Overview of Levitra
LEVITRA (vardenafil hydrochloride) is primarily used for addressing erectile dysfunction. The assembly of this drug includes a monohydrochloride salt of vardenafil, which is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Vardenafil HCl is characterized as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl] sulfonyl]-4-ethyl-, monohydrochloride, with the following structural illustration:
LEVITRA® (vardenafil hydrochloride) Structural Formula Illustration
Vardenafil HCl appears as a nearly colorless solid, possessing a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water.
LEVITRA tablets are formulated as orange, round, film-coated tablets, marked with "BAYER" on one side and dosage strength indications of “2.5”, “5”, “10”, and “20” mg on the opposite side, corresponding to the respective dosages of vardenafil. Along with the active ingredient vardenafil HCl, each tablet contains inactive ingredients such as microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.
Indications for Levitra
LEVITRA® is specifically indicated for the treatment of erectile dysfunction.
Recommended Dosage for Levitra
General Dosage Information
The typical starting dose for Levitra is 10 mg, taken orally as needed around 60 minutes prior to sexual activity. Depending on individual response and any side effects, the dosage may be adjusted upwards to a maximum of 20 mg or reduced to 5 mg. The maximum recommended frequency for dosing should not exceed once daily. Effective sexual stimulation is necessary for Levitra to exert its therapeutic effect.
Dosage with Food Considerations
LEVITRA can be consumed with or without food; however, be cautious with grapefruit products as they can interfere with the metabolism of the drug.
Guidelines for Specific Populations
Geriatric Patients
For patients aged 65 years or older, consider initiating therapy with a starting dose of 5 mg LEVITRA.
Patients with Hepatic Dysfunction
Patients with moderate hepatic impairment (Child-Pugh B) should begin with a 5 mg LEVITRA starting dose, with a maximum of 10 mg. Avoid use in patients with severe hepatic impairment (Child-Pugh C).
Patients with Renal Impairment
LEVITRA should not be prescribed to patients undergoing renal dialysis.
Usage with Additional Medications
Nitrate Medications
The concomitant use of nitrates and nitric oxide donors in any form is prohibited due to the risk of severe hypotension.
Guanylate Cyclase (GC) Stimulators
Concomitant administration of such medications is also contraindicated.
CYP3A4 Inhibitors
Patients on strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) may require dosage modification.
Medication Formulation
Dosage Forms and Strengths
LEVITRA is available as orange, round, film-coated tablets, bearing the "BAYER" imprint on one side and dosage markings of “2.5”, “5”, “10”, and “20” on the opposite side.
Levitra Warnings
A comprehensive evaluation for erectile dysfunction should consist of a medical evaluation, assessment of potential underlying causes, and determination of appropriate treatment options.
Prior to prescribing LEVITRA, physicians must note:
Cardiovascular Considerations
Patients’ cardiovascular status should be assessed, given the inherent risks associated with sexual activity.
Potential Drug Interactions with CYP3A4 Inhibitors
Concurrent use of strong CYP3A4 inhibitors may elevate plasma levels of vardenafil; therefore, dosage adjustments are essential.
Risk of Priapism
Rare occurrences of extended erections or priapism have been documented. Seek immediate medical help if an erection persists beyond 4 hours.
Ocular Effects
Patients should discontinue LEVITRA and consult a healthcare provider upon experiencing sudden vision loss.
Auditory Effects
In cases of sudden hearing loss, patients should cease taking LEVITRA and seek prompt medical attention.
Clinical Pharmacology of Levitra
Mechanism of Action
PDE5 inhibitors, including vardenafil, enhance erectile responses by elevating cGMP levels in the corpus cavernosum, resulting in increased penile blood flow upon sexual arousal.
Pharmacodynamics
LEVITRA possesses systemic vasodilatory effects, which may transiently lower blood pressure. Patients receiving alpha-blockers should be closely monitored for potential hypotensive effects.
Pharmacokinetics
Vardenafil has an approximate mean terminal half-life of 4-5 hours, with about 95% binding to plasma proteins.
Clinical Studies
LEVITRA has been subjected to numerous clinical trials establishing its effectiveness in enhancing erectile function among men diagnosed with erectile dysfunction.
Patient Guidance for Levitra
Review the Patient Information leaflet regarding LEVITRA prior to use, and consult your healthcare provider with any questions regarding this medication.
LEVITRA is specifically indicated for male patients experiencing erectile dysfunction and is not prescribed for women or minors.
Patient counseling plays a vital role in understanding how to use LEVITRA appropriately, its effects, and potential adverse reactions.