In adult men with premature ejaculation, what are the indications, dosing regimen, contraindications, precautions, adverse effects, and alternative treatments for dapoxetine tablets?

Dapoxetine Tablet Uses

Dapoxetine is a short-acting SSRI specifically approved for on-demand treatment of premature ejaculation in adult men, taken 1-3 hours before sexual activity at doses of 30 mg or 60 mg. 1

Primary Indication

• Premature ejaculation (PE) in adult men - Dapoxetine is the only SSRI specifically developed and approved for PE treatment, designed for on-demand use rather than daily dosing. 1, 2

Dosing Regimen

• Starting dose: 30 mg taken 1-3 hours before anticipated sexual intercourse 1
• Maximum dose: 60 mg if 30 mg is insufficient and well-tolerated 1, 3
• Frequency: On-demand only (not daily) - Take only when sexual activity is anticipated, with a maximum of one dose per 24 hours 3, 4

Expected Efficacy

• 30 mg dose produces a 2.5-fold increase in intravaginal ejaculatory latency time (IELT), rising to 3.4-fold in men with baseline IELT <30 seconds 1
• 60 mg dose produces a 3.0-fold increase in IELT, rising to 4.3-fold in men with baseline IELT <30 seconds 1
• Efficacy is evident from the first dose and maintained throughout treatment 3, 2

Contraindications and Precautions

• Avoid in men with bipolar depression due to risk of triggering mania 1
• Do not combine with other serotonergic drugs (SSRIs, tricyclic antidepressants, amphetamines, cocaine) due to risk of serotonin syndrome, which presents with clonus, tremor, hyperreflexia, agitation, mental status changes, diaphoresis, fever, and in severe cases seizures and rhabdomyolysis 1
• Use caution in adolescents due to potential increased risk of suicidal ideation, though this has not been documented in non-depressed adult men with PE 1
• Vasovagal-mediated syncope risk has been documented with dapoxetine use 5

Adverse Effects

• Most common (dose-dependent): Nausea (8.7% at 30 mg, 20.1% at 60 mg), diarrhea (3.9% at 30 mg, 6.8% at 60 mg), dizziness (3.0% at 30 mg, 6.2% at 60 mg), and headache (5.9% at 30 mg, 6.8% at 60 mg) 1, 3
• No documented effects on sperm parameters, fertility, or testicular function based on clinical evidence from over 10,000 men 6
• No anxiety, akathisia, suicidality, mood changes, or discontinuation syndrome following abrupt withdrawal 2

Treatment Discontinuation Considerations

• High discontinuation rates: 90% at 2 years, primarily due to cost (29.9%) and disappointment with the on-demand nature of treatment (25%) 1
• Patient education is critical - Address concerns about medication expectations and cost upfront to improve adherence 1

Combination Therapy

• Can be safely combined with PDE5 inhibitors (sildenafil, tadalafil, etc.) for men with coexisting erectile dysfunction 1
• If erectile dysfunction coexists, treat ED first or concomitantly, as secondary PE may resolve when ED is effectively managed 1, 7

Alternative First-Line Treatments

• Daily SSRIs (off-label): Paroxetine 10-40 mg daily (most effective, 8.8-fold IELT increase), sertraline 50-200 mg daily, fluoxetine 20-40 mg daily, or citalopram 20-40 mg daily provide greater ejaculatory delay than on-demand dosing but require daily administration 1, 8
• Topical lidocaine/prilocaine spray: EMA-approved formulation increases IELT up to 6.3-fold over 3 months with minimal systemic effects and only minor local side effects (genital hypoesthesia) 1, 7
• On-demand clomipramine: 12.5-50 mg taken 3-6 hours before intercourse, though less favored than SSRIs due to worse side effect profile 1

Treatment Selection Algorithm

• For frequent sexual activity (≥2-3 times per week): Daily SSRI therapy (paroxetine preferred) provides superior efficacy compared to on-demand options 1, 8
• For infrequent sexual activity (<2 times per week): Dapoxetine 30-60 mg on-demand or topical lidocaine/prilocaine spray are preferred to avoid daily medication exposure 1, 7
• For patients concerned about systemic medication effects: Topical lidocaine/prilocaine spray is the optimal choice 7
• For partial responders: Consider combination therapy with daily low-dose SSRI plus on-demand dapoxetine, or SSRI plus PDE5 inhibitor 7

Critical Pitfall to Avoid

• Dapoxetine is NOT approved in the United States - It is approved in many other countries but remains unavailable in the USA, where off-label daily SSRIs or topical anesthetics must be used instead 1, 7