Description
Zudena (Udenafil) 100 mg
Zudena 100 mg is a product name for udenafil, a prescription medicine in the phosphodiesterase type 5 (PDE5) inhibitor class. The supplied product description is consistent with udenafil being used for erectile dysfunction. Udenafil has also been investigated in clinical studies and regulatory orphan-designation material for other potential uses, but those are not established routine indications.
Active Ingredient and Medicine Class
The verified active ingredient is udenafil. It belongs to the PDE5 inhibitor class, which also includes medicines such as sildenafil, tadalafil, vardenafil and avanafil. This class is used to improve erectile function by enhancing the natural nitric-oxide/cGMP pathway involved in penile blood flow.
Established Medical Uses
Available human clinical studies support udenafil for the treatment of erectile dysfunction. Randomized trials and a meta-analysis found improved erectile-function scores versus placebo and generally good tolerability. Udenafil has been studied in men with different causes of erectile dysfunction, including diabetes and hypertension, but these studies do not create a separate verified labelled indication here.
How It Works
During sexual stimulation, nitric oxide triggers the production of cyclic guanosine monophosphate (cGMP), which relaxes smooth muscle and increases blood flow in the corpus cavernosum. Udenafil inhibits PDE5, the enzyme that breaks down cGMP, thereby helping maintain the signal that supports an erection. It does not create an erection without sexual stimulation.
Important Safety Information
Udenafil is in the same safety category as other PDE5 inhibitors, so important precautions are similar across the class. It should not be used with nitrates because of the risk of a marked blood-pressure drop. Caution is also needed with riociguat and with medicines that can interact through CYP3A4 metabolism, which may increase exposure to PDE5 inhibitors. Men with significant cardiovascular disease, recent serious heart events, severe low blood pressure, or other conditions that make sexual activity unsafe need careful medical assessment.
Possible Side Effects
Common adverse effects reported in clinical studies include headache and flushing. Other PDE5-inhibitor effects may include nasal congestion, dizziness, dyspepsia, and back pain. Serious but uncommon reactions seen with the class can include prolonged erection, sudden vision or hearing changes, and symptomatic hypotension, especially when interacting medicines are involved.
Scientific Evidence
In a phase III randomized, placebo-controlled trial, udenafil produced greater improvement in erectile-function scores than placebo over 12 weeks. A later meta-analysis of five randomized trials involving 1,109 patients found significant benefit versus placebo and reported mainly mild to moderate adverse events, with no serious adverse events during the study periods.
Medical Information Notice
This summary is an educational overview based on sources available at the time of review. It does not replace the official patient leaflet, prescribing information, or individual assessment by a qualified healthcare professional.
Medical Sources
- European Medicines Agency (EMA) — EU/3/16/1807 – orphan designation for treatment of functional single ventricle congenital heart disease
- Hong J, et al. — The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction — International Journal of Impotence Research, 2008
- Li H, et al. — Efficacy and safety of udenafil for erectile dysfunction: a meta-analysis of randomized controlled trials — Urology, 2012
