Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
Tamsulosin Hydrochloride
ASTELLAS PHARMA SINGAPORE PTE. LTD.
G04CA02
0.4mg/tablet
TABLET, FILM COATED, EXTENDED RELEASE
Tamsulosin Hydrochloride 0.4 mg
ORAL
Prescription Only
Astellas Pharma Europe B.V.
ACTIVE
2009-08-21
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 Przeczytaj cały dokument
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 Przeczytaj cały dokument