Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) specifically developed for the on-demand treatment of premature ejaculation (PE) in men aged 18-64 years. It is the first and only oral pharmacotherapy approved for this indication. Unlike other SSRIs used for PE, it has a rapid absorption and elimination profile, making it suitable for use 1-3 hours before anticipated sexual activity.
Adult: Recommended starting dose is 30 mg, taken orally 1 to 3 hours before anticipated sexual activity. Dose may be increased to 60 mg based on efficacy and tolerability. Maximum dosing frequency is once every 24 hours.
Note: Tablet should be swallowed whole with a full glass of water, with or without food. Taking with food may delay absorption and reduce peak concentration (Cmax) by up to 10%, but this is not clinically significant. Do not break, crush, or chew the tablet.
Dapoxetine is a potent, short-acting, selective inhibitor of the serotonin (5-HT) transporter. By blocking the reuptake of serotonin into the presynaptic neuron, it increases extracellular serotonin levels in the synaptic cleft within the central nervous system, particularly in the hypothalamic and limbic regions. This enhanced serotonergic neurotransmission is believed to exert an inhibitory effect on the ejaculatory reflex, thereby increasing intravaginal ejaculatory latency time (IELT).
Pregnancy: Not indicated for use in women. No data on use in pregnant women.
Driving: May cause dizziness, syncope, somnolence, and blurred vision. Patients should be cautioned about driving or operating hazardous machinery until they are certain the medication does not adversely affect them.
| Monoamine Oxidase Inhibitors (MAOIs) - Phenelzine, Selegiline, Tranylcypromine | Risk of Serotonin Syndrome (hyperthermia, rigidity, myoclonus). | Contraindicated |
| Potent CYP3A4 Inhibitors - Ketoconazole, Itraconazole, Ritonavir, Clarithromycin | Markedly increases dapoxetine plasma levels (up to 3-4 fold). Increases risk of adverse effects. | Contraindicated |
| Thioridazine | Risk of QT prolongation and serious cardiac arrhythmias. | Contraindicated |
| Other SSRIs/SNRIs (e.g., Fluoxetine, Sertraline, Venlafaxine) | Additive serotonergic effects, increased risk of Serotonin Syndrome. | Major |
| Tramadol, Triptans (e.g., Sumatriptan), Tricyclic Antidepressants | Increased risk of Serotonin Syndrome. | Major |
| Alcohol | Increases risk of syncope, hypotension, dizziness, and decreased alertness. | Major |
| Alpha-adrenergic blockers (e.g., Tamsulosin, Prazosin) | Increased risk of orthostatic hypotension and syncope. | Major |
| Moderate CYP3A4 Inhibitors (e.g., Erythromycin, Fluconazole, Diltiazem) | Increases dapoxetine exposure. Maximum dose should be 30 mg. | Moderate |
| CYP2D6 Inhibitors (e.g., Fluoxetine, Paroxetine) | Increases dapoxetine exposure. Caution advised. | Moderate |
| NSAIDs, Aspirin, Warfarin | Increased risk of bleeding due to SSRI effect on platelets. | Moderate |