Super Zhewitra (Vardenafil with Dapoxetine): Comprehensive Patient Information for Australia
1. Basic Product Information
| International Nonproprietary Name (INN) | Vardenafil with Dapoxetine |
| Australia Brand Names | Super Zhewitra (may be supplied as a compounded or imported product, subject to TGA approval or authorized prescriber scheme) |
| ATC Code | G04BE09 (Vardenafil), G04BE (Dapoxetine) |
| Available Forms & Strengths | Oral tablets, typically containing Vardenafil 20 mg and Dapoxetine 60 mg |
| Manufacturers | Various licensed pharmaceutical manufacturers (imported generic; not routinely supplied via PBS) |
| Prescription Status | Prescription-only medicine (Schedule 4, S4); requires consultation with a medical practitioner |
2. Mechanism of Action
- For patients: Super Zhewitra works by combining two different medicines. Vardenafil helps increase blood flow to the penis, making it easier to get and keep an erection when sexually stimulated. Dapoxetine improves control over ejaculation, which can help men who experience premature ejaculation.
- For healthcare professionals: Vardenafil is a PDE-5 inhibitor, enhancing nitric oxide-mediated vasodilation in the corpus cavernosum. Dapoxetine, a short-acting selective serotonin reuptake inhibitor (SSRI), delays ejaculation through serotonergic mechanisms at the spinal and cerebral level.
3. Pharmacokinetics
- Absorption: Both ingredients are rapidly absorbed after oral administration. Vardenafil peaks in plasma within 0.7–1.5 hours; Dapoxetine peaks within 1–2 hours.
- Metabolism: Vardenafil is metabolised primarily by CYP3A4, with minor CYP3A5 and CYP2C. Dapoxetine is metabolised mainly by CYP2D6 and CYP3A4.
- Elimination: Vardenafil has a terminal half-life of ~4–5 hours. Dapoxetine’s half-life is approx. 1.5 hours (distribution) and 19 hours (elimination); both are mainly excreted in urine (as metabolites).
- Duration of Action: Vardenafil lasts for up to 4–5 hours. Dapoxetine’s effect persists for several hours.
4. Use in Everyday Life and Best Practices
- Indication: Prescribed for adult men experiencing erectile dysfunction (ED) and/or premature ejaculation (PE). A dual-action approach helps men who have both difficulties.
- Typical Dosage: One tablet (20 mg Vardenafil/60 mg Dapoxetine) taken 1–3 hours before anticipated sexual activity. Do not exceed one tablet in 24 hours.
- How to Use: Swallow the tablet whole with water. It can be taken discreetly at home or when ready for intimacy.
- English Context: Sexual health support is available from GPs, sexual health clinics, or telehealth services. Super Zhewitra is not available via the PBS but may be prescribed on a private prescription.
5. Dosing in the Morning vs Evening
- Morning Use: Advantages—flexibility for anticipated daytime intimacy; Disadvantages—may result in reduced efficacy if intercourse is delayed; risk of overlap with food intake and daily activities.
- Evening Use: Most common, aligns with typical patterns of intimacy; easier to plan; lower risk of interference with work or driving.
- Regularity Tips: Do not use daily or on a fixed schedule; only as needed. Keep track of use to avoid accidental overdosing.
6. Taking with Food or on an Empty Stomach
- Effect of Meals: Taking with a large, high-fat meal may delay absorption of Vardenafil and reduce its effectiveness. Light meals or fasting are preferable for rapid onset.
- Australian Dietary Habits: Standard meals (toast, cereal, salads, meats) are generally acceptable. Avoid heavy “pub” meals, fried foods or high-fat cheeses before taking your dose.
7. Interaction Warnings
| Substance | Potential Effect | Clinical Recommendation |
| Alcohol | Increases risk of side effects (dizziness, low blood pressure, fainting, impaired judgement) | Limit or avoid alcohol before and after use |
| Grapefruit/juice | May increase plasma levels of Vardenafil, risk of toxicity | Avoid grapefruit and grapefruit juice on the day of use |
| Antihypertensives (beta-blockers, ACE inhibitors) | Possible additive blood pressure-lowering effects | Consult your GP for monitoring |
| Nitrates/nitrite donors | Severe, life-threatening hypotension may occur | Contraindicated—never use concurrently |
| Other PDE5 inhibitors, SSRIs | Risk of overdose, serotonin syndrome; additive side effects | Consult a doctor before use |
| St John’s Wort | May reduce efficacy of Dapoxetine (CYP450 inducer) | Avoid concurrent use |
8. Indications
| Clinical Indication | Status | Notes |
| Erectile Dysfunction (ED) | Approved, off-label (combination) | TGA-approved separately, not as combination |
| Premature Ejaculation (PE) | Approved, off-label (combination) | Dapoxetine is registered for PE in Australia |
| Dual ED/PE in adult men | Specialist/authorised prescriber use | Combination products may be imported for personal use |
9. Dosing According to Clinical Indications
| Patient Group | Recommended Dose | Maximum Dose | Special Considerations |
| Adult Men (18–64 years) | 1 tablet (20 mg/60 mg) as required | 1 tablet/24h | Start with half a dose if new to PDE5 inhibitors/SSRIs |
| Elderly (>65 years) | Consider lower starting dose (e.g. 10 mg/30 mg equivalent if available) | 1 tablet/24h | Increased sensitivity to side effects; monitor BP |
| Pediatric | Not for use under 18 years | N/A | Safety/efficacy not established |
10. Safety Profile & Side Effects
- Common Side Effects:
- Headache
- Flushing
- Nasal congestion
- Dizziness, light-headedness
- Nausea or upset stomach
- Diarrhoea
- Dry mouth
- Increased sweating
- Difficulty sleeping
- Less Common/Rare Side Effects:
- Blurry vision or changes in colour vision
- Palpitations or irregular heartbeat
- Fainting/low blood pressure (especially with alcohol or other medicines)
- Prolonged or painful erection (priapism) – medical emergency
- Serotonin syndrome (rare; agitation, confusion, tremor, rapid heart rate)
- Seizures (very rare)
- Warnings:
- Do not take if you are using nitrate medications (angina, heart disease).
