TAMSULOSIN HYDROCHLORIDE capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)

제공처:

Aidarex Pharmaceuticals LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Tamsulosin hydrochloride capsules USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules USP are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules USP are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules USP. Reactions have included skin rash, urticaria, pruritus, angioedema and respiratory symptoms [see Adverse Reactions (6.2)]. Teratogenic Effects, Pregnancy Category B. Administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. Administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. Tamsulosin hydrochloride capsules USP are not indicated for use in women. Tamsulo

제품 요약:

Tamsulosin hydrochloride capsules USP 0.4 mg are supplied in high density polyethylene bottles containing hard gelatin capsules with an olive green opaque cap and an orange opaque body.  The cap is imprinted with the code “TSL 0.4” in black ink. Store at 25°C (77°F). Excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules USP and all medicines out of reach of children. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
AIDAREX PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAMSULOSIN HYDROCHLORIDE CAPSULES USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TAMSULOSIN HYDROCHLORIDE CAPSULES USP.
TAMSULOSIN HYDROCHLORIDE CAPSULES USP, 0.4 MG
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2) 10/2014
Warnings and Precautions
Intraoperative Floppy Iris Syndrome (5.5) 07/2014
INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules USP are an alpha adrenoceptor
antagonist indicated for treatment of the signs and
symptoms of benign prostatic hyperplasia (1)
Tamsulosin hydrochloride capsules USP are not indicated for the
treatment of hypertension (1)
DOSAGE AND ADMINISTRATION
0.4 mg once daily taken approximately one-half hour following the same
meal each day. Tamsulosin hydrochloride
capsules USP should not be crushed, chewed or opened. (2)
Can be increased to 0.8 mg once daily for patients who fail to respond
to the 0.4 mg dose after 2 to 4 weeks of dosing
(2)
If discontinued or interrupted for several days, therapy should start
again with the 0.4 mg once-daily dose (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 0.4 mg (3)
CONTRAINDICATIONS
Contraindicated in patients known to be hypersensitive to tamsulosin
hydrochloride or any component of tamsulosin
hydrochloride capsules USP (4, 6.2)
WARNINGS AND PRECAUTIONS
Advise patients about the possibility of symptoms related to postural
hypotension and to avoid situations where injury
could result should syncope occur (5.1)
Should not be used in combination with strong inhibitors of CYP3A4.
Use with caution in combination with moderate
inhibitors of CYP3A4, with strong or moderate inhibitors of CYP2D6, in
patients known to be CYP2D6 poor
metabolizers, or in combination with other cytochrome P450 inhibitors.
(5.2, 7.1, 12.3)
Should not be used in combination with other alpha adrenergic blocking
agents (5.2, 7.2