DUTASTERIDE- dutasteride capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

West-Ward Pharmaceuticals Corp.

INN (Jina la Kimataifa):

DUTASTERIDE

Tungo:

DUTASTERIDE 0.5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: 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 Category X. Dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. Dutasteride is 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 pregnant while taking dutasteride, the

Bidhaa muhtasari:

Dutasteride Capsules 0.5 mg capsules are supplied as a clear, oily solution encapsulated in yellow opaque, oblong shaped soft gelatin capsules with "D5" imprinted with red ink on one side of the capsule. NDC 0054-0395-13: Bottle of 30 Capsules NDC 0054-0395-22: Bottle of 90 Capsules 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)].

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

DUTASTERIDE- DUTASTERIDE CAPSULE
WEST-WARD PHARMACEUTICALS CORP.
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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, 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 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
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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 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 WEST-WARD
PHARMACEUTICALS CORP. AT 1-800-962-8364
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Use with caution in patients taking potent, chronic CYP3A4 enzyme
inhibitors (e.g., ritonavir). (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2017
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
Pregnancy and women of childbearing potential. (4, 5.4, 8.1)
Pediatric patients. (4)
Patients with previously demonstrated, clinically significant
hypersensit