Priligy (Dapoxetine) – Patient Information for Australia
Basic Product Information
| International Nonproprietary Name (INN) | Dapoxetine |
|---|---|
| Available Brand Names in Australia | Priligy® |
| ATC Code | G04BX14 |
| Available Forms & Strengths | Film-coated tablets: 30 mg & 60 mg |
| Manufacturers | Menarini Australia Pty Ltd, A Menarini Industrie Farmaceutiche Riunite s.r.l., and authorised generics |
| Prescription Status | Prescription only (Schedule 4) |
Mechanism of Action
For Patients:Dapoxetine is a medicine used to treat premature ejaculation in men. It works by increasing the activity of serotonin (a natural substance in the brain) that helps delay ejaculation and improve control over ejaculation during sexual activity.
For Specialists:Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) designed for on-demand use. It inhibits presynaptic serotonin transporters, increasing synaptic serotonin and modulating neurological pathways controlling ejaculation reflex latency.
Pharmacokinetics
- Absorption: Rapid oral absorption; peak plasma levels in 1–2 hours post-dose.
- Metabolism: Extensively hepatic via CYP2D6, CYP3A4, and CYP2C19 enzymes.
- Elimination: Renal and fecal; terminal half-life is short (~19 hours), with most activity within the first 2–3 hours.
- Duration of action: Therapeutic effect lasts 4–6 hours post-dose, making it suitable for on-demand use.
Priligy in Everyday Life and Best Practices
- Who uses Priligy? Adult men diagnosed with premature ejaculation (PE), typically defined as ejaculation occurring within 2 minutes of penetration and associated with distress or interpersonal difficulty.
- Typical doses: Initial dose is 30 mg, taken 1–3 hours before anticipated sexual activity. If effectiveness is insufficient and side effects remain tolerable, dose may be increased to 60 mg.
- How to take: Swallow whole with at least one full glass of water. Do not take more than once in 24 hours and not on a daily basis unless advised by your healthcare provider.
- Context for Australia: Discuss with your GP or pharmacist, especially if you have a history of mental health conditions, liver, or heart problems.
Dosing: Morning vs Evening
- Dapoxetine should be taken 1–3 hours before sexual activity. Time of day (morning vs evening) is less important than proximity to intended activity.
- Regularity tips: Do not take regularly (for example, every morning or every evening); use only when sexual activity is anticipated.
- Practical advice: To minimise sleep disturbances, avoid late-evening dosing if planning to sleep soon after use.
Taking Priligy with Food or on an Empty Stomach
- Priligy may be taken with or without food. The absorption is not significantly affected by a typical meal.
- High-fat meals may delay onset of action marginally, but not enough to affect clinical use.
- Dietary habits in Australia: You can take Priligy before, with, or after typical Australian cuisine without concern, but always swallow with a full glass of water to reduce the risk of fainting.
Interaction Warnings
| Interacting Substance | Recommendation/Effect |
|---|---|
| Alcohol | Can increase risk of fainting, dizziness, and impaired judgment. Avoid alcohol while using Priligy. |
| Monoamine oxidase inhibitors (MAOIs) | Do not use with Priligy or within 14 days of taking an MAOI (risk of severe interactions). |
| Other SSRIs/SNRIs/Tricyclic antidepressants | Increased risk of serotonin syndrome. Typically not co-prescribed for PE. |
| Thioridazine | Contraindicated due to heart rhythm disturbances. |
| St John’s Wort | May reduce efficacy of Priligy. |
| Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) | Increase dapoxetine levels—potential toxicity. |
| NSAIDs and aspirin | May increase risk of bleeding, especially with high doses. |
| Grapefruit juice | May increase risk of side effects—avoid regular intake. |
Indications and Off-Label Uses
| Indication | Status | Age Range |
|---|---|---|
| Treatment of primary premature ejaculation in men | Approved | 18 to 64 years |
| Other uses (off-label) | Not recommended/Not approved | – |
Dosing According to Clinical Indications
| Population | Starting Dose | Maximum Dose | Notes |
|---|---|---|---|
| Adult men (18–64) | 30 mg 1–3 hours before activity | 60 mg (if needed and tolerated) | Do not take more than once per 24 hours |
| Men over 65 | Not recommended | – | Limited clinical data; consult specialist |
| Children & Adolescents | Contraindicated | – | Not safe or effective |
Safety Profile and Side Effects
Most side effects are mild to moderate and short-lived. Take care with activities requiring full alertness until you know how Priligy affects you.
| Side Effect | Frequency | Severity/Advice |
|---|---|---|
| Nausea | Common | Usually mild, brief; eat light meal before dose if affected |
| Dizziness/Vertigo | Common | Avoid driving and alcohol; stand up slowly from sitting/lying |
| Headache | Common | Over-the-counter analgesics can help |
| Insomnia, sleepiness | Uncommon | Avoid late evening dosing |
| Diarrhoea | Uncommon | Usually transient |
| Fainting/syncope | Rare | Seek urgent medical help; sit/lie down if dizzy |
| Mood changes (anxiety, depression, agitation) | Rare | Report to doctor immediately |
| Serotonin syndrome (e.g., agitation, high temperature, confusion) | Very rare | Medical emergency—seek urgent help |
Warnings: Not suitable for patients with severe heart, liver, or mental health disorders. May increase bleeding risk with anticoagulants/NSAIDs.
