Dutasteride

Prostatic Hyperplasia

Drug Status

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Government Approvals

US(FDA), UK(BNF)

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WHO Essential Medicine

NO

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Known Teratogen

NO

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Pharmaceutical Class

5-alpha Reductase Inhibitor

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Controlled Drug Substance

NO

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Drug Ingredient

Dutasteride

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Summary

  • Dutasteride is used to treat conditions such as Benign Prostatic Hyperplasia (BPH) and Male Pattern Baldness. It helps reduce prostate size, improving urinary flow and reducing symptoms like frequent urination. It can also slow down hair loss and promote hair regrowth.

  • Dutasteride works by blocking the production of a hormone called DHT (dihydrotestosterone) in the body. DHT is responsible for causing the prostate gland to enlarge and contributes to hair thinning. By reducing DHT levels, dutasteride helps to shrink the enlarged prostate in most men and slow down hair loss.

  • The usual dosage for Dutasteride is one capsule once a day. The capsule should be swallowed whole and can be taken with or without food. Do not crush or chew the capsule.

  • The most common side effects of Dutasteride include problems with erections, low sex drive, breast tenderness and difficulty ejaculating. Some men may stop taking the medicine because of erection problems. Serious side effects like allergic reactions and severe skin reactions are rare but possible.

  • Dutasteride is harmful to unborn babies especially male babies. Women who are pregnant or may become pregnant should not touch or handle dutasteride capsules. If a pregnant woman comes into contact with dutasteride, it could cause birth defects in her male baby. Men taking dutasteride should not donate blood for at least 6 months after their last dose.

Indications and Purpose

How does Dutasteride work?

Dutasteride works by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone responsible for prostate growth. By reducing DHT levels, Dutasteride helps shrink the prostate, improve urinary symptoms, and reduce the risk of acute urinary retention and the need for surgery.

How does one know if Dutasteride is working?

The benefit of Dutasteride is evaluated through regular monitoring of symptoms, prostate-specific antigen (PSA) levels, and prostate volume. Patients should keep all appointments with their doctor and the laboratory for tests to check the body's response to Dutasteride. Any changes in symptoms or PSA levels should be discussed with a healthcare provider.

Is Dutasteride effective?

Clinical trials have shown that Dutasteride effectively reduces the risk of acute urinary retention and the need for BPH-related surgery. It improves symptoms of benign prostatic hyperplasia (BPH), decreases prostate volume, and increases maximum urinary flow rates. These effects suggest that Dutasteride arrests the disease process of BPH in men with an enlarged prostate.

What is Dutasteride?

Dutasteride is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It works by blocking the production of dihydrotestosterone (DHT), a hormone that causes prostate growth. By reducing DHT levels, Dutasteride helps shrink the prostate, improve urinary symptoms, and reduce the risk of acute urinary retention and the need for surgery.

What is Dutasteride used for?

Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It is used to improve symptoms, reduce the risk of acute urinary retention, and decrease the need for BPH-related surgery. Dutasteride is not approved for the prevention of prostate cancer.

Directions for Use

For how long do I take Dutasteride?

Dutasteride is typically used for long-term treatment. While some men may notice improvement in symptoms after 3 months, it may take 6 months or longer to see the full benefits. It is important to continue taking the medication as prescribed by your doctor.

How do I dispose of Dutasteride?

If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.

How do I take Dutasteride?

Take Dutasteride as a capsule by mouth once a day, with or without food. Swallow the capsules whole; do not open, chew, or crush them. There are no specific food restrictions while taking Dutasteride, but it is important to follow your doctor's instructions and take the medication at the same time each day.

How long does it take for Dutasteride to start working?

Some men may notice improvement in symptoms after 3 months of taking Dutasteride, but it may take 6 months or longer to see the full benefits. It is important to continue taking the medication as prescribed by your doctor, even if you do not notice immediate improvements.

How should I store Dutasteride?

Store Dutasteride capsules at room temperature, between 59°F to 86°F (15°C to 30°C). Keep the medication in its original container, tightly closed, and away from excess heat and moisture. Do not store it in the bathroom. Dispose of any capsules that are deformed, discolored, or leaking.

What is the usual dose of Dutasteride?

The usual daily dose of Dutasteride for adults is 0.5 mg taken once daily. Dutasteride is not indicated for use in children, and its safety and effectiveness in pediatric patients have not been established.

