Important Safety Information for Dapoxetine Users

& Althof, S.

How does premature ejaculation impact a man's life?

• Dapoxetine is not a treatment for erectile dysfunction; separate management may be needed.
• It does not affect libido or sexual desire; action is solely on ejaculation reflex.
• The drug does not interact with phosphodiesterase-5 inhibitors (e.g., sildenafil) in a clinically harmful way.

Bailey, G. C. & Trost, L.

W.

• Before starting Dapoxetine 60 mg, confirm no contraindications with your healthcare provider.
• Regular check-ups may be recommended to monitor your response to the medication.
• Dapoxetine has been shown to delay ejaculation and prolong intimacy.
• Do not use Dapoxetine if you are taking nitrates or medications for blood pressure.
• A dose adjustment may be necessary based on individual response and side effects.
• Avoid high-fat meals close to the time of taking the medication for optimal absorption.
• The medication can be effective in combination with psychological therapy if needed.
• Be aware of potential drug interactions with antidepressants or certain antibiotics.

Current diagnosis and management of premature ejaculation. Curr Sex Health Rep 6, 65–80 (2014). Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Carson, C.

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However, from a review of all the studies reported in the literature, AEs of dapoxetine are generally tolerable. In the integrated analysis of the McMahon et al16 study, total AEs occurred in 35.1%, 47.0%, 60.3% subjects with placebo, dapoxetine 30 mg and dapoxetine 60 mg on-demand orally, respectively. In Figure 7, the total number of AEs occurred in 49.1% (2601/5293) and 20.7% (1040/5017) of subjects treated with dapoxetine and placebo, respectively. In Figure 8, the total number of AEs occurring with dapoxetine 60 mg or 30 mg were 58.2% (1421/2441) and 36.6% (907/2476), respectively. The most frequently reported AEs were nausea, dizziness, headache, diarrhea and insomnia22,23.

3.2 Dosage and Administration

Fortunately, the most common AEs with dapoxetine were mild or moderate in nature and were transient symptoms9,10,11,12,13,15,16,17,18,19,20,21,24,25. The present findings agree with the results of previous clinical trials that reported similar low incidence rates of side effects. Dapoxetine is a short-acting SSRI and doses of 30 mg and 60 mg have been evaluated through our meta-analysis. Peak plasma concentrations of dapoxetine were observed within 1.01–1.27 hours after oral administration24. The elimination half-life time is 1.3–1.4 hours and there appears to be very little accumulation24.

Chemical Names

Dapoxetine undergoes rapid absorption, elimination and dose-dependent pharmacokinetics, which are unaffected by multiple dosing. The unique pharmacokinetic characteristics might be the reason why dapoxetine is the on-demand treatment of choice for PE. Safety and efficacy data have demonstrated that dapoxetine use produces acceptable improvement in the IELT and PGIC with on-demand use. Thus, we also believe it is probably better suited as an on-demand treatment option for PE26. Our systematic review and meta-analysis has many drawbacks, the primary one being that this was a heterogeneous trial. & Gunn, K.

Premature ejaculation: definition and prevalence.

Similar Trials

In an attempt to reduce the high heterogeneity, we carried out a subgroup analysis among studies involving the drug dosage used (30 mg versus 60 mg groups). The heterogeneity was significantly decreased when comparing dapoxetine with placebo in the IELT by subgroup analysis. However, this heterogeneity of data still exists in the PGIC and AEs analyses, which we were unable to improve. We believe this heterogeneity might have resulted in the evaluation of the PGIC value using a 7-point scale (from −3 = much worse to 3 = much better) and AEs that were assessed using a subjective evaluation by individual patients. Additional factors might have been potentially amplified heterogeneity; these include differences in treatment duration, individual differences and mental or physical conditions.

Authors and Affiliations

Secondly, some of the included studies did not report the outcome measures; hence, the statistical results might be influenced by the statistical parameters used for calculations. Additionally, nearly all trials included in this study lacked a clear description of the allocation concealment, but all trials included in this meta-analysis were RCTs, the methods were designed well. Thus, the data from the studies included in our meta-analysis were reliable. In summary, our meta-analysis has shown that either 30 mg or 60 mg dapoxetine on-demand orally was associated with a significantly greater increase in mean IELT and PGIC compared placebo. Additionally, 60 mg had a better efficacy than 30 mg dapoxetine on-demand orally.

2.3 Pharmacokinetics

However, the meta-analysis also demonstrated that those treated with dapoxetine (especially 60 mg on-demand orally) reported more AEs than placebo or the dapoxetine 30 mg group. Nonetheless, the most commonly reported AEs were mild and tolerated. We searched the following databases up to and including June 2014: MEDLINE by PubMed, EMBASE, Cochrane Central Register of Controlled Trials (Cochrane Library). We did not restrict our search to articles tadalafil with dapoxetine online published in English and the following search terms were used in conjunction with: dapoxetine, SSRIs and premature ejaculation, sexual dysfunction. We also searched the relevant references of all studies included in the analysis. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomized controlled trials. Treatment benefit of dapoxetine for premature ejaculation: result from a placebo-controlled phase III trial.

Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine.

• Dapoxetine 60 mg is designed to be taken on an as-needed basis.
• Using Dapoxetine can significantly improve sexual satisfaction for some men.
• Always read the patient information leaflet provided with the medication.
• The medication is not suitable for women or individuals under 18 years old.
• Keep track of any side effects experienced and report them to your doctor.
• Do not combine Dapoxetine with other SSRIs or monoamine oxidase inhibitors.
• The effectiveness varies; some men may experience better control than others.
• Avoid driving or operating heavy machinery after taking Dapoxetine if feeling dizzy.

Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 trial in 22 Countries.

Ethics declarations

Statistical analysis of dichotomous variables (PGIC and AEs) were performed using the RR as the summary analysis, while continuous variable (IELT) was analyzed using the MD; accompanying 95% CIs and P-values were reported. For all statistical results, P < 0.05 was considered statistically significant. The Mantel-Haenszel χ2 test and I2 statistic for heterogeneity were conducted. I2 values of <50% were defined as acceptable; those >50% indicated high levels of heterogeneity. When there was a lack of heterogeneity, a fixed-effects models was used, otherwise random-effects model was applied for the meta-analysis.

Dapoxetine 60 mg: Side Effects

Sexual problems among women and men aged 40–80 y: prevalence and correlates identified in the global study of sexual attitudes and behaviors. The Premature Ejaculation Prevalence and Attitudes (PEPA) survey: prevalence, comorbidities and professional help-seeking. An update of the international society of sexual medicine's guidelines for the diagnosis and treatment of premature ejaculation (PE). An evidence-base definition of lifelong premature ejaculation: report of the internation society for sexual medicine ad hoc committee for the definition of premature ejaculation. Symonds, T., Roblin, D., Hart, K. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine for treatment of lifelong premature ejaculation. Comparison of paroxetine and dapoxetine, a novel selective serotonin reuptake inhibitor in the treatment of premature ejaculation. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. & Dinsmore, W.

Medical uses

All retrieval literatures were independently performed by Cao D and HY. Included in the study were all published or unpublished RCTs evaluating dapoxetine interventions for PE. Studies comparing dapoxetine intervention versus placebo or another drug intervention were eligible for this review. All relevant studies were included in this study if they met the following criteria: (1) all patients were older than 18 years; (2) patients were diagnosed with PE; (3) patients were treated with oral dapoxetine on-demand (1–3 hours before sexual activity); (4) data were available for at least one of the predefined outcome measurements. Studies were excluded if (1) patients were diagnosed with mixed sexual dysfunction such as erectile dysfunction plus PE; (2) patients were treated with a fixed-dose orally daily; (3) the data referred to data from an animal study; or (4) studies reported data from non-RCTs or quasi-RCTs.

Brief Summary

The following variables from each study were recorded independently by two reviewers and cross-checked: first author name, publication year, research design type, total number of patients enrolled, patient age, intervention method, outcome measures. In addition, the following primary outcome was extracted: IELT, defined as the time from the start of vaginal insertion to the start of intravaginal ejaculation and measured using the stopwatch. The secondary outcomes were as follows: PGIC, also called the clinical global impression of change (CGIC or CGI) in some studies, defined as a validated tool used to measure overall perceived change in patients with better and much better results after treatment (i.e., “Compared to the start of the study, would you describe your PE problem as much worse, worse, slightly worse, no change, slightly better, better, or much better?27”) and AEs, defined as potential symptoms related to dapoxetine discontinuation sildenafil and dapoxetine syndrome such as nausea, diarrhea, insomnia, headache, dizziness, erectile dysfunction, fatigue. The methodological quality of the included studies was measured independently by two reviewers using the Cochrane Handbook for Systematic Reviews of Interventions28. The main evaluation items included: (1) random sequence generation (selection bias), (2) allocation concealment (selection bias), (3) blinding of participants (performance bias), (4) blinding of outcome assessment (detection bias), (5) incomplete outcome data (attrition bias), (6) selective reporting (reporting bias) and (7) other bias.

Inclusion Criteria

These criteria for a judgment of low, high, or unclear risk of bias for each item were used to describe the bias. A “Yes,” “No,” or “Unclear” assessment expressed as low risk of bias, high risk of bias, or uncertain risk of bias, respectively. Disagreements were discussed and resolved by using a third person-evaluation. These assessments were reported for each individual study in the “risk of bias in included studies” in Figure 2. All statistical analyses were conducted using Review Manager, version 5.1.0 (Cochrane Collaboration, Oxford, UK). W. Dapoxetine: an evidence-based review of its effectiveness in treatment of premature ejaculation. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study.