Priligy is one of the best medicines on the market to fight premature ejaculation. Its active ingredient dapoxetine is a selective serotonin reuptake inhibitor. Priligy influences the passing of information between nerve cells allowing some control over ejaculation.When is Priligy used?
This is a medication intended to treat premature ejaculation. Premature ejaculation is when you are not able to control your orgasm and ejaculate either before or shortly after penetration. This can cause serious relationship issues as well as feelings of frustration. Priligy will help delay ejaculation, giving you a better sex life. Cialis will act by stimulating the arterial vessels in the penis, allowing more blood to flow. It is important to state that the medication alone does nothing as it is always required sexual stimulation in order to achieve and maintain an erection. With Cialis you can expect to revert the normal process of the body where blood vessel stimulants created by the body are broken down; Cialis blocks this, resulting in a longer erection.How to use Priligy?
You should take a tablet 1-3 hours before any sexual activity. You should swallow it with a glass of water. Please keep in mind that while taking Priligy you should drink plenty of fluids in order to avoid dizziness and fainting as side effects. In order to avoid complications in terms of side effects, please do not take Priligy more than three times per week.Dosage
The normal dose is: 1 30 mg tablet for men aged 18-64 years This is the maximum daily dose. Do not take more and always follow your doctors advice.
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An online doctor consultation means filling out a medical questionnaire. A registered EU doctor assesses your medical questionnaire and analize whether Priligy (dapoxetine) is suitable and safe for you to buy. After approval, a prescription is issued and send to the registered EU pharmacy. You will receive your discretely shipped Priligy pills within 3 business days.
A clinical trial (phase III) with more than a thousand men and their female partners assessed the improvement of premature ejaculation while on 30mg/60mg of Dapoxetine. The results show significant improvements in men with premature ejaculation when taking Dapoxetine 30mg/60mg versus the placebo group.
Dapoxetine is a potent selective serotonin reuptake inhibitor. Ejaculation in humans is regulated, first of all, by the sympathetic nervous system. Ejaculation is triggered by the spinal reflex center with the participation of the brain stem, which is primarily affected by a number of brain nuclei (medial preoptic and paraventricular nuclei). The mechanism of action of dapoxetine in premature ejaculation is probably associated with the inhibition of serotonin reuptake by neurons and the subsequent increase in the effect of neurotransmitters on pre- and postsynaptic receptors.
The effectiveness of Priligy in the treatment of premature ejaculation was established in five double-blind clinical trials with a placebo control, in which there was a randomized total of 6081 patients. Patients were over 18 years old. 6 months before the inclusion of these individuals in the study, they had premature ejaculation in most sexual acts. Premature ejaculation was determined according to the diagnostic criteria DSM-IV (Guidelines for the diagnosis and statistics of mental disorders): the short time of onset of ejaculation (latent time of intravaginal ejaculation [IELT, time from vaginal penetration to the time of intravaginal ejaculation] is less than two minutes, which was measured with using a stopwatch in four studies), poor control over ejaculation,
People with other types of sexual dysfunction, including erectile dysfunction, as well as people who use other drugs to treat PE, were excluded from all studies. The results of all randomized trials are comparable. Efficacy was observed after 12 weeks of treatment. One study included patients from both EU countries and other countries, the duration of their treatment was 24 weeks. In the study, 1162 patients were randomized, 385 took a placebo, 388 patients took Priligy 30 mg if necessary, 389 patients took Priligy 60 mg if necessary. The average value and average IELT (Intravaginal Ejaculatory Latency Time) at the end of the study are presented in Table 1, and the total distribution of patients.
The magnitude of IELT lengthening was associated with the output IELT and was variable in individual patients: the clinical significance of Priligy's treatment efficacy was demonstrated in the given efficacy indices and analysis of the data of patients with therapeutic effect.
A patient with a therapeutic effect was defined as having at least a category 2 increase in ejaculation control plus at least a category 1 decrease in ejaculation disorders. Statistically, the majority of patients had a therapeutic effect in each group using Priligy compared to the placebo group at the end of the study: week 12 or 24. A higher percentage of patients with a therapeutic effect in the Priligy group was 30 mg (11.1% - 95%). CI [7.24; 14.87]) and Priligy 60 mg (16.4% - 95% CI [13.01; 19.75]) compared with the placebo group at week 12 (generalized analysis).
