Dutasteride
- Atc Codes:G04CB02
- CAS Codes:164656-23-9
- PHARMGKB ID:164656-23-9
Table of contents
- Brand Names
- Drug Combinations
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Caution and personalized dose adjustment in patients with the following genotypes
- Other genes that may be involved
- Substrate of
- Drug Interactions
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Avodart; Belgium: Avodart; Bulgaria: Avodart; Cyprus: Avodart; Czech Republic: Avodart; Denmark: Avidart, Avodart; Estonia: Avodart; Finland: Avodart; France: Avodart; Germany: Avodart; Greece: Avodart, Duagen; Hungary: Avodart; Ireland: Avodart; Italy: Avodart, Duagen; Latvia: Avodart; Lithuania: Avodart; Luxembourg: Avodart; Malta: Avodart; Netherlands: Avodart; Poland: Avodart, Duagen; Portugal: Avodart, Duagen; Romania: Avodart; Slovakia: Avodart; Slovenia: Avodart; Spain: Avidart, Avolve; Sweden: Avidart, Avodart, Avolve, Duagen; UK: Avodart.
North America
Canada: Avodart; USA: Avodart.
Latin America
Argentina: Avodart; Mexico: Avodart.
Drug combinations
Dutasteride and Tamsulosin
Chemistry
Dutasteride: C~27~H~30~F~6~N~2~O~2~. Mw: 528.53. (1)(5α,17β)-N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-1-ene-17-carboxamide; (2) α,α,α,α’, α’,α’-Hexafluoro-3-oxo-4-aza-5 α-androst-1-ene-17b-carboxy-2′,5′-xylidide. CAS-164656-23-9 (1997).
Pharmacologic Category
5-α-Reductase Inhibitors. (ATC-Code: G04CB02).
Mechanism of action
A synthetic 4-azasteroid compound. Inhibits conversion of testosterone to 5α-dihydrotestosterone (5α-DHT) by selectively inhibiting steroid 5α-reductase isoenzymes types 1 and 2, and markedly suppresses serum dihydrotestosterone levels. 5α-DHT appears to be the principal androgen responsible for stimulation of prostatic growth.
Therapeutic use
Treatment of symptomatic benign prostatic hyperplasia (BPH).
Pregnancy and lactiation implications
May cause fetal harm; teratogenicity demonstrated in animals. Dutasteride is absorbed through the skin, therefore pregnant women or women who may become pregnant should not handle the capsules. It is not known whether the drug is distributed into milk in humans.
Unlabeled use
Treatment of male patterned baldness.
Contraindications
Hypersensitivity to dutasteride, other 5α-reductase inhibitors (e.g. finasteride), or any component of the formulation. Use in women or children. Pregnant women or those trying to conceive should not handle the product.
Warnings and precautions
Hazardous product. Women can absorb the active ingredient through the skin. Caution in large residual urinary volume or severely diminished urinary flow (risk of obstructive uropathy). Use with caution in hepatic impairment. Caution if used concurrently with CYP3A4 inhibitors. Other urological diseases including cancer should be ruled out before initiating therapy. Blood donation should be avoided during or for 6 months following treatment (risk of administration to a pregnant female transfusion recipient). Decreases prostate specific antigen (PSA) concentrations (may interfere with interpretation of serum PSA determinations).