TAMSULOSIN HYDROCHLORIDE- tamsulosin hydrochloride capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Mylan Institutional Inc.

INN (International namn):

TAMSULOSIN HYDROCHLORIDE

Sammansättning:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2)]. 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 are not indicated for use in women. Tamsulosin hydrochloride capsules are not indicated for use in women

Produktsammanfattning:

Tamsulosin Hydrochloride Capsules, USP are available containing 0.4 mg of tamsulosin hydrochloride, USP. The 0.4 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and a blue opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 2500 in black ink on both the cap and the body. They are available as follows: NDC 51079-294-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
MYLAN INSTITUTIONAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAMSULOSIN HYDROCHLORIDE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TAMSULOSIN HYDROCHLORIDE
CAPSULES.
TAMSULOSIN HYDROCHLORIDE CAPSULES, FOR ORAL USE
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 are 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. Tamsulosin hydrochloride
capsules 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 ( 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)
Exe