DEPOJOY 30/MG FC TAB 6/FC TAB

Indications

Approved Uses

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

Off-Label Uses

None commonly known. Other SSRIs (fluoxetine, paroxetine) are used off-label for premature ejaculation, but dapoxetine is specifically approved for this use.

Dosage & Administration

Dosing by Condition

Premature Ejaculation (Adults 18-64): Initial dose is 30mg taken 1-3 hours before sexual activity. If response is insufficient and side effects are tolerable, may be increased to 60mg. Maximum one dose per 24 hours.

Initial Dose

30mg taken as needed, 1 to 3 hours before sexual activity.

Maintenance Dose

30mg or 60mg taken as needed, 1 to 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

Start with 30 mg as needed; may increase to 60 mg only if 30 mg is well tolerated and response is insufficient; with moderate CYP3A4 inhibitors the maximum dose is 30 mg; avoid/use not recommended in moderate hepatic impairment and contraindicated in severe hepatic impairment.

How to Take

Swallow the tablet whole with a full glass of water (do not crush/chew); 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.

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, fatigue, insomnia, dry mouth, anxiety, agitation/restlessness, tremor, hyperhidrosis, flushing, yawning, blurred vision, tinnitus, nasopharyngitis. Uncommon (0.1-<1%): orthostatic hypotension, presyncope/syncope. Rare/very rare: seizures, serotonin syndrome, mania/hypomania.

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 (Child‑Pugh B/C); concomitant MAOIs (or within 14 days), thioridazine (or within 14 days), SSRIs/SNRIs/TCAs/other serotonergic drugs (e.g., triptans, tramadol, linezolid, lithium, St John’s wort); and potent CYP3A4 inhibitors. Use in severe renal impairment is generally not recommended/avoid.

Warnings & Precautions

Key precautions: counsel on syncope/orthostatic hypotension (hydration, rise slowly, lie down if prodromal symptoms); assess cardiovascular risk before use; avoid alcohol and caution with PDE5 inhibitors/vasodilators; avoid concomitant serotonergic drugs (serotonin syndrome); caution in patients with psychiatric history (mania/depression), seizure disorders, and bleeding risk/anticoagulants; use only on demand (not continuous daily use).

Age Restriction

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

Drug Interactions

Drug Interactions

Major interactions: MAOIs and thioridazine (contraindicated); other serotonergic agents including SSRIs/SNRIs/TCAs, triptans, tramadol, linezolid, lithium, St John’s wort (avoid/contraindicated due to serotonin syndrome); potent CYP3A4 inhibitors (contraindicated) and moderate CYP3A4 inhibitors/CYP2D6 inhibitors (increase exposure-dose limits/caution); PDE5 inhibitors and alcohol (additive hypotension/syncope risk); anticoagulants/antiplatelets (caution-bleeding risk).

Interaction Severity

MAJOR/Contraindicated: MAOIs (and within 14 days), thioridazine, potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir), and other strongly serotonergic antidepressants/agents where serotonin syndrome risk is significant (e.g., SSRIs/SNRIs/TCAs; caution/avoid with other serotonergic drugs). MODERATE: Moderate CYP3A4 inhibitors (limit to 30 mg), strong CYP2D6 inhibitors (increased exposure-use caution; many references recommend not exceeding 30 mg), PDE5 inhibitors (additive hypotension/syncope risk), alcohol (increases orthostatic hypotension/CNS effects).

Food Interaction

May be taken with or without food; a high-fat meal can delay absorption (later Tmax) without clinically meaningful loss of effect.

Special Populations

Children

Not approved for children or adolescents under 18 years

Storage & Patient Advice

Missed Dose

Not applicable because it is taken as needed; take only when anticipating sexual activity and do not take more than one dose in 24 hours.

Stopping the Medicine

On-demand use: no taper is required. If taken daily or frequently for an extended period, consult the prescriber before stopping due to possible SSRI-like discontinuation symptoms.

Patient Counseling

Take 30 mg 1-3 hours before sexual activity; swallow whole with a full glass of water; do not take more than once in 24 hours; avoid alcohol and be cautious with PDE5 inhibitors due to fainting/low blood pressure risk; if dizzy/lightheaded, lie down with legs raised until symptoms pass; avoid driving/operating machinery if affected; do not use with MAOIs, thioridazine, potent CYP3A4 inhibitors, or other serotonergic antidepressants/agents unless prescriber confirms safety; not for women or patients <18 years.

Pharmacology

Mechanism of Action

Inhibits the serotonin transporter (SSRI), increasing synaptic serotonin neurotransmission in relevant CNS pathways and thereby delaying the ejaculatory reflex.

Onset of Action

1-3 hours.

Duration of Effect

Short-lived; clinically intended effect covers the few hours after dosing (roughly 3-4 hours), with peak concentrations at ~1-2 hours and levels falling to a small fraction of peak by 24 hours.

Half-Life

Rapid initial half-life about 1.3-1.5 hours; terminal half-life about 19 hours (reflecting distribution/metabolite kinetics).

Metabolism

Extensive hepatic metabolism via CYP2D6, CYP3A4, and FMO1 to multiple metabolites (including desmethyldapoxetine).

Excretion

Primarily excreted in urine as metabolites; only a small fraction is excreted unchanged.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

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

OTC Alternatives

No OTC alternative.

Mechanism

SSRI-based

Onset Time

1-3 hours

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