TAMSULOSIN HYDROCHLORIDE capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Cardinal Health 107, LLC

Designació comuna internacional (DCI):

TAMSULOSIN HYDROCHLORIDE

Composición:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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, USP are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules, USP are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules, USP. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2)] . Risk Summary Tamsulosin hydrochloride is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. No adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [see Data ]. In the U.S. general pop

Resumen del producto:

Tamsulosin hydrochloride capsules USP, 0.4 mg are supplied in high density polyethylene bottles containing hard gelatin capsules with light green cap and yellow body imprinted with “TML 0.4” on cap and body. Overbagged with 10 capsules per bag, NDC 55154-7649-0 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules, USP and all medicines out of reach of children.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
CARDINAL HEALTH 107, LLC
----------
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
INDICATIONS AND USAGE
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
Tamsulosin hydrochloride capsule, USP is an alpha adrenoceptor
antagonist indicated for treatment
of the signs and symptoms of benign prostatic hyperplasia (1)
1
Tamsulosin hydrochloride capsules, USP are not indicated for the
treatment of hypertension (1)
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)
Capsules: 0.4 mg (3)
Contraindicated in patients known to be hypersensitive to tamsulosin
hydrochloride or any component
of tamsulosin hydrochloride capsules, USP (4, 6.2)
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 combi