DEPOJOY 60/MG FC TAB 6/FC TAB

Indications

Approved Uses

Premature ejaculation in adult men aged 18 to 64 years.

Off-Label Uses

None commonly recommended; dapoxetine is not used as a standard treatment for depression/anxiety/OCD/PTSD due to its short-acting, on-demand design.

Dosage & Administration

Dosing by Condition

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

Initial Dose

30 mg taken 1-3 hours before sexual activity (this product is 60 mg; initiation should ideally begin with 30 mg strength)

Maintenance Dose

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

Maximum Dose

60 mg per 24 hours; maximum one dose per day

Children's Dosage

Not approved for children or adolescents under 18 years

Dose Adjustment Notes

Hepatic impairment: contraindicated in moderate to severe hepatic impairment; mild hepatic impairment-use with caution. Renal impairment: mild to moderate-use with caution; severe-use with caution/not recommended (limited data). CYP3A4 inhibitors: contraindicated with potent inhibitors; with moderate inhibitors, do not exceed 30 mg per dose. Elderly (≥65 years): limited data-use with caution.

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 any 24-hour period; may be taken with or without food.

Side Effects

Common Side Effects

Nausea, dizziness, headache, diarrhea, insomnia, fatigue, somnolence, and nasopharyngitis; dry mouth not reported in clinical trials

Side Effect Frequency

Very common (>10%): nausea (22.2% at 60 mg), dizziness (10.9% at 60 mg). Common (1-10%): headache (8.8% at 60 mg), diarrhea (6.9% at 60 mg), somnolence (4.7% at 60 mg), fatigue (4.1% at 60 mg), insomnia (3.9% at 60 mg). Uncommon (<1%): syncope (0.23% at 60 mg). Dry mouth not reported in clinical trials

Safety & Warnings

Contraindications

Contraindicated with: hypersensitivity; significant cardiac disease (e.g., heart failure, conduction abnormalities, significant ischemic/valvular disease); history of syncope; moderate-to-severe hepatic impairment; concomitant MAOIs (or within 14 days), thioridazine (or within 14 days), SSRIs/SNRIs/TCAs or other serotonergic drugs/agents for serotonin syndrome risk; and potent CYP3A4 inhibitors.

Warnings & Precautions

Key warnings: syncope/orthostatic hypotension (especially within hours of dosing) with counseling to sit/lie down at prodrome and avoid alcohol; assess cardiovascular risk; avoid concomitant serotonergic agents (serotonin syndrome); caution with bleeding risk/anticoagulants, seizure history, and history of mania/bipolar disorder or severe depression; on-demand use only and not for erectile dysfunction.

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 other serotonergic drugs (SSRIs/SNRIs/TCAs, triptans, tramadol, linezolid, lithium, St John’s wort) → serotonin syndrome risk (many are contraindicated/avoid); thioridazine (contraindicated); potent CYP3A4 inhibitors (contraindicated); moderate CYP3A4 inhibitors (avoid or use lowest dose with caution per local label); alcohol and other vasodilators/PDE5 inhibitors → increased orthostatic hypotension/syncope risk.

Interaction Severity

MAJOR/Contraindicated: MAOIs; thioridazine; other serotonergic antidepressants (SSRIs/SNRIs/TCAs) and other potent serotonergic drugs where serotonin syndrome risk is significant; potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir); alcohol should be avoided due to increased syncope/orthostatic hypotension risk. MODERATE: moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem/verapamil)-limit dapoxetine to 30 mg; PDE5 inhibitors-additive hypotension/syncope risk; other serotonergic agents (e.g., tramadol, triptans, lithium)-increased serotonin syndrome risk. MINOR: none specific/clinically established.

Food Interaction

May be taken with or without food; a high-fat meal may delay absorption/onset; avoid grapefruit juice (CYP3A4 inhibition) around dosing.

Special Populations

Children

Not approved for children or adolescents under 18 years

Storage & Patient Advice

Missed Dose

Not applicable because it is taken on demand; if you did not take it before sexual activity, do not double up-take only one dose and never more than one dose in 24 hours.

Stopping the Medicine

On-demand use; may be stopped without tapering. If taken daily or regularly for an extended period, consult a doctor before stopping due to potential SSRI discontinuation symptoms.

Patient Counseling

Take one tablet as needed 1-3 hours before sex with a full glass of water; do not take more than one dose in 24 hours and it is not for daily use. Avoid alcohol and rise slowly to reduce fainting risk; sit/lie down if dizzy or lightheaded. Do not use with MAOIs, other antidepressants/serotonergic drugs, or strong CYP3A4 inhibitors; avoid grapefruit. Use caution with driving/machinery if dizzy or sleepy; seek urgent care for fainting or serotonin syndrome symptoms (agitation, confusion, sweating, fast heartbeat, tremor).

Monitoring Requirements

No routine laboratory monitoring; clinically monitor for orthostatic hypotension/syncope (especially after first doses), dizziness, and symptoms of serotonin syndrome; assess psychiatric history and monitor for mood changes/suicidality if clinically indicated.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI) that inhibits presynaptic serotonin reuptake, increasing serotonergic neurotransmission and delaying ejaculation via modulation of the ejaculatory reflex.

Onset of Action

About 1-3 hours (peak effect around the time of dosing 1-3 hours before intercourse).

Duration of Effect

Approximately several hours (about 3-4 hours) after a single dose.

Half-Life

Initial half-life ~1.3-1.5 hours; terminal half-life ~19 hours (reported range ~19-22 hours).

Metabolism

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

Excretion

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

Product Information

Available Dosage Forms

Film-coated tablet

Mechanism

SSRI-based

Onset Time

1-3 hours

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