Tadalafil with Dapoxetine: Comprehensive Patient Information
Basic Product Information
| Generic Name (INN) | Tadalafil with Dapoxetine |
| Common Australia Brand Names | Priligy with Cialis, Super Tadarise, Tadapox, other compounded brands |
| ATC Code | G04BE08 (Tadalafil), G04BX14 (Dapoxetine) |
| Available Forms & Strengths | Film-coated tablets in combinations such as 20 mg Tadalafil / 60 mg Dapoxetine or 10 mg Tadalafil / 30 mg Dapoxetine |
| Manufacturers | Various international manufacturers; combination products are mainly supplied through compounding pharmacies in Australia |
| Prescription Status | Prescription-only medicine (Schedule 4, S4, per TGA regulations) |
Mechanism of Action
- For Patients: Tadalafil helps relax and widen blood vessels in your penis, making it easier to achieve and sustain an erection during sexual activity. Dapoxetine acts on certain chemicals in the brain, helping to delay the urge to ejaculate, which can help with premature ejaculation.
- For Specialists: Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor, increasing levels of cyclic guanosine monophosphate (cGMP) in corpus cavernosum tissue. Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) that enhances postsynaptic serotonin activity in neural pathways involved in ejaculatory control.
Pharmacokinetics
- Absorption: Both medicines are well absorbed orally; peak plasma concentration for tadalafil occurs within 2 hours and for dapoxetine within 1-2 hours post-dose.
- Metabolism: Tadalafil is metabolised by hepatic CYP3A4 enzymes; Dapoxetine is also mainly processed via CYP3A4 and CYP2D6.
- Elimination: Tadalafil elimination half-life is ~17.5 hours, predominantly through faecal excretion. Dapoxetine’s effective half-life is ~1.5 hours (short-acting), but active metabolites may persist for several hours. They are eliminated largely via the kidneys and liver.
- Duration of Action: Tadalafil’s effect lasts up to 36 hours; Dapoxetine’s onset is rapid (within 1 hour), and action dissipates after 4–6 hours.
Use in Everyday Life and Best Practices
This combination is designed for men who experience both erectile dysfunction (ED) and premature ejaculation (PE). The tablet is usually taken as needed, about 1–3 hours before anticipated sexual activity, with a full glass of water. Do not use more than once in a 24-hour period.
- Typical Dosage: 20mg Tadalafil + 60mg Dapoxetine (single tablet), as prescribed.
- Australian Context: As with all prescription medicines, only use after consultation with your GP or sexual health specialist. Do not source medication from unregulated providers or overseas websites.
- Best Practice: Keep a regular sexual health check and discuss ongoing symptoms with your doctor to ensure optimal treatment and monitor for side effects.
Dosing in the Morning vs Evening
- Morning: Can be useful if sexual activity is planned earlier in the day; may interfere with workday routines or cause mild side effects (dizziness, headache).
- Evening: Most men prefer evening dosing as sexual activity often occurs later. Taking the tablet 1-3 hours prior to desired effect supports the timing of the medicines' peak activity.
- Tips: Maintain consistency in timing when possible. Avoid dosing at variable hours to keep side effects predictable and efficacy optimal.
Taking with Food or on an Empty Stomach
- Effect of Meals: Tadalafil’s absorption is not substantially affected by food, including typical Australian meals. Dapoxetine’s onset can be delayed with a heavy or high-fat meal.
- Recommendation: Take on an empty stomach or after a light meal for fastest onset, but with a full glass of water. Avoid grapefruit juice, which interferes with metabolism.
- Australian Diet Tips: No need for major diet adjustments—just avoid very fatty takeaway before dosing.
Interaction Warnings
| Interaction | Effect | Advice |
| Alcohol | Increased risk of dizziness, low blood pressure, fainting | Limit intake; avoid heavy drinking |
| Nitrates (e.g. GTN, isosorbide) | Dangerous drop in blood pressure | Absolute contraindication |
| CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, erythromycin) | Increased exposure to both actives; increased risk of side effects | Consult doctor for dosing adjustments |
| SSRIs, SNRIs, MAO inhibitors | Serotonin syndrome risk with Dapoxetine | Avoid unless under specialist supervision |
| Other erectile dysfunction medication | Excessive blood pressure lowering, risk of priapism | Never combine without explicit medical direction |
| Grapefruit juice | Slows breakdown of active drugs | Avoid completely |
Indications
| Official Indications | Off-label Indications |
- Treatment of erectile dysfunction (ED)
- Treatment of premature ejaculation (PE) in adult men | - Some clinicians use combo therapy for men who do not respond to monotherapy
- Possible use in certain psychological ED cases (specialist only) |
Dosing According to Clinical Indications
| Patient Group | Indication | Recommended Dose | Comment |
| Adult men (18–64) | ED + PE | 20mg/60mg tablet (once as needed, max 1 per 24 hrs) | Standard initial dose; may use lower strengths in some cases |
| Older men (≥65) | ED + PE | 10mg/30mg tablet if renal/hepatic function compromised | Use with caution and close monitoring |
| Pediatrics (<18) | N/A | Not indicated | Use is contraindicated |
| Severe renal/hepatic impairment | ED + PE | Not recommended | Contraindicated |
Safety Profile, Side Effects, and Warnings
| Frequency | Side Effect(s) | Action |
| Common | Headache, flushing, nasal congestion, dyspepsia, nausea, dry mouth, dizziness, mild blurred vision, diarrhoea, mild back pain | Usually resolves spontaneously; consult pharmacist for advice if persistent |
| Less Common | Increased heart rate, low blood pressure, sleep disturbance, restlessness, erection lasting longer than 4 hours (priapism) | Seek medical advice promptly |
| Rare/Serious | Sudden loss of vision or hearing, severe allergic reaction (rash, swelling, difficulty breathing), seizure, serotonin syndrome symptoms (fever, agitation, confusion) | Stop medicine, seek urgent medical attention (call 000 if symptoms severe) |
- Contraindications: Not to be used if taking nitrates, in severe heart/liver/kidney disease, or if allergic to any ingredient.
