Priligy Dapoxetine Hydrochloride Tablets

1. Indications and Usage
Premature Ejaculation: Indicated for the treatment of premature ejaculation (PE) in men aged 18 to 64 years.
2. Dosage and Administration
Standard Dosage: The recommended starting dose is 30 mg taken orally 1 to 3 hours before sexual activity.
Dose Adjustment: If the 30 mg dose is ineffective and well-tolerated, the dose may be increased to a maximum of 60 mg. The maximum frequency is once every 24 hours.
Administration: Tablets should be swallowed whole with a full glass of water. It can be taken with or without food.
3. Mechanism of Action
SSRI Activity: Dapoxetine is a selective serotonin reuptake inhibitor. It works by blocking the reabsorption of serotonin (5-hydroxytryptamine) in the synaptic cleft.
Physiological Effect: The increased concentration of serotonin in the central nervous system delays the ejaculatory reflex.
4. Safety and Warnings
Syncope and Hypotension: Dizziness, syncope, or orthostatic hypotension may occur. Patients should be advised to lie down if faintness occurs to prevent injury from falling.
Manic Episodes: Patients with a history of depression or bipolar disorder may be at risk of mania.
Seizure Risk: Use with caution in patients with a history of seizures.
Hepatic Impairment: Contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh class B or C).
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most frequently reported dose-dependent adverse reactions include nausea, headache, dizziness, diarrhea, insomnia, and dry mouth.
Clinical Research: Pivotal randomized controlled trials have demonstrated that on-demand dapoxetine significantly increases intravaginal ejaculatory latency time (IELT) and improves patient confidence and control.
6. Drug Interactions
Monoamine Oxidase Inhibitors (MAOIs): Concomitant use is contraindicated due to the risk of serotonin syndrome. MAOIs must be discontinued for 14 days before initiating dapoxetine.
Other Serotonergic Drugs: Concomitant use with other SSRIs, SNRIs, triptans, or tramadol is contraindicated due to increased risk of serotonin syndrome.
Strong CYP3A4 Inhibitors: Concomitant use with ketoconazole, ritonavir, or nefazodone is contraindicated as they significantly increase dapoxetine plasma levels.
Alcohol: Alcohol may enhance the effects of dapoxetine, such as dizziness and hypotension, and should be avoided.
7. Pharmaceutical Information
Active Ingredient: Dapoxetine Hydrochloride.
Excipients: Microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate.
Appearance: White or off-white tablets.
Storage: Store in a dry place at controlled room temperature.