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Plezer is prescribed for the management of premature ejaculation (PE) in adult men aged 18 to 64 years. It is particularly suitable for individuals experiencing one or more of the following conditions:
- Frequent or recurrent ejaculation occurring with minimal stimulation, before, during, or soon after penetration, and earlier than desired.
- Significant personal distress or interpersonal relationship issues resulting from premature ejaculation.
- Lack of control over the timing of ejaculation.
- Dapoxetine is not approved for individuals under 18 years of age.
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✅ Description:
The primary mechanism by which Dapoxetine exerts its effect in premature ejaculation is through selective inhibition of serotonin reuptake. This action enhances the activity of serotonin at both presynaptic and postsynaptic receptors, which is believed to delay ejaculation.
Human ejaculation is governed by the sympathetic nervous system, originating from spinal reflex centers influenced by the brainstem, especially the medial preoptic and paraventricular nuclei.
Dapoxetine is rapidly absorbed, with peak plasma concentration typically occurring within 1–2 hours after oral administration. Its absolute bioavailability stands at approximately 42%. In plasma, over 99% of Dapoxetine binds to serum proteins, while its active metabolite, desmethyl dapoxetine, is 98.5% protein-bound. The drug demonstrates extensive tissue distribution, with a steady-state volume of distribution of around 162 liters.
Dapoxetine undergoes metabolism via several pathways, including N-oxidation, N-demethylation, hydroxylation of the naphthyl ring, glucuronidation, and sulfation. It is subject to significant first-pass metabolism, and its metabolites are primarily eliminated through the urine in conjugated forms. It is rapidly cleared from the system, with a terminal half-life of around 19 hours.
Relevant Products / প্রাসঙ্গিক পণ্য
✔️ Composition: Plezer Tablet
Dapoxetine Hydrochloride
✔️ Dosage and Administration
For adult males (ages 18–64) with premature ejaculation:
- The recommended initial dose is 30 mg, taken 1 to 3 hours before anticipated sexual activity.
- If the response is inadequate and side effects are tolerable, the dose may be increased to a maximum of 60 mg.
- It should not be taken more than once in 24 hours.
- The tablet can be taken with or without food.
- Elderly (≥65 years): Safety and effectiveness have not been sufficiently studied in this group.
- Renal Impairment: Use cautiously in mild to moderate renal impairment; not recommended in severe cases.
- Hepatic Impairment: Contraindicated in patients with moderate to severe hepatic dysfunction.
Dapoxetine is not approved for individuals under 18 years of age.
✔️
Side Effects
Commonly reported side effects include:
- Nausea
- Dizziness
- Dry mouth
- Headache
- Diarrhea
- Insomnia
Discontinuation due to side effects is dose-dependent: 0.3% (placebo), 1.7% (30 mg), and 5.3% (60 mg). Compared to SSRIs used in depression, Plezer causes minimal sexual dysfunction. The incidence of reduced libido is below 1%, and erectile dysfunction is reported in less than 4% of users.
✔️ Overdose
No cases of overdose have been reported. Doses up to 240 mg (two 120 mg doses within 3 hours) were studied without unexpected adverse effects. Symptoms of overdose may include serotonin-related effects such as:
- Drowsiness
- Nausea or vomiting
- Rapid heartbeat
- Tremors
- Agitation
- Dizziness
No evidence of withdrawal symptoms was observed following 62 days of regular or on-demand use at 60 mg.
✔️ Drug Interactions
- CNS-active drugs: Since combination with other centrally acting agents hasn’t been thoroughly studied, caution is advised when co-administering with such agents.
- PDE5 inhibitors (e.g., Sildenafil, Tadalafil): These may slightly influence Dapoxetine pharmacokinetics, potentially affecting blood pressure. Co-use requires caution due to the risk of hypotension and fainting.
- Alpha-blockers (e.g., Tamsulosin): No significant changes in pharmacokinetics, but co-administration can increase the risk of orthostatic hypotension.
- Warfarin: Long-term coadministration has not been studied; caution is recommended.
- Alcohol: Combined use enhances the risk of neurocognitive and cardiovascular adverse effects like dizziness, drowsiness, poor judgment, and syncope. Alcohol consumption should be avoided during treatment.
✔️ Plezer is not recommended in patients who:
- Have hypersensitivity to Dapoxetine or its components.
- Have significant cardiovascular conditions such as heart failure (NYHA class II–IV), conduction abnormalities without a pacemaker, or severe ischemic or valvular heart disease.
- Are on monoamine oxidase inhibitors (MAOIs), thioridazine, or have recently discontinued these agents within 14 days.
- Are concurrently using serotonergic antidepressants (SSRIs, SNRIs, TCAs) or herbal products with serotonergic effects, or have discontinued them within the past 14 days.
✔️ Pregnancy and Lactation
Dapoxetine is not intended for use by women. It is unknown whether it or its metabolites are excreted in breast milk.
✔️ Precautions and Warnings
- Recreational drugs: Combining Plezer with drugs like ketamine, MDMA, or LSD can lead to serious adverse events, including arrhythmia and serotonin syndrome.
- Alcohol: Can increase the likelihood of adverse effects such as dizziness and fainting.
- Syncope risk: Some patients may faint, with or without warning signs such as nausea, dizziness, palpitations, or sweating, particularly within the first 3 hours of dosing.
- Orthostatic Hypotension: An orthostatic blood pressure assessment should be performed before treatment initiation, especially in patients with a history of postural hypotension.
- Bleeding Risk: Caution is required in patients with bleeding tendencies or those on anticoagulants or medications that affect platelet function.
✔️ Storage
- Store below 30°C.
- Protect from light and moisture.
- Keep out of reach of children.
⚠️Disclaimer:
At ePharma, we’re committed to providing accurate and accessible health information. However, all content is intended for informational purposes only and should not replace medical advice from a qualified physician. Please consult your healthcare provider for personalized guidance. We aim to support, not substitute, the doctor-patient relationship.
