What is the recommended dosage and usage of TADALAFIL (tadalafil) for erectile dysfunction (ED)?

Tadalafil Dosage and Usage for Erectile Dysfunction

For erectile dysfunction, tadalafil can be prescribed as either 10 mg taken as needed prior to sexual activity (which may be increased to 20 mg or decreased to 5 mg based on individual efficacy and tolerability) or as a daily dose of 2.5 mg (which may be increased to 5 mg) taken at approximately the same time every day. 1

As-Needed Dosing

• The recommended starting dose for as-needed use is 10 mg taken prior to anticipated sexual activity 1
• Dose may be increased to 20 mg or decreased to 5 mg based on individual response and side effects 1
• Maximum recommended dosing frequency is once per day 1
• Tadalafil improves erectile function for up to 36 hours after dosing, which should be considered when advising patients on optimal use 1
• Sexual stimulation is necessary for tadalafil to be effective, and incorrect use accounts for many treatment failures 2

Daily Dosing

• The recommended starting dose for once-daily use is 2.5 mg, taken at approximately the same time every day 1
• 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 alternative for couples who prefer spontaneous rather than scheduled sexual activity 3, 2
• Tadalafil's efficacy is not dose-dependent between 5-20 mg, making lower daily doses an effective option 3

Special Populations and Considerations

Renal Impairment

• For creatinine clearance 30-50 mL/min:
  • As-needed use: Starting dose of 5 mg not more than once per day, maximum dose 10 mg not more than once every 48 hours 1
  • Daily use: Starting dose of 2.5 mg, may increase to 5 mg based on individual response 1
• For creatinine clearance <30 mL/min or on hemodialysis:
  • As-needed use: Maximum dose 5 mg not more than once every 72 hours 1
  • Daily use: Not recommended 1

Hepatic Impairment

• Mild to moderate impairment (Child-Pugh Class A or B):
  • As-needed use: Should not exceed 10 mg once per day 1
  • Daily use: Has not been extensively evaluated, caution advised 1
• Severe impairment (Child-Pugh Class C): Not recommended 1

Efficacy and Side Effects

• High-quality evidence shows that tadalafil significantly improves erectile function compared to placebo, with 69% of men using tadalafil reporting successful sexual intercourse attempts compared to 33% with placebo 2
• Most common side effects include dyspepsia, headache, back pain, nasal congestion, and myalgia 2, 4
• Tadalafil has lower rates of flushing compared to other PDE5 inhibitors 2
• Men with diabetes and men who are post-prostatectomy have more severe ED at baseline and may respond less robustly to PDE5 inhibitors 5, 3

Important Precautions

• Tadalafil is contraindicated in patients taking oral nitrates due to risk of significant hypotension 2
• When coadministered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment, and tadalafil should be initiated at the lowest recommended dose 1
• Do not split tadalafil tablets; entire dose should be taken 1
• May be taken without regard to food 1

Dose Titration

• The dose should be titrated to provide optimal efficacy while minimizing adverse events 5
• Long-term studies show tadalafil remains safe and effective for up to 24 months of continuous use 6, 4