- Not recommended for those with known severe heart, liver, or kidney disease.
- Seek urgent medical attention if you experience chest pain, severe dizziness, or vision loss.
11. Guidelines for Proper Use
- Pharmacists recommend:
- Keep medicines in the original packaging and out of reach of children.
- Check expiry date before use.
- Store at room temperature away from moisture and heat.
- Australian clinical advice:
- Have a recent cardiovascular health check before starting treatment.
- Discuss all current medicines/supplements with your doctor.
- Read the Patient Information Leaflet attached to your prescription.
- Do not drive soon after taking if you feel dizzy, drowsy, or light-headed.
12. Alternative Treatment Options
| Medicine | Indication | Reimbursed (PBS) | Pros | Cons |
| Sildenafil (Viagra and generics) | ED | Partially for certain indications; mostly private script | Widely available, affordable, well-studied | Shorter duration, food affects absorption |
| Tadalafil (Cialis and generics) | ED | Private only | Longer duration (up to 36h), daily or on-demand | BPH overlap, costlier |
| Dapoxetine | PE | Private only | Registered for PE, flexible dosing | Not reimbursed, side effect profile |
| Behavioural therapy | ED, PE | N/A | No medication side effects, effective for some | Takes time, variable success |
Note: The combination as in Super Zhewitra is not formally reimbursed via the Australian PBS or subsidised by the National Pharmaceutical Services. Your GP or urologist may discuss alternatives depending on individual health and preferences.
13. Legal, Registration, and Reimbursement Status in Australia
- Legal: Prescription medicine (Schedule 4).
- Registration: The individual components (Vardenafil and Dapoxetine) are registered by the Therapeutic Goods Administration (TGA), but the fixed-dose combination is not currently registered.
- Reimbursement: Not covered under the Pharmaceutical Benefits Scheme (PBS); patient self-pay/private prescription required.
- Importation: Possible under the personal importation scheme (up to 3 months’ supply). Ensure it is for personal use and that a valid prescription is held.
- Enforcement: Consult with your pharmacist or prescriber for current legal supply pathways.
14. Latest Research and Clinical Guidance (2022–2025)
- Recent international studies (2022–2024) confirm efficacy and safety profiles for co-administration of PDE5 inhibitors and dapoxetine in men with both ED and PE, with the combination improving overall sexual satisfaction scores (Ref: British Journal of Urology, 2023).
- Australian and European guidelines advise individual dose titration, cardiovascular screening prior to use, and a patient-centred approach to sexual dysfunction (Urology Society of Australia and New Zealand Clinical Guidance 2024).
- No new safety warnings have been issued by the TGA for either component since 2022, but all patients are encouraged to report adverse events and seek advice promptly if concerned.
15. Availability and Delivery
| Pack Size | Indicative Price (AUD) | Estimated Delivery (Metro) | Estimated Delivery (Regional) |
| 4 tablets | $40–60 | 1–3 business days | 3–6 business days |
| 12 tablets | $100–140 | 1–3 business days | 3–6 business days |
- Available from select Australian pharmacies and online outlets with valid prescription.
- Cold chain not required. Standard tracked delivery offered Australia-wide. Express post available in most major cities including Sydney, Melbourne, Brisbane, Perth, and Adelaide.
- Pharmacies will verify prescriptions before dispatch.
16. FAQ – Frequently Asked Questions
- Q: Can I use Super Zhewitra every day?
A: No. This medicine is intended for use as needed, not for daily regular use. Taking too frequently increases risk of side effects. - Q: Is it safe to drink alcohol while using Super Zhewitra?
A: It is best to avoid or strictly limit alcohol use, as it can worsen side effects like dizziness or low blood pressure. Safety first—limit intake on days you plan to use the medicine. - Q: Can women use Super Zhewitra?
A: No. This medicine is not indicated for use in women or those under 18 years of age. - Q: Do I need a prescription?
A: Yes. You must have a valid prescription from a registered Australian medical practitioner. Always obtain medicines from legitimate, registered pharmacies. - Q: What should I do if I miss a dose?
A: This medicine is not meant to be taken regularly. Take only when required before sexual activity. Never take more than one dose in 24 hours.
For more individualised advice, discuss with your GP or a sexual health specialist. This information is provided for educational purposes and does not replace individual medical consultation. Always follow your prescriber’s instructions and the medicine’s approved leaflet.
