Levitra (Vardenafil HCl) 

LEVITRA Rx

Generic Name and Formulations:

Vardenafil (as HCl) 2.5mg, 5mg, 10mg, 20mg; tabs.

Company:

Bayer and GlaxoSmithKline

Indications for LEVITRA:

Erectile dysfunction.

Adult:

Take once daily as needed, about 1hr 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.

Children:

Not established.

Contraindications:

Concomitant nitrates, or nitric oxide donors. Concomitant guanylate cyclase (GC) stimulators (eg, riociguat). 

Warnings/Precautions:

Not for use in women. Confirm diagnosis before therapy. Congenital QT prolongation: avoid use. Cardiovascular disease (eg, MI, stroke or life-threatening arrhythmia within 6 months; systolic BP <90mmHg or BP >170/110mmHg; unstable angina, LV outflow obstruction, severe heart failure), severe hepatic impairment, on renal dialysis, hereditary degenerative retinal disorders and retinitis pigmentosa: not recommended. Anatomical penile deformation. Predisposition to priapism. History of non-arteritic anterior ischemic optic neuropathy (NAION) or those with "crowded" optic disc. Advise patients to discontinue if sudden vision or hearing loss occurs. Patients for whom sexual activity is inadvisable or contraindicated. Bleeding disorders. Active peptic ulcer. Pregnancy (Cat.B). 

Interactions:

See Contraindications. Hypotension with nitrates, GC stimulators. Avoid Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics, others that cause QT prolongation. Additive hypotensive effects with concomitant α-blockers, other antihypertensives; caution. Potentiated by moderate or potent CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, indinavir, saquinavir, atazanavir, ritonavir, grapefruit juice). Concomitant other erectile dysfunction treatments: not recommended.

Pharmacological Class:

Phosphodiesterase type 5 inhibitor (cGMP-specific).

Adverse Reactions:

Headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain, sudden vision or hearing loss, cardiovascular effects; rare: priapism, prolonged erection.

Generic Availability:

NO

How Supplied:

Tabs—30

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a01def95-c0ef-43b9-bd9e-5565b2385ad3