DUTASTERIDE capsule, liquid filled

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Dutasteride (UNII: O0J6XJN02I) (Dutasteride - UNII:O0J6XJN02I)

Dostupno od:

Apotex Corp.

INN (International ime):

DUTASTERIDE

Sastav:

DUTASTERIDE 0.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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. Dutasteride use is contraindicated in women who are pregnant. 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 [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. - Patients with previously demonstrated clinically significant hypersensitivity (e.g.,

Proizvod sažetak:

Dutasteride Capsules 0.5 mg are pale yellow, oblong, gelatin capsules printed with logo “A 0.5” in red ink. Packaged in bottles of 30 (NDC 60505-3877-3) and 90 (NDC 60505-3877-9) with child-resistant closures. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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)] .

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DUTASTERIDE- DUTASTERIDE CAPSULE, LIQUID FILLED
APOTEX CORP.
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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 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 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 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 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 initiating treatment with dutasteride capsules, consideration
should be given to other urological conditi