DUTASTERIDE capsule, liquid filled

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Rising Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

DUTASTERIDE

Kompozīcija:

DUTASTERIDE 0.5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

DUTASTERIDE (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. 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 Population

Produktu pārskats:

DUTASTERIDE soft gelatin capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with “D05” with black edible ink on one side, packaged in bottles of 30 (NDC 64980-224-03) and 90 (NDC 64980-224-09) with child-resistant closures. Store at 25°C (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) ].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

DUTASTERIDE- DUTASTERIDE CAPSULE, LIQUID FILLED
RISING PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUTASTERIDE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR DUTASTERIDE.
DUTASTERIDE (DUTASTERIDE) SOFT GELATIN CAPSULES
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 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 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 similar symptoms. (5.3)
Women who