Harnal OCAS Prolonged Release Film-coated Tablet 400mcg

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Tamsulosin Hydrochloride

Saatavilla:

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ATC-koodi:

G04CA02

Annos:

0.4mg/tablet

Lääkemuoto:

TABLET, FILM COATED, EXTENDED RELEASE

Koostumus:

Tamsulosin Hydrochloride 0.4 mg

Antoreitti:

ORAL

Prescription tyyppi:

Prescription Only

Valmistaja:

Astellas Pharma Europe B.V.

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2009-08-21

Pakkausseloste

 
Harnal
®
 OCAS 

APPROVED NAME 

Tamsulosin hydrochloride 

DESCRIPTION 
Harnal
®
 OCAS is a film-
coated, prolonged release tablet containing 400 μg tamsulosin 
hydrochloride, an α
1
-adrenoceptor blocking agent. It has a high affinity for the 
α
1A
-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). 

Harnal
®
 OCAS also contains macrogoI 7,000,000, macrogol 8,000, magnesium stearate, 
butylated hydroxytoluene, colloidal silica
anhydrous, hypromellose, iron oxide yellow. 
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 α
1
-adrenoceptors. This 
provides the rationale for the use of α
1
-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 α
1-
adrenoceptor antagonist and that it has a greater affinity for the α
1A
-receptor 
subtype, predominantly present in the human prostate. 

α
1
-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 Harnal
®
 OCAS. 

The binding of tamsulosin to α
1
-adrenoceptors�

Valmisteyhteenveto

Harnal
®
OCAS
APPROVED NAME
Tamsulosin hydrochloride
DESCRIPTION
Harnal
®
OCAS is a film-coated, prolonged release tablet containing 400 μg
tamsulosin
hydrochloride, an α
1
-adrenoceptor blocking agent. It has a high affinity for the α
1A
-
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).
Harnal
®
OCAS also contains macrogoI 7,000,000, macrogol 8,000, magnesium
stearate, butylated hydroxytoluene, colloidal silica anhydrous,
hypromellose, iron oxide
yellow. None of the excipients are 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 α
1
-
adrenoceptors. This provides the rationale for the use of α
1
-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 α
1
-adrenoceptor antagonist and that it has a greater affinity for the α
1A
-
receptor subtype, predominantly present in the human prostate.
α
1
-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 Harnal
®
OCAS.
The binding of tamsulosin to α
1
-adrenoceptors in the prostate results in relaxation of
prostate smooth muscle followed by improvements in urodynamics. Thus,
Harnal
®
OCAS increases maximum urinary flow rate by reducing smooth muscle
tension in the
prostate and urethra and thereby relievi