Levitra Professional (Vardenafil) – Patient Information for Australia
Basic Product Information
| Active Ingredient (INN) | Vardenafil |
|---|---|
| Australia Brand Names | Levitra, Levitra Professional, Vivanza |
| ATC Code | G04BE09 |
| Available Forms & Strengths | Oral tablets: 10 mg, 20 mg (Professional: rapid-dissolving) |
| Manufacturers | Bayer AG, licensed generic manufacturers |
| Prescription Status (Australia) | Prescription only (Schedule 4, S4) |
Mechanism of Action
For Patients: Vardenafil helps men achieve and maintain an erection by boosting the natural process that occurs during sexual arousal. It works by improving blood flow to the penis.
For Specialists: Vardenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. By inhibiting PDE5, it increases levels of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum, resulting in vasodilation and improved erectile function. It is only effective in the presence of sexual stimulation.
Pharmacokinetics
- Absorption: Rapidly absorbed after oral administration; peak plasma concentrations reached in approximately 30–60 minutes.
- Metabolism: Extensively metabolized by liver enzymes (CYP3A4, CYP3A5, CYP2C9).
- Elimination: Half-life of 4–5 hours; eliminated mainly via the liver, with metabolites excreted in the faeces and urine.
- Duration of Action: Up to 4–6 hours; sexual response possible with stimulation during this window.
Use in Everyday Life & Best Practices (Australia)
Levitra Professional is most often prescribed as a single, on-demand dose prior to anticipated sexual activity. The recommended starting dose is usually 10 mg, taken about 25–60 minutes before sex. Your healthcare provider may adjust the dose to a maximum of 20 mg, or lower it to 5 mg, depending on your response and any potential side effects.
- Take only one tablet in any 24-hour period.
- Sexual stimulation is required for the medicine to work.
- Suitable for most forms of erectile dysfunction, including after prostate surgery, diabetes, and psychological causes.
- Store in a cool, dry place, away from direct sunlight (ideally under 25°C, typical of Australian medicine storage guidelines).
Dosing: Morning vs Evening
The timing of your dose can be tailored to your and your partner’s preferences:
- Morning Use: May be preferred if intimacy is planned for the day, but food intake and daily routines can affect absorption.
- Evening Use: Most patients in Australia prefer evening use as it coincides with typical social and relationship habits. Less likely to interfere with work or daily activities. Also, fasting states are more common in the evenings, optimising absorption.
- Tip: Try to take the tablet around the same time prior to sexual activity for more predictable results.
Taking with Food or an Empty Stomach (Australian Dietary Habits)
- Levitra Professional may be taken with or without food.
- However, high-fat meals common in some Australian diets (e.g. traditional “full English” breakfasts, burger meals) can delay the absorption and reduce the speed of onset.
- For fastest results, take on an empty stomach or after a light meal.
- Alcohol may increase certain side effects (see below).
Interaction Warnings
| Substance | Interaction | Advice |
|---|---|---|
| Alcohol | Increases risk of low blood pressure, dizziness, fainting | Limit to 1-2 standard drinks; avoid excessive intake |
| Nitrates (e.g. GTN spray, angina tablets/patches) | Severe, dangerous drop in blood pressure | Absolutely contraindicated – do not use together |
| Alpha-blockers (for prostate/blood pressure) | Increased risk of low blood pressure | Medical supervision required |
| Other ED medications (e.g. sildenafil, tadalafil) | Excessive effects, increased side effect risk | Avoid concurrent use |
| Antibiotics/Antivirals (CYP3A4 inhibitors: clarithromycin, ritonavir) | May increase vardenafil blood levels | Dose adjustment/monitoring may be required |
| Grapefruit or grapefruit juice | Affects absorption and clearance | Best to avoid during use |
Indications
| Indication | Status | Comments |
|---|---|---|
| Erectile Dysfunction (ED) in adult men | Approved | Most common and officially registered use |
| Pulmonary arterial hypertension (PAH) | Off-label | Not preferred; other treatments available |
| Raynaud’s phenomenon | Off-label | Small-scale studies, not routinely used |
Dosing According to Clinical Indications
| Population | Starting Dose | Maximum Dose | Special Considerations |
|---|---|---|---|
| Adult men (18–64 years) | 10 mg as needed, 25–60 min before sex | 20 mg per 24 hrs | Adjust according to efficacy/tolerability |
| Elderly (≥65 years) | 5 mg as needed | 20 mg per 24 hrs | May be more sensitive; start low, monitor side effects |
| Pediatric (<18 years) | Not recommended | Not indicated | Safety/efficacy not established |
| Severe hepatic/renal impairment | Start lower or avoid | Use with caution, specialist advice required | Medical guidance essential |
Safety Profile / Side Effects
- Common: Headache, flushing, nasal congestion, upset stomach, dizziness.
