TAMSULOSIN-TEVA PROLONGED RELEASE FILM-COATED TABLET 400MCG

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

Tamsulosin eqv Tamsulosin hydrochloride

Saadav alates:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC kood:

G04CA02

Ravimvorm:

TABLET, FILM COATED, EXTENDED RELEASE

Koostis:

Tamsulosin eqv Tamsulosin hydrochloride 0.40 mg

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

Teva Pharmaceutical Works Private Limited Company

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2021-05-11

Toote omadused

TAMSULOSIN-TEVA PROLONGED RELEASE FILM-COATED TABLET 400MCG
ACTIVE SUBSTANCE
Tamsulosin hydrochloride
DESCRIPTION
Tamsulosin-Teva is a film-coated, prolonged release tablet containing
400 mcg
tamsulosin hydrochloride, an α1-adrenoceptor blocking agent. It has a
high affinity
for the α1A- receptor subtype predominantly present in the human
prostate. The
chemical structure of tamsulosin hydrochloride is:
The chemical name is
(R)-5-[2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-
methoxybenzenesulfonamide, monohydrochloride. The molecular weight is
444.98.
The CAS registry number is CAS-106463-17-6 (hydrochloride).
Tamsulosin-Teva also contains cellulose microcrystalline, polyethylene
oxide, colloidal
anhydrous silica, magnesium stearate, hypromellose, titanium dioxide,
macrogol 8000,
iron oxide yellow, iron oxide red. None of the excipients is derived
from animal sources.
Tamsulosin hydrochloride is sparingly soluble in water (1:85) and
slightly soluble in
alcohol. It is stable in an acid environment.
PHARMACOLOGY
The tone of the human prostate smooth muscle is maintained primarily
by noradrenaline
released from adrenergic nerves and stimulating post-junctional
α1-adrenoceptors. This
provides the rationale for the use of α1-adrenoceptor antagonists for
lower urinary tract
symptoms associated with benign prostatic hyperplasia (BPH).
PHARMACODYNAMICS
Pharmacological studies have established that tamsulosin is a
selective, potent and
competitive α1-adrenoceptor antagonist and that it has a greater
affinity for the α1A-
receptor subtype, predominantly present in the human prostate.
α1-adrenoceptor antagonists generally can reduce blood pressure by
lowering peripheral
resistance. However, no reduction in blood pressure of any clinical
significance was
observed during studies with Tamsulosin.
The binding of tamsulosin to α1-adrenoceptors in the prostate results
in relaxation of
prostate smooth muscle followed by improvements in urodynamics. Thus,
Tamsulosin
increases maximum urinary flow rate by reducing smooth mus