TAMSULOSIN HYDROCHLORIDE - tamsulosin hydrochloride capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Unit Dose Services

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [ ]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. see Clinical Studies ( ) 14 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 hy

Prehľad produktov:

NDC:50436-0119-1 in a BOTTLE of 30 CAPSULES NDC:50436-0119-3 in a BOTTLE of 90 CAPSULES

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

TAMSULOSIN HYDROCHLORIDE - TAMSULOSIN HYDROCHLORIDE CAPSULE
UNIT DOSE SERVICES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAMSULOSIN HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAMSULOSIN
HYDROCHLORIDE CAPSULES. TAMSULOSIN
HYDROCHLORIDE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration ( ) 10/2014 2
Warnings and Precautions Intraoperative Floppy Iris Syndrome ( )
07/2014
5.5
INDICATIONS AND USAGE
Tamsulosin hydrochloride 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 ( , ) 46.2
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.
( , , ) 5.27.112.3
Should not be used in combination with other alpha adrenergic blocking
agents ( , , ) 5.27.212.3
Exercise caution