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Dutasteride

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(CAS: 164656-23-9)

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CAS: 164656-23-9

Chemical Name: (5(alpha),17(beta))-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide

Formula: C27H30F6N2O2

Molecular Weight: 528.5

Structure:

Dutasteride is a white to pale yellow powder with a melting point of 242< to 250<C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL) and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water.

What is the most important information I should know about dutasteride?

# Dutasteride is intended for use by men only.
# Dutasteride is not intended for use by women. Do not handle this medication if you are pregnant or could become pregnant. Dutasteride is in the FDA pregnancy category X. This means that it is known to cause birth defects in an unborn baby. Women who are or who may become pregnant must not take dutasteride and must not handle dutasteride capsules. The medication can be absorbed through the skin and may cause birth defects in the unborn baby. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.
# Do not donate blood while taking dutasteride and for at least 6 months after the last dose to prevent pregnant women from receiving dutasteride through blood transfusion.

What is dutasteride?

# Dutasteride prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).
# Dutasteride is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
# Dutasteride may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking dutasteride?

# Before taking dutasteride, tell your doctor if you have liver disease. You may not be able to take dutasteride, or you may need a dosage adjustment or special monitoring during therapy.
# Do not donate blood while taking dutasteride and for at least 6 months after the last dose to prevent pregnant women from receiving dutasteride through blood transfusion.
# Dutasteride is intended for use by men only.
# Dutasteride is not intended for use by women. Do not handle this medication if you are pregnant or could become pregnant. Dutasteride is in the FDA pregnancy category X. This means that it is known to cause birth defects in an unborn baby. Women who are or who may become pregnant must not take dutasteride and must not handle dutasteride capsules. The medication can be absorbed through the skin and may cause birth defects in the unborn baby. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.
# Dutasteride is not intended for use by women. It is not known whether dutasteride passes into breast milk. Do not take this medication if you are breast-feeding a baby.

How should I take dutasteride?

# Take dutasteride exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
# Dutasteride is intended for use by men only.
# Take each dose with a full glass of water.
# Swallow the capsules whole. Do not chew, crush or break the capsules.
# Dutasteride can be taken with or without food.
# It is important to take dutasteride regularly to get the most benefit.
# Do not stop taking dutasteride without first talking to your doctor. While some men have fewer problems and symptoms after 3 months of treatment with dutasteride, a treatment period of at least 6 months is usually necessary to see if treatment with dutasteride will be beneficial.
# Your doctor may perform blood tests or other forms of monitoring during treatment with dutasteride. One of the tests that may be performed is called PSA (prostate-specific antigen). This test is used to help detect prostate cancer. Dutasteride will reduce the amount of PSA measured in the blood. Your doctor is aware of this effect and can still use PSA to help detect prostate cancer.
# Store dutasteride at room temperature (77 degrees Fahrenheit/ 25 degrees Celsius) or lower, away from moisture and heat. Dutasteride is supplied in soft gelatin capsules that may become soft and leak or may stick to other capsules if kept at high temperatures. If the capsules are cracked or leaking, do not use them and contact your pharmacist.

What happens if I miss a dose?

# Take the missed dose as soon as you remember during the same day. However, if you don't remember until the next day, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of the medication.

What happens if I overdose?

# Seek emergency medical attention.
# Symptoms of a dutasteride overdose are not known.

What should I avoid while taking dutasteride?

# Do not donate blood while taking dutasteride and for at least 6 months after the last dose to prevent pregnant women from receiving dutasteride through blood transfusion.

What are the possible side effects of dutasteride?

# Stop taking dutasteride and seek emergency medical attention if you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
# Other, less serious side effects have been reported but may resolve with continued treatment. Continue to take dutasteride and notify your doctor if you experience
, decreased libido (sex drive);
, decreased amount of semen released during sex;
, impotence (trouble getting or keeping an erection); or
, breast tenderness or enlargement.
# Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect dutasteride?

# Many drugs may affect the way that dutasteride is metabolized ("broken down") in the body, leading to higher or lower than expected levels of the medication in the blood. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with dutasteride.