Dutasteride + Silodosin

Find more information about this combination medication at the webpages for dutasteride and silodosin

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Brand Name

Silosure D 8mg/0.5mg Capsule 15s , Sildura 8mg Capsule 10s ... show more

Approved Treatment Indication:

Prostatic Hyperplasia

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This medicine contains a combination of 2 drugs dutasteride and silodosin.
dutasteride and silodosin are both used to treat the same disease or symptom but work in different ways in the body.
Most doctors will advise making sure that each individual medicine is safe and effective before using a combination form.

Summary

What conditions are Dutasteride and Silodosin used for?
Dutasteride and Silodosin are both used to treat benign prostatic hyperplasia (BPH), which is a condition characterized by an enlarged prostate gland. This condition can cause urinary symptoms such as difficulty urinating, a weak urine stream, and frequent urination, especially at night. By addressing these symptoms, both medications aim to improve the quality of life for men with BPH.
How do Dutasteride and Silodosin work in the body?
Dutasteride works by inhibiting the enzyme 5-alpha-reductase, which is responsible for converting testosterone into dihydrotestosterone (DHT), a hormone that contributes to prostate enlargement. By reducing DHT levels, Dutasteride decreases prostate size over time. Silodosin, on the other hand, is an alpha-blocker that selectively targets alpha-1 adrenoreceptors in the prostate and bladder neck, leading to muscle relaxation and improved urine flow. Both medications aim to alleviate symptoms of BPH, but they do so through different mechanisms: Dutasteride by hormonal modulation and Silodosin by muscle relaxation.
What are the usual dosages and routes of administration for Dutasteride and Silodosin?
The usual adult daily dose for Dutasteride is 0.5 mg taken once daily, with or without food. For Silodosin, the typical dose is 8 mg taken once daily with a meal. Dutasteride can be taken at any time of the day, while Silodosin should be taken with food to enhance absorption and reduce the risk of side effects. Both medications are taken orally in the form of capsules.
What are the most commonly observed adverse effects of Dutasteride and Silodosin?
Common side effects of Dutasteride include impotence, decreased libido, and ejaculation disorders. Serious adverse effects may include breast changes and an increased risk of high-grade prostate cancer. Silodosin commonly causes retrograde ejaculation, dizziness, and diarrhea. A serious side effect of Silodosin is a painful erection lasting several hours. Both medications can cause dizziness and should be used with caution in patients with low blood pressure.
What are the important safety warnings and contraindications for Dutasteride and Silodosin?
Dutasteride is contraindicated in women, especially those who are or may become pregnant, due to the risk of fetal harm. It should not be handled by pregnant women. Silodosin is contraindicated in patients with severe renal or hepatic impairment and should not be used with strong CYP3A4 inhibitors. Both medications can cause dizziness and hypotension, so caution is advised when driving or operating machinery. Patients should be aware of the potential for serious side effects, such as breast changes with Dutasteride and painful erections with Silodosin, and seek medical attention if these occur.

Government Approvals

None

WHO Essential Medicine

Known Teratogen

Pharmaceutical Class

5-alpha Reductase Inhibitor and Alpha-Adrenergic Blocker

Controlled Drug Substance

Summary

What conditions are Dutasteride and Silodosin used for?
Dutasteride and Silodosin are both used to treat benign prostatic hyperplasia (BPH), which is a condition characterized by an enlarged prostate gland. This condition can cause urinary symptoms such as difficulty urinating, a weak urine stream, and frequent urination, especially at night. By addressing these symptoms, both medications aim to improve the quality of life for men with BPH.
How do Dutasteride and Silodosin work in the body?
Dutasteride works by inhibiting the enzyme 5-alpha-reductase, which is responsible for converting testosterone into dihydrotestosterone (DHT), a hormone that contributes to prostate enlargement. By reducing DHT levels, Dutasteride decreases prostate size over time. Silodosin, on the other hand, is an alpha-blocker that selectively targets alpha-1 adrenoreceptors in the prostate and bladder neck, leading to muscle relaxation and improved urine flow. Both medications aim to alleviate symptoms of BPH, but they do so through different mechanisms: Dutasteride by hormonal modulation and Silodosin by muscle relaxation.
What are the usual dosages and routes of administration for Dutasteride and Silodosin?
The usual adult daily dose for Dutasteride is 0.5 mg taken once daily, with or without food. For Silodosin, the typical dose is 8 mg taken once daily with a meal. Dutasteride can be taken at any time of the day, while Silodosin should be taken with food to enhance absorption and reduce the risk of side effects. Both medications are taken orally in the form of capsules.
What are the most commonly observed adverse effects of Dutasteride and Silodosin?
Common side effects of Dutasteride include impotence, decreased libido, and ejaculation disorders. Serious adverse effects may include breast changes and an increased risk of high-grade prostate cancer. Silodosin commonly causes retrograde ejaculation, dizziness, and diarrhea. A serious side effect of Silodosin is a painful erection lasting several hours. Both medications can cause dizziness and should be used with caution in patients with low blood pressure.
What are the important safety warnings and contraindications for Dutasteride and Silodosin?
Dutasteride is contraindicated in women, especially those who are or may become pregnant, due to the risk of fetal harm. It should not be handled by pregnant women. Silodosin is contraindicated in patients with severe renal or hepatic impairment and should not be used with strong CYP3A4 inhibitors. Both medications can cause dizziness and hypotension, so caution is advised when driving or operating machinery. Patients should be aware of the potential for serious side effects, such as breast changes with Dutasteride and painful erections with Silodosin, and seek medical attention if these occur.

Indications and Purpose

How does combination of Dutasteride and Silodosin work?

