Vardenafil with Dapoxetine: Patient Information for Australia
Basic Product Information
| International Nonproprietary Names (INN) | Vardenafil, Dapoxetine |
| Australia Brand Names | Commonly marketed as "Super Vardenafil", "Super Vilitra", "Vardenafil with Dapoxetine". Note that individual brands may vary. |
| ATC Codes | G04BE09 (Vardenafil), G04BE (Dapoxetine, classified as SSRI for premature ejaculation) |
| Available Forms and Strengths | Film-coated tablets; typical combinations available in 20mg Vardenafil + 60mg Dapoxetine |
| Manufacturers | Various; Sun Pharmaceutical, Centurion Laboratories, etc. |
| Prescription Status in Australia | Prescription-only (S4). Consultation with a healthcare professional required. |
Mechanism of Action
- Vardenafil: A phosphodiesterase type 5 (PDE5) inhibitor, Vardenafil helps to relax blood vessels in the penis, allowing for increased blood flow during sexual stimulation. This eases the ability to achieve and maintain an erection.
- Dapoxetine: A selective serotonin reuptake inhibitor (SSRI) designed to treat premature ejaculation. Dapoxetine works by increasing serotonin activity in the nervous system, delaying the ejaculation reflex, and extending time to ejaculation.
For Specialists
- Vardenafil inhibits PDE5 in the smooth muscle of the corpus cavernosum, leading to improved erectile function.
- Dapoxetine increases synaptic serotonin levels, modulating central ejaculatory pathways via 5-HT receptors.
Pharmacokinetics
- Absorption: Both active ingredients have rapid oral bioavailability. Vardenafil's Tmax ≈ 30-120 minutes; Dapoxetine's Tmax ≈ 1-2 hours.
- Metabolism: Both are mainly metabolised in the liver (CYP3A4 for Vardenafil; CYP2D6, CYP3A4 for Dapoxetine).
- Elimination: Plasma half-life: Vardenafil ≈ 4-5 hours; Dapoxetine ≈ 1.5 hours. Excreted primarily in urine.
- Duration of Action: Vardenafil: up to 5 hours after intake; Dapoxetine: effects last 2–3 hours.
Use in Everyday Life and Best Practices
Common Use: This combination treats men diagnosed with erectile dysfunction (ED) and premature ejaculation (PE). It is best used as needed before sexual activity.
- Consult your doctor to confirm the need for both medications and possible interactions with other prescriptions.
- Take one tablet whole with a glass of water 30–60 minutes before planned sexual activity (do not take more than once per 24 hours).
- Do not use this medicine if you are not engaging in sexual activity or without a clear indication from your healthcare provider.
Dosing in the Morning vs Evening
The combination is taken on demand—not scheduled daily.
Morning: May be practical if sexual activity is planned for earlier in the day, but effects may diminish by afternoon.
Evening: Most users in Australia take ED/PE medications in the evening before bedtime, aligning with typical patterns of sexual activity. Consistency helps, but always stick to doctor’s advice.
Taking with Food or on an Empty Stomach
- Absorption of Vardenafil may be delayed with a high-fat meal, resulting in a slower onset of action.
- For best results, take on an empty stomach or after a light, low-fat English-style meal (e.g., light breakfast or dinner without fatty or fried foods). Heavy Australian BBQ or fried meals may delay effectiveness.
- Always avoid grapefruit or grapefruit juice, which can increase blood levels and risk of side effects.
Interaction Warnings
| Item/Substance | Interaction/Effecct |
|---|
| Alcohol | Increases risk of low blood pressure, dizziness, fainting, and may worsen sexual dysfunction. |
| Grapefruit (juice or fruit) | Potentiates effects; raises blood levels; increases risk of side effects. |
| Nitrate-containing medications (e.g., glyceryl trinitrate for angina) | Serious risk of dangerous hypotension. Never combine. |
| Other ED medications (sildenafil, tadalafil) | Do not use together. Increases side effect risk. |
| SSRIs, MAOIs, SNRIs, and certain antipsychotics | Risk of serotonin syndrome with dapoxetine. Consult your prescriber. |
| Strong CYP3A4/2D6 inhibitors (e.g., ketoconazole, erythromycin) | May raise blood levels of both medicines. Dose adjustment or avoidance needed. |
| St John’s Wort, herbal supplements | Can interact with dapoxetine metabolism. |
Indications
| Indication | Status |
|---|
| Erectile Dysfunction (ED) | Officially approved (Vardenafil component). |
| Premature Ejaculation (PE) | Officially approved (Dapoxetine component). |
| Combined ED + PE (Men with both) | Off-label in this combination, but individual medications approved for each indication. |
Dosing According to Clinical Indications
| Patient Group | Vardenafil Dose | Dapoxetine Dose | Notes |
| Adult men (18–64) | 20mg | 60mg | 1 tablet taken as needed, maximum once per 24 hours |
| Elderly (65+) | 5–10mg may be started | 30mg may be considered | Start at lower dose to minimise side effects; monitor BP and pharmacokinetics. |
| Pediatrics (<18 years) | Not indicated | Not indicated | Contraindicated under 18. |
| Renal/Hepatic impairment | Lower initial dose; avoid in severe impairment. | Generally not recommended. | Consult specialist. |
Safety Profile and Side Effects
- Common (1–10%): Headache, flushing, nasal congestion, dizziness, nausea, indigestion, dry mouth, diarrhoea.
