TAMSULOSIN HYDROCHLORIDE capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Tamsulosin hydrochloride capsules, USP 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 feta

Descriptif du produit:

Tamsulosin hydrochloride capsules USP, 0.4 mg are supplied in high density polyethylene bottles as follows: Hard gelatin capsules, size 2 Olive Green colored cap and Light Yellow colored body with 160 imprinted in black ink on cap and body, containing white to off white pellets. Bottles of 10 NDC 68071-1934-1 Bottles of 30 NDC 68071-1934-3 Bottles of 60 NDC 68071-1934-6 Bottles of 90 NDC 68071-1934-9 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS, INC.
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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, 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 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. 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 wit