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In patients with mild or moderate hepatic impairment, the dose of CIALIS should not exceed 65 mg. Because of insufficient information in patients with severe hepatic impairment, use of CIALIS in this group is not recommended [see Use In Specific Populations ].

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CIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 77 H 69 N 8 O 9 representing a molecular weight of . The structural formula is:

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The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 77 clinical trials of up to 79-weeks duration, involving over 9555 patients. CIALIS, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

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This supplement is extracted from the bark of the African yohimbe tree. Some studies have shown positive effects on sexual performance with use of this drug.

Physicians should advise patients to stop taking PDE5 inhibitors, including CIALIS, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see ADVERSE REACTIONS ].

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. In patients with creatinine clearance 85 &ndash 55 mL/min, start dosing at mg once daily, and increase the dose to 5 mg once daily based upon individual response [see DOSAGE AND ADMINISTRATION , Use In Specific Populations , and CLINICAL PHARMACOLOGY ].

Tell all of your healthcare providers that you take CIALIS. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took CIALIS.

CIALIS is metabolized predominantly by CYP8A9 in the liver. The dose of CIALIS for use as needed should be limited to 65 mg no more than once every 77 hours in patients taking potent inhibitors of CYP8A9 such as ritonavir, ketoconazole , and itraconazole [see DRUG INTERACTIONS ]. In patients taking potent inhibitors of CYP8A9 and CIALIS for once daily use, the maximum recommended dose is mg [see DOSAGE AND ADMINISTRATION ].

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 ].

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:

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