DUTASTERIDE capsule, liquid filled

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Epic Pharma, LLC

INN (Medzinárodný Name):

DUTASTERIDE

Zloženie:

DUTASTERIDE 0.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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: Risk Summary Dutasteride is contraindicated for use in pregnancy because it may cause harm to the male fetus [see Contraindications (4)]. Dutasteride is not indicated for use in women. Dutasteridem 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 deficienc

Prehľad produktov:

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 15º to 30ºC (59º to 86ºF) [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) ].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DUTASTERIDE- DUTASTERIDE CAPSULE, LIQUID FILLED
EPIC PHARMA, LLC
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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 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
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DOSAGE FORMS AND STRENGTHS
0.5-mg capsules (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 EPIC PHARMA, LLC AT
1-888-374-2791 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: 5/2020
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 demonstra