Poxet: Clinically Validated Premature Ejaculation Management
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Poxet represents a significant advancement in the pharmacological management of premature ejaculation (PE), offering men a reliable and well-tolerated therapeutic option. This selective serotonin reuptake inhibitor (SSRI) is specifically formulated to address the neurobiological mechanisms underlying ejaculatory control, providing a targeted approach to a prevalent sexual health concern. Its efficacy is supported by robust clinical data, demonstrating substantial improvements in both intravaginal ejaculatory latency time (IELT) and patient-reported outcomes related to sexual satisfaction and psychological distress. By offering a dedicated treatment pathway, Poxet empowers healthcare providers to effectively manage this condition within a structured clinical framework.
Features
- Active Pharmaceutical Ingredient: Dapoxetine hydrochloride
- Available Strengths: 30 mg and 60 mg film-coated tablets
- Pharmacological Class: Short-acting selective serotonin reuptake inhibitor (SSRI)
- Mechanism of Action: Potent inhibition of serotonin reuptake, enhancing neurotransmission in spinal ejaculatory centers
- Rapid Pharmacokinetic Profile: Designed for on-demand use with a time to maximum plasma concentration (Tmax) of approximately 1-2 hours
- Short Elimination Half-Life: Approximately 15 hours, minimizing long-term systemic exposure
- High Protein Binding: Extensive binding to plasma proteins (>99%)
- Metabolic Pathway: Primarily hepatic via multiple CYP enzymes including CYP3A4, CYP2D6, and CYP2C19
- Excretion: Primarily renal as metabolites
Benefits
- Significant Increase in IELT: Clinical trials demonstrate a 2.5 to 3-fold mean increase in intravaginal ejaculatory latency time compared to placebo
- Improved Ejaculatory Control: Enhances subjective perception of control over ejaculation, reducing ejaculation-related anxiety
- Increased Sexual Satisfaction: Leads to measurable improvements in both patient and partner satisfaction scores on validated instruments such as the Index of Premature Ejaculation (IPE)
- Reduction in Personal Distress: Addresses the psychological burden associated with PE, including reductions in performance anxiety and interpersonal difficulty
- On-Demand Dosing Flexibility: Allows for administration approximately 1-3 hours before anticipated sexual activity, fitting various lifestyles and sexual patterns
- Evidence-Based Formulation: Developed through extensive clinical research specifically for the indication of premature ejaculation
Common use
Poxet 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 (International Society for Sexual Medicine) criteria, which include: persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and within approximately one minute of vaginal insertion; the 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 specifically designed for men who meet these diagnostic criteria and seek pharmacological intervention after consideration of behavioral and psychological approaches.
Dosage and direction
The recommended starting dose is 30 mg, taken orally approximately 1-3 hours before anticipated sexual activity. The tablet should be swallowed whole with at least one full glass of water, with or without food, though high-fat meals may delay absorption. Based on efficacy and tolerability, the dose may be increased to 60 mg, which is the maximum recommended dose. The medication should not be taken more than once every 24 hours. Dose adjustment is recommended in patients with renal impairment (creatinine clearance <30 mL/min) and moderate hepatic impairment (Child-Pugh class B), where the maximum recommended dose is 30 mg. The medication is contraindicated in patients with severe hepatic impairment. In patients who are known CYP2D6 poor metabolizers, consideration should be given to starting with the 30 mg dose.
Precautions
Patients should be carefully evaluated for underlying medical conditions that might contribute to ejaculatory dysfunction. Cardiovascular status should be assessed before initiation, as SSRIs may cause orthostatic hypotension and syncope, particularly within the first 3 hours post-dosing. Patients should be advised to avoid situations where syncope could result in injury. Caution is advised in patients with history of mania/hypomania or seizures. As with other SSRIs, activation of mania/hypomania has been reported. Patients should be monitored for the emergence of serotonin syndrome, particularly when used concomitantly with other serotonergic drugs. Use with caution in patients with bleeding tendencies or those on anticoagulant therapy, as SSRIs may impair platelet aggregation.
