The U.S. Food and Drug Administration (FDA) approved Tadalafil in 2003 for the treatment of erectile dysfunction (ED), a condition in which men are unable to get or sustain an erection.
Belonging to the PDE5-inhibitor class of drugs, Tadalafil improves erections in men by boosting blood flow to the penile organ. It is sold under the brand name Cialis, which can be taken daily (in lower doses) or on an “on-demand” basis.
Since Tadalafil also acts on the smooth muscles of the prostate gland, it has also been approved for the treatment of benign prostate hyperplasia (BPH). However, the exact mechanism of the drug in treating the symptoms of BPH is unclear.
In 2011, the FDA approved tadalafil also for treating the symptoms of BPH in men. It can also be given to men who have both BPH and ED.
The signs and symptoms of BPH include sudden urges to urinate, difficulty urinating, a poor urine stream, and an increased urinary frequency, especially at night.
The FDA reviewed the results of two clinical trials of tadalafil in treating BPH. The trials found that men with BPH who took tadalafil 5 mg daily had a significant improvement in their symptoms when compared with men who were given a placebo.
Another study found that men with ED and BPH who took tadalafil 5 mg daily had a significant improvement in both conditions.
Tadalafil is the first ED drug approved by the FDA for the treatment of BPH.
However, the FDA advises doctors that they should not prescribe tadalafil for men who take nitrates, including nitroglycerin, because the combination of these drugs could decrease blood pressure to a potentially dangerous level. Also, it is not advised along with alpha-blockers, which are used to treat high blood pressure, for the same reason.
The US drug regulatory body also advises doctors that they should not prescribe tadalafil in patients with severe hepatic (liver) impairment. The FDA has approved the daily use of tadalafil to treat urinary symptoms in men with a history of BPH.
