Dapoxetine 60 mg (Film-coated tablet)

1. Description

Dapoxetine 60 mg (active compound: dapoxetine 60 mg) is a short-acting selective serotonin reuptake inhibitor (SSRI) developed and licensed in many countries for the on‑demand treatment of premature ejaculation (PE) in adult men. It is taken shortly before sexual activity rather than as a continuous daily antidepressant regimen. Clinical trials show dapoxetine can increase intravaginal ejaculatory latency time (IELT) and improve patient and partner-reported control over ejaculation and sexual satisfaction. The 60 mg dose is generally reserved for patients who have an inadequate response to the lower starting dose (30 mg) and who tolerate that dose well.

Indication: on‑demand treatment of premature ejaculation in adult men (typically 18–64 years). Not indicated for use in women or children.

2. How does Dapoxetine 60 mg work?

Dapoxetine is a potent inhibitor of the serotonin transporter (SERT). By blocking reuptake of serotonin (5‑HT) into presynaptic neurons in certain central nervous system circuits involved in ejaculatory reflex control, dapoxetine increases serotonergic neurotransmission. Enhanced serotonin signaling (particularly via 5‑HT1A and 5‑HT2 receptors) delays the ejaculatory reflex, thereby increasing time to ejaculation. Dapoxetine has a rapid absorption (Tmax ≈ 1–2 hours) and a relatively short elimination half‑life compared with other SSRIs, which permits single‑dose, on‑demand use with a lower likelihood of accumulation when used intermittently.

3. Dosage

General principles

• Dapoxetine is taken on demand, 1–3 hours before anticipated sexual activity.
• Do not exceed one dose in any 24‑hour period.
• The usual initial dose is 30 mg. If 30 mg does not provide an adequate clinical response and the 30 mg dose is well tolerated, the dose may be increased to 60 mg.
• The 60 mg dose is the maximum recommended single dose.

Recommended adult dosing (typical clinical practice)

• Start: 30 mg taken 1–3 hours before sexual activity.
• If inadequate response and 30 mg well tolerated: increase to 60 mg 1–3 hours before sexual activity.
• Maximum frequency: once every 24 hours.
• Not intended as daily continuous therapy.

Special populations and cautions

• Age: Most approvals restrict use to adult men (typically 18–64). Use in elderly men is uncommon; consider comorbidities and concomitant medications.
• Hepatic impairment: Avoid in severe hepatic impairment. Use with caution in moderate impairment and consult product label/product monograph; dose adjustment or avoidance may be required.
• Renal impairment: Mild to moderate renal impairment usually does not require dose adjustment, but avoid use in severe renal impairment unless advised by a specialist.
• Concomitant medications: Many drug interactions affect dosing choice (see Section 4). Do not combine with MAO inhibitors. Avoid combination with potent CYP3A4 inhibitors; if such a combination cannot be avoided, do not exceed recommended dosing and consult prescribing information.
• Frequency of sexual activity: If multiple sexual events are anticipated, dosing should still not exceed one dose per 24 hours.

Always follow local prescribing information and a physician’s guidance for individualized dosing decisions.

4. Side effects

Adverse events are typically dose-dependent; many are more common with 60 mg than with 30 mg.

Common (≥1% and more frequent at 60 mg)

• Nausea
• Dizziness
• Headache
• Diarrhea
• Insomnia or altered sleep
• Fatigue
• Dry mouth
• Tremor
• Anxiety or nervousness
• Increased sweating

Uncommon / less common

• Syncope (fainting) and presyncope — more likely with standing, may be associated with orthostatic hypotension
• Visual disturbances (blurred vision)
• Palpitations
• Somnolence

Serious but rare

• Serotonin syndrome: risk increases if dapoxetine is combined with other serotonergic drugs (SSRIs, SNRIs, MAOIs, triptans, certain opioids, St John’s wort). Symptoms: agitation, hallucinations, rapid heart rate, labile blood pressure, hyperthermia, hyperreflexia, incoordination. This is a medical emergency.
• Severe syncope with injury
• Suicidal ideation/behavior: rare but monitor patients with known psychiatric history
• Cardiac events: caution in patients with structural heart disease or conduction abnormalities. Use with certain drugs that prolong QT or with thioridazine is contraindicated due to potential cardiac risk.
• Priapism: very rare; persistent painful erection >4 hours requires urgent treatment to avoid permanent injury.

Contraindications and important drug interactions

• Contraindicated with monoamine oxidase inhibitors (MAOIs) and within 14 days of stopping an MAOI. Also avoid starting MAOI within 7–14 days after stopping dapoxetine.
• Contraindicated with thioridazine (risk of cardiac arrhythmias).
• Avoid concomitant use with other SSRIs, SNRIs, tricyclic antidepressants, or other serotonergic medications unless under close medical supervision due to serotonin syndrome risk.
• Potent CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole) markedly increase dapoxetine exposure; many product labels advise against coadministration (or to use a lower dose / avoid 60 mg). Check the specific product monograph for local guidance.
• Caution with drugs that increase risk of orthostatic hypotension or syncope, and with alcohol — combination can increase dizziness, syncope, and impaired judgment.

Overdose

• Symptoms: nausea, vomiting, dizziness, fainting, tachycardia. Management is supportive and symptomatic. Seek emergency care for overdose.

When to stop and seek medical help

• Any signs of serotonin syndrome (fever, confusion, muscle stiffness, tremor), fainting, chest pain, shortness of breath, prolonged or painful erections (>4 hours), or severe allergic reactions require immediate medical evaluation.

5. Storage

• Store at controlled room temperature as specified on the product label (commonly 15–30 °C / 59–86 °F) unless a different temperature range is stated by the manufacturer.
• Keep in original packaging to protect from moisture and light when recommended.
• Do not store in bathrooms or other damp/humid places.
• Keep out of reach of children and pets.
• Dispose of unused or expired medication according to local regulations; do not flush down the toilet unless instructed.

Final notes

• Dapoxetine is a prescription medication. This guide summarizes general clinical information but is not a substitute for individualized medical advice. Discuss personal medical history, concomitant medications, cardiovascular status, psychiatric history, and potential drug interactions with a prescribing physician or pharmacist before starting dapoxetine.