About Dutasteride API
Therapeutic CategoryUrología
CAS Number
164656-23-9
API Technology
Sintética
Dose Form
Sólido Oral/Cápsulas
Dr Reddy's Development Status
Disponible
Available Regulatory Filing
USDMF, DMF de Brasil, EUDMF, DMF de Canadá, DMF de Japón, DMF de Corea, DMF de Rusia
Mechanism of Action
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver.
Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride does not bind to the human androgen receptor.
Indication
AVODART is a 5 alpha-reductase inhibitor 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, and
- Reduce the risk of the need for BPH-related surgery.
AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
Limitations of Use: AVODART is not approved for the prevention of prostate cancer.
Related APIs
Testosterona
Urología
Dutasterida
Urología
Mirabegron (Alfa)
Urología
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Related Resources
Tech Sheet on Dutasteride
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the prostate gland's initial development and subsequent enlargement. Testosterone is converted to DHT by the enzyme 5-alpha-reductase, which exists as 2- isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver [1].
Dutasteride is indicated for treating symptomatic benign prostatic hyperplasia (BPH). When combined with the alpha-adrenergic antagonist, tamsulosin is indicated for treating symptomatic BPH in men with an enlarged prostate [1]. Furthermore, Dutasteride is also approved for treating male androgenic alopecia in South Korea and Japan at a dose of 0.5mg/ day [2].
Dr. Reddy's API Offering
- We offer polymorphic crystalline form 2.
- A novel synthetic process developed for crystalline form 2.
- Quality by design (QBD) based API development for a consistent quality profile.
We manufacture Dutasteride API at our cGMP manufacturing facility, which was successfully inspected by international regulatory authorities - USFDA, WHO GMP, KFDA, PMDA, Health Canada, and ANVISA. We have reliable KSM suppliers to ensure timely deliveries and adhere to stringent specifications.
To know more about our API offerings, please read the Tech sheet on Dutasteride API by filling the contact form below.
FAQs
Almacenar a temperatura ambiente entre 20 °C y 25 °C.
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La dutasterida se utiliza sola o en combinación con tamsulosina (Flomax®) para tratar a hombres que presentan síntomas de agrandamiento de la próstata, también conocido como hiperplasia prostática benigna (HPB). El agrandamiento benigno de la próstata es un problema que puede presentarse en los hombres a medida que envejecen.
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Las mujeres y los niños no deben usar este medicamento. Las mujeres embarazadas o que puedan quedar embarazadas no deben manipular ni tocar las cápsulas. La dutasterida puede absorberse a través de la piel y causar malformaciones en los fetos masculinos.
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La dutasterida pertenece a la clase 4 de la clasificación BCS.
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La dutasterida está disponible en forma de cápsula con una concentración de 0,5 mg.
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Ofrecemos la forma polimórfica 2.
Descargo de responsabilidad
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