This is a fixed combination of two oral medicines, tadalafil and dapoxetine, used together to treat men who have both erectile dysfunction (ED) and premature ejaculation (PE) at the same time. It combines a PDE5 inhibitor (for erections) with a short-acting SSRI (for ejaculatory control). It is a prescription-only medicine.

• Therapeutic Class: Male sexual dysfunction medicine (combination therapy).

• Pharmacological Class: Phosphodiesterase type 5 (PDE5) inhibitor (tadalafil) combined with a selective serotonin reuptake inhibitor (dapoxetine).

• Drug Family: PDE5 inhibitors (erectile dysfunction) plus short-acting SSRIs (premature ejaculation).

• ATC Classification: G04BE08 (Tadalafil) combined with a dapoxetine-specific code, depending on regional classification systems — no single unified ATC code exists for this fixed combination.

• Approved/established use: Erectile dysfunction combined with premature ejaculation in adult men, where both conditions coexist, and a combined treatment approach is considered appropriate by the prescribing doctor.

• Commonly used for: Men experiencing both difficulty achieving/maintaining an erection and difficulty delaying ejaculation, where treating both together may be more convenient and effective than treating either alone.

• Off-label use (only under medical guidance): Not typically described as off-label, since this combination itself is a specific marketed product in the regions where available, rather than a repurposing of another approved use.

Oral tablets: commonly available in combinations such as tadalafil 20 mg / dapoxetine 30 mg or 60 mg, though exact strengths vary by manufacturer.

Tadalafil blocks an enzyme called PDE5, which helps relax blood vessels in the penis and improve blood flow needed for an erection during sexual stimulation. Dapoxetine increases the level of serotonin, a brain chemical messenger, in nerve synapses, which helps improve a man's control over the timing of ejaculation and delays it. Combined, the two medicines address both aspects of male sexual dysfunction that can occur together.

• Standard dose: One tablet taken orally, typically 1 to 3 hours before anticipated sexual activity, depending on the specific product's instructions.

• Condition-wise dose: Do not take more than once every 24 hours; the prescribing doctor chooses the specific tadalafil/dapoxetine strength combination based on individual response and tolerability.

• Route: Oral, taken on an as-needed basis before sexual activity, generally with a full glass of water.

• Missed dose: Not applicable in the traditional sense, as this is an as-needed (not scheduled daily) medicine; simply take before the next planned instance of sexual activity, respecting the 24-hour interval.

• Overdose: May increase the risk of known side effects such as headache, flushing, low blood pressure, or dizziness; requires medical attention.

• Common: Headache, flushing, dizziness, nausea, and nasal congestion.

• Serious: Significant drop in blood pressure (particularly when combined with other blood-pressure-lowering medicines), fainting, and, rarely, prolonged or painful erection (priapism) linked to the tadalafil component.

• Emergency symptoms: An erection lasting more than 4 hours, sudden vision or hearing loss, chest pain, severe dizziness or fainting, or signs of a severe allergic reaction.

• Recovery advice: Mild headache, flushing, or dizziness are common and often manageable; taking the tablet as directed (not more than once daily) and avoiding excess alcohol can help reduce these effects.

• Pregnancy: Not applicable; used only in men.

• Breastfeeding: Not applicable; used only in men.

• Liver disease: Used with caution and dose adjustment guidance from the prescribing doctor, given that both components are processed by the liver.

• Kidney disease: Used with caution; dose adjustment may be needed in significant kidney impairment, based on the tadalafil component's known dosing guidance.

• Elderly: Used with caution, particularly regarding blood pressure effects and interactions with other medicines common in this age group.

• Children: Not applicable; a medicine for adult men.

● Nitrates (e.g., nitroglycerin, used for chest pain): combining with tadalafil can cause a dangerous drop in blood pressure; this combination is contraindicated with nitrate use.

● Alpha-blockers (used for blood pressure or prostate symptoms): can also cause a significant drop in blood pressure when combined with tadalafil; use with caution and follow dose-spacing guidance.

● Other SSRIs, MAO inhibitors, or serotonin-affecting medicines: combining with dapoxetine increases the risk of serotonin syndrome, a potentially serious condition; these combinations are generally avoided.

● Strong CYP3A4 inhibitors (e.g., ketoconazole, certain HIV protease inhibitors): can increase levels of both components, requiring caution or dose adjustment.

Blood pressure review, particularly in men already taking other blood-pressure-lowering medicines.

● Assessment for symptoms of serotonin syndrome (agitation, rapid heartbeat, high body temperature) if combined with other serotonin-affecting medicines.

● General cardiovascular risk assessment before starting, given that sexual activity itself carries a cardiac workload.

Sildenafil, Vardenafil, Avanafil (other PDE5 inhibitors, used alone for ED); Dapoxetine alone (for PE without significant ED); each component can also be prescribed separately rather than as this fixed combination.

This is itself a fixed combination of two medicines addressing different aspects of male sexual dysfunction; not combined with other PDE5 inhibitors or additional SSRIs given overlapping mechanisms and interaction risks.

● Male Sexual Dysfunction Medicines

● Erectile Dysfunction Treatments

● Premature Ejaculation Treatments

1. Common Sexual Health Problems In Men

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10929668/

2. https://www.1mg.com/generics/tadalafil-dapoxetine-403084

The information on this page is for educational purposes only and is not a substitute for medical advice. Please consult your doctor to know if this treatment is appropriate for your condition.