What is the maximum recommended dose of Cialis (tadalafil) for treating erectile dysfunction (ED)?

Maximum Recommended Dose of Cialis (Tadalafil) for Erectile Dysfunction

The highest dose of Cialis for erectile dysfunction is 20 mg when used as needed, or 5 mg when used as a once-daily regimen. 1

As-Needed Dosing (PRN)

• The maximum dose is 20 mg, taken prior to anticipated sexual activity, with a maximum frequency of once per day. 1
• The FDA-approved starting dose is 10 mg, which can be increased to 20 mg or decreased to 5 mg based on individual efficacy and tolerability. 1
• Tadalafil remains effective up to 36 hours following dosing, which should be considered when advising patients on optimal use. 1

Important caveat: Unlike sildenafil and vardenafil, tadalafil does NOT show dose-dependent improvement in erectile function between 5 mg, 10 mg, and 20 mg doses. 2, 3 This means the choice between 10 mg and 20 mg should be based primarily on tolerability rather than expecting dramatically better efficacy at the higher dose. 2

Once-Daily Dosing

• The maximum dose for once-daily use is 5 mg, taken at approximately the same time every day. 1
• The starting dose is 2.5 mg, which may be increased to 5 mg based on individual efficacy and tolerability. 1
• Daily dosing eliminates the need to time medication with sexual activity, providing an option for couples who prefer spontaneous rather than scheduled sexual activity. 2, 3

Dose Adjustments for Special Populations

Renal Impairment (As-Needed Dosing): 1

• Creatinine clearance 30-50 mL/min: Maximum dose is 10 mg, not more than once every 48 hours
• Creatinine clearance <30 mL/min or hemodialysis: Maximum dose is 5 mg, not more than once every 72 hours

Renal Impairment (Once-Daily Dosing): 1

• Creatinine clearance 30-50 mL/min: Start with 2.5 mg, may increase to 5 mg
• Creatinine clearance <30 mL/min or hemodialysis: Once-daily dosing is not recommended

Hepatic Impairment: 1

• Mild or moderate (Child-Pugh Class A or B): Maximum dose is 10 mg once per day
• Severe (Child-Pugh Class C): Tadalafil is not recommended

Critical Safety Considerations Before Prescribing Maximum Doses

• Tadalafil is absolutely contraindicated with nitrate use due to potentially fatal hypotension. 2
• If emergency nitrate administration is required, wait at least 48 hours after tadalafil use under close medical supervision. 2
• Higher cumulative doses significantly increase the risk of headache, dyspepsia, back pain, myalgia, and hypotension. 2
• Verify cardiovascular fitness: patients should be able to walk 1 mile in 20 minutes or climb 2 flights of stairs in 20 seconds; refer to cardiology if unable. 2

Defining an Adequate Trial Before Declaring Treatment Failure

• An adequate trial requires at least 5 separate attempts at maximum dose before concluding the medication is ineffective. 2
• Before declaring failure, address modifiable factors: hormonal abnormalities, proper timing, adequate sexual stimulation, heavy alcohol use, and relationship issues. 2
• Sexual stimulation is mandatory for tadalafil to be effective. 2