Levitra with Dapoxetine (Vardenafil with Dapoxetine) – Comprehensive Patient Guide for Australia
Basic Product Information
| International Nonproprietary Names (INN) | Vardenafil / Dapoxetine |
| Australian Brand Names | Levitra with Dapoxetine, Vardenafil-Dapoxetine Combination Tablets (may be compounded or available in select formulations) |
| ATC Code | G04BE09 (Vardenafil); G04BE10 (Dapoxetine) |
| Available Forms & Strengths | Film-coated tablets: Vardenafil 20 mg / Dapoxetine 60 mg per tablet |
| Manufacturers | Bayer Pharmaceuticals (Levitra), various generics for Dapoxetine component |
| Prescription Status in Australia | Prescription Only Medicine (Schedule 4, S4) |
Mechanism of Action
Simple Terms: Levitra with Dapoxetine combines two medicines that work together to help men with difficulties in sexual performance. - Vardenafil helps increase blood flow to the penis, making it easier to get and keep an erection when sexually excited. - Dapoxetine helps delay ejaculation, giving greater control and confidence during intercourse.
For Specialists: Vardenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor, enhancing nitric oxide-mediated vasodilation by preventing the degradation of cGMP in corpus cavernosum tissue. Dapoxetine is a short-acting serotonin reuptake inhibitor (SSRI), increasing serotonin activity at synaptic clefts which inhibits ejaculatory reflexes via central neurotransmission pathways.
Pharmacokinetics
- Absorption: Both Vardenafil and Dapoxetine are rapidly absorbed. Vardenafil’s peak plasma concentrations occur within 0.7 – 0.9 hours, Dapoxetine within 1 – 2 hours post-dose.
- Metabolism: Both agents are primarily metabolised in the liver via CYP3A4 (major pathway) and CYP2C19/CYP2D6 (minor).
- Elimination: Vardenafil is excreted as metabolites mainly in faeces and some in urine. Dapoxetine is eliminated mostly via the kidneys as metabolites.
- Duration of Action: Vardenafil effects typically last up to 4–5 hours. Dapoxetine's effect is strongest within 1–3 hours after dosing and wanes after 6 hours.
Use in Everyday Life and Best Practices
This medicine is intended for adult men facing erectile dysfunction (ED) and/or premature ejaculation (PE). It is usually taken when planning sexual activity, rather than daily. To use it safely and effectively:
- Take one tablet about 1–2 hours before intended sexual activity.
- Do not take more than one tablet within 24 hours.
- Follow your GP or pharmacist’s instructions and always use as prescribed.
- Discuss any current medical conditions and regular medications with your healthcare provider to prevent interactions.
Dosing in the Morning vs. Evening
- Morning: May be beneficial if sexual activity is planned earlier in the day. Be mindful of possible impacts on alertness if you have plans requiring focus or coordination.
- Evening: Most users prefer evening dosing, aligning with typical social and intimate routines in Australia. Can allow for maximum effect during evenings, but alcohol intake (often higher at night) may increase risks of side effects.
- Tips: Maintain regular routines, and avoid taking with excessive alcohol or fatty meals.
Taking with Food or on an Empty Stomach
Effect of Meals: Vardenafil's absorption may be slowed by high-fat meals, leading to a delayed effect. Dapoxetine is less affected by food, but may slightly delay onset.
- For fastest action, take the tablet on an empty stomach or after a light meal.
- Australian dietary patterns (higher intake of protein and moderate fats) generally present minimal impact if heavy meals are avoided shortly before dosing.
- Avoid grapefruit or grapefruit juice, which can elevate blood levels of both drugs.
Interaction Warnings
| Interaction | Effect | Advice |
|---|---|---|
| Alcohol | May increase risk of dizziness, fainting, or sudden decrease in blood pressure | Limit or avoid alcohol when taking this medicine |
| Other PDE5 Inhibitors (e.g. Sildenafil, Tadalafil) | Risk of additive side effects, unsafe drops in blood pressure | Do not use together |
| CYP3A4 Inhibitors (e.g. ketoconazole, ritonavir) | Increased drug levels, risk of toxicity | Not recommended; seek pharmacist advice |
| Nitrates (e.g. GTN sprays/tablets, isosorbide) | Severe, dangerous drop in blood pressure | Absolute contraindication—never combine |
| SSRIs, SNRIs, MAOIs | Risk of serotonin syndrome with Dapoxetine | Discuss with your GP or pharmacist |
| Grapefruit Juice | May raise blood levels of both agents | Avoid entirely |
Indications
| Indication | Type |
|---|---|
| Erectile Dysfunction (ED) | Approved |
| Premature Ejaculation (PE) | Approved (Dapoxetine component) |
| Mixed sexual performance disorders in men | Off-label (Combination use) |
| Other forms of sexual dysfunction | Review by specialist—off-label |
Dosing According to Clinical Indications
| Patient Group | Recommended Dose | Comments |
|---|---|---|
| Adult Men (18–64 years) | 1 tablet (Vardenafil 20 mg + Dapoxetine 60 mg) as needed, 1–2 hours before sex | Max 1 per 24 hours |
| Older Men (≥65 years) | Start at lower strengths (10 mg + 30 mg), titrate as tolerated | Monitor for blood pressure drops, dizziness |
| Younger Men (<18 years) | Not recommended | Safety and efficacy unproven |
| Renal/Hepatic Impairment | Not recommended without specialist oversight | Potential for increased side effects |
Safety Profile and Side Effects
- Common: Headache, flushing, nasal congestion, dizziness, nausea, mild diarrhoea, dry mouth, back pain, transient vision changes.