Warnings and Precautions

Can Dutasteride be taken safely while breastfeeding?

Dutasteride is not indicated for use in women, and there is no information available on its presence in human milk or its effects on a breastfed child. Therefore, it is not recommended for use while breastfeeding.

Can Dutasteride be taken safely while pregnant?

Dutasteride is contraindicated during pregnancy as it may cause harm to the male fetus, including abnormalities in the development of male genitalia. Women who are pregnant or may become pregnant should not handle Dutasteride capsules, as the medication can be absorbed through the skin. If contact occurs, wash the area with soap and water immediately.

Can I take Dutasteride with other prescription drugs?

Dutasteride may interact with certain medications, such as cimetidine, which can affect its effectiveness. It is important to inform your doctor about all prescription and nonprescription medications, vitamins, and herbal products you are taking. Your doctor may need to adjust doses or monitor you for side effects.

Can I take Dutasteride with vitamins or supplements?

There are no well-documented confirmed interactions between Dutasteride and vitamins or supplements. There is also no evidence that Dutasteride causes nutrient depletion requiring supplementation. However, it's important to inform your healthcare provider about all medications and supplements you are taking to ensure there are no potential interactions or adverse effects.

Does Dutasteride have adverse effects?

Adverse effects are unwanted or harmful effects caused by a medicine. Dutasteride can cause adverse effects like decreased libido, which means reduced sexual desire, erectile dysfunction, which is difficulty getting or keeping an erection, and breast tenderness or enlargement. These effects are not very common. Rarely, it can cause serious allergic reactions, which need immediate medical attention. If you notice any new or worrying symptoms, talk to your healthcare provider before stopping the medicine.

Does Dutasteride have any safety warnings?

Dutasteride has safety warnings, especially for women who are pregnant or may become pregnant, as it can harm the developing fetus. Men taking Dutasteride should not donate blood until at least six months after their last dose to prevent the risk of the medicine being given to a pregnant woman through a blood transfusion. If you experience symptoms like swelling, difficulty breathing, or severe skin reactions, seek medical attention immediately, as these could be signs of an allergic reaction.

Is Dutasteride addictive?

Dutasteride has no known potential for dependence or addiction. It does not cause physical or psychological dependence, so there are no specific behaviors or warning signs to watch for. You can take this medication as prescribed by your healthcare provider without worrying about addiction.

Is Dutasteride safe for the elderly?

No overall differences in safety or efficacy were observed between elderly subjects and younger subjects in clinical trials. However, greater sensitivity of some older individuals cannot be ruled out. It is important for elderly patients to follow their doctor's advice and report any unusual symptoms.

Is it safe to drink alcohol while taking Dutasteride?

Most people tolerate Dutasteride well, and occasional alcoholic drinks should not affect the way this medicine works. There are no well-established interactions between Dutasteride and alcohol that would interfere with the medicine's effectiveness or cause harm. However, it's always a good idea to drink alcohol in moderation and be mindful of how your body responds when combining it with any medication.

Is it safe to exercise while taking Dutasteride?

Dutasteride does not typically limit the ability to exercise. However, if you experience any side effects that affect your physical activity, such as dizziness or fatigue, consult your doctor for advice.

Is it safe to stop Dutasteride?

Dutasteride is used for the long-term management of conditions like benign prostatic hyperplasia, which is an enlarged prostate. Stopping it suddenly may lead to a return of symptoms, such as difficulty urinating. There are no known withdrawal symptoms, but it's important to consult your doctor before stopping, as they can guide you on how to safely discontinue the medication if needed.

What are the most common side effects of Dutasteride?

A side effect is an unwanted effect of a medicine. Common side effects of Dutasteride include decreased libido, which means reduced sexual desire, erectile dysfunction, which is difficulty getting or keeping an erection, and breast tenderness or enlargement. These side effects are not very common. It's important to remember that new symptoms can occur when starting any new medicine and may not be related to the medicine itself. Always talk to your healthcare provider before stopping any medication.

Who should avoid taking Dutasteride?

Dutasteride is contraindicated in women, especially those who are or may become pregnant, due to the risk of fetal harm. It should not be used by patients with severe hepatic impairment or those with hypersensitivity to Dutasteride or other 5-alpha-reductase inhibitors. Men taking Dutasteride should not donate blood until at least 6 months after their last dose to prevent administration to pregnant women.