For healthcare professionals. Compounded preparations are dispensed on a doctor’s prescription.
Short answer: Dapoxetine is an oral medicine studied for premature ejaculation. A 2019 meta-analysis of eight randomised trials (8,422 participants) reported efficacy on intravaginal ejaculatory latency time. Its safety profile was described as acceptable (PMID 32172793).
The clinical question and the indication
Prescribers who consider a pharmacological option for premature ejaculation need two answers before they write anything: how far the ejaculatory latency moves in trials, and what adverse effects the patient should expect.
What the meta-analyses report
The 2019 updated meta-analysis in Sexual Health pooled eight randomised trials of dapoxetine in men with premature ejaculation. The authors report that the pooled results indicated efficacy in intravaginal ejaculatory latency time and in personal distress related to ejaculation. The analysis included subgroups by regimen: 30 mg and 60 mg on-demand dosing, and daily use of 60 mg (PMID 32172793).
An earlier meta-analysis in Clinical Therapeutics pooled six randomised trials with 5,934 patients and compared dapoxetine with placebo. Its authors wrote that the main outcome, intravaginal ejaculatory latency time, was improved significantly in the dapoxetine group compared with placebo. The included trials used 30 mg and 60 mg doses (PMID 25438723).
| Study | Design, population and regimens in the included trials | Outcome as reported | PMID |
|---|---|---|---|
| Sexual Health, 2019 | Systematic review and meta-analysis of eight randomised trials (8,422 participants); regimens: 30 mg and 60 mg on demand; 60 mg daily | Efficacy in intravaginal ejaculatory latency time and personal distress related to ejaculation | 32172793 |
| Clinical Therapeutics, 2014 | Meta-analysis of six randomised trials (5,934 patients) against placebo; doses: 30 mg and 60 mg | Intravaginal ejaculatory latency time improved significantly versus placebo | 25438723 |
What the trials do not establish
Neither abstract reports results for combination with other therapies, and neither describes the response of men with cardiac or hepatic comorbidity. The 2019 analysis pooled its trials with a random-effects model (PMID 32172793).
Adverse effects a prescriber should expect
The 2014 meta-analysis reports that treatment-emergent adverse events in the dapoxetine group were nearly twice as frequent as in the placebo group (50.5% versus 27.9%), that severe adverse events were rare, and that nausea, dizziness, diarrhoea, insomnia and headache were the common events (PMID 25438723). The 2019 meta-analysis describes the overall safety profile as acceptable (PMID 32172793). The abstract does not report adverse-event figures by dose (PMID 25438723).
Strength on the prescription
The strength is a figure the prescriber chooses for the named patient. The regimens in the trials (30 mg and 60 mg, on demand or daily) are reported results, not dosing instructions for any patient (PMID 32172793; PMID 25438723).
Related Lynnity articles
Prescribers reviewing premature ejaculation may also read the Lynnity guide to compounded lidocaine cream for premature ejaculation in Malaysia, which covers a different active and a topical route, and the guide to compounded erectile dysfunction formulations for men’s health clinics.
How to prescribe and order
Dapoxetine HCl is held in Lynnity’s own stock and is prepared there as a non-sterile compounded product. A registered doctor writes the prescription, which names one patient, and the preparation follows Good Compounding Practice (GCP).
The formulary record permits dapoxetine HCl in these forms: capsule, liquid (liposomal solution), powder, cream, serum, gel and spray.
The row records no strength for dapoxetine HCl. The prescriber therefore sets the strength, the quantity and the directions on the prescription.
To send a prescription, use the Lynnity contact page. The GCP laboratory page describes the non-sterile laboratory work for each order.
Frequently asked questions
What does the evidence show for dapoxetine in premature ejaculation?
Two meta-analyses of randomised trials report efficacy on intravaginal ejaculatory latency time. The 2019 analysis of eight trials (8,422 participants) reported efficacy on that outcome, and the 2014 analysis of six trials compared dapoxetine with placebo (PMID 32172793; PMID 25438723).
Which adverse effects were reported with dapoxetine?
The 2014 meta-analysis reports nausea, dizziness, diarrhoea, insomnia and headache as the common events, with treatment-emergent adverse events nearly twice as frequent as placebo (50.5% versus 27.9%) and severe events rare (PMID 25438723). The 2019 analysis describes the safety profile as acceptable (PMID 32172793).
Does the 60 mg regimen have a different safety profile?
The abstract does not report adverse-event figures by dose (PMID 25438723).
Does Lynnity offer a compounded dapoxetine preparation?
Yes. Lynnity prepares dapoxetine HCl from its own stock as a non-sterile compounded preparation, on a registered doctor’s prescription, for one named patient, under Good Compounding Practice (GCP). The strength is the prescriber’s to specify, and the trial regimens above are not a recommendation.
Reviewer
Reviewed by Vitthia Rama Murti, RPh (RPh 15632).