TAMSULOSIN HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

H.J. Harkins Company, Inc.

INN (International Name):

TAMSULOSIN HYDROCHLORIDE

Sammensetning:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TAMSULOSIN HYDROCHLORIDE - TAMSULOSIN HYDROCHLORIDE CAPSULE
H.J. HARKINS COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAMSULOSIN HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAMSULOSIN
HYDROCHLORIDE.
TAMSULOSIN HYDROCHLORIDE CAPSULES USP*, 0.4 MG
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2) 4/2009
Contraindications (4) 12/2009
Warnings and Precautions
Drug Interactions (5.2) 12/2009
Screening for Prostate Cancer (5.4) 12/2009
INDICATIONS AND USAGE
Tamsulosin hydrochloride is an alpha adrenoceptor antagonist indicated
for treatment of the signs and symptoms of
benign prostatic hyperplasia (1)
Tamsulosin hydrochloride capsules 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 (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 (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
(5.2, 7.1). 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, 12.3)
Exercise caution with concomitant administration of w