What are the guidelines for prescribing daily tadalafil (phosphodiesterase type 5 inhibitor) for erectile dysfunction and benign prostatic hyperplasia?

From the Guidelines

Daily tadalafil for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) should be prescribed at a dose of 5 mg once daily, as this dosing regimen has been shown to be effective in improving both erectile function and lower urinary tract symptoms associated with BPH, with a favorable safety profile 1.

Key Considerations for Prescribing Daily Tadalafil

• The medication should be taken at approximately the same time each day, regardless of timing of sexual activity.
• For patients with severe renal impairment (creatinine clearance less than 30 mL/min) or hepatic impairment, the dose should be reduced to 2.5 mg daily.
• Treatment can be continued long-term as the medication maintains efficacy over time.
• Patients should be advised that daily tadalafil takes 3-5 days to reach steady-state plasma concentrations, so the full therapeutic effect may not be immediate.

Mechanism of Action and Benefits

• Daily tadalafil works by inhibiting phosphodiesterase type 5 (PDE5), which increases cyclic guanosine monophosphate (cGMP) levels, promoting smooth muscle relaxation in the penis and prostate.
• This dual action improves both erectile function and lower urinary tract symptoms associated with BPH.

Safety and Contraindications

• Common side effects include headache, dyspepsia, back pain, myalgia, nasal congestion, and flushing.
• Tadalafil is contraindicated in patients taking nitrates due to the risk of severe hypotension, and caution is advised when used with alpha-blockers, requiring dose adjustments or separation of dosing times to avoid blood pressure drops 1.

Clinical Guidelines and Recommendations

• The American Urological Association (AUA) recommends that men with ED be informed about the treatment option of an FDA-approved oral phosphodiesterase type 5 inhibitor (PDE5i), including discussion of benefits and risks/burdens, unless contraindicated 1.
• The AUA also recommends that the dose of PDE5i be titrated to provide optimal efficacy, and that instructions be provided to maximize benefit/efficacy 1.

From the FDA Drug Label

The recommended starting dose of tadalafil tablets for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The tadalafil tablets dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. Tadalafil tablets for Once Daily Use for Benign Prostatic Hyperplasia The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day. Tadalafil tablets for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

The guidelines for prescribing daily tadalafil for erectile dysfunction and benign prostatic hyperplasia are as follows:

• The recommended starting dose for erectile dysfunction is 2.5 mg once daily, which may be increased to 5 mg based on individual efficacy and tolerability.
• The recommended dose for benign prostatic hyperplasia is 5 mg once daily.
• The recommended dose for both erectile dysfunction and benign prostatic hyperplasia is 5 mg once daily. Key considerations include:
• Renal impairment: dose adjustments are necessary for patients with creatinine clearance less than 30 mL/min.
• Hepatic impairment: caution is advised when prescribing tadalafil to patients with mild or moderate hepatic impairment, and it is not recommended for patients with severe hepatic impairment.
• Concomitant medications: concomitant use of nitrates is contraindicated 2.

From the Research

Guidelines for Prescribing Daily Tadalafil

The guidelines for prescribing daily tadalafil for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) are based on several studies that have evaluated the efficacy and safety of tadalafil in these conditions.

• Dosing: The recommended dose of tadalafil for ED is 2.5 mg or 5 mg once daily 3, 4. For BPH, the recommended dose is 5 mg once daily 5, 6.
• Efficacy: Tadalafil has been shown to be effective in improving ED symptoms, as measured by the International Index of Erectile Function (IIEF) domain scores 3, 7, 4. It has also been shown to improve BPH symptoms, as measured by the International Prostate Symptom Score (IPSS) 5, 6.
• Safety: Tadalafil has been shown to be well tolerated in patients with ED and BPH, with common adverse events including dyspepsia, headache, and back pain 3, 5, 7, 4, 6.
• Long-term use: Tadalafil has been shown to be effective and well tolerated for up to 2 years of continuous use in patients with ED 7.
• Concomitant use with other medications: There is no information available on the concomitant use of tadalafil with other medications for ED and BPH. However, it is recommended to use tadalafil with caution in patients taking other phosphodiesterase type 5 inhibitors or nitrates 3, 5, 7, 4, 6.

Patient Selection

Patients who are suitable for daily tadalafil therapy include:

• Men with ED who are sexually active and have a history of ED for at least 3 months 3, 4.
• Men with BPH who have lower urinary tract symptoms (LUTS) and are at least 45 years old 5, 6.
• Men with both ED and BPH who are sexually active and have a history of ED and LUTS for at least 3 months and 6 months, respectively 3.

Monitoring and Follow-up

Patients taking daily tadalafil should be monitored regularly for adverse events and efficacy. Follow-up visits should be scheduled at least every 3-6 months to assess the patient's response to therapy and adjust the dose as needed 3, 5, 7, 4, 6.