FDA Approves Lower-Dose Cialis for Daily Use

Monday, May 12 2008

Reviewed by:  Daniel Williams, MD

New Option for Men Experiencing Erectile Dysfunction

Eli Lilly and Company, the makers of oral erectile dysfunction (ED) drug Cialis, has announced that the U.S. Food and Drug Administration (FDA) has approved a lower-dose version (2.5 mg and 5 mg) version of Cialis for once-daily use.  Since it was approved in 2003, Cialis has typically been issued in only 5mg, 10 mg and 20 mg doses for men who preferred to have the option of achieving an erection for up to 36 hours.  However, these dosages were not recommended to be used every day.

Now that the FDA has approved it, using once-daily Cialis provides a new option for men who prefer to take a drug without having to plan out the timing of sexual activity.  These patients now have a freedom to choose the dosing regimen most appropriate for them and their lifestyles.

About ED

Erectile Dysfunction is defined as the consistent inability to achieve and maintain an erection satisfactory for the completion of sexual intercourse. The majority of ED cases are related to physical causes, such as diabetes, cardiovascular disease, and kidney disease. Lifestyle issues can also have an effect on the ability to achieve an erection. Obesity, alcoholism, smoking and other factors related to an unhealthy lifestyle can also lead to medical problems that cause ED, such as poor circulation.  Psychological problems such as stress, depression, anxiety, guilt, and fear of sexual failure can also contribute to the condition.

About Cialis

Cialis was developed to give men the option of being able to have sex in more natural and spontaneous way. Unlike Viagra and Levitra, which only work for about four or five hours taken, Cialis had provided the ability to wait for up to 36 hours to attempt intercourse. Now with a lower dosing option, Cialis can be used on a daily basis, essentially giving patients control of having sex whenever the time is right for them.

Visit our Cialis health article section to learn more about how Cialis works.

How the Change Was Made

The FDA’s approval of use of Cialis daily was based upon the evaluation of data from randomized, double-blind, placebo-controlled studies – the most powerful clinical study design in existence. Men who had ED and took part in these clinical studies, and men who took 2.5 mg and 5 mg Tadalafil (the generic name for Cialis) once a day, regardless of the timing of sexual activity, experienced improved erectile function compared with men who were administered a placebo.

Possible Side Effects and Interactions with Cialis:

Flushing, Headache, Indigestion, Muscle Aches, and Nasal Congestion

Cialis for once-daily use provides stable concentrations of Tadalafil in the blood stream, something that should be considered when evaluating possible interactions with certain medications (e.g., nitrates, alpha-blockers, or anti-hypertensives) or with alcohol.

Men who use nitrates (heart medication) should not take Cialis as the combination could cause a sudden, unsafe drop in blood pressure. As with any ED drug, in the rare event of priapism (an erection that lasts more than four hours), immediate medical attention should be sought.

In rare instances, men using ED drugs have reported a sudden, mostly temporary loss or decrease in both vision and hearing (sometimes with a ringing in the ears, and dizziness). If a man experiences these symptoms, he should stop taking the ED drug and seek immediate medical attention.