Dapoxetine: Effective On-Demand Treatment for Premature Ejaculation
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Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) specifically developed and approved for the on-demand treatment of premature ejaculation (PE) in adult men. It represents a significant advancement in sexual medicine, offering a pharmacologic option that is taken only as needed, approximately 1–3 hours before anticipated sexual activity. Unlike daily-dosed SSRIs used off-label for PE, dapoxetine’s rapid absorption and elimination profile is designed to align with the episodic nature of sexual encounters, providing a targeted therapeutic effect with a reduced burden of continuous drug exposure. Its efficacy and safety profile have been established in large-scale, randomized, controlled clinical trials, making it a cornerstone of evidence-based management for this common male sexual health disorder.
Features
- Pharmacologic Class: Short-acting selective serotonin reuptake inhibitor (SSRI).
- Mechanism of Action: Potently inhibits the presynaptic serotonin transporter, increasing serotonin activity in the synaptic cleft within the central nervous system. This enhances serotonergic neurotransmission, which is involved in the control of the ejaculatory reflex.
- Rapid Pharmacokinetics: Features a rapid time to maximum plasma concentration (Tmax of approximately 1–2 hours) and a short elimination half-life.
- On-Demand Dosing Regimen: Administered only as needed, not as a daily chronic medication.
- Available Strengths: Typically formulated in 30 mg and 60 mg film-coated tablets.
- Prescription Status: Available only with a valid prescription from a licensed healthcare professional.
Benefits
- Clinically Proven Efficacy: Significantly increases intravaginal ejaculatory latency time (IELT) as measured in controlled studies.
- Improvement in Patient-Reported Outcomes: Leads to improvements in perceived control over ejaculation, satisfaction with sexual intercourse, and personal distress related to the condition.
- On-Demand Convenience: The as-needed dosing schedule eliminates the need for daily medication intake, aligning treatment directly with sexual activity.
- Rapid Onset of Action: Can be taken 1–3 hours before intercourse, allowing for spontaneity within that planning window.
- Targeted Therapy: Its specific pharmacokinetic profile is engineered to address the ejaculatory reflex without the long-term commitment associated with chronic SSRI use.
Common use
Dapoxetine is indicated for the treatment of premature ejaculation (PE) in adult men aged 18–64 years. Premature ejaculation is a multifactorial condition typically characterized by:
- Ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration (lifelong PE) OR a clinically significant and bothersome reduction in latency time, often to three minutes or less (acquired PE).
- The inability to delay ejaculation on all or nearly all vaginal penetrations.
- 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 for whom psychosocial interventions alone are insufficient. It is not intended for use by the general population to enhance sexual performance.
Dosage and direction
The recommended starting dose is 30 mg, taken orally as a single dose approximately 1 to 3 hours before anticipated sexual activity. The tablet should be swallowed whole with at least a full glass of water. It may be taken with or without food; however, a high-fat meal may increase the drug’s exposure and potentially increase the incidence and severity of side effects.
- Dose Adjustment: Based on efficacy and tolerability, the dose may be increased to a maximum recommended dose of 60 mg.
- Dosing Frequency: It is recommended to not take dapoxetine more than once every 24 hours.
- Initiation: Treatment should be initiated and supervised by a physician experienced in diagnosing and treating male sexual dysfunction.
Precautions
- Medical Evaluation: A thorough medical and sexual history should be obtained to confirm a diagnosis of PE and to rule out other sexual dysfunctions (e.g., erectile dysfunction) which may require different management.
- Orthostatic Hypotension: Dapoxetine can cause dizziness, lightheadedness, and syncope (fainting), often related to orthostatic hypotension. Patients should be cautioned about activities requiring alertness (e.g., driving, operating machinery) until they learn how they react to the medication.
- Mood Changes: As with other SSRIs, patients should be monitored for the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Patients with a history of mania/hypomania or bipolar disorder should use dapoxetine with extreme caution.
- Withdrawal: While the risk is lower than with chronic SSRIs due to its short half-life, abrupt cessation could potentially lead to discontinuation symptoms such as dizziness, anxiety, and irritability.
- Priapism: Although very rare, prolonged and painful erections lasting more than 4 hours have been reported with SSRI use. This is a medical emergency requiring immediate treatment.
- Moderate Renal Impairment: Use with caution in patients with moderate renal impairment. It is not recommended for patients with severe renal impairment.
- Hepatic Impairment: Should not be used in patients with significant liver disease.
Contraindications
Dapoxetine is contraindicated in patients with:
- Established Hypersensitivity to dapoxetine or any of the excipients in the formulation.
- Significant Cardiac Conditions such as heart failure (NYHA Class II-IV), conduction abnormalities (e.g., sick sinus syndrome, sinoatrial or AV block), significant ischemic heart disease, or significant valvular disease.
