DAPOX 60/MG FC TAB 4/FC TAB

Indications

Approved Uses

Treatment of premature ejaculation (PE) in adult men aged 18 to 64 years.

Dosage & Administration

Dosing by Condition

Premature ejaculation (adult men): 30 mg orally as needed 1-3 hours before sexual activity; if response is inadequate and tolerated, increase to 60 mg; maximum 1 dose per 24 hours; not intended for daily continuous use.

Initial Dose

30mg taken 1-3 hours before sexual activity (titrate to 60mg if needed and tolerated)

Maintenance Dose

30mg or 60mg taken as needed, 1-3 hours before sexual activity.

Maximum Dose

60mg per 24 hours; maximum one dose per day

Children's Dosage

Not approved for children or adolescents under 18 years

How to Take

Swallow 1 tablet whole with a full glass of water; take 1-3 hours before anticipated sexual activity; do not take more than 1 dose in 24 hours; may be taken with or without food.

Side Effects

Common Side Effects

Nausea, dizziness, headache, diarrhea, insomnia, somnolence, fatigue, dry mouth.

Safety & Warnings

Contraindications

Hypersensitivity to dapoxetine; significant pathological cardiac conditions (e.g., heart failure, conduction abnormalities, significant ischemic/valvular disease); history of syncope; concomitant MAOIs (or within 14 days) and linezolid; concomitant thioridazine (or within 14 days); concomitant SSRIs/SNRIs/TCAs/other serotonergic drugs (e.g., triptans, tramadol, lithium, St John’s wort) due to serotonin syndrome risk; moderate-to-severe hepatic impairment; concomitant potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin/telithromycin).

Warnings & Precautions

Counsel on syncope/orthostatic hypotension (hydrate, rise slowly, lie down if prodromal symptoms); assess cardiovascular status and avoid in patients with syncope history; on-demand use only (not for daily continuous use unless specifically directed); avoid alcohol and recreational drugs; caution with seizure disorders and bipolar disorder/mania risk; caution with bleeding risk (anticoagulants/antiplatelets); not for use in women.

Age Restriction

Indicated for adult men 18-64 years; not indicated <18; not recommended ≥65 (limited data).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Contraindicated: MAOIs/linezolid; thioridazine; other serotonergic agents (SSRIs/SNRIs/TCAs, triptans, tramadol, lithium, St John’s wort) due to serotonin syndrome; potent CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir/atazanavir, clarithromycin/telithromycin) due to increased exposure. Use caution: PDE5 inhibitors (sildenafil/tadalafil) and alcohol (additive hypotension/syncope/CNS effects); anticoagulants/antiplatelets (e.g., warfarin) due to bleeding risk.

Interaction Severity

MAJOR/Contraindicated: MAOIs (and within 14 days), thioridazine (and within 14 days), other serotonergic antidepressants/agents (e.g., SSRIs/SNRIs/TCAs, linezolid, tramadol, triptans) due to serotonin syndrome/QT risk; potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir) due to markedly increased exposure. MODERATE/Use caution: moderate CYP3A4 inhibitors (e.g., erythromycin/clarithromycin/fluconazole-limit to 30 mg), PDE5 inhibitors (orthostatic hypotension/syncope risk), alcohol (syncope/CNS effects).

Food Interaction

May be taken with or without food; a high-fat meal may slightly delay absorption without clinically important impact.

Special Populations

Children

Not approved for children or adolescents under 18 years

Storage & Patient Advice

Missed Dose

Not applicable (on-demand use): take only when needed 1-3 hours before sexual activity; do not take more than one dose in 24 hours; do not take extra doses to ‘make up’ for a missed dose.

Stopping the Medicine

On-demand use: may be stopped without taper. If taken repeatedly/regularly, do not stop abruptly; consult a doctor for a gradual taper to reduce the risk of SSRI discontinuation symptoms.

Patient Counseling

Take 1 tablet 1-3 hours before sex with a full glass of water; do not take more than once in 24 hours and do not use as a daily medicine. Avoid alcohol and be cautious with PDE5 inhibitors due to fainting/low blood pressure risk; if dizzy or faint, lie down with legs raised and seek help if symptoms persist. Avoid use with MAOIs, thioridazine, other serotonergic medicines, and strong CYP3A4 inhibitors; tell your prescriber about liver disease, heart problems, or prior fainting; avoid driving/operating machinery if dizzy or drowsy.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor: inhibits the serotonin transporter (SERT), increasing serotonergic neurotransmission and delaying ejaculation via modulation of central/spinal ejaculatory reflex pathways.

Onset of Action

About 1-3 hours (peak effect/exposure typically around 1-2 hours).

Duration of Effect

Clinically relevant effect is typically within the first few hours after dosing (about 2-4 hours), aligning with peak exposure around 1-2 hours.

Half-Life

Initial half-life ~1.3-1.5 hours; terminal half-life ~15-22 hours.

Metabolism

Extensively metabolized hepatically, primarily by CYP2D6 and CYP3A4, with contribution from FMO1; metabolites include desmethyldapoxetine (active) and didesmethyldapoxetine.

Excretion

Eliminated mainly as metabolites (after hepatic metabolism) with excretion primarily in urine; only a small fraction is excreted unchanged.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: 60mg dapoxetine (as hydrochloride)

Mechanism

SSRI-based

Onset Time

1-2 hours

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