DUTASTERIDE- dutasteride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I)

Available from:

Actavis Pharma, Inc.

INN (International Name):

DUTASTERIDE

Composition:

DUTASTERIDE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

      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 of acute urinary retention (AUR), and - reduce the risk of the need for BPH-related surgery.       Dutasteride capsules in combination with the alpha adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.       Dutasteride capsules are not approved for the prevention of prostate cancer.       Dutasteride capsules are contraindicated for use in: - Pregnancy. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, dutasteride capsules may cause fetal harm when administered to a pregnant woman. If dutasteride capsules are used during pregnancy or if the patient becomes pregnant while taking dutasteride capsules, the patient should be apprised of the potential hazard to the fetus [see Wa

Product summary:

Dutasteride capsules 0.5 mg are yellow opaque gelatin capsules imprinted with 2292 in black ink packaged in bottles of 30 (NDC 0591-2292-30) and 90 (NDC 0591-2292-19) with child-resistant closures.   Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dutasteride is absorbed through the skin. Dutasteride capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5.4 )].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DUTASTERIDE- DUTASTERIDE CAPSULE
ACTAVIS PHARMA, INC.
----------
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 ORAL USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions, Evaluation for Other Urological Diseases
(5.3) 03/2012
INDICATIONS AND USAGE
Dutasteride capsules is 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 capsules in combination with the alpha adrenergic
antagonist, tamsulosin, are 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 and women of childbearing potential. (4, 5.4, 8.1)
Pediatric patients. (4)
Patients with previously demonstrated, clinically significant
hypersensitivity (e.g., serious skin reactions, angioedema)
to dutasteride capsules or other 5 alpha-reductase inhibitors. (4)
WARNINGS AND PRECAUTIONS
Dutasteride capsules reduce 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 capsules may increase the risk of high-grade prostate
cancer. (5.2, 6.1)
Prior to i