DUTASTERIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

AvKARE, Inc.

INN (Διεθνής Όνομα):

DUTASTERIDE

Σύνθεση:

DUTASTERIDE 0.5 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DUTASTERIDE- DUTASTERIDE CAPSULE
AVKARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
DUTASTERIDE CAPSULES
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 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, USP 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 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 simi