TAMSULOSIN HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

RedPharm Drug, Inc.

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)]. 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 USP are not indicated for use in w

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. Tamsulosin hydrochloride capsules USP, 100 capsules (NDC 0228-2996-11). Tamsulosin hydrochloride capsules USP, 500 capsules (NDC 0228-2996-50). 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
REDPHARM DRUG, INC.
----------
1 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.
2 DOSAGE AND ADMINISTRATION
Tamsulosin hydrochloride capsules USP 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 USP 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 USP can be increased to
0.8 mg once
daily. Tamsulosin hydrochloride capsules USP 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 USP 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.
3 DOSAGE FORMS AND STRENGTHS
Capsule: 0.4 mg, olive green opaque cap and an orange opaque body. The
cap is
imprinted with the code “TSL 0.4” in black ink.
4 CONTRAINDICATIONS
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)].
5 WARNINGS AND PRECAUTIONS
5.1 Orthostasis
The signs and symptoms of orthostasis (postural hypotension, dizziness
and vertigo)
were detected more frequently in tamsulosin hydrochloride capsules
USP-treated
patients than in placebo recipients. As with other alpha adrenergic
blocking agents there
is a potentia