DUTASTERIDE capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Amneal Pharmaceuticals LLC

INN (Միջազգային անվանումը):

DUTASTERIDE

Կազմը:

DUTASTERIDE 0.5 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 capsules in combination with the alpha-adrenergic antagonist, tamsulosin, are 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 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 reac

Ապրանքի ամփոփագիր:

Dutasteride Capsules 0.5 mg are supplied as opaque, yellow, oblong soft gelatin capsules imprinted with “A 75”. They are available as follows: Bottles of 30: NDC 65162-750-03 Bottles of 90: NDC 65162-750-09 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Dutasteride, USP 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, USP and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5.4)] .

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

DUTASTERIDE- DUTASTERIDE CAPSULE
AMNEAL PHARMACEUTICALS 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)
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
Dutasteride capsules in combination with the alpha-adrenergic
antagonist, tamsulosin, are indicated for
the treatment of symptomatic BPH in men with an enlarged prostate.
(1.2)
Limitations of Use: Dutasteride capsules are 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
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 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 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, consideration should
be given to other urological
conditions that may cause similar sympto