- Cautions: Avoid driving, using machinery, or tasks requiring alertness if you experience visual or coordination disturbances.
Guidelines for Proper Use
- Fill your prescription at a licensed Australian pharmacy (branded or compounded as per doctor’s authorisation).
- Take medicine exactly as directed; do not change dose or frequency without consulting your doctor.
- Inform your GP of all current medicines, including over-the-counter treatments and supplements (important for repeat scripts and My Health Record updates).
- Monitor for side effects, especially on the first few uses.
- Contact your clinic immediately if you experience chest pain or vision/hearing changes after dosing.
- For privacy and convenience, most pharmacies can provide discreet packaging and express home delivery within Australia.
Alternative Treatment Options
- Single Agents:
- Cialis (Tadalafil) – for ED; available with PBS subsidy for some patients
- Priligy (Dapoxetine) – for PE; private prescription only, not typically subsidised
- Sildenafil (Viagra) – for ED; PBS-listed for certain clinical conditions (e.g. pulmonary arterial hypertension or post-prostatectomy)
- Non-Pharmacological:
- Cognitive-behavioural therapy for psychological ED or PE
- Pelvic floor physiotherapy
- Lifestyle interventions: regular exercise, stress reduction
- Pros/Cons:
- Combination therapy offers convenience and dual action, but higher risk of side effects and drug interactions.
- Single drugs can be titrated for individual needs and better tolerated for some men.
Legal, Registration and Reimbursement Status in Australia
- Classified as Schedule 4 prescription medicine (S4) by the Therapeutic Goods Administration (TGA).
- Both agents individually are registered in Australia; compounded combination tablets are available via authorised compounding pharmacies only.
- Requires prescription by a medical doctor registered in Australia.
- Not listed on the Pharmaceutical Benefits Scheme (PBS) for sexual dysfunction; cost is typically private unless part of special access schemes.
- Not subsidised by Medicare unless prescribed for relevant PBS indications, which usually do not apply to this combination in sexual health.
- See TGA website for further regulation details.
Latest Research and Clinical Guidance (2022–2025)
- Recent clinical reviews (e.g., Urology News UK, 2023) support safety and efficacy of combined PDE5 inhibitors and dapoxetine for select men with concurrent ED and PE not responsive to monotherapy.
- Guidelines from the International Society for Sexual Medicine (ISSM, 2022) and Australian Men’s Health Forum endorse tailored, patient-centred approaches and stress the importance of shared decision-making with GPs or specialists.
- Meta-analyses (e.g. He et al., Andrology, 2023) show combination therapy more effective than monotherapy for coexisting ED and PE, although with increased risk of mild-to-moderate adverse effects.
- Australian practice guidelines recommend thorough exclusion of contraindications (especially cardiac disease, other ED therapy, MAOIs) before initiation.
- Ongoing clinical trials are assessing new dosing regimens and patient satisfaction in the 2025 update pipeline.
Availability and Delivery
- Available in various pack sizes: typical pharmacy packs are 4, 8, 12, and 24 tablets.
- Indicative private cost: $60–$120 per 4-tablet pack (varies by pharmacy, compounding fees, and prescription specifics).
- Express and standard delivery options are available nationwide.
| City | Standard Delivery | Express Delivery |
| Sydney | 1–3 business days | Next-day available |
| Melbourne | 2–4 business days | Next-day available |
| Brisbane | 2–4 business days | Next-day available |
| Perth | 3–6 business days | 2-day express |
| Adelaide | 2–4 business days | Next-day available |
| Hobart | 3–5 business days | 2-day express |
Frequently Asked Questions (FAQ)
- Can I use this product every day?
No, it is not intended for daily use. Use only as prescribed before planned sexual activity—not more than once in 24 hours. - Are there any foods or drinks I should avoid?
Avoid grapefruit products and limit alcohol. No other major dietary restrictions apply; take on an empty stomach or after a light meal for maximum effect. - What should I do if I miss a dose or take too much?
If you miss a dose, simply skip it and take your next as planned. If you accidentally take too much, contact your doctor or seek medical attention, especially if you develop side effects like chest pain or prolonged erection. - Will this affect my fertility or chance to father children?
There is no evidence that either tadalafil or dapoxetine impacts fertility. They do not affect sperm quality or hormonal balance when used as directed. - Can I get my prescription filled online or via telehealth?
Yes, many Australian pharmacies offer telehealth consultations and secure online prescription filling, with delivery to your home. Ensure all services are TGA-licensed and privacy compliant.