- History of Mania or Severe Depression.
- Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy. Concomitant use can lead to serious, sometimes fatal, reactions including serotonin syndrome.
- Concomitant Use with Thioridazine or within 14 days of discontinuing thioridazine.
- Concomitant Use with Other SSRIs, Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), Tricyclic Antidepressants (TCAs), Antipsychotics, or Other Serotonergic Drugs (e.g., tramadol, lithium, tryptophan, triptans) due to the increased risk of serotonin syndrome.
- Concomitant Use with Potent CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, telithromycin).
- Concomitant Use with Potent CYP2D6 Inhibitors (e.g., fluoxetine) or in patients known to be CYP2D6 poor metabolizers who are also taking a potent CYP3A4 inhibitor.
Possible side effect
The most common adverse reactions are usually mild to moderate and often diminish with continued use. They are primarily related to its serotonergic activity and include:
- Very Common (≥1/10): Nausea, dizziness, headache.
- Common (≥1/100 to <1/10): Diarrhea, insomnia, fatigue, somnolence (sleepiness), vomiting, abdominal pain, dry mouth, hyperhidrosis (increased sweating), anxiety, agitation, tremors, blurred vision, tinnitus.
- Uncommon (≥1/1,000 to <1/100): Syncope (fainting), orthostatic hypotension, tachycardia (fast heart rate), palpitations, decreased libido, anorgasmia, erectile dysfunction, confusion, attention disturbance, euphoric mood.
- Rare: Priapism, serotonin syndrome, angle-closure glaucoma, suicidal ideation.
Drug interaction
Dapoxetine is primarily metabolized by multiple enzyme systems, including CYP3A4, CYP2D6, and flavin-containing monooxygenase 1 (FMO1), leading to a high potential for drug-drug interactions.
- Serotonergic Drugs (MAOIs, SSRIs, SNRIs, TCAs, Triptans, Tramadol, Lithium, Tryptophan, St. John’s Wort): Contraindicated. Concomitant use significantly increases the risk of serotonin syndrome, a potentially life-threatening condition.
- Potent CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin): Contraindicated. These drugs markedly increase dapoxetine plasma levels.
- Potent CYP2D6 Inhibitors (e.g., Fluoxetine, Paroxetine): Increase dapoxetine exposure. Concomitant use with fluoxetine is contraindicated. Caution is advised with others.
- CYP3A4 Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine, St. John’s Wort): May decrease dapoxetine plasma levels, reducing its efficacy.
- Alcohol: Concomitant use is not recommended. Alcohol may increase the risk of adverse events such as dizziness, lightheadedness, and syncope, and can impair judgment and motor skills.
- Drugs That Increase Heart Rate or QT Prolongation: Caution is advised with concomitant use of drugs that can affect cardiac conduction.
- Alpha-Adrenergic Antagonists (e.g., Tamsulosin): May potentiate orthostatic hypotension.
Missed dose
As dapoxetine is taken on an as-needed basis, the concept of a “missed dose” does not apply in the traditional sense. If a dose is not taken prior to sexual activity, it should simply be taken prior to the next anticipated episode of sexual activity, adhering to the once-every-24-hours dosing limit. Patients should not take a double dose to make up for a missed opportunity.
Overdose
In the event of overdose, supportive measures should be instituted. Symptoms of overdose are expected to be an exaggeration of the known pharmacological effects and may include serotonergic effects such as serotonin syndrome (agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia), dizziness, nausea, vomiting, and syncope. There is no specific antidote for dapoxetine overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and cardiac rhythm. Gastric lavage and administration of activated charcoal may be considered if presented early after ingestion.
Storage
- Store at or below 30°C (86°F).
- Keep the medication in its original blister package to protect from light and moisture.
- Keep out of the sight and reach of children.
- Do not use after the expiration date printed on the packaging.
Disclaimer
This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for 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 or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on general prescribing guidelines and may not be appropriate for all individuals.
Reviews
- Clinical Trial Data: Large-scale, randomized, double-blind, placebo-controlled studies have consistently demonstrated that dapoxetine 30 mg and 60 mg significantly prolongs IELT and improves patient-reported outcome measures (e.g., perceived control over ejaculation, satisfaction with sexual intercourse) compared to placebo. The effects are noted from the first dose and are maintained over time.
- Real-World Evidence: Post-marketing surveillance and observational studies generally support the findings of clinical trials, confirming its efficacy and tolerability in broader, more diverse populations outside of strict trial protocols. Patient satisfaction is often linked to the on-demand nature of the therapy.
- Expert Consensus: Dapoxetine is recognized in major urological and sexual medicine guidelines (e.g., those from the International Society for Sexual Medicine) as a first-line pharmacological treatment option for men with premature ejaculation, particularly for those who prefer an on-demand dosing strategy.