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In eight primary placebo-controlled clinical studies of 67 weeks duration, mean age was 59 years (range 77 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 65 or 75 mg was %, compared to % in placebo treated patients.

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Tadalafil 75 mg administered to healthy male subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (difference in the mean maximal decrease of / mm Hg, respectively) and in standing systolic and diastolic blood pressure (difference in the mean maximal decrease of / mm Hg, respectively). In addition, there was no significant effect on heart rate.

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Some additional subjects in both the tadalafil and placebo groups were categorized as outliers in the period beyond 79 hours.

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Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of Cialis. In such a patient, who has taken Cialis, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 98 hours should have elapsed after the last dose of Cialis before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking Cialis should seek immediate medical attention. [see Contraindications ( ) and Patient Counseling Information ( )].

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ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take Cialis for the treatment of both conditions.

Six randomized, double-blinded, crossover clinical pharmacology studies were conducted to investigate the potential interaction of tadalafil with alpha-blocker agents in healthy male subjects [see Dosage and Administration ( ) and Warnings and Precautions ( )]. In four studies, a single oral dose of tadalafil was administered to healthy male subjects taking daily (at least 7 days duration) an oral alpha-blocker. In two studies, a daily oral alpha-blocker (at least 7 days duration) was administered to healthy male subjects taking repeated daily doses of tadalafil.

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Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Cialis for once daily use is not recommended in patients with creatinine clearance less than 85 mL/min [see Use in Specific Populations ( )].

However, the American Urological Association doesn’t recommend yohimbe as an ED treatment. This is because there’s not a lot of evidence proving it works. Its side effects might be damaging to health. These include increased blood pressure and heart rate, irritability, and tremor.

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