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CIALIS (TADALAFIL): PRECAUTIONS

Renal Insufficiency

Cialis tablets for Use as Needed

Cialis (Tadalafil) tablets should be limited to 5 mg not more than once in every 72 hours in patients with severe renal insufficiency or end-stage renal disease on hemodialysis. The starting dose of this medicine in patients with a moderate degree of renal insufficiency should be 5 mg not more than once per day, 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.

Tadalafil (Cialis) for Once Daily Use

Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Cialis (Tadalafil) for once daily use is not recommended in patients with severe renal insufficiency. No dose adjustment is required in patients with mild or moderate renal insufficiency.

Hepatic Impairment

Tadalafil (Cialis) tablets for Use as Needed

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 this medication in this group is not recommended.

Cialis tablets for Once Daily Use

Cialis (Tadalafil) tablets for once daily use has not been extensively evaluated in patients with mild or moderate hepatic insufficiency. Therefore, caution is advised if Tadalafil (Cialis) for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of this drug in this group is not recommended.

Alcohol

Patients should be made aware that both alcohol and Cialis (Tadalafil), a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with Tadalafil (Cialis) tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)

Cialis is metabolized predominantly by CYP3A4 in the liver. The dose of Cialis tablets 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. In patients taking potent inhibitors of CYP3A4 and Cialis (Tadalafil) tablets for once daily use, the dose of this medicine should not exceed 2.5 mg.

Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies

The safety and efficacy of combinations of Tadalafil (Cialis) and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take Cialis (Tadalafil) with other PDE5 inhibitors, including Adcirca.

Effects on Bleeding

Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. PDE5 is found in platelets. When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time, relative to aspirin alone. Tadalafil (Cialis) tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration. Although Cialis has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.

Counseling Patients About Sexually Transmitted Diseases

The use of Cialis tablets offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

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