AVODART- dutasteride capsule, liquid filled

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Physicians Total Care, Inc.

INN (Kansainvälinen yleisnimi):

DUTASTERIDE

Koostumus:

DUTASTERIDE 0.5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

AVODART Soft Gelatin Capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” with red edible ink on one side packaged in with child-resistant closures. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dutasteride is absorbed through the skin. AVODART 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)] .

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

AVODART - DUTASTERIDE CAPSULE, LIQUID FILLED
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AVODART SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AVODART.
AVODART (DUTASTERIDE) SOFT GELATIN CAPSULES
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1.3) June 2011
Warnings and Precautions, Increased Risk of High-grade
Prostate Cancer (5.2) June 2011
INDICATIONS AND USAGE
AVODART 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) (1)
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
AVODART in combination with the alpha adrenergic antagonist,
tamsulosin, is indicated for the treatment of symptomatic
BPH in men with an enlarged prostate. (1.2) (1)
Limitations of Use: AVODART is not approved for the prevention of
prostate cancer. (1.3) (1)
DOSAGE AND ADMINISTRATION
Monotherapy: 0.5 mg once daily. (2.1) (2)
Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg
once daily. (2.2) (2)
Dosing considerations: Swallow whole. May take with or without food.
(2) (2)
DOSAGE FORMS AND STRENGTHS
0.5-mg soft gelatin capsules (3) (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 AVODART or other 5 alpha-reductase inhibitors. (4)
WARNINGS AND PRECAUTIONS
AVODART reduces serum prostate-specific antigen (PSA) concentration by
approximately 50%. However, any
confirmed increase in PSA while on AVODART 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)
AVODART may increase the risk of high-grade prostate cancer. (5.2,
6.1)
Assess