What is the recommended dose of Tadalafil (phosphodiesterase type 5 inhibitor) for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH)?

From the Guidelines

For erectile dysfunction, the recommended dose of Tadalafil is 10 mg taken orally before anticipated sexual activity, with the option to increase to 20 mg or decrease to 5 mg based on individual response and tolerability, as suggested by the American College of Physicians 1. Alternatively, a daily dose of 2.5-5 mg can be used regardless of timing of sexual activity. For benign prostatic hyperplasia, the recommended dose is 5 mg taken once daily at approximately the same time. Tadalafil works by inhibiting phosphodiesterase type 5 (PDE5), which increases cyclic guanosine monophosphate (cGMP) levels, leading to smooth muscle relaxation in the penis and prostate. This facilitates increased blood flow for erections and reduces urinary symptoms in BPH. The medication should be taken with or without food, and alcohol should be limited as it may increase the risk of side effects such as dizziness or low blood pressure. Patients with severe liver or kidney impairment may require dose adjustments. Tadalafil should not be taken with nitrates or certain other medications due to potential dangerous interactions. Some key points to consider when prescribing Tadalafil include:

• The dose should be titrated to provide optimal efficacy, as recommended by the American Urological Association 1.
• The medication should be used with caution in patients with certain medical conditions, such as cardiovascular disease or liver failure.
• Patients should be advised to seek medical attention if they experience any severe side effects, such as priapism or sudden vision loss. It's also important to note that the evidence regarding the efficacy and safety of Tadalafil is based on high-quality studies, including randomized controlled trials and systematic reviews 1. However, individual patient responses may vary, and clinicians should monitor patients closely and adjust the dose or discontinue treatment as needed. Overall, Tadalafil is a effective and well-tolerated treatment option for erectile dysfunction and benign prostatic hyperplasia, and its use should be guided by evidence-based recommendations and individual patient needs.

From the FDA Drug Label

The recommended starting dose of tadalafil tablets 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 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 for Benign Prostatic Hyperplasia is 5 mg, taken at approximately the same time every day. The recommended dose of tadalafil tablets for once daily use for Erectile Dysfunction and Benign Prostatic Hyperplasia is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

The recommended dose of Tadalafil for:

• Erectile Dysfunction (ED): 10 mg (as needed) or 2.5 mg to 5 mg (once daily)
• Benign Prostatic Hyperplasia (BPH): 5 mg (once daily)
• ED and BPH: 5 mg (once daily) 2

From the Research

Tadalafil Dose for Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia (BPH)

• The recommended dose of Tadalafil for ED is 5mg or 10mg taken once daily, as shown in a multicenter, randomized, double-blind, placebo-controlled trial 3.
• For patients with both ED and BPH, a dose of 5mg once daily has been shown to significantly improve ED and BPH-related outcomes, with significant improvements in International Index of Erectile Function (IIEF) domain scores and International Prostate Symptom Score (IPSS) scores 4.
• Long-term safety and efficacy of Tadalafil 5mg dosed once daily for the treatment of ED have been established, with no study drug-related serious adverse events observed and significant improvements in IIEF domain scores 5.
• Tadalafil 5mg once daily has also been shown to improve ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of BPH and ED 6.
• Additionally, Tadalafil has been shown to relieve lower urinary tract symptoms secondary to BPH, with significant improvements in IPSS scores and quality of life index 7.

Adverse Events and Tolerability

• Commonly reported adverse events associated with Tadalafil include dyspepsia, headache, back pain, and myalgia 3, 4, 5.
• Tadalafil has been shown to be well tolerated, with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters 4, 7.
• No change in post-void residual volume was seen with Tadalafil treatment 7.

Dosing Considerations

• Tadalafil can be taken once daily, with or without food, and the dose can be adjusted based on individual patient response and tolerability.
• The dose of 5mg once daily is recommended for patients with ED and BPH, while the dose of 10mg once daily may be considered for patients with ED only 3.