TAMSULOSIN HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

TAMSULOSIN HYDROCHLORIDE

Sammensetning:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

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) ]. Teratogenic Effects , Pregnancy Category B. Administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. Administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. Tamsulosin hydrochloride capsules are not indicated for use in women. Tamsulosin hydrochloride

Produkt oppsummering:

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 0615-7995-39 in blistercard of 30 capsules NDC 0615-7995-05 in blistercard of 15 capsules Storage: Store at 20° to 25°C (68° 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
NCS HEALTHCARE OF KY, INC 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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2) 10/2014
Warnings and Precautions
Intraoperative Floppy Iris Syndrome (5.5) 7/2014
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 ca