What is the recommended treatment and dosage of Dutasteride (Avodart) for benign prostatic hyperplasia (BPH)?

From the Guidelines

The recommended treatment for benign prostatic hyperplasia (BPH) with dutasteride (Avodart) is a daily oral dose of 0.5 mg, taken with or without food. This medication should be swallowed whole and not crushed or chewed. Improvement in symptoms typically begins within 3-6 months of starting treatment, though some patients may notice benefits earlier. Dutasteride works by inhibiting the enzyme 5-alpha reductase, which converts testosterone to dihydrotestosterone (DHT), thereby reducing prostate size and improving urinary flow. This medication is intended for long-term use, and patients should continue taking it as prescribed even after symptom improvement. Common side effects may include decreased libido, erectile dysfunction, ejaculation disorders, and breast tenderness or enlargement. It's essential to note that dutasteride can affect PSA levels, reducing them by approximately 50% after 6-12 months of treatment, which should be considered when screening for prostate cancer 1. Women who are pregnant or may become pregnant should not handle dutasteride capsules due to potential risks to male fetuses.

Key Considerations

• Dutasteride is most effective in patients with a prostate volume greater than 30cc or a PSA level greater than 1.5 ng/mL 1.
• The medication should be used with caution in patients with a history of sexual dysfunction, as it may exacerbate these conditions 1.
• Regular monitoring of PSA levels is necessary to assess the effectiveness of treatment and to screen for prostate cancer 1.
• Patients should be informed of the potential risks and benefits of dutasteride, including the reduction in prostate size and improvement in urinary flow, as well as the potential side effects 1.

Dosage and Administration

• The recommended dose of dutasteride is 0.5 mg per day, taken orally with or without food 1.
• The medication should be swallowed whole and not crushed or chewed.
• Patients should be advised to take the medication at the same time each day to maintain a consistent level of dutasteride in the body.

Monitoring and Follow-up

• Regular follow-up appointments are necessary to monitor the patient's response to treatment and to assess for any potential side effects 1.
• PSA levels should be monitored regularly to assess the effectiveness of treatment and to screen for prostate cancer.
• Patients should be advised to report any changes in their symptoms or any side effects to their healthcare provider promptly.

From the FDA Drug Label

1 INDICATIONS AND USAGE

1.1 Monotherapy Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of the need for BPH-related surgery. The recommended treatment and dosage of Dutasteride (Avodart) for benign prostatic hyperplasia (BPH) is:

• Dutasteride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
• The dosage is not explicitly stated in the provided text, but based on the context of the studies, it can be inferred that the typical dosage is 0.5 mg once daily. Key points:
• Improvement of symptoms
• Reduction of risk of acute urinary retention (AUR)
• Reduction of risk of BPH-related surgery 2 2

From the Research

Recommended Treatment and Dosage of Dutasteride for BPH

The recommended treatment and dosage of Dutasteride (Avodart) for benign prostatic hyperplasia (BPH) are as follows:

• The standard dosage of Dutasteride is 0.5 mg per day, taken orally 3.
• Dutasteride can be used alone or in combination with other medications, such as tamsulosin, to treat BPH 4, 5, 6.
• Combination therapy with Dutasteride and tamsulosin has been shown to provide greater benefits than either monotherapy in reducing the risk of acute urinary retention, BPH-related surgery, and clinical progression of BPH 4, 6.

Efficacy and Safety of Dutasteride

The efficacy and safety of Dutasteride for the treatment of BPH have been established in several studies:

• Dutasteride has been shown to improve urinary symptoms, reduce prostate volume, and decrease the risk of acute urinary retention and BPH-related surgery 4, 5, 7, 6.
• The most common side effects of Dutasteride are sexual dysfunction, including reduced libido, impotence, and gynecomastia 5, 7.
• Combination therapy with Dutasteride and tamsulosin has been shown to be well tolerated, with a safety profile consistent with previous experience with Dutasteride and tamsulosin monotherapies 6.

Clinical Outcomes

The clinical outcomes of Dutasteride treatment for BPH have been evaluated in several studies:

• Dutasteride has been shown to reduce the relative risk of acute urinary retention, BPH-related surgery, and clinical progression of BPH 4, 6.
• Combination therapy with Dutasteride and tamsulosin has been shown to provide greater symptom benefit than either monotherapy 4, 6.
• The 4-year CombAT study demonstrated that combination therapy with Dutasteride and tamsulosin reduced the relative risk of AUR or BPH-related surgery and clinical progression of BPH compared to tamsulosin monotherapy 6.