Vitria (Vardenafil, marketed as Levitra Strips) – Patient Information Guide
Basic Product Information
| International Nonproprietary Name (INN) | Vardenafil |
|---|---|
| Australia Brand Names | Vitria, Levitra Strips, Levitra |
| ATC Code | G04BE09 |
| Available Forms & Strengths | Oral strips: 10 mg, 20 mg; also available as tablets (5 mg, 10 mg, 20 mg, 40 mg) |
| Manufacturers | Bayer AG, Gedeon Richter, Generic manufacturers |
| Prescription Status | Prescription only (Schedule 4, S4) |
Mechanism of Action
For Everyone: Vitria (Vardenafil) helps men with erectile dysfunction by increasing blood flow to the penis when sexually stimulated. It makes it easier to achieve and maintain an erection.
For Specialists: Vardenafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP concentrations in the corpus cavernosum, resulting in enhanced vasodilation and penile erection upon sexual stimulation.
Pharmacokinetics
- Absorption: Rapid, with peak plasma levels (~0.7–1 hour) for oral strips (may be faster than tablets).
- Metabolism: Extensively hepatic, primarily by CYP3A4, and to a lesser extent CYP3A5 and CYP2C isoforms.
- Elimination: Mainly via faeces (about 91%); only a small amount in urine.
- Duration of Action: Onset within 15–30 minutes, effective for up to 4–5 hours.
Everyday Use & Best Practices in Australia
- Typical Adult Dose: Most men start with 10 mg strip before anticipated sexual activity. May be adjusted (max 20 mg).
- How to Use:
- Remove strip from the packaging.
- Place it directly on your tongue. It will dissolve. No water needed.
- Take about 30–60 minutes before sexual activity.
- Do not exceed one dose per day.
- Use only on prescription from your GP or specialist.
- Keep out of reach of children.
- Store below 30°C; protect from moisture.
Dosing in the Morning vs. Evening
- Morning: Not usually recommended as the medicine acts within a few hours after intake. Spontaneous daily use is not required.
- Evening/Before Sexual Activity: Preferred as it matches the timing of sexual activity and maximises efficacy.
- Tips: Take at approximately the same time before sex for routine; regular timing may assist couples with scheduled intimacy.
Taking with Food or on an Empty Stomach
- Oral strips can be taken with or without food. However, heavy or high-fat meals, such as those common in some Australian diets (grilled meats, dairy-based meals), may slightly delay the action.
- Best effects are achieved when taken on an empty stomach or after a light meal.
- Avoid grapefruit and grapefruit juice, as these can increase side effect risk.
Interaction Warnings
| Type | Details |
|---|---|
| Medications |
|
| Alcohol | Limit intake. Alcohol can worsen side effects, including dizziness and low blood pressure. |
| Food | High-fat meals may reduce or delay action. Grapefruit to be avoided (see above). |
Indications
| Indication | Status | Description |
|---|---|---|
| Erectile Dysfunction (ED) in men | Approved | First-line use for men aged 18+ with persistent difficulty achieving or maintaining an erection. |
| Pulmonary Arterial Hypertension | Off-label (not recommended in AU) | Occasionally used in other countries; sildenafil is first-line in AU. |
| Raynaud’s Phenomenon | Off-label | Rare case use at specialist discretion. |
Dosing by Clinical Indication
| Patient Group | Starting Dose | Max Dose | Notes |
|---|---|---|---|
| Adult Men (<65 yrs) | 10 mg strip before intercourse | 20 mg strip/day | Can be reduced to 5 mg or increased based on response/tolerability. |
| Adult Men (>65 yrs or with hepatic/renal impairment) | 5 mg strip | 10 mg/day (max) | Extra care required to avoid adverse effects. |
| Children/Minors | Not indicated | Not indicated | Safety and efficacy not established in minors. |
Safety Profile & Side Effects
- Common (may affect up to 1 in 10):
- Headache
- Flushing
- Nasal congestion
- Indigestion
- Dizziness
- Back or muscle pain
- Rare/Important:
- Visual changes (blue tint or blurred vision)
- Priapism (prolonged, painful erection – seek medical help if >4h)
- Severe allergic reaction (rash, swelling, difficulty breathing – emergency!)
- Sudden loss of vision/hearing (very rare, stop and seek urgent care)
- Overall, side effects are dose-related and often short-lived.
- Stop and consult a doctor if chest pain, severe dizziness, or an allergic reaction occurs.
Guidelines for Proper Use (Australian Context)
- Use under medical supervision only – your Australian GP or urologist can prescribe Vitria after assessment.
