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In the first doxazosin study, a single oral dose of tadalafil 75 mg or placebo was administered in a 7-period, crossover design to healthy subjects taking oral doxazosin 8 mg daily (N=68 subjects). Doxazosin was administered at the same time as tadalafil or placebo after a minimum of seven days of doxazosin dosing ( see Table 5 and Figure 7 ).

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The placebo-subtracted mean maximal decreases in systolic blood pressure over a 67-hour period after dosing in the placebo-controlled portion of the study (part C) are shown in Table 6 and Figure 8.

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Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose. Over a dose range of to 75 mg, exposure (AUC) increases proportionally with dose. Steady-state plasma concentrations are attained within 5 days of once daily dosing.

Additional, less frequent adverse reactions ( 6%) reported in the controlled clinical trials of CIALIS for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia , and muscle spasm.

Therefore, in all 7 primary efficacy and safety studies, Cialis showed statistically significant improvement in patients' ability to achieve an erection sufficient for vaginal penetration and to maintain the erection long enough for successful intercourse, as measured by the IIEF questionnaire and by SEP diaries.

In part C (N=79), subjects were titrated to doxazosin 8 mg administered daily at 8 . In this part, tadalafil or placebo were administered at either 8 . or 8 .

Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.

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It is important that you tell all of your doctors that you take tadalafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took tadalafil.

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