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:

NCS HealthCare of KY, LLC dba Vangard Labs

DCI (Dénomination commune internationale):

TAMSULOSIN HYDROCHLORIDE

Composition:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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)].   Risk Summar y 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 population, the estim

Descriptif du produit:

Tamsulosin Hydrochloride Capsules USP, 0.4 mg are olive green opaque/orange opaque size '0' hard gelatin capsules imprinted with 'D' on cap and '53' on body with black edible ink filled with white to off-white beadlets.        Blistercards of 30                                 NDC 0615-8055-39       Blistercards of 15                                 NDC 0615-8055-05       Blistercards of 14                                 NDC 0615-8055-14       Blistercards of 7                                   NDC 0615-8055-07       Unit-dose Boxes of 30                          NDC 0615-8055-30        Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in tight container. Avoid excessive moisture. 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
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
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
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 with concomitant administration of warfarin. (5.2,
7.4, 12.3)
Advise patients about the possibility and serio