TAMSULOSIN HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

DirectRX

INN (Internationale Bezeichnung):

TAMSULOSIN HYDROCHLORIDE

Zusammensetzung:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 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)]. 8.1 Pregnancy 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 wo

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
DIRECTRX
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TAMSULOSIN HYDROCHLORIDE
INDICATIONS AND USAGE
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.
DOSAGE AND ADMINISTRATION
Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as
the dose for the treatment of
the signs and symptoms of BPH. It should be administered approximately
one-half hour following the
same meal each day. Tamsulosin hydrochloride capsules should not be
crushed, chewed or opened.
For those patients who fail to respond to the 0.4 mg dose after 2 to 4
weeks of dosing, the dose of
tamsulosin hydrochloride capsules can be increased to 0.8 mg once
daily. Tamsulosin hydrochloride
capsules 0.4 mg should not be used in combination with strong
inhibitors of CYP3A4 (e.g.,
ketoconazole) [see Warnings and Precautions (5.2)].
If tamsulosin hydrochloride capsules administration is discontinued or
interrupted for several days at
either the 0.4 mg or 0.8 mg dose, therapy should be started again with
the 0.4 mg once-daily dose.
DOSAGE FORMS AND STRENGTHS
Capsule: 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.
CONTRINDICATIONS
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)].
WARNINGS AND PRECAUTIONS
5.1 Orthostasis
The signs and symptoms of orthostasis (postural hypotension,
dizziness, and vertigo) were detected
more frequently in tamsulosin hydrochloride capsule-treated patients
than in placebo recipients. As with
other alpha a