Dutasteride

Dutasteride may be found in some form under the following brand names:

• Avodart

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
• Urinary Incontinence

Usual Adult Dose for Benign Prostatic Hyperplasia:

0.5 mg orally once a day

Use: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to reduce the risk of acute urinary retention (AUR) and BPH-related surgery.

Absorption

Bioavailability

Absolute bioavailability is approximately 60%.1

Onset

Reduces serum and prostatic 5α-dihydroxytestosterone (DHT) concentrations maximally within 1–2 weeks of initiation of therapy.1

Duration

Serum drug concentrations are detectable for up to 4–6 months following discontinuance of therapy.1

Food

Decreases peak serum concentrations.1 Not considered clinically important.1

Distribution

Extent

Widely distributed; volume of distribution is 300–500 L.1

Distributes into semen.1

Plasma Protein Binding

Highly bound to albumin (99%) and α-1 acid glycoprotein (96.6%).1

Elimination

Metabolism

Metabolized by CYP3A4 and CYP3A5 to active metabolites.1

Elimination Route

Excreted in the feces (45%) and urine (<1%) mainly as metabolites; approximately 55% remained unaccounted.1

Half-life

Terminal half-life is approximately 5 weeks at steady state.1

Special Populations

In patients with hepatic impairment, pharmacokinetics not studied.1 Metabolized extensively in the liver, and increased exposure to the drug is probable in hepatic impairment.1

In adolescents (<18 years of age), pharmacokinetics not studied.1

In patients with renal impairment, pharmacokinetics not studied; however, <0.1% of a dose is excreted in urine in healthy individuals.1

In women, pharmacokinetics not studied; use contraindicated.1

Effects of race on pharmacokinetics not studied.1

Take dutasteride exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take dutasteride with or without food.

Swallow the capsule whole. Do not crush, chew, or open it. The contents of the capsule may irritate your lips, mouth, or throat.

dutasteride comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of dutasteride will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of dutasteride. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For benign prostatic hyperplasia:
    • Adults—0.5 milligram (mg) once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of dutasteride, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check you at regular visits to make sure that dutasteride is working properly and to check for any unwanted effects that may be caused by dutasteride.

Women and children should not use dutasteride. Pregnant women or women who may become pregnant should not handle or touch the capsules. Dutasteride can be absorbed through the skin and can cause birth defects in male fetuses. If a pregnant woman does come in contact with dutasteride, the affected area should be washed right away with soap and water, especially if the capsule is broken.

Men who have taken dutasteride should not donate blood until 6 months have passed since the last dose. Dutasteride can remain in your blood for a long time and be passed on to a pregnant woman who receives a blood transfusion.

dutasteride may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.

dutasteride may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using dutasteride.

dutasteride does not usually affect normal sexual abilities for most men. You may notice that you ejaculate less fluid when you have sex.

Clinically significant hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors (eg, finasteride), or any component of the formulation; use in pediatric patients; women of childbearing potential; pregnancy

0.5 mg orally once a day

Use: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to reduce the risk of acute urinary retention (AUR) and BPH-related surgery.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Administration Advice:
-This drug may be taken with or without food.
-Drug capsules should be swallowed whole and not chewed or opened as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.

General:
-This drug is not approved for the prevention of prostate cancer.
-It may take up to 6 months before a treatment response with this drug can be achieved.
-Serum levels of this drug are detectable for 4 to 6 months after treatment cessation.
-Hair loss reduction and induction of hair growth in patients with male pattern hair loss may occur with the use of 5 alpha-reductase inhibitors.
-Overdosage: There is no specific antidote; symptomatic and supportive treatment should be given as appropriate and the long half-life of this drug should be taken into consideration.

Monitoring:
Oncology: New PSA baseline (after 3 months of treatment); digital rectal examination and PSA testing (regularly during treatment)