DUTASTERIDE capsule, liquid filled

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

INN (আন্তর্জাতিক নাম):

DUTASTERIDE

রচনা:

DUTASTERIDE 0.5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is 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 Category X. Dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. Dutasteride are a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male fetuses. Therefore, dutasteride may cause fetal harm when administered to a pregnant woman. If dutasteride is used during pregnancy or if the patient becomes

পণ্য সারাংশ:

Dutasteride Capsules 0.5 mg are opaque, yellow, oblong shape capsules imprinted with “PC23” in red ink, packaged in bottles of 30 (NDC 42806-549-30), 90 (NDC 42806-549-09) 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. 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) ].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DUTASTERIDE- DUTASTERIDE CAPSULE, LIQUID FILLED
HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Evaluation for Other Urological Diseases
(5.3) 03/2012
INDICATIONS AND USAGE
Dutasteride capsules 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)
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Dutasteride capsules 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 capsules 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 capsules or other 5 alpha-reductase inhibitors. (4)
WARNINGS AND PRECAUTIONS
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•
•
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ADVERSE REACTIONS
The most common adverse reactions, reported in ≥1% of subjects
treated with dutasteride capsules and more commonly
than in subjects treated with placebo, are impotence, decreased
libido, ejaculation disorders, and breast disorders. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PURACAP
PHARMACEUTICALS, LLC AT 1-855-215-8180 OR
FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
Use with caution in patients taking potent, chronic CY