Dapoxetine for Premature Ejaculation Management
Dapoxetine
| Product dosage: 30mg | |||
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| 360 | $0.94
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| Product dosage: 60mg | |||
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| Product dosage: 90mg | |||
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Synonyms | |||
Similar products
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 a significant advancement in sexual medicine, offering a pharmacologically targeted approach to a common and often distressing condition. By modulating serotonin neurotransmission, dapoxetine helps to increase intravaginal ejaculatory latency time (IELT), thereby improving control and satisfaction. Its rapid absorption and elimination profile make it uniquely suited for use prior to anticipated sexual activity, distinguishing it from conventional daily SSRIs used off-label for this indication. This product card provides a comprehensive, evidence-based overview for healthcare professionals.
Features
- Active pharmaceutical ingredient: Dapoxetine hydrochloride
- Available in standard dosages of 30 mg and 60 mg film-coated tablets
- Rapid onset of action, with peak plasma concentrations (Tmax) achieved within 1-2 hours post-administration
- Short elimination half-life of approximately 1.5-1.6 hours, minimizing long-term systemic exposure
- Formulated for on-demand (prn) use rather than continuous daily dosing
- Requires prescription and medical supervision for appropriate use
Benefits
- Clinically proven to significantly increase intravaginal ejaculatory latency time (IELT)
- Enhances perceived control over ejaculation and reduces ejaculation-related distress
- Improves sexual satisfaction for both the patient and their partner
- Provides a targeted, on-demand treatment option without the need for daily medication
- Supported by robust clinical trial data involving thousands of patients worldwide
- Offers a standardized, regulated pharmaceutical alternative to unproven therapies
Common use
Dapoxetine is indicated for the treatment of premature ejaculation (PE) in adult men aged 18-64 years. The diagnosis of PE should be made by a healthcare professional based on the criteria of persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it, which leads to marked distress or interpersonal difficulty. It is specifically designed for men who meet these diagnostic criteria and seek medical intervention to improve ejaculatory control. The medication is intended for use prior to anticipated sexual activity, not as a continuous daily treatment.
Dosage and direction
The recommended starting dose is 30 mg taken orally approximately 1-3 hours before anticipated sexual activity. Based on efficacy and tolerability, the dose may be increased to 60 mg or decreased to 30 mg. The maximum recommended dosing frequency is once every 24 hours. Tablets should be swallowed whole with at least a full glass of water, with or without food. Patients should be advised that sexual activity is necessary to experience the therapeutic effect. Dose adjustment is recommended in patients with renal or hepatic impairment, with contraindication in severe cases.
Precautions
Patients should be evaluated for underlying medical conditions that might cause ejaculatory dysfunction before initiating treatment. Use with caution in patients with history of syncope, orthostatic hypotension, or conditions that might predispose to volume depletion. Monitor for changes in mood or emergence of suicidal ideation, particularly during initial treatment or dose changes. Caution is advised when prescribing to patients with bleeding tendencies or those taking anticoagulants due to potential increased bleeding risk. Not recommended for use with moderate or strong CYP3A4 inhibitors. Patients should avoid alcohol consumption while taking dapoxetine due to increased risk of adverse events.
Contraindications
Hypersensitivity to dapoxetine or any excipients in the formulation. Concomitant administration with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy. Concomitant use with thioridazine or within 14 days of discontinuing thioridazine. Concomitant use with other SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or other medicinal/herbal products with serotonergic effects. Patients with history of mania or severe depression. Significant cardiac conditions including heart failure, conduction abnormalities, or significant ischemic heart disease. Severe hepatic impairment.
Possible side effects
Common adverse reactions (≥1%) include nausea (8.7-20.1%), dizziness (6.8-10.9%), headache (5.6-8.8%), diarrhea (3.9-6.8%), insomnia (2.8-5.3%), and fatigue (2.6-4.4%). Less frequently reported effects include orthostatic hypotension (2.6-3.6%), syncope (0.06-0.23%), anxiety, blurred vision, tinnitus, and sweating. Sexual side effects may include erectile dysfunction (1.9-3.6%) and decreased libido (1.8-3.1%). Most adverse events are mild to moderate in severity and tend to decrease with continued use. Serious but rare adverse events include syncope, prolonged erection, and mood changes including suicidal ideation.
Drug interaction
Significant interactions occur with strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin) - contraindicated. Moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem) require maximum dose limitation to 30 mg. Potent CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) may decrease dapoxetine exposure. Concomitant use with other serotonergic drugs increases risk of serotonin syndrome. Increased bleeding risk with anticoagulants and NSAIDs. Potential pharmacodynamic interactions with alpha-adrenergic blockers may enhance orthostatic effects. Alcohol significantly increases risk of adverse events including syncope.
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 apply in the conventional sense. If a patient forgets to take dapoxetine before sexual activity, they should not take a double dose later. The medication should simply be taken approximately 1-3 hours before the next anticipated sexual activity. Patients should be educated that dapoxetine is not intended for continuous daily use and should only be taken when sexual activity is planned.
Overdose
Symptoms of overdose may include serotonergic effects such as agitation, confusion, diaphoresis, tachycardia, hypertension, and hyperthermia. In severe cases, serotonin syndrome may occur, characterized by autonomic instability, neuromuscular abnormalities, and mental status changes. There is no specific antidote for dapoxetine overdose. Treatment should consist of supportive measures including monitoring of vital signs and symptomatic management. Gastric lavage may be considered if presented early after ingestion. Activated charcoal may be administered if the patient presents within one hour of ingestion. Serotonin syndrome should be managed with supportive care and may require benzodiazepines, cyproheptadine, or cooling measures.
Storage
Store at room temperature between 15°C to 30°C (59°F to 86°F). Keep in the original container to protect from moisture and light. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Do not flush medications down the toilet or pour them into drainage unless instructed to do so. Properly discard this product when it is expired or no longer needed through medication take-back programs or community drug disposal programs.
Disclaimer
This information is intended for healthcare professionals and should not replace professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read in this product information. The prescribing physician should be familiar with the full prescribing information before initiating treatment.
Reviews
Clinical studies demonstrate that dapoxetine significantly improves IELT and patient-reported outcomes measures compared to placebo. In phase III trials, mean IELT increased from approximately 0.9 minutes at baseline to 3.1-3.6 minutes with dapoxetine 60 mg. Patient Global Impression of Change (PGI-C) scores showed 68-71% of patients rated their condition as “better” or “much better” with dapoxetine 60 mg versus 25-32% with placebo. Partner satisfaction scores similarly improved significantly. Real-world evidence supports the efficacy observed in clinical trials, though individual response may vary. Long-term studies up to 24 months show maintained efficacy with continuous use.