IRBESARTAN MYLAN irbesartan 75 mg tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
07-07-2017
Public Assessment Report
(PAR)
26-11-2017
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Active ingredient:
irbesartan, Quantity: 75 mg
Available from:
Alphapharm Pty Ltd
INN (International Name):
Irbesartan
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; macrogol 4000
Administration route:
Oral
Units in package:
14, 7, 30, 90
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
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.
Product summary:
Visual Identification: A white to off-white, film-coated, round, biconvex, bevelled edge tablet debossed with "M" on one side of the tablet and "IN1" 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
Authorization status:
Licence status A
Authorization date:
2013-11-06
Summary of Product characteristics
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
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