- Uncommon or Rare: Fainting, sudden drop in blood pressure, irregular heartbeat, anxiety, blurred vision, priapism (prolonged erection), hearing changes.
- Warnings: Do not use with nitrates, alpha blockers (without medical review), or if there’s a history of significant heart disease, stroke, or severe liver/kidney problems.
- Seek immediate medical care for: Chest pain, severe or prolonged erections (>4 hours), severe dizziness, or vision loss.
Guidelines for Proper Use
- Purchase only from Australian pharmacies with a valid prescription.
- Store at room temperature, away from direct sunlight and moisture.
- Do not share your medication; this is a prescription therapy.
- Be open with your GP and pharmacist about any other health problems to avoid adverse reactions.
- If you miss a dose (unlikely, as use is as-needed), do not double up at the next opportunity.
Alternative Treatment Options
- Sildenafil (Viagra): PDE5 inhibitor, widely prescribed, similar effectiveness for ED but does not treat PE.
- Tadalafil (Cialis): Longer duration, can be taken daily for regular sexual activity; not indicated for PE.
- Avanafil (Stendra): Fast acting, usually less side effects, available by prescription.
- Dapoxetine (as a standalone): For men with only PE, highly selective, rapid-acting SSRI.
- Non-pharmacological: Pelvic floor physiotherapy, psychological counselling, sexual health education (especially useful for younger men).
Comparison Pros & Cons: The combination of Vardenafil and Dapoxetine supports both erection strength and ejaculatory control, but may have more side effects and require careful coordination with meal and alcohol intake. Sildenafil or Tadalafil alone are reimbursed by Medicare for special indications (e.g. following prostate cancer surgery with specialist referral).
Legal, Registration, and Reimbursement Status in Australia
- Regulatory Authority: Therapeutic Goods Administration (TGA)
- Status: Both components are registered as prescription medicines; the combination form may be available as a compounded product or imported by special order upon specialist request.
- Medicare/Pharmaceutical Benefits Scheme (PBS): Currently, PBS does not list the combination; standalone Vardenafil and select PDE5 inhibitors may be reimbursed under specific conditions.
Latest Research and Clinical Guidance (2022–2025)
- International Society for Sexual Medicine (ISSM) 2024 guidelines support on-demand pharmacotherapy for men with mixed sexual performance disorders, emphasising efficacy of combined treatments for those who have not achieved best outcomes with monotherapy (Waldinger et al., J Sex Med. 2024;21(3):501-512).
- Australian Clinical Practice Updates ( RACGP 2022, revised 2024): Recommends individualised choice of ED/PE drugs in consultation with a general practitioner, with emphasis on cardiovascular screening for men aged >40.
- BMJ Clinical Review 2023 (doi:10.1136/bmj-2023-076013): Highlights effectiveness and safety of combination therapy in treatment-resistant cases, but calls for regular side effect monitoring.
Availability and Delivery
| Pack Size | Indicative Price (AUD) |
|---|---|
| 4 tablets | $90–120 |
| 12 tablets | $260–340 |
| 24 tablets | $490–630 |
| Major City | Standard Delivery | Express Delivery |
|---|---|---|
| Sydney | 1–2 business days | Same-day (if ordered before 1pm) |
| Melbourne | 2–3 business days | Next business day |
| Brisbane | 2–3 business days | Next business day |
| Perth | 3–5 business days | 2 business days |
| Adelaide | 2–3 business days | Next business day |
Status as of June 2024. Prices and delivery may vary by pharmacy and region. Prescription required for all orders.
Frequently Asked Questions (FAQ)
1. Can I take Levitra with Dapoxetine if I have heart problems?No. Men with recent heart attack, unstable angina, severe arrhythmias, or those using nitrate medications should not use this combination. Always check with your GP and share your complete cardiac history.
2. Are there any lifestyle changes that can improve results?Yes. Regular exercise, a balanced diet, quitting smoking, and limiting alcohol can all support better results and general men’s health.
3. Can I buy Levitra with Dapoxetine over the counter in Australia?No. It is a prescription-only medicine (Schedule 4) and must be supplied by a registered Australian pharmacy with a valid prescription from an authorised prescriber.
4. What should I do if the first dose doesn’t work?Some men need to try the medication on 3–6 separate occasions for best effect. If you remain unsatisfied, speak openly with your healthcare provider. Do not increase your dose on your own.
5. Are there any long-term risks?When used as directed, long-term risks are minimal. Report ongoing side effects or any new symptoms to your doctor. Rare issues can arise with overuse, especially regarding heart and mental health.