- Sometimes (0.1–1%): Insomnia, back pain, visual disturbances, increased heartbeat.
- Rare (<0.1%): Seizures, fainting (syncope), severe hypotension, priapism (painful, prolonged erection), severe allergic reaction (swelling, rash, anaphylaxis), serotonin syndrome (if combined with other serotonergic drugs).
| Symptom | Frequency | Action |
|---|
| Headache | Common | Usually mild; may take simple analgesic if needed. |
| Flushing, hot face | Common | No treatment needed unless severe. |
| Blurred vision | Sometimes | If persistent, stop medicine and seek care. |
| Prolonged erection (>4 hours) | Rare | Stop medicine, seek immediate emergency care. |
| Fainting, chest pain | Rare | Stop, call Triple Zero (000). |
Guidelines for Proper Use
- Always follow your doctor’s instructions—do not exceed recommended dose.
- Store in original packaging at 15–25°C, away from moisture and out of reach of children.
- Never split or crush the tablet.
- Only use as needed, a maximum of once per day.
- If experiencing side effects, inform your pharmacist or doctor promptly.
- Keep a personal health record, especially if using other cardiovascular or psychiatric medications.
- Use caution driving or operating machinery (can cause dizziness/drowsiness).
- In the Australian context, be aware of the impact of alcohol and heat—dehydration can worsen side effects.
Alternative Treatment Options
- Sildenafil (Viagra), Tadalafil (Cialis), Avanafil (Spedra): Other PDE5 inhibitors for ED. Comparable efficacy, but different onset/duration profiles.
- Dapoxetine (as Priligy): Standalone SSRI for PE.
- Behavioural therapies and counselling: May be used alone or with pharmaceutical options.
Pros: Vardenafil+Dapoxetine offers convenience for men with both ED and PE.
Cons: Slightly higher risk of side effects; not suitable for those with heart problems or certain psychiatric disorders.
Legal, Registration, and Reimbursement Status in Australia
- Both Vardenafil and Dapoxetine are prescription-only (Schedule 4, S4).
- Neither is listed on the Pharmaceutical Benefits Scheme (PBS); not reimbursed for sexual dysfunction. Full cost applies to patient.
- Registration: Both individually approved by the Therapeutic Goods Administration (TGA) for their respective indications; the combination product may be considered off-label use in Australia.
- Prescription: Only available after consultation with an Australian doctor or sexual health physician.
Latest Research and Clinical Guidance (2022–2025)
- Australian & international guidelines continue to support the use of Vardenafil for ED and Dapoxetine for PE in appropriately selected patients (see: European Association of Urology, TGA guidance 2024).
- Combination therapy is considered effective and generally well-tolerated for men with both ED and PE, as summarised in peer-reviewed studies (Int J Impot Res. 2023; BJU Int. 2024).
- Since 2023, the importance of patient-centred shared decision-making and careful cardiovascular screening before prescribing has been strongly emphasised, especially in patients aged 55+ (Australian Journal of General Practice 2023).
- For full clinical references, consult your physician or pharmacist.
Availability and Delivery
| Common Pack Sizes | Indicative Price (AUD) |
|---|
| 4 tablets | $45–$75 |
| 10 tablets | $95–$160 |
| 20 tablets | $180–$299 |
| Major City | Estimated Delivery Time (Standard) | Estimated Delivery Time (Express) |
| Sydney | 1–2 business days | Same/next business day |
| Melbourne | 1–2 business days | Same/next business day |
| Brisbane | 2–3 business days | 1 business day |
| Adelaide, Perth, Hobart | 3–4 business days | 1–2 business days |
| Darwin, regional/remote areas | 5–7 business days | 2–4 business days |
FAQ – Frequently Asked Questions
- Can I use Vardenafil with Dapoxetine if I have high blood pressure?
You must consult your doctor before use. These medications can affect blood pressure. If you are already taking blood pressure medicines, certain combinations may not be safe. - Is it safe to drink alcohol with this medicine?
It is best avoided. Alcohol can increase the risk of dizziness, fainting, and worsen sexual dysfunction. - How quickly will it work?
You can expect an effect within 30–60 minutes of taking the tablet. Sexual stimulation is required for full benefit. - Can I buy this medicine without a prescription in Australia?
No, you need a valid prescription from an Australian doctor, either in person or through an online telehealth service. - What should I do if I experience side effects?
For minor symptoms (e.g., mild headache, flushing), stop use and monitor. For serious effects (fainting, chest pain, priapism), seek immediate medical help by calling Triple Zero (000).
Disclaimer: This information is for general educational purposes only and does not replace medical advice. Always consult your doctor or pharmacist for advice tailored to your health and circumstances.
