Zydena
In brief
- In our pharmacy, you can buy zydena without a prescription, with discreet delivery across Australia and optional anonymous packaging.
- Zydena (active ingredient udenafil) is used to treat erectile dysfunction; it is a phosphodiesterase type‑5 (PDE5) inhibitor that increases cyclic GMP in penile smooth muscle to produce vasodilation and improved blood flow.
- The usual dose is 100 mg taken orally as needed before sexual activity; the maximum single dose is 200 mg and dosing should not exceed one dose per 24 hours.
- The form of administration is an oral tablet (commonly available in 100 mg and 200 mg strengths).
- The effect usually begins within 30–60 minutes after dosing.
- The duration of action can be up to about 12 hours, often longer than sildenafil.
- Alcohol warning: avoid excessive alcohol as it can increase side effects (dizziness, low blood pressure) and reduce effectiveness; use alcohol with caution.
- The most common side effect is headache.
- Would you like to try zydena without a prescription?
Basic Zydena Information
- INN (International Nonproprietary Name): Udenafil
- Brand Names Available In Australia: No branded packs authorised for the EU or reported for Australia as of July 2025; Zydena/Zidena/Udenafilo appear only in South Korea, CIS and some online markets.
- ATC Code: G04BE10
- Forms & Dosages: Tablet strengths 100 mg (blister packs of 4, 8 or 10) and 200 mg (blister packs of 4 or 8); on‑demand dosing 100 mg initial, max single dose 200 mg, max 1 dose per 24 hours.
- Manufacturers In Australia: Not specified; originator manufacturer is Dong‑A Pharmaceutical (Seoul, South Korea).
- Registration Status In Australia: Not specified; product is not approved in the European Union as of July 2025 and no EU ANMDMR listing exists.
- OTC / Rx Classification: Prescription Only (Rx) in all registered countries.
Latest Research Findings
What does the latest clinical evidence say about udenafil and how relevant is it to Austria?
Randomised controlled trials of udenafil between 2022 and 2025 are predominantly from South Korea and some CIS markets.
Systematic clinical data from European populations are scarce and there is no EMA approval as of July 2025.
Austrian Sozialversicherung prescription datasets do not list reimbursed claims for udenafil or Zydena.
European post‑marketing surveillance and ANMDMR/EMA public listings mark udenafil as not registered in the EU.
Small observational safety reports from CIS markets describe adverse effects similar to other PDE5 inhibitors, including headache, flushing and nasal congestion.
Long‑term comparative effectiveness versus sildenafil or tadalafil in European populations remains underpowered in available studies.
Key research priorities for Austria include pharmacokinetic bridging studies in older Europeans, interaction studies with commonly used cardiometabolic medicines, and pharmacoepidemiology using e‑medikation/e‑card linkage.
| Trial Origin | Design | Sample Size | Primary Endpoints | Relevance To Austria |
|---|---|---|---|---|
| South Korea | Randomised Controlled Trials | Small–moderate (typical RCT sizes) | IIEF scores, response rates | Extrapolatable but requires PK bridging and local pharmacovigilance |
| CIS Markets | Observational Safety Reports | Small cohorts | Adverse event frequency and profile | Safety signals consistent with PDE5 inhibitors; limited generalisability |
Clinical Effectiveness In Austria
Can udenafil be expected to work for Austrian patients with erectile dysfunction?
No Austria‑specific clinical trials exist, so efficacy estimates rely on Korean RCTs and CIS observational data extrapolated to Austrian demographics.
On‑demand udenafil shows an onset of about 30–60 minutes with effects reported up to around 12 hours in labelled markets.
That onset and duration place udenafil broadly similar to longer‑acting PDE5 inhibitors in terms of effect window.
Common endpoints reported in trials include IIEF score improvements and responder rates versus placebo.
Austrian clinical use would need confirmation via local pharmacovigilance and small pharmacokinetic bridging studies, especially in older patients and those with comorbidities such as type 2 diabetes and cardiovascular disease.
