DUTASTERIDE- dutasteride capsule, liquid filled

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

AvPAK

INN (Nama Internasional):

DUTASTERIDE

Komposisi:

DUTASTERIDE 0.5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.  Dutasteride is not approved for the prevention of prostate cancer.  Dutasteride is contraindicated for use in: •        Pregnancy. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, dutasteride may cause fetal harm when administered to a pregnant woman. If dutasteride is used during pregnancy or if the patient becomes pregnant while taking dutasteride, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.4), Use in Specific Populations ( 8.1)] . •

Ringkasan produk:

Dutasteride capsules 0.5 mg are yellow, oblong capsules containing clear liquid printed with ‘AT131’ with black ink, packaged: NDC 50268-282-13 (5 capsules per card, 6 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. 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)] . 

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DUTASTERIDE- DUTASTERIDE CAPSULE, LIQUID FILLED
AVPAK
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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 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 in combination with the alpha adrenergic antagonist,
tamsulosin, is indicated for the treatment of symptomatic
BPH in men with an enlarged prostate. ( 1.2)
Limitations of Use: Dutasteride is 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 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 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
c