Cialis - Potent Weekend Drug
Nov. 25, 2003 -- Cialis, a drug for male impotence, was approved by the US
Food and Drug Administration last week. Cialis joins sildenafil
(Viagra), approved by the FDA in 1998, and vardenafil (Levitra), approved
earlier this year, as drugs for erectile dysfunction. The effect of Cialis can
last 24 to 36 hours, several times longer than Viagra or Levitra. "In
France, it's called 'le weekend' drug," according to the drugmaker.
Our Thoughts: The FDA announcement of Cialis follows. Whenever
possible, we prefer to provide you with the FDA announcement of a new drug
rather than a rewrite of it which is often selective and biased.
Note that, if the effects of a drug are longer lasting, so usually are the
dangers and side effects longer lasting.
For additional information, please see the following MedicineNet.com areas:
Barbara K. Hecht,
Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com
FDA Approves Third Drug To Treat Erectile Dysfunction
The Food and Drug Administration (FDA) today approved Cialis® (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 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 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 body's 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.
Source: FDA Talk Paper #T03-79, November 21, 2003
Last Editorial Review: 7/7/2004
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