Priligy (Dapoxetine) is used to delay ejaculation and prolong sexual intercourse in men suffering from premature ejaculation. The active ingredient dapoxetine can significantly reduce the production of hormone Serotonin, which in turn significantly delay the moment of ejaculation in most men.
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The mechanism of action of Priligy in premature ejaculation is associated with inhibition of the reuptake of serotonin by neurons, followed by an increase in the action of the neurotransmitter on pre- and postsynaptic receptors. The mechanism of ejaculation is regulated mainly by the sympathetic nervous system. Postganglionic sympathetic nerve fibers innervate the seminal vesicles, the vas deferens, the prostate, the urethra and the neck of the bladder, causing their coordinated contraction to achieve ejaculation.
Dapoxetine + excipients.
Dapoxetine is rapidly absorbed, and the maximum concentration in the blood plasma (Cmax) is reached 1-2 hours after taking the drug. The intake of fatty food moderately reduces Cmax of dapoxetine (by 10%) and increases by 12% the AUC and the time to reach the maximum concentration in the blood plasma.
However, the degree of absorption of dapoxetine remains unchanged. These changes are not clinically significant. Priligy can be taken regardless of food intake. More than 99% of dapoxetine binds to plasma proteins. The active metabolite, desmethyldapoxetine, binds to plasma proteins by 98.5%. Dapoxetine is rapidly distributed throughout the body with an average equilibrium volume of distribution of 162 liters. Studies suggest that dapoxetine is metabolized by many liver and kidney enzymes, especially CYP2D6, CYP3A4 and flavin-containing monooxygenase (FM01) kidney.
In a clinical study in which the metabolism of 14C-dapoxetine was studied, dapoxetine was actively metabolized after oral administration mainly by N-oxidation, N-demethylation, hydroxylation of the naphtho group, glucuronization and addition of the sulfo group. After oral administration, signs of a pre-systemic metabolism in the liver were found. The main components circulating in the blood plasma were intact dapoxetine and dapoxetine-N-oxide. In studies, it was found that dapoxetine-N-oxide is inactive. In addition, desmethyldapoxetine and didezmethyldapoxetine were detected in an amount of less than 3% of the total number of circulating metabolites of dapoxetine.
The study found that desmethyldapoxetine is comparable in activity to dapoxetine, and didezmethyldapoxetine is about 2 times less active than dapoxetine. The exposure (AUC and Cmax) of unbound desmethyldapoxetine was 50% and 23% of unbound dapoxetine, respectively. Metabolites of dapoxetine are excreted mainly with urine in the form of conjugates. An unchanged active substance in the urine is not detected.
Dapoxetine is rapidly excreted, as evidenced by the low concentration of the substance in the blood plasma (less than 5% of the maximum) 24 hours after the dose. With daily intake of accumulation of matter in the body is minimal. When taken orally, the final elimination half-life is approximately 19 hours. A single dose of dapoxetine in a dose of 60 mg did not reveal a significant difference in pharmacokinetics in healthy older men and men of a younger age.
Indications for use
The treatment of premature ejaculation in men aged 18 to 64 years (reflex enhancement of potency due to prolonged sexual intercourse and increase confidence).
Forms of release
Tablets coated with 30 mg and 60 mg.
Instructions for use and intake chart
For oral administration. The tablet should be swallowed whole, washed down with at least one full glass of water. Priligy can be taken regardless of food intake.
The recommended initial dose for all men is 30 mg; this dose is taken 1-3 hours before the alleged sexual intercourse. With insufficient effect and good tolerability of 30 mg dose, it can be increased to 60 mg. The maximum recommended dose frequency is 1 time every 24 hours.
The doctor who prescribes Priligy for the treatment of premature ejaculation should assess the risk and benefit of using the drug after the first 4 weeks of treatment or after taking 6 doses and should determine the risk-benefit ratio for making a decision about expediency of further treatment with Priligy.