DUTASTERIDE capsule, liquid filled

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Strides Pharma Science Limited

INN (Jina la Kimataifa):

DUTASTERIDE

Tungo:

DUTASTERIDE 0.5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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. 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 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., serious skin reaction

Bidhaa muhtasari:

Dutasteride capsules are yellow to pale yellow colored oblong shaped soft gelatin capsules containing clear oily liquid imprinted with '0.5' in red ink, packaged in bottles of 30 (NDC 64380-763-04) and 90 (NDC 64380-763-05) with child-resistant closures. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F 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 )].

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

DUTASTERIDE - DUTASTERIDE CAPSULE, LIQUID FILLED
STRIDES PHARMA SCIENCE LIMITED
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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 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) (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 reduces 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 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
condit