Dutasteride

What is Dutasteride?

• Dutasteride (Avodart) is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) used in the therapy of symptomatic benign prostatic hypertrophy.

Dutasteride

What are the uses of this medicine?

Dutasteride (Avodart) is a prescription medicine that contains dutasteride. Avodart is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

• Improve symptoms
• Reduce the risk of acute urinary retention (a complete blockage of urine flow)
• Reduce the risk of the need for BPH-related surgery

How does this medicine work?

• Dutasteride (doo tas' ter ide) was the second 5-alpha reductase inhibitor to be approved in the United States for the treatment of symptomatic benign prostatic hypertrophy.
• Dutasteride inhibits the conversion of testosterone to dihydrotestosterone, which is important in the development and maintenance of prostatic hyperplasia.
• Dihydrotesterone levels decrease during dutasteride therapy, but serum testosterone levels do not.
• Dutasteride usually takes several months to have an effect on prostate size and the symptoms of prostatic hypertrophy (urinary hesitancy and poor stream), unlike the alpha-1 adrenergic receptor blockers (alpha blockers) which have a more immediate effect.
• Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT).
• Avodart lowers DHT production in the body, leading to shrinkage of the enlarged prostate in most men.
• While some men have fewer problems and symptoms after 3 months of treatment with Avodart, a treatment of period of at least 6 months is usually necessary to see if Avodart will work for you.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who are:

• pregnant or could become pregnant.
• a child or a teenager.
• allergic to dutasteride or any of the ingredients in Avodart.
• allergic to other 5 alpha-reductase inhibitors, for example, PROSCAR (finasteride) Tablets.

What drug interactions can this medicine cause?

• Use with caution in patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir).

Is this medicine FDA approved?

• Dutasteride was approved for use in the United States in 2001 and is available in 0.5 mg capsules generically and under the trade name Avodart.

How should this medicine be used?

Recommended dosage: Monotherapy:

• The recommended dose of Avodart is 1 capsule (0.5 mg) taken once daily.

Combination With Alpha Adrenergic Antagonist:

• The recommended dose of Avodart is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.

Administration:

• Take 1 Avodart capsule once a day.
• Swallow Avodart capsules whole. Do not crush, chew, or open Avodart capsules because the contents of the capsule may irritate your lips, mouth, or throat.
• You can take Avodart with or without food.
• If you miss a dose, you may take it later that day. Do not make up the missed dose by taking 2 doses the next day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 0.5-mg soft gelatin capsules

This medicine is available in fallowing brand namesː

• Avodart

What side effects can this medication cause?

The most common side effects of this medicine include:

• trouble getting or keeping an erection (impotence)
• a decrease in sex drive (libido)
• ejaculation problems
• enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.
• Avodart has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of Avodart on male fertility is not known.

Avodart may cause serious side effects, including:

• Rare and serious allergic reactions
• Higher chance of a more serious form of prostate cancer

What special precautions should I follow?

• You should not donate blood while taking Avodart or for 6 months after you have stopped Avodart. This is important to prevent pregnant women from receiving Avodart through blood transfusions.
• Avodart reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on Avodart may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men.
• Avodart may increase the risk of high-grade prostate cancer.
• Lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Assess patients to rule out other urological diseases, including prostate cancer, prior to prescribing Avodart.
• Women who are pregnant or could become pregnant should not handle Avodart Capsules due to potential risk to a male fetus.
• Dutasteride is associated with a low rate of transient serum aminotransferase elevations, but has yet to be linked to instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg.

Management of overdosage:

• There is no specific antidote for dutasteride.
• Therefore, in cases of suspected overdosage symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Avodart is contraindicated for use in women of childbearing potential and during pregnancy.
• Avodart may harm your unborn baby.
• Pregnant women should not touch Avodart Capsules.
• If a woman who is pregnant with a male baby gets enough Avodart in her body by swallowing or touching Avodart, the male baby may be born with sex organs that are not normal.
• If a pregnant woman or woman of childbearing potential comes in contact with leaking Avodart Capsules, the contact area should be washed immediately with soap and water.

Can this medicine be used in children?

Avodart is contraindicated for use in pediatric patients.

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dutasteride.
• Inactive ingredients: butylated hydroxytoluene, ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, mono-di-glycerides of caprylic/capric acid, titanium dioxide, and edible red ink.

Who manufactures and distributes this medicine?

• Manufactured by Catalent Pharma Solutions
• Somerset, NJ for
• GlaxoSmithKline
• Research Triangle Park, NC

What should I know about storage and disposal of this medication?

• Store Avodart Capsules at room temperature (59°F to 86°F or 15°C to 30°C).
• Avodart Capsules may become deformed and/or discolored if kept at high temperatures.
• Do not use Avodart if your capsules are deformed, discolored, or leaking.
• Safely throw away medicine that is no longer needed.
• Keep Avodart and all medicines out of the reach of children.

Alpha-blockers used to treat benign prostatic hypertrophy (BPH):

• Alfuzosin
• Doxazosin
• Silodosin
• Tamsulosin
• Terazosin

5-Alpha Reductase Inhibitors

• Dutasteride
• Finasteride

• Dailymed label info on Dutasteride
• FDA Dutasteride

Dutasteride Resources
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