Guidelines for Proper Use — Pharmacist and Clinic Advice
- Consult your doctor before starting, especially if using other antidepressants or SSRIs.
- Take only as prescribed; do not exceed recommended dose or frequency.
- Drink plenty of water with each tablet to reduce risk of fainting.
- If you feel faint, dizzy, or nauseous, lie down immediately and seek medical advice if symptoms persist.
- Do not use if you have a history of heart rhythm disorders, severe liver impairment, or are taking certain antidepressants (see interactions).
- Discontinue and seek help immediately if you notice mood changes, suicidal thoughts, or symptoms of serotonin syndrome.
- Discuss any other medications (prescription, over-the-counter, herbal, recreational) you are taking with your pharmacist or GP.
- Store at room temperature below 30°C, away from direct sunlight and out of reach of children.
- Never share your medication with others.
Alternative Treatment Options
- Psychological therapies: Cognitive-behavioural therapy (CBT), couples counselling, sexual therapy—first-line where possible, or in combination with medicines.
- Other medicines:
- Sertraline, paroxetine: Used off-label by Australian GPs; longer acting, higher risk of sexual side effects, requires daily use.
- Local anaesthetic sprays (e.g., lidocaine-prilocaine spray): Reimbursed and available, applied to the penis before sex; can numb sensation but less systemic side effects.
- Clomipramine: Older antidepressant, sometimes prescribed; higher side effect burden.
- Pros & Cons Comparison:
- Dapoxetine is fast-acting, "on-demand" dosing; less risk of persistent side effects compared to daily SSRIs.
- Topical anaesthetics have fewer systemic effects but are less suitable for some couples/partners.
- The choice depends on medical history, side effect profile, personal preference, and discussions with your doctor or sexual health clinic.
Legal, Registration, and Reimbursement Status in Australia
- Therapeutic Goods Administration (TGA) Registered: Priligy is registered and approved for use in Australia for adult males with confirmed PE.
- Prescription requirements: Prescription only; Schedule 4 under the SUSMP. Cannot be obtained legally without a valid script from an authorised prescriber (GP, urologist, or sexual health specialist).
- Reimbursement (Pharmaceutical Benefits Scheme—PBS): As of June 2024, Priligy is not listed on the PBS; full private payment applies. Topical anaesthetic sprays and some SSRIs may be PBS-listed for other indications.
- Pharmacy practice: Supplied by most major pharmacy chains with a valid prescription. Telehealth consultations for PE may be available in some states with electronic script delivery.
Latest Research and Clinical Guidance (2022–2025)
- Recent Australian urological guidelines (2023–2024) confirm dapoxetine’s role as the only licensed on-demand oral therapy for PE, with favourable short-term effectiveness compared to daily SSRIs.
- Meta-analysis (BMJ Open, 2023): Dapoxetine significantly improves intra-vaginal ejaculatory latency time with an acceptable safety profile.
- Consensus statement in Australian Journal of General Practice (2024): Suggests discussion of expectations, psychological support, and shared decision-making in PE treatment. Priligy is first pharmacologic choice for many newly diagnosed patients.
- Ongoing studies (2022–25) are investigating long-term outcomes and potential role in "situational" PE and in combination with psychological therapy.
- See your healthcare provider or visit NPS MedicineWise for the latest information.
Availability and Delivery (Australia Context)
| Pack Size | Tablet Strength | Indicative Price (AUD) |
|---|---|---|
| 3 tablets | 30 mg or 60 mg | $27–$55 |
| 6 tablets | 30 mg or 60 mg | $48–$88 |
| 12 tablets | 30 mg or 60 mg | $90–$160 |
| Major City | Delivery Time (from local pharmacy online order) |
|---|---|
| Sydney | Same-day or next business day |
| Melbourne | 1 business day |
| Brisbane | 1–2 business days |
| Perth | 2–4 business days |
| Adelaide | 1–2 business days |
| Hobart, Darwin, Canberra | 2–3 business days |
Order with prescription from your local pharmacy, click-and-collect, or through legitimate telehealth partners. Always check TGA certification when considering online purchases.
FAQ – Common Patient Questions
- How long before sex should I take Priligy?
Take Priligy 1–3 hours before anticipated sexual activity for best results. - Can I drink alcohol while taking Priligy?
It is not recommended. Alcohol can increase the risk of fainting, dizziness, and other side effects. Wait until Priligy has cleared from your system before drinking. - Is Priligy addictive or habit-forming?
Priligy (dapoxetine) does not cause physical dependence or withdrawal syndrome. It is designed for occasional, on-demand use. - What if I forget to take it?
If you have not taken the dose 1–3 hours before sex, do not double the dose. Take it next time as directed. - Can I get Priligy on the PBS?
Currently, Priligy is not subsidised on the PBS for any indication; it is a private prescription medicine.
Further Support
For confidential advice and ongoing support, contact your GP, urologist, or an accredited sexual health clinic. Telehealth prescription services and pharmacist-led consultations are available across Australia for appropriate patients.
