Label: DUTASTERIDE capsule, liquid filled

  • NDC Code(s): 59651-021-30, 59651-021-90
  • Packager: Aurobindo Pharma Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 24, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    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 ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Monotherapy - Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk ...
  • 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 capsules may be administered ...
  • 3 DOSAGE FORMS AND STRENGTHS
    0.5 mg, yellow opaque oblong capsule filled with clear transparent solution and printed with "SZ31" in red ink.
  • 4 CONTRAINDICATIONS
    Dutasteride capsules are contraindicated for use in: Pregnancy. Dutasteride use is contraindicated in women who are pregnant. In animal reproduction and developmental toxicity studies ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection - In clinical trials, dutasteride reduced serum PSA concentration by approximately 50% within 3 to ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Cytochrome P450 3A Inhibitors - Dutasteride is extensively metabolized in humans by the cytochrome P450 (CYP)3A4 and CYP3A5 isoenzymes. The effect of potent CYP3A4 inhibitors on dutasteride ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Dutasteride is contraindicated for use in pregnancy because it may cause harm to the male fetus [see Contraindications (4)]. Dutasteride is not indicated for use ...
  • 10 OVERDOSAGE
    In volunteer trials, single doses of dutasteride up to 40 mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical trial, daily doses ...
  • 11 DESCRIPTION
    Dutasteride is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Dutasteride inhibits the conversion of testosterone to DHT. DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - A 2-year carcinogenicity study was conducted in B6C3F1 mice at doses of 3, 35, 250, and        500 mg/kg/day for ...
  • 14 CLINICAL STUDIES
    14.1 Monotherapy - Dutasteride 0.5 mg/day (n = 2,167) or placebo (n = 2,158) was evaluated in male subjects with BPH in three 2-year multicenter, placebo-controlled, double-blind trials, each ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Dutasteride capsules are available as follows: 0.5 mg – yellow opaque oblong capsule filled with clear transparent solution and printed with "SZ31" in red ink. Bottles of 30 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). PSA Monitoring - Inform patients that dutasteride capsules reduces serum PSA levels by approximately 50 ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - Dutasteride Capsules - (doo-TAS-ter-ide) Dutasteride capsules are for use by men only. What are Dutasteride Capsules? Dutasteride capsules are a ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5 mg (30 Capsules Bottle)
    NDC 59651-021-30 - Rx only - Dutasteride Capsules - 0.5 mg - WARNING: Dutasteride should not be used by women or - children. Women who are or may potentially be pregnant should - not use or ...
  • INGREDIENTS AND APPEARANCE
    Product Information