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Dapoxetine belongs to a class of selective serotonin reuptake inhibitors (SSRIs). This short-acting inhibitor is used to treat premature ejaculation in men. Dapoxetine should not be used by pregnant/nursing women or children as well as by the patients having demonstrated a reaction of hypersensitivity to it.
If you have missed your dose, take it as soon as you remember. If you see that it is near the time for the next dose, skip the missed dose and resume your usual dosing schedule. Do not take your dose twice. If you think you have used too much of this medicine seek emergency medical attention right away.
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The symptoms of overdose usually include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting. Store your medicines at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store your drugs in the bathroom. Keep all drugs away from reach of children and pets.
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Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI) with an IC50 of 1.12 nM, and its major metabolites in humans, desmethyldapoxetine (IC50 < 1.0 nM) and didesmethyldapoxetine (IC50 < 2.0 nM), are equivalent or less strong (dapoxetine-N-oxide (IC50 = 282 nM)).
Ejaculation in humans is primarily regulated by the sympathetic nervous system. Ejaculation is triggered by the spinal reflex center with the participation of the brain stem, which is initially influenced by a number of brain nuclei (medial preoptic and paraventricular nuclei).
The mechanism of action of dapoxetine in premature ejaculation is presumably associated with inhibition of serotonin reuptake by neurons and a subsequent increase in the effects of neurotransmitters on pre- and postsynaptic receptors.
In rats, dapoxetine inhibits the reflex mechanism of ejaculation by acting on the lateral paragiant cell nucleus at the supraspinal level. Postganglionic sympathetic fibers innervating the seminal vesicles, vas deferens, prostate gland, muscles covering the bulbourethral glands and the bladder neck cause their coordinated contractions necessary for the onset of ejaculation. In rats, dapoxetine alters this reflex mechanism for the onset of ejaculation.
Clinical efficacy and safety
The effectiveness of Priligy in the treatment of premature ejaculation was established in five double-blind, placebo-controlled clinical trials in which a total of 6081 patients were randomized. The age of the patients was 18 years and older. For the period of 6 months before the inclusion of these individuals in the study, they had premature ejaculation in most sexual acts. Premature ejaculation was defined according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria: a short ejaculatory onset time (intravaginal ejaculation latent time [IELT; time from vaginal penetration to intravaginal ejaculation] time) of less than two minutes, which measured using a stopwatch in four studies), poor control of ejaculation, and significant interpersonal stress or difficulty associated with this condition.
The results of all randomized trials were comparable. Efficacy was demonstrated after 12 weeks of treatment. One study included patients from both the EU and other countries, and the duration of treatment was 24 weeks. In this study, 1162 patients were randomized: 385 to placebo, 388 to Priligy 30 mg as needed, and 389 to Priligy 60 mg as needed. The mean and median mean IELT score at the end of the study is presented in Table 1 below, and the cumulative distribution of subjects who achieved at least a representative mean IELT level at the end of the study is presented in Table 2 below. Other studies and pooled data analysis at week 12 showed similar results.