AVODART- dutasteride capsule, liquid filled

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

GlaxoSmithKline LLC

INN (International Name):

DUTASTERIDE

রচনা:

DUTASTERIDE 0.5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

AVODART (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: 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: Risk Summary AVODART is contraindicated for use in pregnancy because it may cause harm to the male fetus [see Contraindications (4)] . AVODART is not indicated for use in women. AVODART is a 5 alpha‑reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. Abnormalities in the genitalia of male fetuses is an expected physiological consequence of inhibition of this conversion. These results are similar to observations in male infants with genetic 5 alpha‑reductase deficiency. In the U.S. general populat

পণ্য সারাংশ:

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 bottles of 30 (NDC 0173-0712-15) and 90 (NDC 0173-0712-04) 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. 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)] .

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

AVODART- DUTASTERIDE CAPSULE, LIQUID FILLED
GLAXOSMITHKLINE LLC
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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
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)
•
•
•
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)
Limitations of Use: AVODART is not approved for the prevention of
prostate cancer. (1.3)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
0.5-mg soft gelatin capsules (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions, reported in ≥1% of subjects
treated with AVODART 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 GLAXOSMITHKLINE AT
1-888-825-5249 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Use with caution in patients taking potent, chronic cytochrome P450
(CYP)3A4 enzyme inhibitors (e.g., ritonavir). (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2020
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
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)
Pregnancy. Dutasteride use is contraindicated in women who are
pregnant. (4, 5.4, 8.1)
Patients with previously demonstrated, clinically significant
hypersensitivity (e.g., seriou