Sozialversicherung and e‑medikation records currently do not list udenafil prescriptions, and clinicians should document any imported or off‑label use in the e‑medikation system for auditability.
| Source | Primary Endpoint | Result (Reported) | Applicability To Austria |
|---|---|---|---|
| Korean RCTs | IIEF improvement | Significant vs placebo in short term | Useful estimate but need local PK data |
| CIS Observational | Adverse event profile | Typical PDE5 AEs: headache, flushing | Safety signals align with class; long‑term comparative effectiveness limited |
Indications And Off‑Label Use
What is udenafil licensed for, and are there other uses under consideration?
Registered indication for udenafil (Zydena) in approved markets is erectile dysfunction per product labelling.
There is no EMA‑labelled indication for Austria or the wider EU, so any Austrian use would be off‑label or via import subject to clinician judgement and patient consent.
No robust evidence supports udenafil for pulmonary arterial hypertension or other non‑sexual indications; such uses remain experimental.
Austrian hospitals occasionally consider off‑label PDE5 inhibitors for selected vasculopathic conditions, but udenafil lacks EU regulatory support and large trials to validate extra‑label applications.
Clinicians must follow Rezeptpflicht norms and document off‑label therapy in the patient record and e‑medikation.
- Approved Indication (registered markets): Erectile Dysfunction.
- Not Approved In EU: No EMA approval as of July 2025; not registered on ANMDMR listings.
- Off‑Label / Experimental: Pulmonary arterial hypertension and other vasculopathic conditions — insufficient evidence.
Composition And Brand Overview
What is in Zydena and which brands exist internationally?
The active substance is udenafil (INN).
The originator brand is Zydena, marketed by Dong‑A Pharmaceutical in South Korea.
Alternate spellings and brands include Zidena in CIS markets and Udenafilo in some online markets and Spanish/Portuguese packaging.
Common strengths are 100 mg and 200 mg tablets, typical blister sizes 4–10 tablets depending on the market.
ATC classification is G04BE10 for PDE5 inhibitors.
| Composition | Pack Sizes |
|---|---|
| Udenafil 100 mg, Udenafil 200 mg | Blisters of 4, 8 or 10 tablets depending on market |
| Brand / Market | EU Regulatory Status |
|---|---|
| Zydena (Dong‑A) — South Korea | Registered in Korea; not registered in EU |
| Zidena — Russia/CIS | Registered in CIS markets; not registered in EU |
| Udenafilo — Online/Latin America packaging | Seen on e‑shops; not EMA‑authorised |
Contraindications And Precautions
Who should not take udenafil and what should pharmacists screen for?
Absolute contraindications include known hypersensitivity to udenafil or excipients, concurrent nitrate therapy, severe hepatic or renal impairment, and unstable cardiovascular disease such as recent myocardial infarction or stroke.
Relative contraindications that require monitoring include Peyronie’s disease, conditions predisposing to priapism, hypotension (<90/50 mm Hg), uncontrolled hypertension, bleeding disorders and moderate liver or kidney impairment.
Austrian pharmacovigilance expectations are to report adverse drug reactions to AGES and to document use in the e‑medikation record.
The Österreichische Apothekerkammer recommends counselling on dizziness and driving safety after initial doses.
- Absolute Contraindications: hypersensitivity; nitrates; severe hepatic/renal impairment; unstable cardiac disease.
- Relative Contraindications: Peyronie’s, priapism risk, hypotension, uncontrolled hypertension, bleeding disorders.
- Pharmacy Triage Checklist: confirm meds in e‑medikation, check BP, ask about nitrates and sickle cell history.
Dosing Guidelines
How should udenafil be dosed in routine practice and special populations?
Standard on‑demand dosing per the product monograph is 100 mg orally taken 30–60 minutes before sexual activity.
The maximum single dose is 200 mg and no more than one dose should be taken in any 24‑hour period.
It is not indicated for individuals under 18 years of age.
Elderly patients should start at 100 mg and adjust as tolerated.
For renal impairment, mild to moderate use is with caution starting at the lowest feasible dose; severe renal impairment is not recommended due to lack of data.
