DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE- dutasteride and tamsulosin hydrochloride capsules capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I), TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)

זמין מ:

Par Pharmaceutical, Inc.

INN (שם בינלאומי):

DUTASTERIDE

הרכב:

DUTASTERIDE 0.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. Dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in: - Pregnancy. Dutasteride use is contraindicated in females who are pregnant. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, dutasteride and tamsulosin hydrochloride capsules may cause fetal harm when administered to a pregnant female. [see Warnings and Precautions (5.6), Use in Specific Populations (8.1) ] . - Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any other component o

leaflet_short:

Dutasteride and tamsulosin hydrochloride capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are blue, opaque cap imprinted with “C280” and white, opaque body imprinted with “0.5/0.4” in black ink containing white to off-white spherical shaped pellets and one oblong, opaque yellow softgel capsule printed with “C300” in black ink. They are available in bottles with child-resistant closures as follows: Bottle of 30 (NDC 10370-280-11). Bottle of 90 (NDC 10370-280-09). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Capsules may become deformed and/or discolored if kept at high temperatures. Dutasteride is absorbed through the skin. Dutasteride and tamsulosin hydrochloride capsules should not be handled by females 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 (5.6) ] .

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE- DUTASTERIDE AND
TAMSULOSIN HYDROCHLORIDE CAPSULES CAPSULE
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUTASTERIDE AND
TAMSULOSIN HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES.
DUSTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
Contraindications (4) 12/2020
INDICATIONS AND USAGE
Dutasteride and tamsulosin hydrochloride capsules are a combination of
dutasteride, a 5-alpha-reductase
inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated
for the treatment of symptomatic
benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
(1.1)
Limitations of Use: Dutasteride-containing products, including
dutasteride and tamsulosin hydrochloride
capsules, are not approved for the prevention of prostate cancer.
(1.2)
DOSAGE AND ADMINISTRATION
Take one capsule daily approximately 30 minutes after the same meal
each day. (2)
Swallow capsule whole. (2)
DOSAGE FORMS AND STRENGTHS
0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride. (3)
CONTRAINDICATIONS
Pregnancy. Dutasteride use is contraindicated in females who are
pregnant. (4, 5.6, 8.1)
Patients with previously demonstrated, clinically significant
hypersensitivity (e.g., serious skin reactions,
angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride,
other 5-alpha-reductase
inhibitors, tamsulosin, or any component of dutasteride and tamsulosin
hydrochloride capsules. (4)
WARNINGS AND PRECAUTIONS
Orthostatic hypotension and/or syncope can occur. Advise patients of
symptoms related to postural
hypotension and to avoid situations where injury could result if
syncope occurs. (5.1)
Do not use dutasteride and tamsulosin hydrochloride capsules with
other alpha-adrenergic antagonists,
as this may increase the risk of hypotension. (5.2)
Dutasteride and tamsulosin