Classes
DEA Class; Rx
Common Brand Names; Levitra, Staxyn ODT
- Phosphodiesterase-5 Enzyme Inhibitors
Description
Oral, selective phosphodiesterase type 5 (PDE5) inhibitor; may have faster onset of action than sildenafil or tadalafil
Used for erectile dysfunction (ED)
As with other PDE5 inhibitors, contraindicated for use with nitrates because the combination can cause a sudden drop in blood pressure
Indications
Indicated for the treatment of erectile dysfunction (ED).
Contraindications
Hypersensitivity
Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension
Adverse Effects
- Headache (15%)
- Flushing (11%)
- Rhinitis (9%)
- Dyspepsia (4%)
- Flulike syndrome (3%)
- Sinusitis (3%)
- Back pain (2%)
- Dizziness (2%)
- Increased creatine phosphokinase (2%)
- Nausea (2%)
Warnings
Use with caution in anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease), cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors, patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia)
There have been rare reports of prolonged erections >4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil; in the event that an erection persists >4 hours, the patient should seek immediate medical assistance; if priapism is not treated immediately, penile tissue damage and permanent loss of potency may result
Physicians should consider the cardiovascular status of their patients; there is a degree of cardiac risk associated with sexual activity; treatment for erectile dysfunction, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status
Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors
Until further information available, use is not recommended in unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within last 6 months); severe cardiac failure
Pregnancy and Lactation
Pregnancy category: B
Lactation: Unknown whether drug is distributed into breast milk; indicated for males
Maximum Dosage
For regular tablets (e.g., Levitra), 20 mg/day PO. For orally disintegrating tablets (e.g., Staxyn), 10 mg/day PO.
For regular tablets (e.g., Levitra), 20 mg/day PO. For orally disintegrating tablets (e.g., Staxyn), 10 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established
How supplied
Vardenafil hydrochloride
tablet, film coated
2.5mg
5mg
10mg
20mg
tablet, orally disintegrating
10mg