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Eli Lilly and Company, the makers of oral erectile dysfunction (ED) drug Tadalafil, has announced that the FDA has approved a lower-dose version (2.5 mg and 5 mg) version of Tadalafil for once-daily use.
Since it was approved in 2003, Tadalafil 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 Tadalafil 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 Erectile Dysfunction
Erectile Dysfunction(ED) 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 Tadalafil
Tadalafil 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, Tadalafil had provided the ability to wait for up to 36 hours to attempt intercourse. Now with a lower dosing option, Tadalafil can be used on a daily basis, essentially giving patients control of having sex whenever the time is right for them. Tadalafil works by increasing blood flow to the penis. Like Levitra and Viagra, Cilis belongs to a group of medicines called PDE5 inhibitors. Tadalafil works by inhibiting the enzyme called a phosphodiesterase type 5 which is responsible for cyclic GMP degradation. The mechanism of erection includes the release of nitrogen oxide in response to sexual stimulation. Nitric oxide interacts with guanylate cyclase which produces cyclic GMP. Cyclic GMP interacts with muscle proteins of the cavernous tissue and causes them to relax. The relaxation of the smooth muscles in the cavernous body increases blood flow to penis causing erection sufficient for the satisfactory sexual intercourse.
How the Change Was Made?
The FDA's approval of use of Tadalafil 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 Tadalafil) 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 Tadalafil:
In most cases Tadalafil does not causes side effects, however because of inhibiting PD5 which is also found on the facial skin, nasal cavity the medication can cause nasal congestion and hot flashes. Other common side effects may include headache and dizziness. This is probably related to dilation of cerebral blood vessels. Other common Tadalafil side effect include dyspepsia, muscle pain, indigestion, muscle aches.
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.
Tadalafil 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.
Tadalafil is metabolized in liver and therefore can interact with inhibitors or inductors of liver enzymes such as antimycotics (antifungals), protease inhibitors. The medication should also be avoided while taking any grape fruit products.
In addition, Tadalafil is not intended for use in combination with other PDE5 inhibitors like Viagra and Levitra. Men who use nitrates (heart medication) should not take Tadalafil as the combination could cause a sudden, unsafe drop in blood pressure. If this takes place seek immediate medical attention.
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