IRBESARTAN HCT MYLAN 300/25 irbesartan/hydrochlorothiazide 300/25 mg tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
20-09-2017
Public Assessment Report
(PAR)
26-11-2017
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Active ingredient:
hydrochlorothiazide, Quantity: 25 mg; irbesartan, Quantity: 300 mg
Available from:
Alphapharm Pty Ltd
INN (International Name):
Hydrochlorothiazide,Irbesartan
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; povidone; lactose monohydrate; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 3350; iron oxide black
Administration route:
Oral
Units in package:
7, 90, 30, 14
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
ABISART HCT is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.
Product summary:
Visual Identification: A reddish-brown film-coated, oval, biconvex tablet debossed with "M" on one side of the tablet and "I35" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2013-11-29
Summary of Product characteristics
ABISART
HCT
_Irbesartan/Hydrochlorothiazide _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient:
Irbesartan
Hydrochlorothiazide
Chemical name:
2-butyl-3-[(2'-(1
_H_
-tetrazol-5-yl)biphenyl-
4-yl)methyl]-1,3-diazaspiro
[4,4]
non-1-
en-4-one
6-chloro-3,4-dihydro-2
_H_
-1,2,4-
benzothiadiazine-7-sulphonamide 1, 1-
dioxide
Structural formula:
Molecular formula:
C
25
H
28
N
6
O
C
7
H
8
N
3
S
2
O
4
Cl
Molecular weight:
428.5
297.7
CAS registry no.:
138402-11-6
58-93-5
DESCRIPTION
ABISART HCT (irbesartan/hydrochlorothiazide) is an oral
antihypertensive agent combining a nonpeptide
angiotensin II receptor (AT
1
subtype) antagonist, irbesartan, and a thiazide diuretic,
hydrochlorothiazide.
Irbesartan is a white to almost-white crystalline powder. It is a
relatively non-polar compound with a partition
coefficient (octanol-water) of 10.1 at a pH of 7.4. Irbesartan is
practically insoluble in water and slightly soluble
in alcohol and methylene chloride.
Hydrochlorothiazide is a white crystalline powder. It is slightly
soluble in water and freely soluble in sodium
hydroxide solution.
ABISART HCT 150/12.5 tablets contain 150 mg of irbesartan and 12.5 mg
of hydrochlorothiazide
ABISART HCT 300/12.5 tablets contain 300 mg of irbesartan and 12.5 mg
of hydrochlorothiazide.
ABISART HCT 300/25 tablets contain 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
The inactive ingredients in ABISART HCT tablets include: colloidal
anhydrous silica, magnesium stearate,
sodium lauryl sulfate, microcrystalline cellulose, pregelatinized
maize starch, povidone, lactose, croscarmellose
sodium, quinoline yellow aluminum lake, Opadry II complete film
coating system 32F540072 pink (ARTG no
109229) (150/12.5 mg and 300/12.5 mg) and Opadry II complete film
coating system 32F500006 purple (ARTG
no. 109227) (300/25 mg).
ABISART HCT – Product Information
2
PHARMACOLOGY
PHARMACODYNAMICS
Irbesartan is a specific antagonist of angiotensin II receptors (AT
1
subtype). Angiotensin II is an important
component of the renin-angiotensin system an
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