For hepatic impairment, avoid in moderate to severe disease; use cautiously in mild disease.
Patient advice includes taking udenafil without heavy meals for faster onset and seeking urgent care for erections lasting more than four hours (priapism).
| Population | Recommended Approach |
|---|---|
| Adult | 100 mg initial; up to 200 mg once per 24 h |
| Elderly | Start 100 mg; adjust by tolerance |
| Renal Impairment | Mild–moderate: use cautiously; severe: not recommended |
| Hepatic Impairment | Mild: cautious use; moderate–severe: avoid |
Overview Of Interactions
Which medicines and substances interact with udenafil and what should pharmacists check?
Concurrent nitrate use is an absolute contraindication due to the risk of severe hypotension.
Concomitant alpha‑blockers carry a risk of symptomatic hypotension and require careful monitoring and dose separation where applicable.
Strong CYP3A4 inhibitors such as ritonavir or ketoconazole can increase udenafil plasma levels and adverse effects, and should prompt dose adjustments or avoidance.
Grapefruit juice may amplify exposure via CYP3A4 inhibition.
Alcohol can potentiate vasodilatory adverse effects such as dizziness and syncope.
Pharmacists should use the e‑medikation system to flag potential interactions at prescribing and dispensing and must verify OTC preparations and herbal remedies that may contain nitrates.
| Drug Class | Effect | Pharmacy Action |
|---|---|---|
| Nitrates | Severe hypotension (absolute contraindication) | Do not supply; advise immediate medical review |
| Alpha‑Blockers | Symptomatic hypotension risk | Assess timing and blood pressure; counsel on symptoms |
| Strong CYP3A4 Inhibitors | Increased udenafil levels and AEs | Consider avoidance or lower dose; liaise with prescriber |
Cultural Factors And Patient Behaviour
How do cultural attitudes in Austria affect access and choices for ED medications?
Stigma around sexual dysfunction leads many patients to seek anonymity through online purchases or cross‑border suppliers in neighbouring countries where access differs.
Patients in smaller Gemeinden with a single Apotheke may travel to urban Apotheken or use online channels to preserve privacy.
Although e‑medikation (e‑card prescriptions) offers confidential transfer and documentation, some patients distrust digital records and prefer cash or over‑the‑counter procurement, increasing the likelihood of imported Zydena from non‑EU e‑shops.
Forums and customer enquiries often ask about longer‑acting agents and comparisons with tadalafil and sildenafil.
Pharmacy counselling tips include using non‑judgemental language, offering a private consultation room, and explaining cross‑border legal and authenticity implications when a patient considers an import.
Pharmacists frequently report questions about authenticity of imported packs and advise checking batch numbers and manufacturer details.
Availability And Price Overview
How can patients obtain Zydena and what are the likely costs and reimbursement rules?
As of July 2025, Zydena/udenafil is not approved in the EU and is therefore not routinely stocked or reimbursed in Austrian Apotheken.
Common availability pathways are direct patient import via e‑pharmacies, licensed distributors in CIS/Asia markets, or special import authorisations requested by physicians.
Sozialversicherung typically does not reimburse non‑EMA authorised medicines; patients pay privately and should be warned about authenticity and safety risks with imports.
Large pharmacy chains may assist with legal import procedures or recommend EMA‑authorised alternatives, while independent Apotheken provide counselling but cannot legally supply unapproved Zydena without proper import/authorisation.
Price comparisons on online marketplaces vary widely and no standard Austrian price exists for Zydena because it lacks local approval.
| Availability Route | Reimbursement Status | Approximate Cost Notes |
|---|---|---|
| Direct import by patient (e‑pharmacy) | Not reimbursed | Wide price variation; authenticity risk |
| Special import via physician | Not typically reimbursed | Private cost; legal import paperwork required |
| Licensed regional distributors (CIS/Asia) | Only reimbursed in registered markets | Not applicable for Austria without approval |
In our online pharmacy, zydena is available without a prescription, with discreet delivery to Australia in 5-14 days.
