Silvitra (Sildenafil Citrate 100 mg + Vardenafil 20 mg): Patient Information for Australian Consumers
Basic Product Information
| International Nonproprietary Name (INN) | Sildenafil Citrate + Vardenafil |
|---|---|
| Australian Brand Names | Silvitra (not currently listed on the Australian Register of Therapeutic Goods as of 2024) |
| ATC Code | G04BE53 (Sildenafil); G04BE09 (Vardenafil) |
| Available Forms & Strengths | Oral tablets: 100 mg sildenafil + 20 mg vardenafil |
| Manufacturers | Various international manufacturers; verify with your pharmacist for specific brand and country of origin |
| Prescription Status | Prescription only. Must be prescribed by a registered Australian health practitioner. |
Mechanism of Action
In Everyday Terms: Silvitra contains two medicines — sildenafil and vardenafil — both of which help to increase blood flow to the penis. This improved circulation helps men with erectile dysfunction (ED) to achieve and maintain an erection when sexually stimulated.
For Healthcare Professionals: Both sildenafil and vardenafil are selective phosphodiesterase type 5 (PDE5) inhibitors. They enhance the effects of nitric oxide (NO) by inhibiting PDE5-mediated degradation of cGMP in the corpus cavernosum. The dual agent combination may theoretically offer more sustained PDE5 inhibition; however, clinical data on combined use is limited, and concurrent administration is not routinely recommended under current clinical guidelines.
Pharmacokinetics
- Absorption: Sildenafil and vardenafil are rapidly absorbed, with peak plasma concentrations reached within 30–120 minutes after oral administration.
- Metabolism: Both drugs are predominantly metabolised in the liver by cytochrome P450 isoenzymes (mainly CYP3A4).
- Elimination: Sildenafil is mainly excreted as metabolites via faeces (80%) and urine (13%); vardenafil via similar pathways.
- Duration of Action: Effective for 4–6 hours for sildenafil; 4–5 hours for vardenafil. The combined effect has not been robustly studied, so actual duration may vary.
Use in Everyday Life and Best Practices
- Typical Adult Dose: 1 tablet (100 mg sildenafil + 20 mg vardenafil) once as needed, about 30–60 minutes before sexual activity. Do not exceed more than one dose in 24 hours.
- Do not take more than prescribed; excessive dosing increases the risk of side effects and complications.
- This medicine does not increase sexual desire and only works when you are sexually aroused.
- Discuss any health conditions or other medicines with your doctor before starting Silvitra.
Dosing: Morning vs Evening
- Time of Use: Silvitra is intended for use “as needed”, not on a scheduled basis.
- Morning Use: May be preferred by individuals with a consistent morning routine or when planning sexual activity earlier in the day. However, avoid combination with heavy breakfast for optimal effect.
- Evening Use: Common for most couples; be mindful of dietary intake (see next section).
- Regularity: Maintain a consistent approach to timing. Take the tablet at least 30–60 minutes before planned activity.
Taking With Food or on an Empty Stomach
- Taking Silvitra on an empty stomach generally leads to a quicker onset and stronger effect.
- High-fat meals and very rich foods (e.g., traditional Australian BBQ, fish and chips, creamy desserts) can delay absorption and reduce the effectiveness of both sildenafil and vardenafil.
- If you eat before taking Silvitra, wait 2–3 hours after a large meal for best results.
- Moderate, low-fat meals (toast, cereal, fruit) are unlikely to significantly impact effect.
Interaction Warnings
| Type | Interacting Substance | Effect | Advice |
|---|---|---|---|
| Food | High-fat meals | Delay and reduce effect | Take on an empty stomach when possible |
| Alcohol | Alcohol | Increases risk of hypotension, dizziness, reduced alertness | Limit or avoid alcohol with Silvitra |
| Medications | Nitrates (e.g., GTN spray, isosorbide dinitrate) | Profound hypotension (dangerous blood pressure drop) | Absolute contraindication — never combine |
| Medications | Alpha-blockers, antihypertensive drugs | Drop in blood pressure | Monitor closely; dose adjustment may be required |
| Medications | CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) | Increased effect and toxicity risk | Consult your doctor; dose adjustment may be needed |
| Other | Grapefruit juice | Increases drug levels | Avoid grapefruit and its juice |
Indications
| Type | Description |
|---|---|
| Official | Treatment of erectile dysfunction in adult males |
| Off-label | Investigational use in severe ED refractory to monotherapy; combination use is not standard in Australia and may be considered only if advised by a sexual health specialist. |
Dosing According to Clinical Indication
| Patient Group | Recommended Dose | Notes |
|---|---|---|
| Adults | 1 tablet as needed (not more than once per 24 hours) | Start with lowest effective dose |
| Elderly (>65 years) | Consider lower initial dose (half tablet) | Increased risk of adverse effects |
| Pediatric | Not recommended | ED treatment is not indicated in children/adolescents |
| Renal/Hepatic impairment | Start with reduced dose, increased monitoring | Discuss with specialist |
Safety Profile & Side Effects
- Most common: Headache, flushing, stuffy or runny nose, indigestion, mild visual changes
- Less common: Dizziness, back pain, muscle aches, nausea
- Rare but serious: Sudden vision loss, sudden hearing decrease, priapism (erection lasting more than 4 hours), severe hypotension, allergic reactions (swelling, rash, difficulty breathing)
- Warnings: See immediate medical attention for chest pain, fainting, vision or hearing loss, or persistent/painful erections
Guidelines for Proper Use (Australian Context)
- Obtain Silvitra only with a script from an Australian registered medical practitioner or urologist.
