Description of cialis2.1 Erectile Dysfunction CIALIS for Use as Needed • The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. • The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. • CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration. CIALIS for Once Daily Use • The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. • The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. 2.2 Use with Food CIALIS may be taken without regard to food. 2.3 Use in Special Populations Renal Insufficiency CIALIS for Use as Needed • Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. • Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. • Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended dose is 5 mg not more than once in every 72 hours. CIALIS for Once Daily Use • Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. • Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required. • Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended. Hepatic Impairment CIALIS for Use as Needed • Mild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency and therefore, caution is advised. • Severe (Child Pugh Class C): The use of CIALIS is not recommended CIALIS for Once Daily Use • Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients. • Severe (Child Pugh Class C): The use of CIALIS is not recommended Geriatrics • No dose adjustment is required in patients >65 years of age. CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) CIALIS for use as needed: Starting dose: 10 mg up to once daily. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose . • CIALIS for once daily use: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability (2.1). • CIALIS may be taken without regard to food. |
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