TAMSULOSIN HYDROCHLORIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Physicians Total Care, Inc.

INN (Nome Internazionale):

TAMSULOSIN HYDROCHLORIDE

Composizione:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 hydrochloride

Dettagli prodotto:

Tamsulosin hydrochloride capsules 0.4 mg are supplied in high density polyethylene bottles as follows: Tamsulosin hydrochloride capsules 0.4 mg – Bright orange opaque body and light green opaque cap imprinted with "G821" in black ink on the cap and body. Contains white to off-white spherical particles. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in tightly closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Keep out of reach of children.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TAMSULOSIN HYDROCHLORIDE - TAMSULOSIN HYDROCHLORIDE CAPSULE
PHYSICIANS TOTAL CARE, 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, 0.4 MG
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warnings and Precautions
Intraoperative Floppy Iris Syndrome
(5.5)
07/2011
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.
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 seriousness of priapism