The clinical significance of the effect of Priligy's treatment is presented as an example of a group for measuring the result of the overall clinical impression of a patient (CGIC), in which patients were asked to compare their premature ejaculation from the very beginning of the study, with a gradation of responses from “much better” to “much worse”. At the end of the study (week 24), 28.4% (30 mg group) and 35.5% (60 mg group) of patients reported that their condition was better or much more preferable compared to 14% in the placebo group. Also, 53.4% and 65.6% of patients taking Priligy 30 mg and 60 mg, respectively, reported that their condition was at least slightly better compared to 28.8% in the placebo group.
Dapoxetine is rapidly absorbed and reaches a maximum plasma concentration (C max) approximately 1-2 hours after administration. Bioavailability is 42% (range 15-76%), and in the range from 30 mg to 60 mg, C max and AUC (area under the curve) increased in proportion to the dose. After repeated administration, the AUC values for dapoxetine and the active metabolite desmethyldoxetine increased by approximately 50% compared to AUC values after taking the drug in a single dose. Eating fatty foods slightly decreased C max (by 10%) and slightly increased the AUC of dapoxetine (by 12%), and also slightly extended the time to reach the peak concentration of dapoxetine. These changes were not clinically significant. Priligy can be taken without regard to meals.
Distribution. In vitro, 99% of dapoxetine binds to plasma proteins in humans. The active metabolite desmethyldoxetine binds to proteins by 98.5%. The average volume of distribution of dapoxetine in equilibrium is 162 liters.
Metabolism. According to in vitro studies, dapoxetine is metabolized by numerous enzyme systems in liver and kidney tissue (primarily CYP2D6, CYP3A4) and flavins containing monooxygenase (FMO1). After taking 14 C-dapoxetine, the latter is actively metabolized with the formation of numerous metabolites, involving, first of all, such biotransformation pathways of N-oxidation, N-demethylation, hydroxylation of naphthyl, glucuronidation and sulfation. There is evidence of a systemic effect of the first passage after ingestion.
Most of the substances circulating in the plasma were intact dapoxetine and dapoxetine N-oxide. In vitro binding and transport, studies have shown that dapoxetine N-oxide is inactive. Additional metabolites, including desmethyldapoxetine and didesmethyldoxetine, accounted for less than 3% of the total amount of substances in the plasma associated with the drug. In vitro binding studies have shown that desmethyl dapoxetine and dapoxetine have the same efficacy, and desmethyl dapoxetine activity is approximately 50% dapoxetine activity. The concentration of free desmethyl dapoxetine (AUC and C max) is respectively 50% and 23% of the concentration of free dapoxetine.
Conclusion. Dapoxetine metabolites are excreted primarily with urine in the form of conjugates. The active substance in unchanged form in the urine did not show. After administration, the initial half-life of dapoxetine (pharmacokinetics) was approximately 1.5 hours, the plasma level was less than 5% of the peak concentration 24 hours after administration, and the final half-life was approximately 19 hours, as was the final half-life of desmethyl dapoxetine.
The metabolite desmethyldoxetine promotes the pharmacological effect of Priligy, in particular, when the effect of desmethyldoxetine increases. Below is an increase in the indices of the active fraction in some groups of patients. This is the result of the free effects of dapoxetine and desmethyl dapoxetine. Desmethyl dapoxetine has the same potency as dapoxetine. A preliminary calculation provides for a uniform distribution of desmethyldoxetine in the central nervous system, but it is not known whether this will be so.
Race. An analysis of the clinical pharmacology of a single dose of 60 mg of dapoxetine did not show statistically significant differences in patients of different races.
Analysis of a study of clinical pharmacology after a single dose of dapoxetine at a dose of 60 mg did not reveal a statistically significant difference between the representatives of Hispanics, as well as of the Caucasian, Negroid and Mongoloid races. Clinical studies have been conducted to compare the pharmacokinetics of dapoxetine in Japanese and Europeans and found that Japanese have a higher plasma dapoxetine level (10-20%) (area under the curve and maximum concentration) due to lower body weight. The significant clinical effect, if the concentration is slightly higher, is not expected.
A pharmacology analysis of a single dose of 60 mg of dapoxetine showed no significant differences in the pharmacokinetics (C max, AUC inf, T max) of healthy elderly men and healthy young men. Efficacy and safety have not been established for patients in this group.
A clinical pharmacological study of the use of a single dose of 60 mg of dapoxetine was conducted in patients with mild (creatinine clearance from 50 to 80 ml / min), moderate (creatinine clearance from 30 to <50 ml / min) and severe renal impairment (creatinine clearance <30 ml / min) and patients with normal renal function (creatinine clearance> 80 ml / min). There was no tendency to increase the AUC of dapoxetine with a decrease in renal function. The AUC in patients with severe renal failure was approximately 2 times greater than in patients with normal renal function, although limited data are available for patients with severe renal failure. The pharmacokinetics of dapoxetine has not been evaluated in patients requiring hemodialysis.
