FDA Approves Cialis as
Third Pill for Impotence
Nov. 21, 2003 A pill named
Cialis (tadalafil), which the
maker claims lasts longer, today joined Viagra and Levitra as impotence
treatment medicines approved by the Food and Drug Administration.
Shooting for a slice of this billion
dollar market, Eli Lilly & Co., the maker of Cialis, says research shows
their drug last longer than Viagra. They say studies show a 20 mg dose
of Cialis is active for 24 to 36 hours. It is reported that in France,
where the Cialis has been on the market for some time, it is called "Le
weekend" pill. Levitra and Viagra reach their full effectiveness in an
hour, on average, they say.
Cialis will come to the pharmacy as the
new kid on the block to compete with Levitra, approved earlier this
year, and Viagra, the oral drug that was approved in 1998.
These drugs act on an enzyme that helps
prompt and maintain erections by relaxing muscles in the penis and blood
vessels. The duration and onset of the drug action is different,
however, with each.
According to the FDA,
Cialis improved the ability of patients to achieve and maintain a
penile erection. In other studies, sexual activity was improved in some
patients at 30 minutes after taking a dose; additional studies
demonstrated improvements for up to 36 hours after taking Cialis when
compared to placebo.
They say studies show a 20 mg dose of
Cialis is active for 24 to 36 hours. It is reported that in France,
where the Cialis has been on the market for some time, it is called "Le
weekend" pill. Levitra and Viagra reach their full effectiveness in an
hour, on average, they say.
Some market studies suggest that about
30 million men over the age of 40 have symptoms of impotence. The sales
of Viagra last year were reported at $1.2 billion.
Cialis, whose chemical name is tadalafil,
was tested in trials with 4,000 men. The studies found that it helped
promote erection within a half hour and enhanced that ability for up to
36 hours.
The drug is not recommended for patients
on some heart medications, such as nitroglycerin tablets or some alpha
blockers, because the combination can cause a sharp drop in blood
pressure. This can cause fainting or even death in some men.
Recommendations call for dosage
limitations of Cialis for patients with kidney or liver disorders. The
drug should not be taken by men for whom sexual activity is inadvisable
because of heart conditions.
The most common reported side effects
from clinical trials of Cialis were headache, indigestion, back pain,
muscle aches and flushing, although a few had blurred vision.
FDA
Approves Third Drug To Treat Erectile Dysfunction
The Food and Drug
Administration (FDA) today approved Cialisฎ (tadalafil), an oral
medication to treat erectile dysfunction (ED, or impotence) in men. This
is the third oral product approved for this condition. This drug is
different than currently approved products for ED in that it stays in
the body longer.
Erectile dysfunction (ED)
affects millions of men in the United States. Cialis acts by relaxing
muscles in the penis and blood vessels, allowing increased blood flow
into the penis, which produces an erection.
Cialis was evaluated in
randomized, placebo-controlled trials involving more than 4,000 men with
erectile dysfunction. In two of these trials, men had ED associated with
diabetes mellitus or following radical prostatectomy for prostate
cancer.
The drugs 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 that erection was maintained to
allow completion of intercourse. In all of these trials, Cialis improved
patients ability to achieve and maintain a penile erection. In other
studies, sexual activity was improved in some patients at 30 minutes
after taking a dose; additional studies demonstrated improvements for up
to 36 hours after taking Cialis when compared to placebo.
The recommended starting
dose for most patients is 10 mg taken prior to anticipated sexual
activity. A higher dose of 20mg is available for patients whose response
to the 10mg dose is not adequate. A lower dose (5 mg) is also available
and may be necessary for patients taking other medicines or having
medical conditions that may decrease the bodys ability to metabolize
tadalafil. Cialis should not be used more than once per day.
Cialis should not be used
with nitrates (such as nitroglycerin tablets or patches) or with an
alpha blocker other than FLOMAX 0.4mg daily (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.
Because some drugs affect
the metabolism of Cialis, patients should inform their doctors that they
are taking Cialis. For example, patients taking ketoconazole or
ritonoavir should not take more than a 10mg dose of Cialis once every 72
hours.
Also, in patients with
moderately or severely decreased kidney function, the starting dose is
5mg taken once daily. In this group, the dose may be increased to 10mg
taken once every 48 hours. In patients with mild or moderate liver
impairment, the maximum dose of Cialis is 10mg.
In most patients, after
taking a single dose of Cialis, some of the drug will remain in the body
for more than 2 days. In those with decreased kidney function,
impairment of the liver, or those taking certain medications (e.g.
ketoconazole or ritonavir) tadalafil can remain in the body longer.
Cialis should not be taken
by men in whom sexual activity is inadvisable because of their
underlying cardiovascular status (heart condition). Patients should
inform their doctor about any heart problems that they have experienced
before taking Cialis.
Cialis 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).
The most common side
effects reported in clinical trials included headache, indigestion, back
pain, muscle aches, flushing, and stuffy or runny nose. Patients who get
back pain and muscle aches usually get it 12 to 24 hours after taking
Cialis and these usually go away by themselves within 48 hours. A small
number of patients taking Cialis also reported abnormal vision.
Before taking Cialis,
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.
Cialis confers no
resistance to AIDS or other sexually transmitted diseases.
Cialis is manufactured for
Lilly ICOS LLC by Eli Lilly and Company.
Additonal information on Cialis
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