Dutasteride is an orally effective selective 5 α - reductase dual inhibitor that can simultaneously inhibit type I and type II 5 α - reductase isoenzymes, thereby blocking the conversion of testosterone to dihydrotestosterone.

1、 Drug name

1. Product Name: AVODART

2. Common name: Duasteride Soft Capsules

2、 Indications

1. This product is used for the treatment of male benign prostatic hyperplasia (BPH) with prostate enlargement:

Improve symptoms.

Reduce the risk of acute urinary retention (AUR).

Reduce the risk of requiring BPH related surgery.

2. This product can be used in combination with alpha adrenergic antagonist (tamsulosin) for symptomatic BPH accompanied by prostate enlargement.

3. Limitations: This product is not suitable for preventing prostate cancer.

3、 Specifications

Specification: 0.5mg/capsule.

4、 Main components

Active ingredient: Dutasteride.

5、 Usage and dosage

1. Single drug therapy: The recommended dosage is 1 pill (0.5mg), taken orally once a day.

2. Combination therapy: Dutasteride 0.5mg once daily+Tamsulosin 0.4mg once daily.

3. Capsules should be swallowed whole and should not be chewed, opened, or crushed to avoid irritation of the oral and pharyngeal mucosa caused by the contents.

4. Can be taken with food or taken separately.

6、 Dose adjustment

For patients with liver dysfunction, due to the extensive metabolism of dutasteride in the liver, liver function damage may lead to increased exposure, but specific dosage adjustment recommendations are not clear. Renal function is impaired and dosage adjustment is necessary.

7、 Medication precautions

1. Before and after meals: can be taken together with or separately from food, and taking after meals has no clinically significant effect on absorption.

2. Missing medication: can be replenished later on the same day; It should not be taken twice the next day.

8、 Medication for special populations

1. Pregnant women: absolutely prohibited. Dutasteride can be absorbed through the skin and may cause damage to male fetuses. Pregnant or potentially pregnant women are not allowed to come into contact with damaged or leaking capsules.

2. Breastfeeding women: This product is not suitable for women and there is no relevant data available.

3. Men and women with fertility: may affect sperm characteristics (reducing total sperm count, semen volume, and sperm motility), but the clinical significance for fertility is unknown.

4. Children: Safety and efficacy are uncertain and not suitable for children.

5. Elderly patients: Over 60% of patients are aged 65 years or older and do not require dose adjustment. The half-life of elimination increases with age (approximately 170 hours for ages 20-49 and 300 hours for ages>70).

6. Renal dysfunction: No need to adjust dosage (urinary recovery less than 0.1%).

7. Liver function impairment: Not studied, due to extensive metabolism, individuals with liver function impairment may have increased exposure levels.

9、 Adverse reactions

1. Common adverse reactions (incidence ≥ 1%, and higher than placebo):

Erectile dysfunction, decreased libido, ejaculation disorders, breast diseases (including breast enlargement and tenderness).

Additional common adverse reactions of combination therapy (+tamsulosin):

Dizziness (the incidence of ejaculation disorders significantly increased to 11%).

2. Serious adverse reactions:

Elevated risk of high-grade prostate cancer (Gleason score 8-10).

Allergic reactions (rash, itching, urticaria, localized edema, severe skin reactions, angioedema).

Male breast cancer (post marketing report).

Depressive emotions.

Partial sexual dysfunction related adverse reactions may persist after discontinuation of medication.

10、 Contraindications

1. Pregnant women (may cause harm to male fetuses).

2. History of clinically significant hypersensitivity reactions (such as severe skin reactions, angioedema) to dutasteride, other 5 α - reductase inhibitors (such as finasteride), or any component of this product.

11、 Drug interactions

1. Strong CYP3A4 inhibitors (such as ritonavir): may increase the blood concentration of dutasteride, caution should be exercised when used in combination.

2. Calcium channel antagonists (verapamil, diltiazem): reduce the clearance rate of dutasteride and increase exposure, but have no clinical significance and do not require dose adjustment.

3. Alpha adrenergic antagonists (tamsulosin, terazosin): no significant interaction.

4. Kaolaienamine: does not affect the relative bioavailability of dutasteride.

5. Digoxin and warfarin: no significant interaction.

12、 Storage method

1. Storage temperature: 25 ° C, allowable deviation to 15-30 ° C.

2. Avoid high temperatures, as high temperatures may cause the capsule to deform or fade.

3. If the capsule is deformed, discolored, or leaking, it should not be used.

4. Keep out of reach of children.

13、 Other important precautions

1. PSA monitoring: Treatment can reduce serum PSA by about 50% within 3-6 months, and attention should be paid when interpreting PSA results. Any confirmed increase in PSA should be evaluated for the possibility of prostate cancer.

2. Blood donation restriction: During the treatment period and at least 6 months after discontinuation of medication, blood donation is not allowed to prevent pregnant women from receiving blood containing dutasteride.

3. Risk of exposure to pregnant women: Pregnant women or women who may become pregnant should not come into contact with Tenasteride capsules; If in contact with a leaking capsule, the contact area should be immediately cleaned with soap and water.

Dutasterideinformation