Avana (Avanafil): Comprehensive Patient Information for Australia
Basic Product Information
- International Non-proprietary Name (INN): Avanafil
- Brand Names in Australia: Avana, Spedra®
- ATC Code: G04BE10
- Available Forms & Strengths: Film-coated tablets in 50 mg, 100 mg, and 200 mg
- Manufacturers: Menarini Australia Pty Ltd, others under license
- Prescription Status: Prescription Only Medicine (Schedule 4, S4)
Mechanism of Action
Avanafil is a phosphodiesterase type 5 (PDE5) inhibitor, primarily used to treat erectile dysfunction (ED) in men. In simple terms, it helps to relax blood vessels in the penis, allowing increased blood flow during sexual stimulation. This physiological change makes it easier for men with ED to achieve and maintain an erection sufficient for sexual activity.
For healthcare professionals: Avanafil selectively inhibits cyclic guanosine monophosphate (cGMP)-specific PDE5, enhancing the vasodilatory effects of nitric oxide released in the corpus cavernosum. This increases cGMP levels, smooth muscle relaxation, and subsequent inflow of blood.
Pharmacokinetics (How the Body Handles Avanafil)
- Absorption: Rapid, with peak plasma concentration in about 30–45 minutes after oral intake.
- Metabolism: Primarily metabolised by liver enzymes CYP3A4, with minor contribution from CYP2C9.
- Elimination: Mostly excreted as metabolites in faeces (approx. 63%) and urine (approx. 21%).
- Duration of Action: Effective for up to 6 hours post-dose; some clinical effect may last up to 12 hours.
Everyday Use & Best Practices in Australia
Avanafil is prescribed to men living with erectile dysfunction and is typically taken as needed before anticipated sexual activity. It is not intended for continuous daily use.
- Starting Dose: 100 mg taken about 15 to 30 minutes prior to sexual activity.
- Depending on individual response and tolerability, your doctor may adjust the dose to 50 mg or 200 mg.
- No more than one dose in any 24-hour period.
Avanafil should not be split, chewed, or crushed. Tablets should be swallowed whole, with a glass of water. In Australia, be mindful of using legitimate, TGA-approved medicines obtained from reputable pharmacies.
Dosing Time: Morning vs Evening
- Morning: Some patients prefer morning dosing for recreational predictability; however, ensure that sexual activity is planned within 15–30 minutes post-dose.
- Evening: Traditionally, Avanafil is used in the evening, aligning with intimacy patterns.
- Tips: Choose a consistent time that matches your schedule and lifestyle. Keeping regularity helps the body respond better to the medication. Avanafil works rapidly, so last-minute planning is possible.
- Important: Do not exceed the prescribed frequency or dosage provided by your healthcare professional.
Taking with Food or on an Empty Stomach
- Avanafil can be taken with or without food.
- Heavy or high-fat meals may slightly delay absorption, making the effect take longer to start.
- Light, typical Australian meals (grilled meat, seafood, vegetables, legumes) do not significantly impact drug absorption.
- For fastest results, use on an empty stomach or after a light meal.
Interaction Warnings
| Interacting Substance or Group | Potential Effect | Advice/Precaution |
|---|---|---|
| Nitrate medications (e.g., GTN spray, nitroglycerin patches) | Severe, potentially life-threatening blood pressure drop | Never use with Avanafil; contraindicated |
| Certain blood pressure medicines (alpha-blockers, e.g., doxazosin) | Increased risk of low blood pressure and fainting | Use only under strict medical supervision |
| Alcohol | Enhances blood-pressure-lowering effects; may impair erection | Limit or avoid alcohol with Avanafil |
| Grapefruit or grapefruit juice | May increase drug levels and side effects | Avoid while on Avanafil |
| Other PDE5 inhibitors (Sildenafil, Tadalafil, Vardenafil) | Risk of overdose, increased side effects | Never combine with Avanafil |
| Strong CYP3A4 inhibitors (ketoconazole, ritonavir) | Increased Avanafil blood levels; toxicity | Avoid; check with your doctor |
Indications
| Condition | Status | Notes |
|---|---|---|
| Erectile Dysfunction (ED) in adult men | Approved | Main indication; TGA registered |
| Pulmonary arterial hypertension | Off-label | Not recommended; insufficient evidence, not TGA approved |
Dosing According to Clinical Indications
| Population | Starting Dose | Maximum Dose | Dosing Interval | Notes |
|---|---|---|---|---|
| Adult men (18–64 years) | 100 mg | 200 mg | Once per 24 hours | Take 15–30 min before activity |
| Elderly men (>65 years) | Start at 50 mg | 100 mg | Once per 24 hours | Cautious titration, monitor side effects |
| Pediatric (under 18) | Not indicated | N/A | N/A | Not approved |
| Renal/hepatic impairment | Consider 50 mg | Do not exceed 100 mg | Once per 24 hours | Specialist supervision required |
Safety Profile and Side Effects
- Common: Headache, flushing, nasal congestion, back pain, dizziness
- Less common: Nausea, drowsiness, blurred vision, indigestion
- Rare but serious: Sudden loss of vision or hearing (seek immediate help), chest pain, erections lasting longer than 4 hours (priapism)
| Adverse Event | Frequency | Action |
|---|---|---|
| Headache | ~10% | Usually self-resolves; take with food or water |
| Flushing | ~7% | Temporary; cool environment helps |
| Vision changes | <1% | Stop medication; contact doctor |
| Prolonged erection (>4h) | <0.01% | Medical emergency; seek help immediately |
Warnings: Not recommended for men taking nitrates, alpha-blockers for BPH, or severe cardiac conditions. Use with caution in those with history of stroke, seizure, or severe renal/hepatic impairment.
