Vardenafil Tablets

Generic name: Vardenafil

Drug class: Phosphodiesterase type 5 (PDE5) inhibitors

Dosage form: Tablets (2.5 mg, 5 mg, 10 mg, 20 mg)

Route of administration: Oral

Dose: Adults: 10 mg taken approximately 1 hour before sexual activity; may be adjusted to 5 mg or 20 mg based on efficacy and tolerability. Maximum recommended dosing frequency is once per day. For individuals over 65 years, a starting dose of 5 mg is recommended.

Mechanism of action: Vardenafil inhibits the enzyme phosphodiesterase type 5 (PDE5), leading to increased levels of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the penis. This results in relaxation of the smooth muscle and increased blood flow, facilitating an erection in response to sexual stimulation.

Drug usage cases:

• Treatment of erectile dysfunction in men

Drug contraindications:

• Concurrent use with nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate) due to risk of severe hypotension
• Concurrent use with riociguat (Adempas) due to risk of severe hypotension
• Known hypersensitivity to vardenafil or any component of the formulation
• Recent history of stroke or heart attack
• Severe liver impairment
• Severe kidney impairment or end-stage renal disease requiring dialysis
• Uncontrolled high or low blood pressure
• History of non-arteritic anterior ischemic optic neuropathy (NAION)
• History of priapism or anatomical deformation of the penis (e.g., Peyronie’s disease)
• Concurrent use with other PDE5 inhibitors

Side effects:

• Common: Headache, flushing, dizziness, nasal congestion, dyspepsia (indigestion), back pain, muscle pain, visual disturbances (e.g., blurred vision, color tinge)
• Serious: Priapism (prolonged erection lasting more than 4 hours), sudden decrease or loss of vision, sudden decrease or loss of hearing, chest pain, irregular heartbeat, swelling in the ankles or hands, difficulty breathing, allergic reactions (e.g., rash, swelling of the face or throat)

Warnings:

• Use with caution in patients with cardiovascular risk factors; sexual activity may pose a risk to individuals with heart conditions
• Monitor for signs of priapism; seek immediate medical attention if an erection lasts longer than 4 hours
• Discontinue use and seek medical attention if sudden vision or hearing loss occurs
• Alcohol consumption may increase the risk of side effects; limit alcohol intake during treatment
• Not recommended for use in women; safety and efficacy have not been established
• Use with caution in patients with a history of stomach ulcers or bleeding disorders
• Not recommended for use in children

Use during pregnancy or breastfeeding: Vardenafil is not approved for use in women, and the effects during pregnancy or breastfeeding are unknown. It is not recommended for use in these populations.