TAMSULOSIN HYDROCHLORIDE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Par Pharmaceutical, Inc.

INN (International Name):

TAMSULOSIN HYDROCHLORIDE

Sammensætning:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske 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) ]. 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 are not indicated for use in women. Tamsulosin hydrochlorid

Produkt oversigt:

Tamsulosin Hydrochloride Capsules, USP, 0.4 mg are supplied in high density polyethylene bottles containing 100 or 500 hard gelatin capsules with green opaque cap and yellow opaque body imprinted with “A169” on the cap and “0.4” on the body in black ink containing white to off-white spherical-shaped coated pellets. Bottle of 100….…NDC# 10370-169-01 Bottle of 500…….NDC# 10370-169-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
PAR PHARMACEUTICAL, 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)
Exercise caution