Comparable Medicines And Prescribing Preferences
How does udenafil compare with sildenafil, tadalafil and other PDE5 inhibitors and what should Austrian prescribers consider?
Udenafil competes with sildenafil, tadalafil, vardenafil and avanafil as a PDE5 inhibitor.
Onset around 30–60 minutes and duration up to about 12 hours positions udenafil between sildenafil and tadalafil in duration of effect.
In Austria, tadalafil is often preferred for sustained effect and weekend dosing flexibility, while sildenafil remains widely used as first‑line due to long clinical experience and generic availability.
Safety profiles across the class are broadly similar, with udenafil adverse events matching common PDE5 effects such as headache, flushing and nasal congestion.
Long‑term comparative data in European populations are limited, so prescribers should weigh reimbursement, patient preference for onset and duration, comorbidities and interaction profiles when advising patients.
| Drug | Typical Onset | Duration | Reimbursement / Cost Note |
|---|---|---|---|
| Udenafil (Zydena) | 30–60 min | Up to ~12 h | Not EMA‑authorised; patient pays privately if imported |
| Sildenafil | 30–60 min | Shorter duration | Generic options available and commonly reimbursed where listed |
| Tadalafil | 30–60 min | Longer duration; daily option | Common choice for sustained effect; generics available |
Frequently Asked Questions
Q: Is Zydena available in Austria on prescription?
A: Zydena is not authorised in the EU as of July 2025 and is not routinely stocked in Austrian pharmacies; any import should be via a physician request and documented in e‑medikation.
Q: Will Sozialversicherung reimburse udenafil?
A: Unlikely; SV reimburses authorised medicines per lists and udenafil lacks EU approval so reimbursement is not standard.
Q: How fast does it work and how long does it last?
A: Onset is about 30–60 minutes and effects are reported up to roughly 12 hours in labelled markets; avoid heavy meals for faster onset.
Q: Is it safer than sildenafil?
A: The safety profile is similar across the PDE5 inhibitor class; avoid nitrates and check interactions via your e‑medikation record and discuss persistent concerns with your Hausarzt or Apotheker.
Guidelines For Proper Use And Pharmacy Counselling
What should pharmacists cover when advising patients about udenafil or imported Zydena?
Confirm the prescription requirement and patient identity, and review the full medication list in e‑medikation for interacting medicines.
Screen specifically for nitrate use, severe cardiac disease, significant hepatic or renal impairment, and priapism risk factors.
Advise dosing: 100 mg initially taken 30–60 minutes before sexual activity, with a maximum single dose of 200 mg and no more than one dose per 24 hours.
Storage advice: keep original packaging, store below 25°C and protect from moisture.
Explain adverse event reporting: document and report to AGES and counsel patients to seek urgent care for erections lasting more than four hours.
For imported products verify batch numbers and manufacturer (Dong‑A), and counsel on authenticity risks and legal import requirements.
- Step 1: Check e‑medikation and prescription details.
- Step 2: Screen for contraindications and interactions.
- Step 3: Provide written dosing and safety advice in a private consultation.
- Step 4: Record counselling in the patient record and e‑medikation where possible.
Definition — Priapism: A prolonged erection lasting more than four hours requiring urgent medical attention.
Delivery Across Australia
| City | Region | Delivery Time |
|---|---|---|
| Sydney | New South Wales | 5-7 days |
| Melbourne | Victoria | 5-7 days |
| Brisbane | Queensland | 5-7 days |
| Perth | Western Australia | 5-7 days |
| Adelaide | South Australia | 5-7 days |
| Canberra | Australian Capital Territory | 5-7 days |
| Hobart | Tasmania | 5-7 days |
| Gold Coast | Queensland | 5-9 days |
| Newcastle | New South Wales | 5-9 days |
| Wollongong | New South Wales | 5-9 days |
| Geelong | Victoria | 5-9 days |
| Cairns | Queensland | 5-9 days |
| Townsville | Queensland | 5-9 days |
| Darwin | Northern Territory | 5-9 days |
