FDA Approval

On 21 st November 2003 , The Food and Drug Administration (FDA) 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.

Cialis is different than currently approved products for ED like Viagra and Levitra because it stays in the body longer.

Cialis is manufactured by Lilly ICOS LLC ( Eli Lilly and ICOS ).

Mode of Action:
Cialis acts by relaxing muscles in the penis and blood vessels, allowing increased blood flow into the penis, which produces an erection.

Clinical Trials:
Nearly 4,000 men with erectile dysfunction underwent random, placebo-controlled trials clinical trials. 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.

Recommended Dose:

•  Cialis should not be used more than once per day.

•  The recommended starting dose for most patients is 10 mg taken prior to anticipated sexual activity.

•  A higher dose of 20mg is prescribed for patients whose response to the 10mg dose is not adequate.

•  A lower dose (5 mg) recommended for patients taking other medicines or having medical conditions that may decrease the body’s ability to metabolize Tadalafil.

It should not be taken with

•  Nitrates (such as nitroglycerin tablets or patches)

•  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.

•  Cialis should not be taken by men in whom sexual activity is inadvisable because of their underlying cardiovascular status (heart condition).

•  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).

Side Effects:
The most common side effects reported in clinical trials included a headache, indigestion, back pain, muscle aches, flushing, and stuffy or a 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 does not protect from AIDS or other sexually transmitted diseases.