Dutasteride works by inhibiting the enzyme 5-alpha-reductase, which is responsible for converting testosterone into dihydrotestosterone (DHT), a hormone that contributes to prostate enlargement. By reducing DHT levels, Dutasteride decreases prostate size over time. Silodosin, on the other hand, is an alpha-blocker that selectively targets alpha-1 adrenoreceptors in the prostate and bladder neck, leading to muscle relaxation and improved urine flow. Both medications aim to alleviate symptoms of benign prostatic hyperplasia (BPH), but they do so through different mechanisms: Dutasteride by hormonal modulation and Silodosin by muscle relaxation.

How effective is combination of Dutasteride and Silodosin?

Clinical trials have demonstrated the effectiveness of both Dutasteride and Silodosin in treating symptoms of benign prostatic hyperplasia (BPH). Dutasteride has been shown to reduce prostate size, lower the risk of acute urinary retention, and decrease the need for BPH-related surgery. Silodosin has been proven to improve urinary flow rates and reduce BPH symptoms such as difficulty urinating and incomplete bladder emptying. Both medications have been evaluated in placebo-controlled studies, showing significant improvements in BPH symptoms compared to placebo. While Dutasteride works by hormonal modulation, Silodosin provides quicker symptom relief through muscle relaxation.

Directions for Use

What is the usual dose of combination of Dutasteride and Silodosin?

The usual adult daily dose for Dutasteride is 0.5 mg taken once daily, with or without food. For Silodosin, the typical dose is 8 mg taken once daily with a meal. Both medications are used to manage symptoms of benign prostatic hyperplasia (BPH), but they have different dosing requirements. Dutasteride is taken in a smaller dose and can be taken with or without food, while Silodosin requires a larger dose and should be taken with food to enhance absorption and reduce the risk of side effects.

How does one take combination of Dutasteride and Silodosin?

Dutasteride can be taken with or without food, and it should be taken at the same time each day. Silodosin should be taken with a meal to enhance absorption and reduce the risk of side effects. Patients taking Silodosin should avoid taking it on an empty stomach. While there are no specific food restrictions for Dutasteride, patients taking Silodosin should discuss the consumption of grapefruit juice with their doctor, as it may interact with the medication. Both medications require adherence to dosing instructions for optimal effectiveness.

For how long is combination of Dutasteride and Silodosin taken?

Dutasteride is typically used long-term, as it may take 6 months or longer to see the full benefits in reducing prostate size and improving symptoms. Silodosin is also used for long-term management of BPH symptoms, but it provides more immediate relief, often within a few days to a week. Both medications are intended for ongoing use to manage symptoms of benign prostatic hyperplasia, but Dutasteride requires a longer period to achieve its full effect, while Silodosin acts more quickly.

How long does it take for combination of Dutasteride and Silodosin to work?

Dutasteride may take up to 3 months to show improvement in symptoms, with full benefits potentially taking 6 months or longer. Silodosin, on the other hand, can start relieving symptoms of benign prostatic hyperplasia (BPH) relatively quickly, often within a few days to a week. Both medications are used to treat symptoms of BPH, but they work at different rates. Dutasteride works by reducing the size of the prostate over time, while Silodosin provides more immediate relief by relaxing the muscles in the prostate and bladder neck.

Warnings and Precautions

Are there harms and risks from taking combination of Dutasteride and Silodosin?

Common side effects of Dutasteride include impotence, decreased libido, and ejaculation disorders. Serious adverse effects may include breast changes and an increased risk of high-grade prostate cancer. Silodosin commonly causes retrograde ejaculation, dizziness, and diarrhea. A serious side effect of Silodosin is a painful erection lasting several hours. Both medications can cause dizziness and should be used with caution in patients with low blood pressure. While Dutasteride's side effects are more related to hormonal changes, Silodosin's are primarily due to its muscle-relaxing effects.

Can I take combination of Dutasteride and Silodosin with other prescription drugs?

Dutasteride can interact with medications like cimetidine, which may alter its effectiveness. Silodosin should not be used with strong CYP3A4 inhibitors such as ketoconazole, as these can significantly increase silodosin levels in the blood. Both medications require caution when used with other drugs that affect blood pressure, as they can enhance the risk of hypotension. Patients should inform their healthcare provider of all medications they are taking to avoid potential interactions and ensure safe use of Dutasteride and Silodosin.

Can I take combination of Dutasteride and Silodosin if I am pregnant?

Dutasteride is contraindicated during pregnancy as it can cause harm to a male fetus, particularly affecting the development of male genitalia. Women who are pregnant or may become pregnant should not handle Dutasteride capsules, especially if they are leaking. Silodosin is not indicated for use in females and should not be used during pregnancy. Both medications pose significant risks during pregnancy, and appropriate precautions should be taken to avoid exposure.

Can I take combination of Dutasteride and Silodosin while breastfeeding?

Dutasteride is not indicated for use in women, and there is no information available on its excretion in human milk. Silodosin is also not indicated for use in females, including those who are breastfeeding. Both medications are intended for use in men for the treatment of benign prostatic hyperplasia (BPH) and should not be used by women, particularly during lactation, due to the lack of safety data and potential risks to infants.

Who should avoid taking combination of Dutasteride and Silodosin?

Dutasteride is contraindicated in women, especially those who are or may become pregnant, due to the risk of fetal harm. It should not be handled by pregnant women. Silodosin is contraindicated in patients with severe renal or hepatic impairment and should not be used with strong CYP3A4 inhibitors. Both medications can cause dizziness and hypotension, so caution is advised when driving or operating machinery. Patients should be aware of the potential for serious side effects, such as breast changes with Dutasteride and painful erections with Silodosin, and seek medical attention if these occur.