TAMSULOSIN HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bryant Ranch Prepack

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 population, the es

Produkt oppsummering:

Tamsulosin Hydrochloride Capsules, USP 0.4 mg are supplied in high density polyethylene bottles. Tamsulosin Hydrochloride Capsules, 0.4 mg - Hard gelatin capsules with olive green opaque cap and orange opaque body. The capsules are imprinted on one side with “TAM” on cap & “0.4 mg” on body in black ink. NDC: 71335-1538-1 30 CAPSULE in a BOTTLE NDC: 71335-1538-2 100 CAPSULE in a BOTTLE NDC: 71335-1538-3 60 CAPSULE in a BOTTLE NDC: 71335-1538-4 10 CAPSULE in a BOTTLE NDC: 71335-1538-5 90 CAPSULE in a BOTTLE NDC: 71335-1538-6 180 CAPSULE in a BOTTLE NDC: 71335-1538-7 7 CAPSULE in a BOTTLE NDC: 71335-1538-8 15 CAPSULE in a BOTTLE NDC: 71335-1538-9 120 CAPSULE in a BOTTLE Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
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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 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 with concomitant administration of warfarin
(5.2,7.4,12.3)
· Advise patients about the possibility and seriousness of priapism
(5