- Occasional: Back pain, vision changes (mild, temporary), indigestion.
- Rare/Serious: Priapism (painful, prolonged erection >4h), sudden vision or hearing loss, severe allergic reaction, significant drop in blood pressure.
Warnings: Not suitable for patients with severe heart disease (unstable angina, recent stroke/MI), hereditary degenerative retinal disorders, or those on nitrate therapy. Seek immediate medical attention for chest pain, vision changes, or erection over 4 hours.
Guidelines for Proper Use
- Always take as directed by your Australian prescriber or pharmacist.
- Do not exceed the prescribed dose.
- Take whole with water, or allow to dissolve (Professional form) as instructed.
- If you miss a scheduled dose, wait until the next time you plan sexual activity — do not double up.
- Discuss any other conditions, medications, or supplements with your GP/pharmacist prior to starting.
- Monitor for side effects the first few times and report anything concerning.
Alternative Treatment Options
- Sildenafil (Viagra, generic): Similar effect, more established, often PBS-reimbursed for some conditions; slightly longer onset and duration than vardenafil.
- Tadalafil (Cialis, generic): Longer half-life (up to 36h), “weekend pill,” may be taken daily; broader PBS reimbursement (including some LUTS indications).
- Avanafil (not currently PBS listed): Faster onset, slightly fewer interactions.
- Non-pharmacological: Vacuum erection devices, penile implants, psychological therapies.
Your pharmacist or doctor can guide you toward the most appropriate and cost-effective choice for your situation.
Legal, Registration, and Reimbursement Status in Australia
- Registered with the Therapeutic Goods Administration (TGA).
- Schedule 4 (S4) - prescription required from a licensed Australian prescriber.
- Not routinely reimbursed by the PBS for typical erectile dysfunction (except for certain chronic conditions such as spinal cord injury).
- Available from community and online (TGA-accredited) pharmacies with a valid prescription.
Latest Research & Clinical Guidance (2022–2025)
- Levitra Professional and Vardenafil continue to be recommended as first-line therapy for erectile dysfunction per Australian and international urological guidelines (Urological Society of Australia and New Zealand, EAU, AUA 2022–2024).
- Recent comparative studies (Ozturk et al, 2023; Trussell et al, 2024) show similar effectiveness between PDE5 inhibitors, with vardenafil often preferred for its favorable side effect profile, especially less visual disturbance than sildenafil.
- TGA guidance (2023 update) reaffirms contraindications and safe use parameters.
- Ongoing research explores microdose regimens and combination therapies, but these are not yet standard practice.
Availability and Delivery in Australia
| Pack Size | Indicative Price (AUD) | Delivery Time (Sydney) | Delivery Time (Melbourne) | Delivery Time (Brisbane) |
|---|---|---|---|---|
| 4 tablets (10 mg) | $45–$65 | Same or next day | Same or next day | 1–2 days |
| 8 tablets (20 mg) | $78–$130 | Same or next day | Same or next day | 1–2 days |
| 16 tablets (mixed) | $145–$240 | Next business day | Next business day | 2–3 days |
| Other (ask your pharmacy) | Variable | Ask pharmacy | Ask pharmacy | Ask pharmacy |
FAQ – Frequently Asked Questions
- Is Levitra Professional safe for older adults?
Yes, but a lower starting dose (5 mg) is recommended for those over 65, and your doctor may need to monitor for side effects more closely. - Can I drink alcohol while taking Levitra Professional?
Limited alcohol (1–2 standard drinks) is generally safe, but too much alcohol increases the risk of side effects such as dizziness or fainting. - What should I do if Levitra Professional does not work for me?
Inform your doctor—dose adjustments or alternative treatments may be needed. Sometimes several uses are needed to gauge effect. - Is it safe to use with heart medications?
Not if you use nitrates (for angina) or certain alpha-blockers. Always check with your GP or pharmacist before starting. - Can I get Levitra Professional online in Australia?
Yes—with a valid Australian prescription. Only use accredited online pharmacies (TGA-accredited).
This information is for Australian patients and carers. Always consult your GP, pharmacist, or specialist for advice tailored to your needs before starting any medication, and review the Consumer Medicine Information (CMI) leaflet for full detail.
