Vardenafil

Vardenafil orally disintegrating tablet is indicated for the treatment of erectile dysfunction.  Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 )

• Vardenafil orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA)
• Vardenafil orally disintegrating tablet provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA)
• Vardenafil orally disintegrating tablet is taken as needed, orally, approximately 60 minutes before sexual activity
• The maximum recommended dosing frequency is one tablet per day
• Vardenafil orally disintegrating tablet should be placed on the tongue where it will disintegrate
• It should be taken without liquid
• Vardenafil orally disintegrating tablet may be taken with or without food
• General Vardenafil is available in 10 mg orally disintegrating tablets
• Vardenafil orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA)
• Vardenafil orally disintegrating tablet provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). [See Clinical Pharmacology .] Vardenafil orally disintegrating tablet should be taken orally, as needed, approximately 60 minutes before sexual activity
• The maximum dosing frequency is one Vardenafil orally disintegrating tablet per day
• Sexual stimulation is required for a response to treatment
• Vardenafil orally disintegrating tablet should be placed on the tongue where it will disintegrate
• The tablet should be taken without liquid

Vardenafil orally disintegrating tablets, USP are available in 10 mg white, to off-white round biconvex uncoated tablets debossed with “T 41” on one side and plain on the other side (not scored). Vardenafil orally disintegrating tablet 10 mg: White to off-white, round, biconvex, orally disintegrating tablets (not scored) ( 3 )

• Vardenafil orally disintegrating tablet is not indicated for use
• In pediatric patients
• Safety and efficacy in children has not been established

Vardenafil AUC and C max in elderly males 65 years or older taking vardenafil orally disintegrating tablet were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below. No overall differences in safety or effectiveness were observed between patients ≥65 years old and those < 65 years old in placebo-controlled clinical trials [see Clinical Pharmacology ( 12.3 )].

• See FDA-approved patient labeling (Patient Information) Use with Other Formulations of Vardenafil Inform patients that vardenafil orally disintegrating tablet is not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure
• They should also discuss that the maximum dosage is one vardenafil orally disintegrating tablet per 24 hours
• Nitrates Discuss with patients that vardenafil orally disintegrating tablet is contraindicated with regular and/or intermittent use of organic nitrates. …

Administration with nitrates and nitric oxide donors ( 2.4 , 4.1 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 2.4 , 4.2 ) 4.1 Nitrates Administration of vardenafil orally disintegrating tablet with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology ( 12.2 )] . …

The drug interaction studies described below were conducted using vardenafil film-coated tablets. Vardenafil orally disintegrating tablet can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. ( 7.1 ) Do not use vardenafil orally disintegrating tablet with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. (7.2 ) 7.1 Potential for Pharmacodynamic Interactions with vardenafil orally disintegrating tablet Nitrates: Concomitant use of vardenafil orally disintegrating tablet and nitrates is contraindicated. …

The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment. Before prescribing vardenafil orally disintegrating tablet, it is important to note the following: Cardiovascular Effects: Patients should not use vardenafil orally disintegrating tablet if sex is inadvisable due to cardiovascular status. ( 5.1 ) Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil orally disintegrating tablet in patients taking strong or moderate CYP3A4 inhibitors. …

The following serious adverse reactions with the use of vardenafil orally disintegrating tablet are discussed elsewhere in the labeling: Cardiovascular effects [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1) ] Priapism [see Warnings and Precautions ( 5.3) ] QT Prolongation [see Warnings and Precautions ( 5.7) ] Effects on eye [see Warnings and Precautions ( 5.4 )] Sudden hearing loss [see Warnings and Precautions ( 5.5 )] Adverse reactions reported by ≥ 2% of patients treated with vardenafil orally disintegrating tablet: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. …

8.1 Pregnancy Risk Summary Vardenafil orally disintegrating tablet is not indicated for use in females. There are no data with the use of vardenafil orally disintegrating tablet in pregnant women to inform any drug-associated risks. …

The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the film–coated tablets administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or "abnormal vision". Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects. When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed. No muscle or neurological toxicity was identified. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.