Dutasteride
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 useInitial U.S. Approval: 2001
908832b2-21d6-48ae-89cb-f06687321f74
HUMAN PRESCRIPTION DRUG LABEL
Mar 1, 2023
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dutasteride
Product Details
FDA regulatory identification and product classification information
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INGREDIENTS (10)
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. Dutasteride may be administered with or without food.
2.1 Monotherapy
The recommended dose of dutasteride is 1 capsule (0.5 mg) taken once daily.
2.2 Combination With Alpha Adrenergic Antagonist
The recommended dose of dutasteride is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.
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)
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).
17.1 PSA Monitoring
Physicians should inform patients that dutasteride reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with dutasteride may signal the presence of prostate cancer and should be evaluated by a healthcare provider [see Warnings and Precautions (5.1)].
17.2 Increased Risk of High-Grade Prostate Cancer
Physicians should inform patients that there was an increase in high-grade prostate cancer in men treated with 5 alpha-reductase inhibitors (which are indicated for BPH treatment), including dutasteride, compared with those treated with placebo in trials looking at the use of these drugs to reduce the risk of prostate cancer [see Indications and Usage (1.3), Warnings and Precautions (5.2), Adverse Reactions (6.1)].
17.3 Exposure of Women—Risk to Male Fetus
Physicians should inform patients that dutasteride capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a pregnant woman or woman of childbearing potential comes in contact with leaking dutasteride capsules, the contact area should be washed immediately with soap and water [see Warnings and Precautions (5.4), Use in Specific Populations (Error! Hyperlink reference not valid.)].
17.4 Blood Donation
Physicians should inform men treated with dutasteride that they should not donate blood until at least 6 months following their last dose to prevent pregnant women from receiving dutasteride through blood transfusion [see Warnings and Precautions (5.5)]. Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends [see Clinical Pharmacology (12.3)].
Rev: 11/2015