Plezer 30mg Tablet 1 Strip

✔️ 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.

1. Elderly (≥65 years): Safety and effectiveness have not been sufficiently studied in this group.
2. Renal Impairment: Use cautiously in mild to moderate renal impairment; not recommended in severe cases.
3. 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.