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Brand Name: Adcirca, Cialis Generic Name: tadalafil Drug Class: PAH, PDE-5 Inhibitors; Phosphodiesterase-5 Enzyme Inhibitors WHAT IS TADALAFIL AND HOW DOES IT WORK? Tadalafil is a phosphodiesterase inhibitor used for treating impotence (erectile dysfunction, or ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH). Tadalafil is available under the following different brand names: Adcirca, and Cialis. DOSAGES OF TADALAFIL Dosage Forms and Strengths Tablet (Adcirca) 20 mg Tablet (Cialis) 2.5 mg 5 mg 10 mg 20 mg Dosage Considerations – Should be Given as Follows: Erectile Dysfunction (ED) Cialis As needed use: 10 mg orally initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily Once-daily use: 2.5 mg/day orally in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability Dosing considerations As needed use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (e.g., ritonavir, ketoconazole, itraconazole); not to exceed 10 mg/72 hours Once-daily use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (e.g., ritonavir, ketoconazole, itraconazole); not to exceed 2.5 mg/day Benign Prostatic Hyperplasia Treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction Cialis BPH: 5 mg orally once daily BPH with erectile dysfunction: 5 mg orally once daily, taken at approximately same time each day without regard to timing of sexual activity With finasteride for BPH: tadalafil 5 mg plus finasteride 5 mg orally once daily for up to 26 weeks Pulmonary Arterial Hypertension (PAH) Adcirca 40 mg orally once daily; dividing dose for more frequent dosing is not recommended Patients also taking ritonavir: 20 mg orally once daily initially for 1 week or more; may be increased to 40 mg/day on basis of tolerability Dosing considerations If possible, avoid coadministration with CYP3A4 inhibitors; if coadministration is essential, long-term therapy is indicated, or strong CYP3A4 inhibitors are required, modify or hold dose Patients already taking strong CYP3A4 inhibitor who require tadalafil: 20 mg orally once daily; may be increased to 40 mg/day on basis of tolerability Patients already taking tadalafil who require strong CYP3A4 inhibitor: Avoid using tadalafil while starting strong CYP3A4 inhibitor; stop tadalafil 24 hours or more before starting strong CYP3A4 inhibitor; after 1 week, resume tadalafil at 20 mg orally once daily; may be increased to 40 mg/day on basis of tolerability Geriatric Dosing Erectile Dysfunction (ED) Cialis: No dosage adjustment is warranted solely on basis of age; however, greater sensitivity to medications in some older individuals should be considered Pulmonary Arterial Hypertension (PAH) Adcirca: Lower dose or reduced dosing frequency may be required in elderly because of decreased renal or hepatic clearance Dosing Modifications Pediatric: Safety and efficacy not established Renal impairment (ED) Cialis (as needed use) Mild (CrCl 51 mL/min or more): No dosage adjustment needed Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg orally once daily initially; maximum dosage, 10 mg orally every 48 hours Severe (CrCl less than 30 mL/min and on hemodialysis): Not to exceed 5 mg orally every 72 hours Cialis (once daily use) CrCl 30 mL/min or more: No dosage adjustment needed CrCl less than 30 mL/min: Not recommended Renal impairment (PAH) Adcirca Mild-to-moderate (CrCl 31-80 mL/min): 20 mg orally once daily initially; may be increased to 40 mg once daily on basis of tolerability Severe (CrCl less than 30 mL/min and on hemodialysis): Avoid use Hepatic impairment (ED) Cialis (as needed use) Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg orally once daily Severe (Child-Pugh class C): Not recommended Cialis (once daily use) Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advised Severe (Child-Pugh class C): Not recommended Hepatic impairment (PAH) Adcirca Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg orally once daily Severe (Child-Pugh class C): Avoid use
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