TAMSULOSIN HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

AvPAK

INN (Internationale Bezeichnung):

TAMSULOSIN HYDROCHLORIDE

Zusammensetzung:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 Capsules are not indicated for use in women. Tamsulosin Hydrochloride Capsules 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 H 2 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 H 2 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 dosing. However, patients with end-stage renal disease (CL cr <10 mL/min/1.73 m 2 ) have not been studied [ see Clinical Pharmacology (12.3) ]. Patients with moderate hepatic impairment do not require an adjustment in Tamsulosin Hydrochloride Capsules dosage. Tamsulosin Hydrochloride Capsules has not been studied in patients with severe hepatic impairment [ see Clinical Pharmacology (12.3) ].

Produktbesonderheiten:

Tamsulosin Hydrochloride Capsules 0.4 mg are supplied in Alu-Alu blisters containing 50 hard gelatin capsules with olive green opaque cap and orange opaque body. The capsules are imprinted on one side with "TAM" on cap & "0.4 mg" on body in black ink. They are available as follows: 50 Capsules (5 x 10 Unit Dose) NDC 50268-740-15 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep Tamsulosin Hydrochloride Capsules and all medicines out of reach of children..

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
TAMSULOSIN HYDROCHLORIDE CAPSULES, USP
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, 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)
07/2014
INDICATIONS AND USAGE
Tamsulosin Hydrochloride Capsules 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 ( 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,