LEJAM 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 (on-demand): 30 mg taken 1-3 hours before sexual activity; if tolerated but response inadequate, increase to 60 mg; maximum one dose per 24 hours; not intended for continuous daily dosing.

Initial Dose

30mg taken 1 to 3 hours before anticipated sexual activity.

Maintenance Dose

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

Maximum Dose

60mg per dose; maximum one dose per 24 hours

Children's Dosage

Not approved for children under 18 years.

Dose Adjustment Notes

Start at 30 mg and increase to 60 mg only if 30 mg is tolerated but response is inadequate; contraindicated in moderate-to-severe hepatic impairment; avoid with strong CYP3A4 inhibitors and use caution/consider limiting to 30 mg with moderate CYP3A4 inhibitors; no dose adjustment is generally required in mild-to-moderate renal impairment but use caution in severe renal impairment.

How to Take

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

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): nausea, dizziness, headache. Common (1-10%): diarrhea, insomnia, fatigue, somnolence, dry mouth. Uncommon (<1%): syncope/presyncope (including orthostatic), decreased libido.

Safety & Warnings

Contraindications

Contraindicated with: hypersensitivity to dapoxetine; significant cardiac disease (e.g., heart failure, conduction abnormalities); history of syncope; moderate-severe hepatic impairment; concomitant MAOIs (or within 14 days), thioridazine (or within 14 days), other serotonergic antidepressants/agents (e.g., SSRIs/SNRIs/TCAs, linezolid, lithium, tramadol, triptans) due to serotonin syndrome risk; and potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir).

Warnings & Precautions

Warn about syncope/orthostatic hypotension (hydrate, rise slowly, sit/lie if prodromal symptoms); assess cardiovascular risk before prescribing; avoid alcohol and recreational drugs; avoid concomitant serotonergic drugs and monitor for serotonin syndrome; caution with history of seizures, bipolar/mania, bleeding risk/anticoagulants; not for daily use; not recommended in ≥65 years.

Age Restriction

Indicated for adult men 18-64 years; not recommended in ≥65 years; not for <18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: MAOIs and thioridazine (contraindicated); potent CYP3A4 inhibitors (contraindicated); other serotonergic drugs (SSRIs/SNRIs/TCAs, tramadol, triptans, linezolid, lithium, St John’s wort) increase serotonin syndrome risk; PDE5 inhibitors and alcohol increase risk of orthostatic hypotension/syncope; moderate CYP3A4 inhibitors require caution/avoidance or dose limitation per labeling.

Interaction Severity

MAJOR/Contraindicated: MAOIs (and within 14 days), thioridazine, other serotonergic antidepressants/agents with high serotonin-syndrome risk (e.g., SSRIs/SNRIs) unless specifically directed by prescriber, and strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir). MODERATE/Use caution: PDE5 inhibitors, moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, verapamil/diltiazem), alpha-blockers (e.g., tamsulosin), alcohol; other serotonergic drugs (e.g., tramadol, triptans) increase serotonin-syndrome risk.

Food Interaction

May be taken with or without food; a high-fat meal may delay time to peak slightly without clinically meaningful impact on overall exposure.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children under 18 years.

Storage & Patient Advice

Missed Dose

Not applicable: this medicine is taken as needed 1-3 hours before sexual activity and is not intended for scheduled daily dosing.

Stopping the Medicine

As an on-demand medicine, it may be stopped without tapering; however, if it has been used frequently or continuously, consult a doctor before stopping due to possible SSRI-like discontinuation symptoms.

Patient Counseling

Take 1-3 hours before sex, no more than once in 24 hours; swallow whole with a full glass of water; may take with or without food; avoid alcohol and be cautious with medicines that can cause dizziness/low blood pressure (e.g., PDE5 inhibitors, alpha-blockers); if you feel faint/dizzy, lie down and rise slowly; avoid driving/operating machinery if dizzy or drowsy; do not combine with MAOIs, thioridazine, strong CYP3A4 inhibitors, or other serotonergic drugs (e.g., SSRIs/SNRIs, tramadol, triptans) unless your prescriber directs.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibition increases synaptic serotonin in CNS pathways that modulate the ejaculatory reflex, thereby delaying ejaculation.

Onset of Action

Take 1-3 hours before sexual activity (peak effect aligns with Tmax ~1-2 hours).

Duration of Effect

Clinical effect is intended within the on-demand window around dosing (typically a few hours after a dose); pharmacokinetically, peak occurs ~1-2 hours and concentrations decline substantially by 24 hours.

Half-Life

Dapoxetine has a biphasic half-life: an initial half-life of ~1.5 hours and a terminal half-life of ~19 hours.

Metabolism

Extensive hepatic metabolism primarily via CYP2D6 and CYP3A4, with contribution from FMO1; metabolites are excreted mainly in urine.

Excretion

Primarily excreted in urine as metabolites (conjugated/inactive); 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)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

SSRI-based

Onset Time

1-3 hours

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