DAPOX 30/MG FC TAB 4/FC TAB

Indications

Approved Uses

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

Off-Label Uses

None commonly known.

Dosage & Administration

Dosing by Condition

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

Initial Dose

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

Maintenance Dose

30mg or 60mg taken on-demand, 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

Hepatic impairment: contraindicated in moderate-severe impairment; mild impairment-use with caution (do not exceed 30 mg). Renal impairment: no adjustment in mild-moderate; severe-use with caution. Older adults (≥65): limited data-use with caution. Concomitant moderate CYP3A4 inhibitors: maximum 30 mg; potent CYP2D6 inhibitors: use with caution (higher exposure).

How to Take

Swallow the tablet whole with a full glass of water (to reduce the risk of dizziness/syncope); take 1-3 hours before anticipated sexual activity; do not take more than one dose in 24 hours.

Side Effects

Common Side Effects

Common adverse effects include nausea, dizziness, headache, diarrhea, insomnia, somnolence, fatigue, and dry mouth.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to dapoxetine/excipients; concomitant MAOIs or within 14 days of stopping an MAOI (and wait 7 days after stopping dapoxetine before starting an MAOI); concomitant thioridazine or within 14 days of stopping thioridazine (and wait 7 days after stopping dapoxetine before starting thioridazine); concomitant SSRIs/SNRIs/TCAs or other serotonergic antidepressants; concomitant potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, saquinavir, atazanavir, telithromycin, nefazodone); moderate or severe hepatic impairment; significant pathological cardiac conditions (e.g., heart failure, conduction abnormalities, ischemic heart disease/valvular disease); history of syncope; pregnancy (not indicated for use in women).

Warnings & Precautions

Key warnings/precautions: counsel on syncope/orthostatic hypotension (recognize prodrome; sit/lie down; avoid dehydration/alcohol; caution with driving/hazardous tasks); assess cardiovascular status and avoid in significant cardiac disease; avoid concomitant serotonergic drugs and monitor for serotonin syndrome; monitor for mood changes/suicidality and use caution with history of mania/depression; caution in seizure disorders (stop if seizures occur); caution with bleeding disorders/anticoagulants/NSAIDs; intended for on-demand use in adult men only (not for women or <18).

Age Restriction

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

Drug Interactions

Drug Interactions

Major interactions: MAOIs (contraindicated; serotonin syndrome); thioridazine (contraindicated; QT/CNS risk); other serotonergic drugs including SSRIs/SNRIs/TCAs, triptans, tramadol, linezolid, lithium, St John’s wort (avoid due to serotonin syndrome); potent CYP3A4 inhibitors (contraindicated); moderate CYP3A4 inhibitors (use caution/avoid dose escalation-exposure increases); potent CYP2D6 inhibitors (increase exposure-use caution); PDE5 inhibitors and other vasodilators (additive orthostatic hypotension/syncope risk); alcohol (increases CNS impairment and syncope risk).

Interaction Severity

MAJOR/Contraindicated: MAOIs (and within 14 days), thioridazine (and within 14 days), potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir), and other strongly serotonergic antidepressants/agents where serotonin syndrome risk is clinically significant (avoid/contraindicated depending on agent). MODERATE/Use caution: moderate CYP3A4 inhibitors (limit dapoxetine to 30 mg), PDE5 inhibitors and alpha-blockers (e.g., tamsulosin) due to additive orthostatic hypotension/syncope risk, alcohol (increases CNS effects and syncope risk), and other serotonergic drugs such as tramadol/triptans (avoid or use only with specialist oversight).

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 it as a daily scheduled medicine and do not take more than one dose in 24 hours.

Stopping the Medicine

When used on-demand, tapering is generally not required; however, do not stop abruptly if the patient has been taking dapoxetine frequently/continuously (e.g., daily or near-daily) for an extended period-consider a gradual reduction and monitor for SSRI-like discontinuation symptoms (e.g., dizziness, sensory disturbances, sleep disturbance, irritability).

Pharmacology

Mechanism of Action

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

Onset of Action

Take 1-3 hours before sexual activity (peak concentrations typically occur around 1-2 hours).

Duration of Effect

Clinically relevant effect is short and generally covers the dosing window around intercourse (about 3-4 hours), with drug levels declining substantially thereafter (very low relative to peak by 24 hours).

Half-Life

Initial half-life ~1.5 hours; terminal half-life ~19-22 hours.

Metabolism

Extensive hepatic metabolism primarily via CYP2D6 and CYP3A4, with additional contribution from FMO1; major metabolite is desmethyldapoxetine (with other inactive metabolites).

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

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

Generic Availability

Yes

Mechanism

SSRI-based

Onset Time

1-3 hours

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 14-06-2026