Filitra Professional (Vardenafil): Patient-Friendly Guide for Australia
Basic Product Information
| Active Ingredient (INN) | Vardenafil |
|---|---|
| Australia Brand Names | Filitra Professional, Levitra, Vivanza |
| ATC Code | G04BE09 |
| Available Forms & Strengths | Oral Tablets: 10 mg, 20 mg (Filitra Professional is typically available in 20 mg oral disintegrating tablets) |
| Manufacturers | Various international and local registered pharmaceutical companies; check pack for manufacturer details. |
| Prescription Status (AUS) | Prescription Only (Schedule 4 - S4 medicine) |
Mechanism of Action
For All Patients: Filitra Professional contains Vardenafil, a medicine used to help men with erectile dysfunction (ED). It works by improving blood flow to the penis, helping you achieve and maintain an erection when sexually aroused.
For Healthcare Professionals: Vardenafil is a phosphodiesterase type-5 (PDE5) inhibitor. It increases cGMP levels in the corpus cavernosum of the penis by preventing cGMP breakdown, thereby enhancing nitric oxide-mediated smooth muscle relaxation and inflow of blood upon sexual stimulation.
Pharmacokinetics
- Absorption: Oral bioavailability is moderate. Disintegrating tablets are designed to dissolve rapidly without water, allowing faster bloodstream absorption from the oral mucosa.
- Onset of Action: Effects typically begin within 15–25 minutes after taking.
- Peak Plasma Concentration: Achieved in approximately 0.7–1 hour after dosing.
- Metabolism: Extensively metabolised in the liver (primarily via CYP3A4, with minor CYP3A5/V2C involvement).
- Elimination: Mostly excreted as metabolites via faeces (approx. 91–95%); small urinary excretion (2–6%).
- Duration of Action: Effects last up to 4–6 hours.
Use in Everyday Life and Best Practices
Filitra Professional (Vardenafil) is used by adult men to treat erectile dysfunction (ED), commonly called impotence. In Australia, sexual health is part of holistic wellbeing, and ED is a treatable medical condition.
- Typical Dose: The typical starting dose is 10 mg, taken as needed about 25–60 minutes before sexual activity. Depending on efficacy and tolerability, the dose may be increased to a maximum of 20 mg or reduced to 5 mg. Filitra Professional oral disintegrating tablets are usually administered as a single 20 mg dose.
- How to Take It: Place the tablet on your tongue and allow it to dissolve completely before swallowing. No water is required. Do not split, crush, or chew the tablet.
- Do Not Take More Than Once a Day and do not combine with other PDE5 inhibitors.
- Consult Your Doctor if you have kidney, liver, or heart conditions, or take any regular medicines.
Dosing: Morning vs Evening
- Morning Use: Suitable if sexual activity is expected in the morning. Absorption is not affected by circadian rhythms, but discretion may be an issue in shared or work environments.
- Evening Use: Most men take Filitra in the evening before sexual activity. This is socially convenient and aligns with most partners' preferences.
- Tips on Regularity: Only take when needed; daily use is not recommended. Try to take it at similar times when planning intimacy to establish a routine.
Taking with Food or On an Empty Stomach
- Effect of Meals: High-fat meals may delay the action of Vardenafil. For best results, take Filitra Professional on an empty stomach or after a light meal.
- Australian Dietary Considerations: If having a typical English breakfast or heavy dinner (e.g., fried foods, full English), consider a dosing interval of at least 2 hours between eating and taking the medicine.
- Alcohol: Moderate consumption (1–2 standard drinks) is generally safe, but excessive alcohol can reduce effectiveness and increase side effects such as dizziness.
Interaction Warnings
| Interaction | Details & Recommendations |
|---|---|
| Nitrates (e.g. glyceryl trinitrate) | Severe hypotension risk. Never mix Vardenafil and nitrates. |
| Alpha-blockers (used for prostate or blood pressure) | May lower blood pressure dramatically. Use with caution. |
| Other PDE5 inhibitors (sildenafil, tadalafil) | Do not combine. Increases side effect risk. |
| Antifungals (ketoconazole, itraconazole) | Can raise Vardenafil blood levels. Consult your doctor/pharmacist. |
| HIV Protease Inhibitors (ritonavir, indinavir) | Increase Vardenafil exposure. Use alternative therapies if needed. |
| Grapefruit Juice | May increase Vardenafil levels and side effects. Avoid regularly. |
| Alcohol | Excess may worsen side effects or reduce performance. Drink moderately. |
| Foods (high fat meals) | May delay absorption and onset of action. |
Indications
| Indication | Official/Off-label | Details |
|---|---|---|
| Erectile Dysfunction (ED) | Official | First-line treatment for adult men with inability to achieve/maintain erection sufficient for sexual activity. |
| Pulmonary Arterial Hypertension | Off-label | Not recommended; not standard of care in Australia. |
| Other sexual function disorders | Off-label | Not licensed or sufficiently evidenced for use beyond ED. |
Dosing According to Clinical Indications
| Population/Indication | Recommended Dose | Comment |
|---|---|---|
| Adult men with ED | 10 mg as needed; max 20 mg per dose; not more than once/24h; Filitra Professional: 20 mg orally disintegrating | Start at 10 mg, adjust as needed |
| Elderly men (>65 yrs) | 5 mg as needed; max 10 mg; individualise dose | Increased sensitivity—use lower starting dose |
| Renal impairment | 5 mg as needed; consult specialist | Monitor closely and consider lower dose or alternative |
| Paediatric use | Not indicated, not recommended | Safety and efficacy not established |
Safety Profile and Possible Side Effects
Most side effects are mild or moderate and short-lived. Stop medication and seek urgent help for serious reactions (such as chest pain or shortness of breath).
