Description
Extreme levifil
Extreme levifil is presented as a combination of vardenafil and dapoxetine. Based on the available regulatory and scientific sources, vardenafil is an established phosphodiesterase type 5 (PDE5) inhibitor used for erectile dysfunction, while dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) developed for on-demand treatment of premature ejaculation. The combination has been studied in men with both erectile dysfunction and premature ejaculation, but product-specific regulatory status for this trade name could not be verified from the sources reviewed.
Active Ingredient and Medicine Class
Vardenafil belongs to the PDE5 inhibitor class. It acts on erectile tissue by enhancing the effect of nitric oxide and increasing blood flow during sexual stimulation. Dapoxetine is an SSRI with rapid absorption and short half-life, which is why it has been investigated for on-demand treatment of premature ejaculation.
Established Medical Uses
Vardenafil has established use for erectile dysfunction. Dapoxetine has established use for premature ejaculation in markets where it is authorised. Clinical studies have evaluated dapoxetine in men with premature ejaculation who also had erectile dysfunction and were already using a PDE5 inhibitor. The evidence supports the individual ingredients more clearly than this specific fixed-dose combination product.
How It Works
Vardenafil helps relax smooth muscle in the penis so that blood can flow more readily during sexual arousal. Dapoxetine increases serotonin signalling at nerve pathways involved in ejaculation, which can delay ejaculation in some men. Together, the two medicines are intended to address two different aspects of male sexual dysfunction.
Important Safety Information
Vardenafil should not be used with nitrates because the combination can cause a dangerous fall in blood pressure. Caution is also needed with alpha-blockers and in men with significant cardiovascular disease. Dapoxetine is associated with important precautions including syncope, dizziness, and interaction risk with other serotonergic medicines and certain antidepressants. The combination may increase the chance of dizziness, low blood pressure, flushing, headache, or other adverse effects seen with either ingredient.
Possible Side Effects
Reported adverse effects of dapoxetine commonly include nausea, dizziness, headache, diarrhoea, somnolence, and insomnia. In clinical studies of dapoxetine used with a PDE5 inhibitor, common events also included nausea, headache, diarrhoea, and dizziness. Vardenafil is associated with adverse effects such as headache, flushing, nasal congestion, and dyspepsia. Serious but less common concerns include syncope, marked hypotension, and cardiovascular events in susceptible patients.
Scientific Evidence
A randomized, placebo-controlled phase III study found that dapoxetine added to stable PDE5 inhibitor treatment improved measures of premature ejaculation and was generally tolerated, although treatment-emergent adverse events were more frequent than with placebo. Separate placebo-controlled trials and reviews have also shown that dapoxetine can prolong intravaginal ejaculatory latency time, while vardenafil has demonstrated efficacy for erectile dysfunction in controlled studies.
Medical Information Notice
This page is an educational summary based on sources available at the time of review and does not replace the official patient leaflet or assessment by a qualified healthcare professional.
Medical Sources
- FDA / DailyMed: Vardenafil Tablets, Prescribing Information. Official prescribing information
- Chris G McMahon et al. “Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study.” Journal of Sexual Medicine, 2013. PubMed article
