Top Avana (Avanafil with Dapoxetine Hydrochloride): Comprehensive Patient Information for Australians
1. Basic Product Information
| International Nonproprietary Names (INN) | Avanafil / Dapoxetine Hydrochloride |
|---|---|
| Available Brand Names in Australia | No current registered Australian brand; Top Avana is used internationally. Equivalent products may be compounded by selected pharmacies. |
| ATC Code | G04BE10 (Avanafil), G04BE09 (Dapoxetine) |
| Available Forms & Strengths | Oral tablets: Avanafil 100mg + Dapoxetine 60mg |
| Manufacturer | Sunrise Remedies / Other international manufacturers |
| Prescription Status | Prescription only (S4 – Prescription Medicine, as per TGA guidelines in Australia) |
2. Mechanism of Action
For Patients:Top Avana combines two medicines: Avanafil, which helps men with erectile dysfunction by increasing blood flow to the penis, and Dapoxetine, which helps men control premature ejaculation by affecting certain chemicals in the brain. This combination aims to improve both erection quality and duration of sexual activity.
For Healthcare Specialists:- Avanafil is a potent, selective PDE5 inhibitor, rapidly absorbed and acts by enhancing the NO–cGMP pathway, resulting in smooth muscle relaxation in the corpus cavernosum.
- Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI), providing on-demand modulation of serotonergic neurotransmission, thereby delaying ejaculation via central pathways.
3. Pharmacokinetics
- Absorption: Avanafil reaches maximum plasma concentrations in ~30–45 minutes; Dapoxetine peaks in 1–2 hours after oral administration.
- Metabolism: Both agents are metabolised primarily via hepatic pathways (CYP3A4 major for avanafil and dapoxetine; CYP2C9 minor for avanafil, CYP2D6 for dapoxetine).
- Elimination: Excretion is mainly through urine (Avanafil) and faeces (Dapoxetine metabolites).
- Duration of Action: Avanafil: 6–8 hours; Dapoxetine: ~8–12 hours (clinical effect ~4 hours).
Both medicines are suitable for "on-demand" use due to their rapid onset and short duration.
4. Use in Everyday Life and Best Practices in Australia
- Intended use: For adult men diagnosed with erectile dysfunction and/or premature ejaculation, after a complete assessment by a healthcare provider.
- How to take: Swallow 1 tablet whole with a glass of water, 30–60 minutes before anticipated sexual activity. Do not use more than once in 24 hours.
- Both medicines are for "on-demand" use, not daily administration.
- Discuss with your doctor or pharmacist if you have heart disease, liver/kidney impairment, or are taking other medications.
5. Dosing in the Morning vs Evening
- Morning dosing: Less common due to the nature of sexual activity, but possible if anticipated. May interfere less with evening routines or medication timing.
- Evening dosing: Preferred by most patients as it aligns with typical activity. May interact with food/alcohol commonly consumed at night.
- Choose the timing that suits your lifestyle; keep dosing regular if routine sexual activity is planned.
6. Taking with Food or on an Empty Stomach
- Best taken on an empty stomach for faster onset of action (especially for Avanafil).
- High-fat meals may delay the effect; try to time dosing at least 2 hours after a major meal.
- Standard English/Australian diet (cereal, toast for breakfast; meat/pasta for dinner) generally poses no problem if these timing considerations are followed.
7. Interaction Warnings
| Interaction Substance | Effect | Advice |
|---|---|---|
| Grapefruit or grapefruit juice | May increase blood levels of avanafil | Avoid during use |
| Alcohol | Increases sedative and hypotensive side effects | Limit intake; avoid heavy drinking |
| Nitrates (e.g., GTN spray, isosorbide) | Severe blood pressure drop risk | Contraindicated – do not use together |
| SSRIs/SNRIs, MAOIs | Serotonin syndrome risk with dapoxetine | Discuss with your doctor |
| Other PDE5 inhibitors | Unsafe increase in vasodilation | Do not combine |
| Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) | Raises drug levels; toxicity risk | Avoid |
8. Indications
| Indication Type | Details |
|---|---|
| Official (TGA) |
|
| Off-label |
|
9. Dosing According to Clinical Indications
| Population | Recommended Dose | Maximum Frequency | Notes |
|---|---|---|---|
| Adults (18–64 years) | 1 tablet (100mg avanafil/60mg dapoxetine) | Once per 24 hours | On-demand |
| Elderly (≥65 years) | Start at lower 50mg avanafil/30mg dapoxetine (if available) | Once per 24 hours | Careful monitoring due to metabolism changes |
| Paediatric (<18 years) | Not recommended | – | No clinical data; not for use in minors |
| Renal/Liver Impairment | Avoid or use with clinical supervision | – | Dose adjustment may be needed; consult specialist |
10. Safety Profile and Side Effects
Common (≥1/100):- Flushing or redness in the face
- Headache
- Nasal congestion
- Dizziness or light-headedness
- Nausea/indigestion
- Dry mouth
- Back pain or muscle aches (Avanafil)
- Insomnia, mild anxiety (Dapoxetine)
- Irregular heartbeat, palpitations
- Blurred vision
- Seizures (rare, with dapoxetine; higher risk in epilepsy)
- Fainting or severe drop in blood pressure
- Priapism (erections lasting >4 hours—urgent medical attention required)
- Serotonin syndrome (very rare, possible if used with other serotonergic meds)
11. Guidelines for Proper Use (Australian Patients)
- Only take Top Avana if prescribed by your doctor or urologist following a confirmed diagnosis of ED or PE.
