers, a single dose of dutasteride up to 40 mg / day (80 times more than therapeutic) for 7 days did not cause adverse reactions, taking into account the safety of their use . In clinical studies, a dose of dutasteride was administered at 5 mg/day for 6 months without the appearance of additional adverse effects compared to dutasteride at a dose of 0.5 mg/day. There is no specific antidote, therefore, in case of a possible overdose, symptomatic treatment is carried out.



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