DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE- 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:

Actavis Pharma, Inc.

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. 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 woman. If dutasteride and tamsulosin hydrochloride capsules are used during pregnancy, or if the patient becomes pregnant while taking dutasteride and tamsulosin hydrochloride capsules, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)] . - Women of childbearing potential [see Warnings and Precautions (5.6), Use

Product summary:

Dutasteride and tamsulosin hydrochloride capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are size “00”, hard capsule, white opaque cap and body, containing white to off-white pellets and one yellow colored soft gelatin capsule.  The hard capsule is imprinted with “WPI 3771 ” in black ink. They are available in bottles with child-resistant closures as follows: Bottle of 30                (NDC 0591-3771-30). Bottle of 90                (NDC 0591-3771-19). 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 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:

Abbreviated New Drug Application

Summary of Product characteristics

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE- DUTASTERIDE AND TAMSULOSIN
HYDROCHLORIDE CAPSULE
ACTAVIS PHARMA, 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.
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES, FOR ORAL USE.
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
Dutasteride and tamsulosin hydrochloride capsules is 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 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)
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 hydrochloride capsules reduce serum
prostate-specific antigen (PSA)