- Attend a check-up if it is your first time taking ED medications; inform your doctor of your full medical history.
- Do not use Silvitra recreationally or share with others, as risks from misuse or interactions are significant.
- Report side effects immediately using the TGA Medicines Adverse Events Reporting System.
- Store below 25°C, away from children and direct sunlight.
Alternative Treatment Options
- Sildenafil (Viagra™; PBS reimbursed): Single agent, well-established, widely available.
- Vardenafil (Levitra™, Vivanza™): For patients who do not tolerate sildenafil.
- Tadalafil (Cialis™; PBS reimbursed): Longer acting, can be used daily for continuous effect.
- Avanafil (Spedra™): Rapid onset, short duration; not PBS reimbursed as of 2024.
- Vacuum devices, penile implants, counselling: For patients who cannot use or do not respond to oral medicines.
Pros/Cons Comparative Overview:
Sildenafil/vardenafil: Fast onset, as-needed use.
Tadalafil: Allows flexible dosing, suits spontaneous lifestyle.
Legal, Registration and Reimbursement Status in Australia
- Therapeutic Goods Administration (TGA) listing: Silvitra is not currently approved for supply by the TGA. Imported medicines are subject to the Personal Importation Scheme — always check latest TGA advice.
- Legal Status: Prescription-Only Medicine (Schedule 4).
- Reimbursement: Sildenafil and tadalafil are PBS reimbursed for specific indications. Vardenafil is not reimbursed. Silvitra combination is not currently supported for reimbursement.
- NFZ and URPL: Not applicable in Australia (these are Polish terms). All supply is governed by TGA, MBS, and PBS guidance.
Latest Research & Clinical Guidance (2022–2025)
- The most recent Australian and international EAU/AUA erectile dysfunction guidelines (2023–2024) recommend single-agent PDE5 inhibitors as first-line treatment. As of March 2024, combination therapy (sildenafil plus vardenafil together) is not standard due to a lack of high-quality evidence for added efficacy and greater risk of side effects (AUA Guideline 2023).
- A 2023 review in the journal "Sexual Medicine Reviews" concluded that there is insufficient safety and effectiveness data to recommend dual PDE5 inhibitor therapy (Sex Med Rev. 2023;11(2):345-357).
- Australian urology consensus: Monotherapy is preferred. Combination therapy is reserved for select, specialist-supervised cases ("Australian Urological Association Meeting Abstracts, 2024").
- Therapeutic Goods Administration (TGA) emphasises the importance of using registered, approved medicines and reporting any adverse events promptly.
Availability and Delivery
| Pack Size | Indicated Price Range (AUD) | Delivery Time – Sydney | Delivery Time – Melbourne | Delivery Time – Brisbane | Delivery Time – Perth | Delivery Time – Regional/Rural |
|---|---|---|---|---|---|---|
| 4 tablets | $55–$75 | 1–2 business days | 1–3 business days | 1–3 business days | 2–4 business days | 3–6 business days |
| 12 tablets | $135–$180 | 1–2 business days | 1–3 business days | 1–3 business days | 2–4 business days | 3–6 business days |
Note: Actual availability may vary. Always purchase from a reputable, Australian-registered pharmacy. Shipping times are estimates and can depend on location and pharmacy stock.
Frequently Asked Questions (FAQ)
1. Is Silvitra available in Australia?
As of June 2024, Silvitra (sildenafil + vardenafil) is not officially listed on the Australian Register of Therapeutic Goods (ARTG). It may be legally imported with a valid prescription under the TGA Personal Importation Scheme but is not routinely available through local pharmacies. Consult your doctor for approved alternatives like sildenafil and tadalafil.
2. Is it safe to take Silvitra every day?
No. Silvitra is designed for ‘as needed’ use only. Daily or frequent use increases the chance of side effects and is not recommended without specialist urological supervision.
3. Will Silvitra interact with my other medications?
Possibly. Silvitra has several known interactions, especially with nitrates, blood pressure medications, and some antibiotics and antifungals. Always inform your doctor and pharmacist of all your medicines and supplements before starting treatment. See the “Interaction Warnings” table above for details.
4. What should I do if I experience side effects?
For mild side effects like headache or flushing, rest and stay hydrated. For severe reactions (such as chest pain, fainting, loss of vision, or an erection lasting more than 4 hours), seek urgent medical care. Report all side effects to your doctor and via the TGA Adverse Events portal.
5. Can I drink alcohol or eat as normal while using Silvitra?
Limit alcohol, as it can increase side effects like dizziness and lower blood pressure. Avoid heavy, fatty meals right before taking Silvitra, as this may delay or lessen the effect. A light, balanced Australian meal is fine.