In patients with moderate hepatic impairment, the free C max value of dapoxetine is reduced by 28%, and the free AUC value is unchanged. The free value of C max and AUC of the active fraction (the sum of the free influence of dapoxetine and desmethyl dapoxetine) was reduced by 30% and 5%, respectively. In patients with moderate hepatic impairment, the free C max value of dapoxetine remains virtually unchanged (a decrease of 3%) and free AUC increases by 66%. The free C max and AUC of the active fraction of dapoxetine and desmethyl dapoxetine were practically unchanged and doubled, respectively.
In patients with severe hepatic insufficiency, the free C max value of dapoxetine was reduced by 42%, but the free AUC value was increased by about 223%. C max and AUC of the active fraction had similar changes.
Treatment of premature ejaculation (PE) in adult men aged 18 to 64 years. Priligy is recommended only for patients who meet the following criteria: • The latent time of intravaginal ejaculation (IELT) is less than two minutes; • persistent or repeated ejaculation after minimal sexual stimulation before, during or shortly after sexual penetration, which occurs earlier than the patient's desired moment; • severe stress or difficulties that arose in interpersonal relationships as a result of PE;
the beginning of premature ejaculation in most attempts at sexual intercourse in the last 6 months. Priligy should be taken if necessary only as a treatment - before the alleged sexual intercourse. Priligy cannot be prescribed to delay ejaculation for men who have not been diagnosed with PE.
Simultaneous administration of MAO inhibitors (MAO inhibitors) or if less than 14 days have passed after stopping their administration. Priligy should be discontinued at least 7 days before the start of therapy with MAO inhibitors.
Concomitant use of thioridazine or within 14 days after the end of an administration. The use of Priligy should be discontinued at least 7 days before starting thioridazine therapy.
Concomitant use of serotonin reuptake inhibitors (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SIZSN), tricyclic antidepressants (TCAs)) or other herbal medicines with serotonergic tri-Phyto-L-like action triptans, tramadol, linezolid, lithium, Hypericum perforatum (Hypericum perforatum)] or within 14 days after cancellation of these drugs / herbal products. These medicines / herbal preparations should not be taken within 7 days after the end of taking Priligy.
Simultaneous administration of potent CYPZA4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc. (see Section "Interaction with other drugs and other types of interactions").
When taking SSRIs in combination with MAO inhibitors, serious reactions were reported, sometimes with a fatal outcome, which included hyperthermia, rigidity, myoclonia, disorders of the autonomic nervous system with the possible occurrence of rapid changes in vital functions, as well as changes in mental status, including severe agitation, rolling into delirium and to whom. Such reactions have also been reported in patients who have recently completed taking SSRIs and started taking MAO inhibitors. There have been isolated cases with symptoms resembling malignant antipsychotic syndrome. Data on the combined use of SSRIs and MAO inhibitors from animal studies suggest that these drugs can act synergistically, raising blood pressure and causing arousal. Therefore Priligy should not be used in combination with MAO inhibitors or within 14 days after they are canceled. MAO inhibitors should not be taken within 7 days after the end of taking Priligy.
Taking thioridazine causes an extension of the QTk interval, which is associated with the occurrence of severe ventricular arrhythmias. Drugs such as Priligy that inhibit the CYP2D6 isoenzyme are likely to inhibit thioridazine metabolism. It is expected that the elevated level of thioridazine resulting from this leads to a more pronounced lengthening of the QTk interval. Priligy should not be used in combination with thioridazine or within 14 days after its withdrawal. Thioridazine should not be taken within 7 days after taking Priligy.
Medicines / herbal preparations with serotonergic effects. As with selective serotonin reuptake inhibitors, co-administration with herbal drugs / drugs with a serotonergic mechanism of action (including MAO inhibitors, L-tryptophan, triptans, tramadol, linezolid, SSRIs, SIZZNS (selective serotonin reuptake inhibitors ), lithium, and Hypericum-based preparations (Hypericum perforatum)) can lead to an increase in the frequency of serotonin effects. Priligy should not be used in combination with other SSRIs, with MAO inhibitors, or with other herbal medicines with a serotonergic mechanism of action or within 14 days after they are canceled. In a similar way,
A systematic assessment of Priligy's intake together with drugs acting on the central nervous system (such as antiepileptic drugs, antidepressants, antipsychotics, anxiolytics, hypnotics with sedative effects) was not performed in patients with premature ejaculation. Therefore, if co-administration of Priligy and these drugs is necessary, caution is recommended.