Cialis - Warnings & Precautions

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Renal Insufficiency

CIALIS should be limited to 5 mg not more than once daily in patients with severe renal insufficiency or end-stage renal disease. The starting dose of CIALIS in patients with a moderate degree of renal insufficiency should be 5 mg not more than once daily, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. No dose adjustment is required in patients with mild renal insufficiency (see Pharmacokinetics in Special Populations under CLINICAL PHARMACOLOGY).

Hepatic Impairment

In patients with mild or moderate hepatic impairment, the dose of CIALIS should not exceed 10 mg. Because of insufficient information in patients with severe hepatic impairment, use of CIALIS in this group is not recommended (see Pharmacokinetics in Special Populations under CLINICAL PHARMACOLOGY).

Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4) CIALIS is metabolized predominantly by CYP3A4 in the liver. The dose of CIALIS should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole (see Effects of Other Drugs on CIALIS under Drug Interactions).

General

As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. In a clinical pharmacology study, tadalafil 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/ 0.8 mm Hg in healthy subjects (see Clinical Studies under CLINICAL PHARMACOLOGY). While this effect should not be of consequence in most patients, prior to prescribing CIALIS, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.

Patients with significant left ventricular outflow obstruction or severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators.

The safety and efficacy of combinations of CIALIS and other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. CIALIS should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).