DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prasco Laboratories

INN (International Name):

DUTASTERIDE

Composition:

DUTASTERIDE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Category X. There are no adequate and well-controlled studies in pregnant women with the fixed-dose formulation of Dutasteride and Tamsulosin Hydrochloride capsules or its individual components. Dutasteride 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

Product summary:

Dutasteride and Tamsulosin Hydrochloride capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are oblong hard-shell capsules with a brown body and an orange cap imprinted with “GS 7CZ” in black ink. They are available in bottles with child-resistant closures as follows: Bottle of 30           (NDC 66993-580-30). Bottle of 90           (NDC 66993-580-85). Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°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 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 (5.6)] .

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE- DUTASTERIDE AND TAMSULOSIN
HYDROCHLORIDE CAPSULE
PRASCO LABORATORIES
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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.
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES
INITIAL U.S. APPROVAL: 2010
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
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DOSAGE FORMS AND STRENGTHS
0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Take one capsule daily approximately 30 minutes after the same meal
each day. (2)
Swallow capsule whole. (2)
Pregnancy and women of childbearing potential. (4, 5.6, 8.1)
Pediatric patients. (4)
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)
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 Hydrochloride capsu