Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) specifically developed for the on-demand treatment of premature ejaculation (PE) in adult men. It represents the first and only oral medication approved in numerous countries for this indication, offering a targeted pharmacological approach to a common male sexual health concern. Its rapid absorption and elimination profile differentiate it from chronic-dosing SSRIs used off-label, providing a tailored solution for situational use. This product card provides a comprehensive, expert-level overview of its medical characteristics, appropriate use, and safety profile for healthcare professionals and informed patients.

Features

• Pharmacological Class: Selective Serotonin Reuptake Inhibitor (SSRI)
• Chemical Name: (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine hydrochloride
• Available Strengths: 30 mg and 60 mg film-coated tablets
• Mechanism of Action: Potent inhibitor of serotonin transporter, increasing synaptic serotonin levels in the central nervous system
• Onset of Action: Rapid absorption with median Tmax of 1-2 hours post-dose
• Elimination Half-Life: Approximately 1.5-2 hours, facilitating short duration of effect
• Metabolism: Primarily hepatic via multiple CYP enzymes including CYP3A4, CYP2D6, and CYP2C19
• Excretion: Predominantly renal (approximately 42% of dose) with minor fecal elimination

Benefits

• Clinically proven to significantly increase intravaginal ejaculatory latency time (IELT)
• Provides on-demand dosing flexibility without requiring daily medication commitment
• Improves patient-reported outcomes including perceived control over ejaculation and sexual satisfaction
• Reduces ejaculation-related personal distress and interpersonal difficulty
• Offers rapid onset suitable for planned sexual activity
• Minimizes accumulation risk due to short elimination half-life compared to chronic SSRIs

Common use

Dapoxetine is indicated for the treatment of premature ejaculation in adult men aged 18-64 years. The diagnosis of PE should be established according to the ISSM definition, which includes: persistent or recurrent ejaculation occurring within approximately one minute of vaginal penetration (lifelong PE) or a clinically significant reduction in latency time (acquired PE), an inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences such as distress, bother, frustration, and/or the avoidance of sexual intimacy. It is intended for men who meet these diagnostic criteria and seek pharmacological intervention. The medication is taken only when sexual activity is anticipated, typically 1-3 hours before intercourse, rather than as continuous daily therapy.

Dosage and direction

The recommended starting dose is 30 mg taken orally with at least one full glass of water approximately 1-3 hours before anticipated sexual activity. The dose may be increased to 60 mg if the 30 mg dose is well-tolerated but insufficiently effective. Dosing should not exceed one tablet in a 24-hour period. The tablet should be swallowed whole and not chewed, crushed, or divided. Administration with or without food is acceptable, though high-fat meals may delay absorption by approximately 30 minutes. Patients should be advised that efficacy requires sexual stimulation; the medication does not automatically induce ejaculation delay without sexual context. Dose adjustment is recommended in patients with renal impairment (creatinine clearance <30 mL/min) or hepatic impairment (Child-Pugh class A, B, or C), with a maximum dose of 30 mg in these populations.

Precautions

Patients should be carefully evaluated for underlying medical conditions that might contribute to ejaculatory dysfunction before initiating treatment. Orthostatic hypotension may occur, particularly with the initial doses; patients should be cautioned about rising slowly from sitting or lying positions. Syncope or pre-syncope has been reported in approximately 0.06-0.2% of patients in clinical trials, typically within 3 hours of the first dose. Use with caution in patients with history of syncope, hypotension, or cardiovascular disease. Monitor for signs of serotonin syndrome, particularly when used concomitantly with other serotonergic drugs. Patients should be advised that dapoxetine does not protect against sexually transmitted infections or serve as contraception. Mood changes including anxiety and agitation have been reported; patients with history of mood disorders should be monitored appropriately. Not recommended for use in men with anatomical deformities of the penis or conditions that might predispose to priapism.

Contraindications

Dapoxetine is contraindicated in patients with known hypersensitivity to dapoxetine or any excipients in the formulation. Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated due to risk of serotonin syndrome; at least 14 days should elapse between discontinuing MAOI therapy and initiating dapoxetine. Similarly, dapoxetine should not be used within 7 days of discontinuing treatment. Contraindicated in patients taking thioridazine due to potential QT prolongation. Not recommended with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, or atazanavir. Contraindicated in patients with significant cardiac conditions including heart failure (NYHA Class II-IV), conduction abnormalities (sick sinus syndrome, second or third degree AV block), significant ischemic heart disease, or valvular heart disease. Should not be used in patients with moderate or severe hepatic impairment.

