LEJAM 30/MG FC TAB 4/FC TAB

Indications

Approved Uses

Premature ejaculation in adult men aged 18 to 64 years.

Dosage & Administration

Dosing by Condition

Premature ejaculation (adult men): 30 mg taken 1-3 hours before sexual activity; if tolerated but inadequate response, may increase to 60 mg; maximum 1 dose per 24 hours (on-demand only).

Initial Dose

30mg taken 1-3 hours before sexual activity.

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

Dose Adjustment Notes

Moderate CYP3A4 inhibitors: do not exceed 30 mg. Strong CYP3A4 inhibitors: contraindicated. Hepatic impairment: contraindicated in moderate-severe; avoid/use with caution in mild. Renal impairment: no adjustment in mild-moderate; use with caution in severe. CYP2D6 inhibitors: no mandatory dose change, but use caution due to increased exposure/adverse effects (especially if considering 60 mg).

How to Take

Swallow 1 tablet (30 mg) whole with a full glass of water; take as needed 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, fatigue, somnolence, dry mouth.

Side Effect Frequency

Very common (>10%): nausea, dizziness, headache. Common (1-10%): diarrhea, somnolence, insomnia, fatigue, dry mouth, hyperhidrosis, flushing; may also include anxiety and erectile dysfunction in some references. Uncommon/rare: syncope/presyncope (notable safety concern), tremor, tinnitus, blurred vision, palpitations, hypertension.

Safety & Warnings

Contraindications

Contraindicated with: hypersensitivity; significant cardiac disease (e.g., heart failure, conduction abnormalities, significant ischemic/valvular disease); history of syncope; moderate-severe hepatic impairment; concomitant MAOIs (or within 14 days), thioridazine (or within 14 days), other serotonergic antidepressants/agents (SSRIs/SNRIs/TCAs, other dapoxetine, linezolid, lithium, tramadol, triptans, St John’s wort); and potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, saquinavir, nefazodone, atazanavir, telithromycin).

Warnings & Precautions

Key warnings: syncope/orthostatic hypotension (counsel hydration and to lie/sit at prodrome; avoid alcohol and caution with PDE5 inhibitors/alpha‑blockers/other BP‑lowering drugs); avoid concomitant serotonergic agents (serotonin syndrome); monitor for mood changes/suicidality and avoid in mania/bipolar history; caution in epilepsy/seizure history and bleeding risk (anticoagulants/NSAIDs); not for women and not for continuous daily use.

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); serotonergic drugs (SSRIs/SNRIs/TCAs, triptans, tramadol, lithium, linezolid, St John’s wort) due to serotonin syndrome (avoid/contraindicated); potent CYP3A4 inhibitors (contraindicated); moderate CYP3A4 inhibitors (use caution/limit to 30 mg); PDE5 inhibitors and alpha‑blockers (additive orthostatic hypotension/syncope risk); alcohol (increases CNS effects and orthostatic hypotension).

Interaction Severity

MAJOR/Contraindicated: MAOIs (and within 14 days), thioridazine (and within 14 days), other serotonergic antidepressants/agents with significant serotonergic activity (risk serotonin syndrome), and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir). MODERATE: moderate CYP3A4 inhibitors (limit to 30 mg), PDE5 inhibitors and alpha-blockers (additive orthostatic hypotension/syncope), alcohol (increases CNS effects and syncope risk). MINOR: antacids (no clinically significant effect).

Food Interaction

May be taken with or without food; a high-fat meal can delay time to peak concentration slightly without clinically meaningful loss of effect.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

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 1 dose in 24 hours.

Stopping the Medicine

On-demand use; may be stopped without tapering. Do not take more than one dose in 24 hours; consult your prescriber if you have been using it frequently or experience withdrawal-like symptoms.

Patient Counseling

Take 1 tablet 1-3 hours before sexual activity, no more than once in 24 hours; swallow whole with a full glass of water; may take with or without food; avoid alcohol; rise slowly and sit/lie down if dizzy or faint; avoid driving/operating machinery if dizzy/somnolent; do not use with MAOIs, thioridazine, strong CYP3A4 inhibitors, or other serotonergic medicines unless prescriber approves; report mood changes or suicidal thoughts; for adult men only.

Pharmacology

Mechanism of Action

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

Onset of Action

Approximately 1-3 hours (peak effect aligns with peak plasma concentrations around 1-2 hours).

Duration of Effect

Clinically relevant effect is typically within the first few hours after dosing (around 3-4 hours), with concentrations declining substantially by 24 hours.

Half-Life

Initial half-life ~1.3-1.5 hours; terminal half-life ~19-22 hours (reflecting distribution/metabolite kinetics).

Metabolism

Extensively hepatic metabolism primarily via CYP2D6 and CYP3A4, with contribution from flavin-containing monooxygenase 1 (FMO1); forms metabolites including desmethyldapoxetine and didesmethyldapoxetine.

Excretion

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

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 30mg dapoxetine (as hydrochloride)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

SSRI-based

Onset Time

1-2 hours

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