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Depressed mood, mood changes, disturbances in thinking, syncope, and other orthostatic reactions have been reported occasionally. Occurrence of depressive symptoms and suicidality is a general concern with SSRIs, there is no specific data for dapoxetine available. Visual disturbances, tinnitus, and dizziness have been reported occasionally. Bradycardia, tachycardia, blood pressure fluctuations with hypotension or hypertension, as well as orthostatic hypotension and syncope may occur. Nausea occurs very frequently (in more than 10% of patients).
Diarrhea, vomiting, abdominal pain, and flatulence occur frequently. Dapoxetine must not be coadministered with monoamine oxidase inhibitors (MAO inhibitors), selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or other serotonergic agents (such as St. John’s wort, tramadol, triptans, linezolid, lithium, or thioridazine) because of the risk of serotonin syndrome. Dapoxetine must not be combined with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, or similar agents, because these drugs can markedly increase dapoxetine plasma concentrations. Concomitant use of anticoagulants or antiplatelet agents may increase the risk of bleeding.
Exercise caution when dapoxetine is used with other centrally acting depressants (such as alcohol, sedatives, or opioids) because of the potential for additive sedative effects. Moderate and severe hepatic impairment (Child–Pugh B and C). Severe renal impairment with an estimated glomerular dapoxetine over counter filtration rate of less than 30 mL/min. Significant structural heart disease (such as heart failure New York Heart Association class II–IV, clinically relevant conduction disorders, significant coronary artery disease, or severe valvular heart disease). Mania, major depression, or ongoing psychiatric pharmacotherapy (see above). Eligible patients attended our andrology clinic with premature ejaculation were randomly allocated into three groups: group A (92 participants) received on-demand tadalafil, 5 mg; group B (91 participants) were given on-demand dapoxetine, 30 mg; and group C (89 participants) received on-demand combination of tadalafil, 5 mg, and dapoxetine, 30 mg. We assessed the changes in the intravaginal ejaculatory latency time (IELT) and the satisfaction scores 1, 2, and 3 months after treatment.
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Highly statistically significant improvements were found in the mean IELT and satisfaction scores 1, 2, and 3 months post-treatment in all groups (P = <0.001). Post hoc analysis suggested this improvement was more pronounced in group C (P < 0.001).
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You are here: Urology Textbook > Drugs in Urology > Dapoxetin Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) with a short duration of action. By inhibiting the serotonin transporter, it increases serotonin concentrations in the synaptic cleft, which delays the ejaculatory reflex and prolongs the intravaginal ejaculatory latency time (IELT). On-demand medication for the treatment of premature ejaculation in men 18 to 64 years of age (typically characterized by an IELT of less than two minutes, lack of control over ejaculation, marked distress, and interpersonal difficulties) in whom sexual counseling alone has not resulted in a satisfactory improvement. The largest randomized, placebo-controlled trial included 1,162 patients (Buvat 2009). Starting from a mean IELT of approximately one minute at baseline, mean IELT values after 24 weeks were 1.9 minutes with placebo, 3.2 minutes with dapoxetine 30 mg, and 3.5 minutes with dapoxetine 60 mg. Both tadalafil and dapoxetine are effective in the treatment of patients with premature ejaculation, but the combination of both drugs gives better results.
Premature ejaculation (PE) is a male sexual disorder characterized by a brief intra-vaginal ejaculatory latency time (IELT) and lack of ability to properly control ejaculation which has detrimental personal effects [Citation1]. There is no global definition for PE.
Dapoxetine is not approved for women, children, or adolescents. The recommended starting dose for on-demand use is 30 mg taken orally 1 to 3 hours before anticipated sexual activity. The maximum dosing frequency is once per day. If the response is inadequate and tolerability is good, the dose may be increased to 60 mg. If there is no meaningful improvement or if adverse effects are unacceptable, clinicians should discontinue treatment.
& Giuliano, F. Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 Countries. It presents diseases of the genital organs through detailed text and images. Some content may not be suitable for children or sensitive readers. Many illustrations are available exclusively to Steady members. PE is defined according to the International Society for Sexual Medicine (ISSM) guidelines as ejaculation that always happens in fewer than 1 minute following vaginal penetrating from the initial sexual encounter (lifelong PE), or a decrease in IELT, less than 3 min (acquired PE) with inability to delay ejaculation on all or nearly all vaginal penetrations and negative personal consequences, such as distress, frustration, bother and/or avoidance of sexual intimacy [Citation2]. Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) define PE as a persistent or recurrent ejaculation that occurs within approximately 1 minute after vaginal penetration and before the individual wishes it.
| Advice Point | Explanation |
|---|---|
| Take 1-3 hours before sex | Ensures optimal effectiveness |
| Do not exceed 1 dose per 24 hrs | Risk of side effects and overdose |
| Avoid alcohol during use | Can increase side effects |
| Report adverse effects promptly | E.g., suicidal thoughts, severe dizziness |
| Use as part of a complete plan | Consult a healthcare provider for best results |
The problem must present for at least 6 months and present on almost all (approximately 75–100%) or on all occasions of sexual attempts with clinically significant distress and cannot be explained by a nonsexual mental disorder or as a result of severe relationship distress and is not attributable to the effects of a substance/medication or other medical condition [Citation3,Citation4]. A recent comprehensive novel classification of PE was reported by Raveendran A. In this classification, the grading of the severity of reduction of IELT was reported as mild or grade 1 (IELT of 2 to 3 minutes), moderate or grade 2 (IELT of 1 to less than 2 minutes), severe or grade 3 (IELT less than 1 minute), and extreme or grade 4 (ejaculation occurring prior to vaginal penetration) [Citation5].
Patients’ global assessment of treatment response after 24 weeks (placebo vs. 30 mg vs. 60 mg dapoxetine) showed no change or worsening in 68% vs. 42% vs. 28%, “a little better” or “better” in 28% vs.
48% vs. 60%, and “much better” in 4% vs. 10% vs. 12%, respectively. Dapoxetine is rapidly absorbed from the gastrointestinal tract, with a maximum plasma concentration reached after 1 to 2 hours.
Its bioavailability is approximately 42%, with considerable interindividual variability (15–76%), and food has only a minor effect on absorption. Dapoxetine undergoes extensive metabolism in the liver and kidneys, primarily via the cytochrome P450 (CYP) isoenzymes CYP2D6 and CYP3A4 as well as monooxygenases, and its metabolites are eliminated predominantly via the kidneys. The initial elimination half-life is approximately 1.5 hours, whereas the terminal half-life of active and inactive metabolites ranges from 18 to 22 hours. Nausea (2.2% of patients) and dizziness (1.2% of patients) are the most frequent adverse effects leading to discontinuation of dapoxetine treatment. Anxiety, restlessness, somnolence, headache, tremor, and dizziness occur commonly.