Contraindications
Poxet is contraindicated in patients with known hypersensitivity to dapoxetine or any excipients in the formulation. It must not be used in combination with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy due to the risk of serotonin syndrome. Concomitant use with thioridazine is contraindicated. It is contraindicated in patients with significant pathological cardiac conditions such as heart failure (NYHA Class II-IV), conduction abnormalities (e.g., sick sinus syndrome, Wolff-Parkinson-White syndrome), significant ischemic heart disease, or valvular heart disease. Use is contraindicated in patients with severe hepatic impairment.
Possible side effect
The most commonly reported adverse reactions (≥5%) include nausea (11.0-21.9%), dizziness (5.7-12.6%), headache (5.6-10.4%), diarrhea (3.8-8.4%), insomnia (3.0-7.8%), and fatigue (2.5-6.9%). These are typically mild to moderate in intensity and often diminish with continued use. Less common but clinically significant adverse effects may include orthostatic hypotension (1.1-3.4%), syncope (0.1-0.9%), blurred vision (0.1-2.9%), and anxiety (1.2-3.2%). As with other SSRIs, sexual side effects including decreased libido (1.1-3.4%), erectile dysfunction (1.1-3.4%), and anorgasmia (0.6-2.9%) may occur. Serotonin syndrome, though rare, represents a serious potential adverse effect requiring immediate medical attention.
Drug interaction
Poxet has significant interaction potential due to its metabolism by multiple CYP enzymes and serotonergic effects. Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) increase dapoxetine exposure approximately 3-fold; concomitant use is not recommended. Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem) may increase exposure and require caution. Concomitant use with other SSRIs, SNRIs, tricyclic antidepressants, tramadol, tryptophan, or St. John’s Wort may increase the risk of serotonin syndrome. Concurrent use with alcohol may increase the risk of adverse events including dizziness, somnolence, and orthostatic hypotension; patients should be advised to avoid alcohol consumption. Drugs that prolong QT interval should be used with caution. Potent CYP2D6 inhibitors may increase dapoxetine exposure.
Missed dose
As Poxet is taken on an as-needed basis rather than on a continuous dosing schedule, the concept of a “missed dose” does not apply in the conventional sense. The medication should be taken only when sexual activity is anticipated. If a dose is not taken within the recommended time frame before sexual activity, patients should not take a double dose to make up for the missed timing. The next dose may be taken when needed, adhering to the 24-hour dosing interval restriction.
Overdose
In cases of overdose, symptoms may include serotonergic effects such as agitation, confusion, diaphoresis, tachycardia, hypertension, hyperthermia, nausea, vomiting, and tremor. Severe overdose may lead to serotonin syndrome, characterized by autonomic instability, neuromuscular abnormalities, and mental status changes. There is no specific antidote for dapoxetine overdose. Management should include supportive care and symptomatic treatment. Gastric lavage may be considered if performed soon after ingestion. Activated charcoal may be administered. Monitoring of vital signs and ECG is recommended. Treatment of serotonin syndrome may require benzodiazepines for agitation, cyproheptadine as a serotonin antagonist, and aggressive supportive care including temperature management.
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 transfer tablets to other containers, as the original packaging provides necessary protection from environmental factors. Discard any medication that shows signs of deterioration, such as discoloration or physical damage.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Poxet is a prescription medication that should only be used under the supervision of a qualified healthcare professional. The patient information provided here is not exhaustive; please refer to the full prescribing information for complete details. Individual response to medication may vary, and only a healthcare provider can determine the appropriate treatment based on a patient’s specific medical condition, history, and current medications. Never initiate, discontinue, or change the dosage of any medication without consulting your healthcare provider.
Reviews
Clinical studies involving over 6,000 patients demonstrate consistent efficacy and tolerability. In randomized, double-blind, placebo-controlled trials, Poxet 30 mg and 60 mg showed statistically significant improvements in all primary and secondary endpoints. Mean IELT increased from approximately 0.9 minutes at baseline to 3.1 minutes with Poxet 30 mg and 3.6 minutes with Poxet 60 mg, compared to 1.9 minutes with placebo. Patient Global Impression of Change (PGIC) scores showed that 57-69% of patients treated with Poxet reported “much improved” or “very much improved” compared to 27-33% with placebo. Long-term extension studies up to 24 weeks have demonstrated maintained efficacy with a consistent safety profile. Real-world evidence studies have corroborated these findings, showing high patient satisfaction and adherence rates when prescribed according to guidelines.