Guidelines for Proper Use (Australian Pharmacy Advice)
- Always obtain Avanafil from a licensed Australian pharmacy with a valid prescription.
- Store below 25°C, in original packaging, away from children and pets.
- Be honest with your prescriber about your medicines and medical history.
- If you miss a dose, do not double up; simply wait until your next planned occasion.
- Never share this medicine with others, even if symptoms appear similar.
- Regular GP review is advised if using Avanafil for longer than a few months.
- If you experience chest pain or loss of consciousness, seek emergency help (000) right away.
Alternative Treatment Options
- Sildenafil (Viagra®): Longer time to effect (30–60 minutes), effect lasts up to 4–6 hours. Available as PBS item in select populations; cost-effective.
- Tadalafil (Cialis®): Can be taken ‘on demand’ or daily, onset 30–60 minutes, lasts up to 36 hours ("weekend pill"); more expensive, longer effect.
- Vardenafil (Levitra®): Similar to Sildenafil in profile, often preferred for certain patients with diabetes.
- Penile devices/pumps: For those unable to use oral medications or those seeking non-pharmacologic options.
- Counselling/psychological therapy: Especially beneficial if ED is stress or relationship-related.
Pros and Cons Comparison: Avanafil is noted for its quick onset and lower risk of certain visual side effects, but it may not be suitable for all due to price and limited historical usage compared to other ED medicines.
Legal, Registration, and Reimbursement Status in Australia
- Regulated by the Therapeutic Goods Administration (TGA), Australian Government.
- Prescription required (Schedule 4/S4 under the Poison’s Standard).
- PBS status: Not subsidised for erectile dysfunction. Full private cost applies except for restricted access, such as specific cases of spinal cord injury (PBS item codes available for prescriber review).
- Legal importation for personal use only via TGA regulations and import permit if supplied from abroad.
- Not covered by state/territory hospital formularies except for narrow indications.
Latest Research and Clinical Guidance (2022–2025)
- Multiple studies confirm Avanafil’s rapid onset, with strong efficacy for ED of mixed causes (Gacci et al., J Sex Med 2022).
- Generally well tolerated; no significant difference in adverse event rates from other PDE5 inhibitors in several meta-analyses (Wu et al., Int J Impot Res 2023).
- Current European Association of Urology (EAU) guidelines support Avanafil as a first-line oral therapy for ED, particularly in men with need for rapid effect (EAU Guidelines 2024).
- No clear evidence of benefit in pulmonary hypertension; current clinical trials focus on broader ED populations and optimal dosing strategies.
- Therapeutic Goods Administration reviews confirm continued safety monitoring, especially in those taking cardiovascular medicines (TGA Safety Update, 2024).
Availability and Delivery in Australia
| Pack Size | Typical Retail Price (AUD) | Delivery Time – Sydney | Melbourne | Brisbane | Adelaide | Perth |
|---|---|---|---|---|---|---|
| 4 tablets (100 mg) | $78–$95 | 1 day | 1 day | 1–2 days | 2 days | 2–3 days |
| 8 tablets (100 mg) | $130–$175 | 1 day | 1 day | 1–2 days | 2 days | 2–3 days |
| 12 tablets (200 mg) | $240–$295 | 1 day | 1–2 days | 1–2 days | 2 days | 3–4 days |
Note: All deliveries require ID check and valid prescription. Price and shipping times may differ slightly between pharmacies and regions.
Frequently Asked Questions (FAQ)
- How fast does Avanafil work?
Most men feel the effect within 15–30 minutes after taking a tablet. It’s best taken shortly before planned sexual activity. - Can I drink alcohol with Avana?
Alcohol should be limited while using Avanafil, as combining the two can lower blood pressure and increase the risk of side effects like dizziness or fainting. - Is Avana available on the PBS?
For most men, Avana is not subsidised by the Pharmaceutical Benefits Scheme (PBS) and must be paid at full private cost. Some exceptions apply for certain medical conditions; consult your prescriber. - Is it safe to buy Avana online?
Only purchase Avana from reputable online Australian pharmacies with a valid pharmacist and TGA approval. Avoid overseas sellers due to risk of counterfeit or unapproved medicines. - What should I do if Avanafil does not work?
Do not increase the dose yourself. Speak with your doctor or pharmacist; they may suggest a different dose, alternative treatment, or investigate other underlying health issues.
For More Information
Always consult your healthcare provider or pharmacist for personalised advice. For the latest updates, visit the Therapeutic Goods Administration (TGA) and NPS MedicineWise websites.
