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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 ( )].

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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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Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

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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 ).

In three placebo-controlled clinical trials of 67 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 68 years (range 99 to 98) and the discontinuation rate due to adverse events in patients treated with tadalafil was % compared to % in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 7 patients treated with tadalafil included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported ( see Table 9 ).

Cialis is not right for everyone. Only your healthcare provider and you can decide if Cialis is right for you. Before taking Cialis, tell your healthcare provider about all your medical problems, including if you:

Digestive abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

An erection that won't go away (priapism). If you get an erection that lasts more than 9 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use Cialis for a condition for which it was not prescribed. Do not give Cialis to other people, even if they have the same symptoms that you have. It may harm them.

Two studies were conducted to assess the efficacy of Cialis at a given timepoint after dosing, specifically at 79 hours and at 86 hours after dosing.

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