TAMSULOSIN HYDROCHLORIDE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Zydus Pharmaceuticals USA Inc.

Designación común 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 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)]. Risk Summary Tamsulosin hydrochloride capsules are not indicated for use in women. There are no adequate data on the developmental risk associated with the use of Tamsulosin hydrochloride capsules 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

Resumen del producto:

Tamsulosin Hydrochloride Capsules USP, 0.4 mg are white to off-white free flowing pellets filled in size '2' empty hard gelatin capsules with green colored cap printed with "ZA-18" in black ink and peach colored body printed with "0.4 mg" in black ink and are supplied as follows: NDC 68382-132-06 in bottle of 30 capsules NDC 68382-132-14 in bottle of 60 capsules NDC 68382-132-16 in bottle of 90 capsules NDC 68382-132-01 in bottle of 100 capsules NDC 68382-132-05 in bottle of 500 capsules NDC 68382-132-10 in bottle of 1000 capsules NDC 68382-132-30 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
ZYDUS PHARMACEUTICALS USA 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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
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
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 with concomitant administration of warfarin (5.2,
7.4, 12.3)
Advise patients about the possibility and seriousness of priapism.
(5.3)
Intra