Is Rugiet a suitable medication for erectile dysfunction (ED)?

Rugiet is Not an FDA-Approved Medication for Erectile Dysfunction

Rugiet is not listed among the FDA-approved medications for erectile dysfunction treatment according to the American Urological Association guidelines. 1

FDA-Approved Medications for ED

• The only FDA-approved oral phosphodiesterase type 5 inhibitors (PDE5i) available for management of ED in the U.S. are sildenafil, tadalafil, vardenafil, and avanafil 1
• These medications have been extensively studied in nearly a quarter of a million men from the general ED population and approximately 25,000 men with specific underlying conditions 1
• All FDA-approved PDE5 inhibitors have similar efficacy in the general ED population, with some variations in side effect profiles 2

First-Line Treatment Recommendations

• Men with ED should be informed about FDA-approved oral PDE5 inhibitors as the first-line treatment option, including discussion of benefits and risks, unless contraindicated 1
• When prescribing PDE5 inhibitors, proper instructions should be provided to maximize efficacy, as incorrect use accounts for many treatment failures 1, 2
• Dose titration should be performed to provide optimal efficacy while minimizing side effects 1

Side Effect Profiles of FDA-Approved PDE5 Inhibitors

• Common adverse events with PDE5 inhibitors include dyspepsia, headache, flushing, back pain, nasal congestion, myalgia, visual disturbance, and dizziness 1
• Avanafil has the lowest rates of dyspepsia among PDE5 inhibitors 2
• Tadalafil has the lowest rates of flushing 1
• Vardenafil and avanafil have the lowest rates of myalgia 1

Important Contraindications and Precautions

• All PDE5 inhibitors are absolutely contraindicated with nitrate medications due to the risk of severe hypotension 3, 4
• For patients taking sildenafil or vardenafil, nitrates should be avoided for at least 24 hours; for tadalafil, at least 48 hours 3
• Patients with certain cardiovascular risks should be assessed before prescribing PDE5 inhibitors 3
• Use with caution in patients with mild to moderate hepatic or renal impairment, initially at lower doses 3

Alternative Treatment Options When PDE5 Inhibitors Fail or Are Contraindicated

• Vacuum erection devices (VED) are a non-pharmacological option for men with ED 1
• Intraurethral (IU) alprostadil is an option for men who cannot take PDE5 inhibitors or prefer to avoid oral medication 1
• Intracavernosal injection (ICI) therapy using alprostadil, papaverine, phentolamine, and/or atropine can be effective 1
• Penile prosthesis implantation is a surgical option for men who do not respond to other treatments 1

Clinical Approach to ED Treatment

• An adequate trial of a PDE5i is defined as at least 5 separate occasions at the maximum dose before reporting it as ineffective 3
• If one PDE5i fails, consider trying a different FDA-approved PDE5i before moving to second-line therapies 3
• Risk factor modification should be addressed alongside pharmacological treatment, including smoking cessation, weight loss, increasing physical activity, and avoiding excess alcohol consumption 3, 5

ED is associated with reduced quality of life and may be an early sign of cardiovascular disease, making proper treatment with approved medications important for both sexual function and overall health 4, 5.