Possible side effect

The most commonly reported adverse reactions (≥5%) include nausea (8.7-20.1%), dizziness (6.8-11.7%), headache (5.6-9.4%), diarrhea (3.9-6.8%), insomnia (3.9-6.8%), and fatigue (2.8-6.1%). These effects are generally mild to moderate in intensity and often diminish with continued use. Less common but clinically significant adverse effects include orthostatic hypotension (0.6-2.6%), syncope (0.06-0.2%), anxiety (1.5-3.8%), blurred vision (0.9-3.6%), tinnitus (0.4-1.4%), and increased sweating (0.4-1.2%). Sexual side effects including erectile dysfunction (1.5-3.8%), decreased libido (1.2-3.1%), and anorgasmia (0.8-2.4%) have been reported. Rare cases of serotonin syndrome, priapism, and angle-closure glaucoma have been documented in post-marketing surveillance.

Drug interaction

Dapoxetine is metabolized by multiple CYP enzymes and has significant interaction potential. Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) increase dapoxetine exposure approximately 3-4 fold and are contraindicated. Moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem) should be used with caution with maximum 30 mg dose. CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine) may increase dapoxetine exposure by approximately 50-100%. Concomitant use with other SSRIs, SNRIs, tricyclic antidepressants, tramadol, triptans, or other serotonergic drugs increases risk of serotonin syndrome. May potentiate effects of alcohol; patients should avoid alcohol consumption while taking dapoxetine. May enhance orthostatic effects of antihypertensive medications. Theoretical increased bleeding risk when combined with anticoagulants or antiplatelet agents due to serotonin effects on platelet aggregation.

Missed dose

As dapoxetine is taken on an as-needed basis rather than on a scheduled regimen, the concept of a “missed dose” does not directly apply. If a patient forgets to take the medication before sexual activity, they should not take it during or after sexual activity. The next dose may be taken when needed for subsequent anticipated sexual activity, maintaining the minimum 24-hour interval between doses. Patients should not double the dose to make up for a missed administration. Healthcare providers should reinforce that dapoxetine is not intended for chronic daily use and should only be taken when sexual activity is planned within the next 1-3 hours.

Overdose

Cases of overdose have been reported with doses up to 240 mg. Symptoms may include serotonin syndrome manifestations (agitation, confusion, diaphoresis, tachycardia, hypertension, hyperthermia, hyperreflexia, nausea, vomiting), dizziness, lightheadedness, syncope, or gastrointestinal distress. There is no specific antidote for dapoxetine overdose. Management should include supportive measures and symptomatic treatment. Gastric lavage may be considered if presentation is early after ingestion. Activated charcoal may be administered if the patient presents within one hour of ingestion. Cardiovascular monitoring is recommended, particularly for orthostatic hypotension. Serotonin syndrome should be managed with supportive care, benzodiazepines for agitation, cyproheptadine consideration in severe cases, and temperature control measures. Hemodialysis is unlikely to be effective due to high protein binding and extensive tissue distribution.

Storage

Store at room temperature between 15-30°C (59-86°F). Protect from light and moisture. Keep in the original container with the lid tightly closed. Do not store in bathroom cabinets where humidity levels may fluctuate. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Properly dispose of any unused medication through medication take-back programs or according to local regulations. Do not flush medications down the toilet or pour down the drain unless specifically instructed to do so.

Disclaimer

This information is intended for educational purposes only and does not constitute medical advice. Dapoxetine is a prescription medication that should only be used under the supervision of a qualified healthcare professional. Individual response to treatment may vary. Patients should consult with their healthcare provider for proper diagnosis and treatment recommendations based on their specific medical situation. The prescribing information provided here may not include all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. Healthcare professionals should refer to the official prescribing information for complete details before prescribing this medication.

Reviews

Clinical trials demonstrate that dapoxetine 30 mg and 60 mg significantly improved IELT from baseline approximately 2.5-3.0-fold and 3.0-4.0-fold, respectively, compared to placebo. Patient-reported outcomes showed statistically significant improvements in perceived control over ejaculation, satisfaction with sexual intercourse, and ejaculation-related personal distress. Systematic reviews and meta-analyses confirm its efficacy with number needed to treat (NNT) of approximately 3-5 for clinical improvement. Real-world evidence studies report similar efficacy outcomes with approximately 70-80% of patients reporting meaningful improvement in ejaculatory control. Long-term extension studies (up to 24 months) demonstrate maintained efficacy with consistent safety profile. Patient satisfaction surveys indicate high treatment continuation rates when properly prescribed to appropriate candidates.