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On 19 th August, 2003 , The Food and Drug Administration
(FDA) approved Levitra ( (Vardenafil Hydrochloride ), an oral
medication to treat erectile dysfunction (ED, or impotence)
in men. This is the second oral product approved for this condition.
Levitra is different than currently approved product for
ED like Viagra because it works faster and also stays in
the body longer.
Manufacturer:
Levitra is manufactured by Bayer and GlaxoSmithKline.
Mode of Action :
Levitra acts by relaxing muscles in the
penis and blood vessels, allowing increased blood flow into the
penis, which produces an erection.
Clinical Trials:
Levitra was evaluated in randomized, placebo-controlled trials
involving more than 2000 men with erectile dysfunction. In two
of the trials men had erectile dysfunction associated with diabetes
mellitus or following radical prostatectomy for prostate cancer.
The drug's effectiveness was assessed using a sexual function
questionnaire. In addition, patients were asked to report if
they were able to achieve an erection adequate for intercourse
and whether the erection was maintained to allow completion of
intercourse. In all of the trials, Levitra improved patients'
ability to achieve and maintain a penile erection.
Recommended Dose :
- The recommended dose is 10 mg taken 1 hour before sexual
activity.
- A higher dose of 20 mg is available for patients whose response
to the 10 mg dose is not adequate.
- Two lower doses (2.5 mg and 5.0 mg) are also available and
may be necessary for patients taking other medicines or have
medical conditions that may decrease the body's ability to
metabolize vardenafil.
- Levitra should not be used more than once a day.
Precautions:
It should not be taken with
• Nitrates (such as nitroglycerin tablets or patches)
• An alpha blocker: alpha blockers are medicines
used to treat benign prostatic hyperplasia and high blood pressure
because the combination may significantly lower blood pressure
and lead to fainting or even death in some men.
• Levitra should not be used in patients who have
a rare heart condition known as "prolongation of the QT interval" because
of the possibility of producing abnormal heart rhythm.
• Levitra should not be taken by men in whom sexual
activity is inadvisable because of their underlying cardiovascular
status (heart condition).
• Levitra is not recommended in patients who have
suffered a heart attack or stroke within the last six months,
or patients who have significantly low blood pressure, uncontrolled
high blood pressure, unstable angina, severe liver impairment,
or retinitis pigmentosa (an eye disorder).
Side Effects :
The most common side effects reported
in clinical trials included headache, flushing, rhinitis, and
indigestion. Dizziness was reported in about two percent of patients.
A small number of patients taking Levitra also reported abnormal
vision.
Before taking Levitra, patients are advised to undergo a thorough
medical history and physical examination to attempt to diagnose
the underlying cause of the erectile dysfunction and to identify
appropriate treatment.
Levitra does not protect from AIDS or other sexually transmitted
diseases.
Source : http://www.fda.gov/
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