IRBESARTAN MYLAN irbesartan 300 mg tablet bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

irbesartan, Quantity: 300 mg

Disponível em:

Alphapharm Pty Ltd

DCI (Denominação Comum Internacional):

Irbesartan

Forma farmacêutica:

Tablet

Composição:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; povidone; magnesium stearate; titanium dioxide; hypromellose; macrogol 4000

Via de administração:

Oral

Unidades em pacote:

30, 7, 14, 90

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

IRBESARTAN MYLAN is indicated for the treatment of hypertension., IRBESARTAN MYLAN is indicated for delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (> 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.

Resumo do produto:

Visual Identification: A white to off-white, film-coated, oval, biconvex, bevelled edge tablet debossed with "M" on one side of the tablet and "IN3" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Licence status A

Data de autorização:

2013-11-06

Características técnicas

ABISART
_Irbesartan _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
Irbesartan
Chemical name
:
2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4,4]
non-1-en-4-one
Structural formula
:
Molecular formula
:
C
25
H
28
N
6
O
Molecular weight
:
428.53
CAS Registry no.
:
138402-11-6
DESCRIPTION
Irbesartan is a white, to practically white, powder that is less than
0.1mg/mL soluble in water and slightly soluble
in alcohol and methylene chloride.
Abisart (irbesartan) is a nonpeptide angiotensin II receptor (AT
1
subtype) antagonist. It is available as 75 mg, 150
mg or 300 mg tablets for oral administration. The inactive ingredients
are: povidone, lactose, microcrystalline
cellulose, croscarmellose sodium, magnesium stearate, colloidal
anhydrous silica and OPADRY II Complete
Film Coating System OY-LS-28908 White (ARTG no. 12435).
PHARMACOLOGY
PHARMACODYNAMICS
Irbesartan is a specific antagonist of angiotensin II receptors (AT1
subtype). Angiotensin II is an important
component of the renin-angiotensin system and is involved in the
pathophysiology of hypertension and in sodium
homeostasis. Irbesartan does not require metabolic activation for its
activity.
Irbesartan blocks the potent vasoconstrictor and aldosterone-secreting
effects of angiotensin II by selective
antagonism of the angiotensin II (AT
1
subtype) receptors localized on vascular smooth muscle cells and in
the
adrenal cortex. It has no agonist activity at the AT
1
receptor and a much greater affinity (more than 8500-fold)
for the AT
1
receptor than for the AT
2
receptor (a receptor that has not been shown to be associated with
cardiovascular homeostasis).
Irbesartan does not inhibit enzymes involved in the renin-angiotensin
system (i.e., renin, angiotensin converting
enzyme [ACE]) or affect other hormone receptors or ion channels
involved in the cardiovascular regulation of
blood pressure and sodium homeostasis.
ABISART – PRODUCT INFORMATION
2
In healthy subjects, single oral irbesartan doses of up to 300 mg
produced dose-dependent