Dutasteride 0.5 mg Capsules — Generic For Avodart — Aurobindo

These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES.

DUTASTERIDE capsules for oral use

Initial U.S. Approval: 2001

Indications And Usage

Dutasteride capsules are a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1)

improve symptoms,

reduce the risk of acute urinary retention, and

reduce the risk of the need for BPH-related surgery.

Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2)

Limitations of Use: Dutasteride capsules are not approved for the prevention of prostate cancer. (1.3)

Dosage And Administration

Monotherapy: 0.5 mg once daily. (2.1)

Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily. (2.2)

Dosing considerations: Swallow whole. May take with or without food. (2)

Dosage Forms And Strengths

0.5 mg soft gelatin capsules (3)

Contraindications

Pregnancy. Dutasteride use is contraindicated in women who are pregnant. (4, 5.4, 8.1)

Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride or other 5 alpha-reductase inhibitors. (4)

Warnings And Precautions

• Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride capsules may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. (5.1)
• Dutasteride may increase the risk of high-grade prostate cancer. (5.2, 6.1)
• Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. (5.3)
• Women who are pregnant or may be pregnant should not handle dutasteride capsules due to potential risk to a male fetus. (5.4, 8.1)
• Patients should not donate blood until 6 months after their last dose of dutasteride. (5.5)

• Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride capsules may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. (5.1)
• Dutasteride may increase the risk of high-grade prostate cancer. (5.2, 6.1)
• Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. (5.3)
• Women who are pregnant or may be pregnant should not handle dutasteride capsules due to potential risk to a male fetus. (5.4, 8.1)
• Patients should not donate blood until 6 months after their last dose of dutasteride. (5.5)

Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride capsules may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. (5.1)

Dutasteride may increase the risk of high-grade prostate cancer. (5.2, 6.1)

Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. (5.3)

Women who are pregnant or may be pregnant should not handle dutasteride capsules due to potential risk to a male fetus. (5.4, 8.1)

Patients should not donate blood until 6 months after their last dose of dutasteride. (5.5)

Adverse Reactions

The most common adverse reactions, reported in ≥1% of subjects treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Use with caution in patients taking potent, chronic cytochrome P450 (CYP)3A4 enzyme inhibitors (e.g., ritonavir). (7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 1/2023