TAMSULOSIN HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Actavis Pharma, 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 and GD 6 to 18 in the rabbit) [see Data ]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Administration of tamsulosin hydrochloride to pregnant female rats during the period of organogenesis 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 during the period of organogenesis at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. Tamsulosin hydrochloride capsules is not indicated for use in women. There are no data on the presence of tamsulosin hydrochloride in human milk, the effects of tamsulosin hydrochloride on the breastfed infant, or the effects of tamsulosin hydrochloride on milk production. Tamsulosin hydrochloride is present in the milk of lactating rats [see Data ]. Data Oral administration of radiolabeled tamsulosin hydrochloride to rats demonstrated that tamsulosin hydrochloride and/or its metabolites are excreted into the milk of rats. Infertility Males Abnormal ejaculation including ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease has been associated with tamsulosin hydrochloride capsules [see Clinical Trials Experience (6.1) ]. Studies in rats revealed significantly reduced fertility in males considered to be due to impairment of ejaculation, which was reversible [see Nonclinical Toxicology (13.1) ]. Females Tamsulosin hydrochloride capsules are not indicated for use in women. Female fertility in rats was significantly reduced, considered to be due to impairment of fertilization [see Nonclinical Toxicology (13.1) ]. Tamsulosin hydrochloride capsules USP are not indicated for use in pediatric populations. Efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 years of age with elevated detrusor leak point pressure (>40 cm H2 O) associated with known neurological disorder (e.g., spina bifida). Patients in both studies were treated on a weight-based mg/kg schema (0.025 mg, 0.05 mg, 0.1 mg, 0.2 mg, or 0.4 mg tamsulosin hydrochloride) for the reduction in detrusor leak point pressure below 40 cm H2 O. In a randomized, double-blind, placebo-controlled, 14-week, pharmacokinetic, safety and efficacy study in 161 patients, no statistically significant difference in the proportion of responders was observed between groups receiving tamsulosin hydrochloride and placebo. In an open-label, 12-month safety study, 87 patients were treated with tamsulosin hydrochloride. The most frequently reported adverse events (≥5%) from the pooled data of both studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation. Of the total number of subjects (1783) in clinical studies of tamsulosin, 36% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3)]. Patients with renal impairment do not require an adjustment in tamsulosin hydrochloride capsules USP dosing. However, patients with end-stage renal disease (CLcr <10 mL/min/1.73 m2 ) have not been studied [see Clinical Pharmacology (12.3)]. Patients with moderate hepatic impairment do not require an adjustment in tamsulosin hydrochloride capsules USP dosage. Tamsulosin hydrochloride capsules USP have not been studied in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

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
ACTAVIS PHARMA, 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 possibility and serious