- Common: Headache, flushing, stuffy or runny nose, indigestion, dizziness, visual changes (colour tinge, light sensitivity).
- Less common: Back pain, muscle ache, nausea, heart palpitations.
- Rare/Serious: Priapism (prolonged erection >4 hours), sudden hearing/vision loss, severe hypotension, allergic reaction, chest pain.
| Side Effect | Frequency | Management |
|---|---|---|
| Headache | Common | Often resolves; paracetamol may help |
| Flushing | Common | Not harmful, usually brief |
| Nasal congestion | Common | Temporary, no treatment needed |
| Priapism (prolonged erection) | Rare | Urgent medical attention required |
| Visual changes | Rare | Stop medication, see a doctor |
| Allergic reaction | Very rare | Discontinue and seek immediate help |
Guidelines for Proper Use (Australia Context)
- Always obtain from a registered Australian pharmacy with a doctor's prescription.
- Inform your pharmacist/doctor of all allergies, medications, and medical history.
- Never share your tablets with others, even if they have similar symptoms.
- Check Australian medication schedules and plan for repeat scripts if ongoing use is needed.
- If you experience chest pain, severe dizziness, or a prolonged erection (>4 hours), seek urgent medical care.
- Store below 25°C, away from moisture, and out of reach of children.
- Arrange follow-up with your GP or sexual health clinic to monitor progress and check for underlying conditions (such as diabetes or hypertension) commonly associated with ED.
Alternative Treatment Options (Australia)
- Sildenafil (Viagra, generic): Widely used, similar action, available via PBS when prescribed for certain conditions (non-reimbursed for routine ED).
- Tadalafil (Cialis, generic): Longer action (24–36 hours), can be used daily or as-needed. More flexibility, also used for benign prostatic enlargement.
- Avanafil (Spedra): Newer agent, rapid onset, less data, higher price.
- Other options: Psychosexual therapy, vacuum erection devices (cost-shared), penile injections, implants (consider referral to urologist for non-responders).
Comparative Overview: Vardenafil is similar in efficacy and safety to sildenafil, though some men prefer one over the other due to individual tolerability and response.
Legal, Registration, and Reimbursement Status in Australia
- Legal: Filitra Professional (Vardenafil) is a Schedule 4 (Prescription Only) medicine in Australia per the Therapeutic Goods Administration (TGA) and local state/territory health authorities.
- Registration: Registered medicines can be verified on the TGA ARTG (Australian Register of Therapeutic Goods) database.
- Reimbursement: ED treatments are not reimbursed under the PBS (Pharmaceutical Benefits Scheme) for most men except under specific medical indications (e.g., post-prostatectomy, diabetes-related ED). Private prescription/cost applies in most cases.
Latest Research and Clinical Guidance (2022–2025)
- Guidelines: The most recent European Association of Urology (EAU, 2024) and local Australian Urological Society publications continue to recommend PDE5 inhibitors as first-line therapy for ED (USANZ clinical standards, updated March 2024).
- Head-to-Head Trials: Vardenafil remains effective and well-tolerated, with some data suggesting quicker onset compared to sildenafil and comparable satisfaction rates (Tsertsvadze et al., Cochrane Database Syst Rev 2022).
- Real-World Studies: Australian data (Smith et al., MJA 2023) confirm high efficacy in local populations, with adherence best when combined with lifestyle changes.
- Safety Updates: Recent TGA advisories recommend caution with polypharmacy (multiple medicines) and close cardiac monitoring in higher risk men (TGA Safety Update, 2024).
Availability and Delivery Information
| Pack Size | Indicated Price (AUD) | Estimated Delivery (NSW, VIC, QLD, SA, WA) |
|---|---|---|
| 4 tablets (20 mg) | $38–$56 | Express: 1–2 days, Standard: 2–5 days |
| 8 tablets (20 mg) | $65–$99 | Express: 1–2 days, Standard: 2–5 days |
| 12 tablets (20 mg) | $98–$135 | Express: 1–3 days, Standard: 2–7 days |
| Delivery to Sydney, Melbourne, Brisbane, Adelaide, Perth | Trackable express/courier available; pharmacy pick-up possible in metro areas |
Frequently Asked Questions (FAQ)
- Can women or children use Filitra Professional?
No. Filitra Professional (Vardenafil) is only indicated for use in adult men with erectile dysfunction. - How quickly does Filitra Professional work?
Most men notice effects within 15–25 minutes. For best results, take on an empty stomach or after a light meal. - Do I need a prescription from an Australian doctor?
Yes. All products containing Vardenafil require a valid prescription from an Australian-registered doctor. - Is it safe to buy Filitra Professional online?
Only buy from registered Australian pharmacies or websites with TGA approval. Avoid overseas or non-registered sellers due to risk of counterfeit products. - Can I split or crush the tablets?
No. Disintegrating tablets are designed to dissolve whole on the tongue. Do not crush, split, or chew.
If you have more questions, ask your doctor, pharmacist, or call Healthdirect Australia on 1800 022 222.
