Monograph Details
|
|
Urogenital System
> Erectile dysfunction
|
|
LEVITRA |
| Manufacturer |
|
Bayer and GlaxoSmithKline |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Phosphodiesterase type 5 inhibitor (cGMP-specific). |
| Generic Name |
|
Vardenafil (as HCl) 2.5mg, 5mg, 10mg, 20mg; tabs. |
| Indications |
|
Erectile dysfunction. |
| Children |
|
Not recommended. |
| Adults |
|
Take once daily, about 1 hour before sexual activity. Initially 10mg; range: 5–20mg. Elderly (≥65yrs): initially 5mg. Moderate hepatic impairment: initially 5mg; max 10mg. Concomitant ketoconazole 200mg or itraconazole 200mg daily, or erythromycin: max 5mg. Concomitant indinavir, saquinavir, atazanavir, ketoconazole 400mg or itraconazole 400mg daily, clarithromycin: max 2.5mg. Concomitant ritonavir: max 2.5mg/72hrs. Concomitant α-blocker: initially 5mg/day. |
| Contraindications |
|
Concomitant nitrates, or nitric oxide donors (eg, sodium nitroprusside). |
| Precautions |
|
Confirm diagnosis. Congenital QT prolongation: avoid use. Cardiovascular disease (eg, MI, stroke or life-threatening arrhythmia within 6 months; systolic BP <90 or BP >170/110; unstable angina, LV outflow obstruction, impaired autonomic regulation of BP, severe heart failure), severe hepatic impairment, renal dialysis, retinitis pigmentosa and related retinal disorders: not recommended. Anatomical penile deformation. Predisposition to priapism. Patients for whom sexual activity is inadvisable or contraindicated. Bleeding disorders. Active peptic ulcer. Pregnancy (Cat.B). |
| Interactions |
|
See Contraindications. Avoid class IA or III antiarrhythmics, others that cause QT prolongation. Hypotension with nitrates, α-blockers, other antihypertensives. Plasma levels increased by CYP3A4 inhibitors. Concomitant other erectile dysfunction treatments: not recommended. |
| Adverse Reactions |
|
Headache, flushing, rhinitis, dyspepsia, sinusitis, dizziness, sudden vision or hearing loss (discontinue if occurs), cardiovascular effects (eg, hypotension, tachycardia); rare: priapism. |
| How Supplied |
|
Tabs—30 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
