TAMSULOSIN HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

TAMSULOSIN HYDROCHLORIDE

Sammensetning:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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

Produkt oppsummering:

Tamsulosin hydrochloride capsules USP 0.4 mg are supplied in high density polyethylene bottles containing 100 or 500 hard gelatin capsules with an olive green opaque cap and an orange opaque body.  The cap is imprinted with the code “TSL 0.4” in black ink. (NDC 43063-264-30) Bottles of 30 (NDC 43063-264-90) Bottles of 90 (NDC 43063-264-01) Bottles of 100 Store at 25°C (77°F), excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules USP and all medicines out of reach of children.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAMSULOSIN HYDROCHLORIDE
CAPSULES USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR TAMSULOSIN
HYDROCHLORIDE CAPSULES USP.
TAMSULOSIN HYDROCHLORIDE CAPSULES USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules USP are an alpha
adrenoceptor antagonist indicated for treatment
of the signs and symptoms of benign prostatic hyperplasia ( 1)
Tamsulosin hydrochloride capsules USP 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 USP 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 USP ( 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 possi