- Review cardiovascular health; ED can be an early sign of heart disease. Australian guidelines recommend regular check-ups.
- Safely dispose of expired or unused strips—return to your pharmacy’s “Return Unwanted Medicines” bin.
- Discuss all other medicines, supplements, and health conditions with your pharmacist or prescriber.
- Do not share your strips with others, even if they have similar symptoms.
- If dose missed (rare “event based” use), simply take as needed—do not double dose.
- Only purchase from reputable, TGA-licensed pharmacies; avoid “grey market” online sellers.
Alternative Treatment Options in Australia
- Sildenafil (Viagra) – Widely reimbursed, similar use but less convenient if swallowing is difficult; duration 4–6 h.
- Tadalafil (Cialis) – Longer action (up to 36 h), once-daily and on-demand doses; available on PBS for some groups.
- Avanafil (Spedra) – Fastest onset; limited PBS access.
- Alprostadil cream/injection – Used if oral treatments fail; requires specialist supervision.
- Vacuum devices/penile implants – Non-pharmacological alternatives for refractory cases, often specialist-managed.
Vitria is generally preferred for men seeking a fast-acting, easy-to-use option. Tablets and daily dosing options (Tadalafil) may better suit those with regular sexual activity or specific comorbidities.
Legal, Registration, and Reimbursement Status in Australia
- Regulatory Approval: Therapeutic Goods Administration (TGA) approved; ARTG listed.
- Prescription Category: S4 (Prescription Only).
- Reimbursement: Not generally listed on the Pharmaceutical Benefits Scheme (PBS) for erectile dysfunction; private scripts only. Some related conditions (e.g., post-prostatectomy, diabetes) may qualify for PBS-subsidised PDE5 inhibitors.
- Pharmacy Supply: Only via prescription, at TGA-licensed pharmacies.
- Clinical Standards: Aligned with RACGP and Urological Society of Australia and New Zealand guidelines.
Latest Research & Clinical Guidance (2022–2025)
- Recent meta-analyses confirm Vardenafil’s superior efficacy for hard-to-treat erectile dysfunction compared to other PDE5 inhibitors, with fewer visual side effects *(Cui et al., 2023 – BJU International)*.
- Levitra oral strips may offer improved discretion and convenience, benefiting adherence and satisfaction (McMahon et al., 2024 – Sexual Medicine Reviews).
- Australian expert consensus supports early cardiovascular assessment for new ED cases and joint management with cardiologists for men with additional cardiac risk factors (RACGP Red Book, 2024, USANZ guidelines).
- No recent safety alerts or major contraindication changes for Vardenafil (TGA, 2023–2024).
Availability and Delivery
| Pack Size | Typical Retail Price (AUD, 2024) | Delivery to Major Cities |
|---|---|---|
| 4 strips (10 mg) | $54–$64 | Overnight – 2 business days (Sydney, Melbourne, Brisbane) |
| 8 strips (10 mg) | $95–$108 | 2 business days (Perth, Adelaide, Canberra) |
| 12 strips (20 mg) | $175–$197 | Overnight in metro areas, 3–4 days in NT/Tasmania |
- Dispensed with original leaflet and storage advice.
- Some online pharmacies may offer same-day courier in metropolitan centres when script is validated.
- Courier delivery ensures discretion for all parcels.
Frequently Asked Questions (FAQ)
- 1. How soon after taking Vitria strips can I expect them to work?
- Most men feel effects in 15–30 minutes, with best results usually noticed after 45–60 minutes. Sexual stimulation is still required for the medicine to work.
- 2. Can I drink alcohol if I take Vitria?
- Small amounts are unlikely to cause problems, but avoid excessive drinking. Alcohol can weaken erections and increase side effects like dizziness or low blood pressure.
- 3. What should I do if I experience side effects?
- Mild side effects (headache, flushing) are common and usually resolve. Stop taking the medicine and seek urgent care if you develop chest pain, a prolonged erection (>4 hours), sudden loss of sight, or a severe allergic reaction.
- 4. Is Vitria safe with my other medications?
- Discuss all medicines with your doctor or pharmacist. Never combine with nitrates or riociguat, and caution is advised with strong antibiotics, antifungals, or anti-HIV drugs.
- 5. Do I need a prescription for Vitria or Levitra strips in Australia?
- Yes, you need a valid prescription from an Australian healthcare provider. It is illegal and unsafe to obtain these medicines without a script, and buying from unregulated sources may put your health at risk.
Disclaimer: This information is provided as a guide only and does not replace professional medical advice. Always consult your doctor or pharmacist for personalised recommendations based on your health and medications.
