HARNAL D TABLET DISPERSIBLE 0,2 MG

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

TAMSULOSIN HYDROCHLORIDE

Tersedia dari:

COMBIPHAR - Indonesia

INN (Nama Internasional):

TAMSULOSIN HYDROCHLORIDE

Dosis:

0,2 MG

Bentuk farmasi:

TABLET DISPERSIBLE

Unit dalam paket:

DUS, 2 BLISTER @ 14 TABLET DISPERSIBEL

Diproduksi oleh:

ASTELLAS PHARMA TECH CO., LTD. - Japan

Tanggal Otorisasi:

2020-03-08

Karakteristik produk

1
NAME OF THE MEDICINAL PRODUCT
Harnal
®
D 0.2 mg Tablet
Dispersible Tablet
DESCRIPTION
Tamsulosin hydrochloride is a white crystal. It is freely soluble in
formic acid, sparingly soluble in water,
slightly soluble in acetic acid (100), and very slightly soluble in
ethanol (99.5).
PHARMACEUTICAL FORM
Brand name
Harnal

D 0.2 mg Tablet
Active ingredient
(Content
per
tablet)
Tamsulosin hydrochloride
0.2 mg
Appearance
(mm)
Orally dispersible tablet
Diameter: 8.5
Thickness: 4.2
Weight (g)
0.20
Color
White
Identification
code
PHARMACOLOGY
1.
PHARMACOLOGICAL EFFECTS
(1)
EFFECTS IN HUMANS
In a receptor binding assay using human prostate preparations,
tamsulosin hydrochloride was 2.2 times
more potent than prazosin hydrochloride and 40 times more so than
phentolamine mesylate in

1
-receptor
blocking activity.
(2)
EFFECTS IN ANIMALS
1)
Blockade of

-adrenergic receptors
In a receptor binding assay using isolated rat cerebral membrane and
an _ in vitro _ experiment using
isolated rabbit aorta, tamsulosin hydrochloride inhibited

1
-receptors selectively and competitively.
Its action was 1/2.2 to 22 times more potent than prazosin
hydrochloride and 45 to 140 times more
potent than phentolamine mesylate.
_In vitro _ experiments using isolated rabbit aorta, isolated rat vas
deferens and isolated guinea pig
intestine, tamsulosin hydrochloride proved to be 5,400 to 24,000 times
more selective for

1
-
receptors
than for

2
-receptors.
2)
Effect on the lower urinary tract (urethra and urinary bladder) and
prostate
In a receptor binding assay using isolated smooth muscle from rabbit
urethra, prostate and urinary
bladder base, tamsulosin hydrochloride was 23 to 98 times more potent
than prazosin hydrochloride
in

1
-receptor blocking activity, and 87 to 320 times more potent than
phentolamine mesylate. In
anesthetized dogs, the drug inhibited the

1
-agonist (phenylephrine)-induced increase in intrauretheral
pressure with 13 times greater potency than the increase in diastolic
blood pressure.
3)
Improv