APX-IRBESARTAN HCTZ 300/12.5 irbesartan 300 mg and hydrochlorothiazide 12.5 mg tablets blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

irbesartan, Quantity: 300 mg; hydrochlorothiazide, Quantity: 12.5 mg

Verfügbar ab:

Arrotex Pharmaceuticals Pty Ltd

INN (Internationale Bezeichnung):

Hydrochlorothiazide,Irbesartan

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: polysorbate 80; iron oxide yellow; sodium starch glycollate type B; colloidal anhydrous silica; iron oxide red; mannitol; povidone; hypromellose; magnesium stearate; titanium dioxide; Carnauba Wax; macrogol 3350

Verabreichungsweg:

Oral

Einheiten im Paket:

30 (3x10 in carton)

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Produktbesonderheiten:

Visual Identification: Peach coloured, capsule shaped, biconvex, film-coated tablets, approx.18 mm long and 9 mm wide debossed with 'IH2' on one face and plain on other face; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2017-03-14

Fachinformation

1
PRODUCT INFORMATION
IRBERAK HCTZ MLABS
150/12.5 MG, 300/12.5 MG, 300/25 MG TABLETS
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Irbesartan/Hydrochlorothiazide
Irbesartan: 2-butyl-3-[(2'-(1H-tetrazol-5-yl) biphenyl-4-yl)
methyl]-1,3-diazaspiro [4,4] non-1-
en-4-one.
Hydrochlorothiazide:
6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-
dioxide.
CHEMICAL STRUCTURE
The chemical structure of irbesartan is
IRBESARTAN
Molecular formula: C
25
H
28
N
6
O
Molecular weight: 428.5
CAS number: 138402-11-6
The chemical structure of hydrochlorothiazide is:
HYDROCHLOROTHIAZIDE
Molecular formula: C
7
H
8
ClN
3
O
4
S
2
Molecular weight: 297.7
CAS number: CAS-58-93-5
2
DESCRIPTION
Irberak
HCTZ
MLabs
(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 off-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, sparingly soluble in methanol, slightly soluble in methylene
chloride
Hydrochlorothiazide is a white crystalline powder. It is slightly
soluble in water but freely
soluble in sodium hydroxide solution.
Irberak HCTZ MLabs 150/12.5mg tablets are Peach coloured, capsule
shaped, biconvex, film-
coated tablets, approximately 14 mm long and 7 mm wide, debossed with
‘IH’ on one face and
plain on other face.
Irberak HCTZ MLabs 300/12.5mg tablets are Peach coloured, capsule
shaped, biconvex, film-
coated tablets, approximately 18 mm long and 9 mm wide debossed with
‘IH2’ on one face and
plain on other face.
Irberak HCTZ MLabs 300/25mg tablets are Brick red coloured, capsule
shaped, biconvex, film-
coated tablets, approximately 18 mm long and 9 mm wide, debossed with
‘IH1’ on one face and
plain on other face.
Irberak HCTZ MLabs150/12.5mg & 300/25mg tablets contain the inactive
ingredients: mannitol,
sodium starch gl