TAMSULOSIN HYDROCHLORIDE capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

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Parsisiųsti Prekės savybės (SPC)
27-12-2017

Veiklioji medžiaga:

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

Prieinama:

St Marys Medical Park Pharmacy

INN (Tarptautinis Pavadinimas):

TAMSULOSIN HYDROCHLORIDE

Sudėtis:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

                                TAMSULOSIN HYDROCHLORIDE - TAMSULOSIN HYDROCHLORIDE CAPSULE
ST MARYS MEDICAL PARK PHARMACY
----------
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 CAPSULES.
TAMSULOSIN HYDROCHLORIDE CAPSULES, USP
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warnings and Precautions
Intraoperative Floppy Iris Syndrome (5.5) 7/2011
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. (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.
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 warfarin. (5.2,
7.4, 12.3)
Advise patients about the possibility and seri
                                
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