- Store at room temperature (below 25°C); keep out of reach of children and pets.
- Do not share your medicine—even with someone who has similar symptoms.
- Avoid driving, cycling, or using heavy machinery if you feel dizzy or lightheaded after taking the tablet.
- For repeat prescriptions, book regular check-ups (every 6–12 months) to assess ongoing suitability.
- If you miss a dose, do not double up; use only as needed.
- If side effects are bothersome, report them promptly to your clinic or pharmacy.
12. Alternative Treatment Options (Reimbursed by PBS)
- Sildenafil (Viagra): First-line, widely available and PBS-reimbursed for select patients. Onset: 30–60min, duration: 4–5h.
- Tadalafil (Cialis): Longer duration (up to 36h), daily or on-demand dosing. PBS for some indications.
- Vardenafil (Levitra): Similar onset/duration to sildenafil. Not always covered; used off-PBS more often.
- Dapoxetine (Priligy): On-demand SSRI for PE; available but not routinely PBS-reimbursed.
Comparative Overview:
- Top Avana’s main advantage is combining ED and PE treatment in one pill. Other options often treat only one aspect at a time.
- Potential for more side effects due to combination therapy vs. single drug use—always weigh risk/benefit with your healthcare provider.
13. Legal, Registration, and Reimbursement Status in Australia
- Legal Classification: Prescription required (S4) under the Poisons Standard (Therapeutic Goods Administration - TGA).
- Australian Registration: As of June 2024, Top Avana itself is not officially registered in Australia; avanafil and dapoxetine may be prescribed as individual components.
- Reimbursement: Not currently listed on the Pharmaceutical Benefits Scheme (PBS) for the fixed-dose combination. Individual agents may qualify in limited circumstances.
- Compounding pharmacies in Australia may create similar preparations on a case-by-case, specialist basis.
14. Latest Research and Clinical Guidance (2022–2025)
- Recent European and Asia-Pacific urology guidelines (EAU 2023, Asia-Pacific Society of Sexual Medicine 2024) endorse PDE5 inhibitors and dapoxetine as first-line therapy for appropriate men.
- Combination therapy for men with mixed ED/PE provides greater patient satisfaction than single-agent therapy (Int J Impot Res 2023;35:213–22).
- No serious new safety issues identified in pooled data and post-market surveillance to date.
- Australian clinical practice recommends use in carefully selected, otherwise healthy men under ongoing review.
15. Availability and Delivery (Across Australia)
| Pack Size | Typical Price (AUD) | Delivery Times* |
|---|---|---|
| 4 tablets | $68–$92 | Sydney: 1–2 working days Melbourne: 1–2 working days Brisbane: 2–3 working days |
| 10 tablets | $148–$215 | Adelaide: 2–4 working days Perth: 3–5 working days Hobart/Darwin: 3–6 working days |
| 20 tablets | $280–$390 | Regional/Rural: 4–7 working days after dispatch |
16. Frequently Asked Questions (FAQ)
Q1: Can I use Top Avana with my regular antidepressant or blood pressure medication?A: Discuss this with your doctor—Top Avana interacts with several classes of medicines, including SSRIs, MAOIs, nitrates, and some antihypertensives. Never adjust or add to your medication without expert advice.
Q2: Am I allowed to drive after taking Top Avana?
A: If you experience dizziness, drowsiness, or blurred vision, avoid driving or dangerous activities until you know how Top Avana affects you.
Q3: Is it safe to consume alcohol before or after taking Top Avana?
A: Limit alcohol intake—excessive consumption increases the risk of side effects like low blood pressure, dizziness, or fainting. Moderate drinking (no more than 1–2 standard drinks) is not expected to impair effectiveness for most patients.
Q4: Can I buy this product without a prescription in Australia?
A: No, you need a valid Australian prescription for all PDE5 inhibitors and dapoxetine. Legal, safe supplies are only available via a pharmacy with a doctor’s prescription.
Q5: What should I do if I miss a dose or take too much?
A: This medicine is not intended for regular daily use, so only take it when needed. If you have accidentally taken more than one tablet in a 24-hour period, seek medical advice immediately.
Further Information
Your community pharmacist or GP can provide personalised advice. For independent patient support, contact Healthdirect Australia at 1800 022 222 or use the Healthdirect website.
