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LEVITRA
Erectile dysfunction
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Drug Name:

LEVITRA Rx

Generic Name and Formulations:
Vardenafil (as HCl) 2.5mg, 5mg, 10mg, 20mg; tabs.

Company:
Bayer and GlaxoSmithKline



Therapeutic Use:

RECENT UPDATES

10/27/14
Additional Warnings/Precautions regarding effects on the eyes.

Indications for LEVITRA:

Erectile dysfunction.

Adult Dose for LEVITRA:

Take once daily, 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's Dose for LEVITRA:

Not recommended.

Pharmacological Class:

Phosphodiesterase type 5 inhibitor (cGMP-specific).

Contraindications:

Concomitant nitrates, or nitric oxide donors (eg, sodium nitroprusside).

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, impaired autonomic regulation of BP, severe heart failure), severe hepatic impairment, on renal dialysis, retinitis pigmentosa and related retinal disorders: not recommended. Anatomical penile deformation. Predisposition to priapism. History of non-arteritic anterior ischemic optic neuropathy (NAION). "Crowded" optic disc. Patients for whom sexual activity is inadvisable or contraindicated. Bleeding disorders. Active peptic ulcer. Pregnancy (Cat.B).

Interactions:

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

Adverse Reactions:

Headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain, sudden vision or hearing loss (discontinue if occurs), cardiovascular effects (eg, hypotension, tachycardia); rare: priapism, prolonged erection, NAION.

How Supplied:

Tabs—30

LEVITRA

  • 20mg tablets (Qty:10)
  • appx. price $318.00
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