EVOKA 60/MG FC TAB 4/FC TAB

Indications

Approved Uses

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

Off-Label Uses

None commonly known. It was initially developed as an antidepressant but found to be more suitable for PE due to its rapid absorption and elimination.

Dosage & Administration

Dosing by Condition

Premature ejaculation (adult men): 30 mg taken as needed 1-3 hours before sexual activity; if response is inadequate and tolerated, increase to 60 mg; maximum 1 dose per 24 hours.

Initial Dose

30mg taken 1-3 hours before sexual activity (note: this pack contains 60mg tablets; 30mg initiation requires a separate 30mg product)

Maintenance Dose

30mg or 60mg taken as needed, 1 to 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

Usual initiation is 30 mg on-demand with possible increase to 60 mg if tolerated; avoid use in moderate-to-severe hepatic impairment (contraindicated); with moderate CYP3A4 inhibitors limit to 30 mg and avoid strong CYP3A4 inhibitors; no dose adjustment is generally required in mild-moderate renal impairment but use caution in severe renal impairment.

How to Take

Swallow the tablet whole with a full glass of water; take 1-3 hours before anticipated sexual activity; may be taken with or without food; do not take more than one dose in 24 hours; if dizziness occurs, sit/lie down and rise slowly.

Side Effects

Common Side Effects

Nausea, dizziness, headache, diarrhea, insomnia, somnolence, fatigue, dry mouth, nasopharyngitis, anxiety

Side Effect Frequency

Very common (≥10%): nausea, dizziness, headache. Common (1-10%): diarrhea, insomnia, fatigue, somnolence, dry mouth, anxiety, hyperhidrosis (sweating), flushing; other events such as tremor, blurred vision, tinnitus, vomiting, erectile dysfunction, decreased libido, and hypertension are generally less frequent (often uncommon/rare depending on dataset).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to dapoxetine/excipients; 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 of stopping an MAOI; concomitant thioridazine or within 14 days of stopping thioridazine; concomitant SSRIs/SNRIs/TCAs or other serotonergic drugs (e.g., tramadol, triptans, linezolid, lithium, St John’s wort) due to serotonin syndrome risk; concomitant potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir).

Warnings & Precautions

Key precautions: risk of syncope/orthostatic hypotension (especially early-advise hydration, rise slowly, avoid driving/operating machinery if dizzy); assess cardiovascular status before use; on-demand use only (not continuous daily use); avoid alcohol; caution with seizure history; monitor for serotonin syndrome when combined with serotonergic agents; caution with bleeding risk/anticoagulants; caution in patients with bipolar disorder/mania history; not recommended in men ≥65 due to limited data.

Age Restriction

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

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: MAOIs (contraindicated); thioridazine (contraindicated); SSRIs/SNRIs/TCAs and other serotonergic drugs (avoid/contraindicated due to serotonin syndrome); potent CYP3A4 inhibitors (contraindicated); moderate CYP3A4 inhibitors (use caution and generally limit to 30 mg if used); PDE5 inhibitors and alpha-blockers (additive hypotension/syncope risk-caution); alcohol (increases CNS effects and syncope risk); recreational serotonergic/stimulant drugs (e.g., MDMA/amphetamines) increase toxicity risk.

Interaction Severity

MAJOR/Contraindicated: MAOIs (and within 14 days), thioridazine (and within 14 days), other serotonergic antidepressants/serotonergic drugs with high serotonin-syndrome risk (e.g., SSRIs/SNRIs/TCAs, linezolid), and strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir). MODERATE/Use caution: moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, verapamil-limit dapoxetine to 30 mg), PDE5 inhibitors and alpha-blockers (additive orthostatic hypotension/syncope), and alcohol (increases CNS effects/syncope risk).

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 because it is taken on-demand; do not take an extra dose to ‘make up’ for a missed dose and do not exceed one dose in 24 hours.

Stopping the Medicine

On-demand use; may be stopped without tapering. If taken regularly/daily for an extended period, consider gradual dose reduction to minimize potential SSRI discontinuation symptoms-consult prescriber.

Patient Counseling

Take 1-3 hours before sex with a full glass of water; do not take more than once in 24 hours; may take with or without food; avoid alcohol and grapefruit; rise slowly and sit/lie down if dizzy (fainting risk); avoid driving/operating machinery if dizzy; do not combine with MAOIs, thioridazine, other SSRIs/SNRIs/serotonergic drugs, or strong CYP3A4 inhibitors without prescriber approval; seek urgent care for fainting, severe dizziness, or symptoms of serotonin syndrome.

Monitoring Requirements

Assess for orthostatic hypotension/syncope risk at initiation (including baseline supine/standing blood pressure and pulse when clinically appropriate), and monitor for dizziness/fainting, mood changes/suicidality, and serotonin syndrome when used with interacting serotonergic agents.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor that increases serotonergic neurotransmission (via inhibition of presynaptic serotonin reuptake), which modulates ejaculatory reflex pathways and delays ejaculation.

Onset of Action

Take 1-3 hours before sexual activity (onset aligns with this window).

Duration of Effect

Clinically, the intended on-demand effect covers the several-hour window after dosing (roughly 3-4 hours), with drug levels declining substantially thereafter though terminal elimination extends longer.

Half-Life

Initial (distribution) half-life ~1.3-1.4 hours; terminal half-life ~18-22 hours.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

SSRI-based

Onset Time

1-3 hours

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 26-05-2026