STADA IRBESARTAN HCT 300/25 irbesartan/hydrochlorothiazide 300 mg/25 mg tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 25 mg; irbesartan, Quantity: 300 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Hydrochlorothiazide,Irbesartan

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: colloidal anhydrous silica; hydrogenated castor oil; microcrystalline cellulose; maize starch; magnesium stearate; lactose monohydrate; croscarmellose sodium; povidone

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

STADA IRBESARTAN HCT is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

Product summary:

Visual Identification: white, oblong, biconvex tablets embossed 1H25 on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Patient Information leaflet

STADA Irbesartan HCT CMI121012
1
STADA IRBESARTAN HCT 150/12.5
STADA IRBESARTAN HCT 300/12.5
STADA IRBESARTAN HCT 300/25
_ _
IRBESARTAN & HYDROCHLOROTHIAZIDE TABLETS_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about STADA Irbesartan HCT.
It does not contain all the available information. It does not take
the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking this medicine
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT STADA IRBESARTAN HCT IS USED FOR
This medicine is used to lower high blood pressure, which doctors call
hypertension.
Everyone has blood pressure. This pressure helps get your blood all
around your body. Your blood
pressure may be different at different times of the day, depending on
how busy or worried you are. You
have hypertension (high blood pressure) when your blood pressure stays
higher than is needed, even
when you are calm and relaxed.
There are often no symptoms of high blood pressure. The only way of
knowing that you have high blood
pressure is to have your blood
pressure checked on a regular basis. If high blood pressure is not
treated it
can lead to serious health problems, such as stroke, heart disease and
kidney failure.
This medicine contains the active ingredients irbesartan and
hydrochlorothiazide. Both medicines reduce
blood pressure in different ways. Irbesartan belongs to a group of
medicines known as angiotensin-II
receptor antagonists. Angiotensin II is a substance produced in the
body that causes blood vessels to
narrow. Irbesartan blocks angiotensin-II and therefore widens your
blood vessels, making it easier for
your heart to pump blood throughout your body. This helps to lower
your blood pressure.
Hydrochlorothiazide belongs to the class of medicines known as
diuretics. Diure

Summary of Product characteristics

_Product Information _
_Page _
_STADA Irbesartan HCT 150mg-12.5mg, 300mg-12.5mg & 300mg-25mg tablets
_
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_STADA Irbesartan HCT PI 091112A _
_ _
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_1_
PRODUCT INFORMATION
STADA IRBESARTAN HCT 150/12.5, STADA IRBESARTAN HCT 300/12.5 &
STADA IRBESARTAN HCT 300/25 TABLETS
NAME OF THE MEDICINE
Generic name:
Irbesartan/hydrochlorothiazide
Chemical name:
Irbesartan: 2-Butyl-3-[[2'-(1H-tetrazol-5-yl)[1,1'-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
The Chemical structure of irbesartan is:
CAS number: 138402-11-6;
Empirical formula: C
25
H
28
N
6
O ;
MW: 428.53
The Chemical structure of hydrochlorothiazide is:
CAS number: 58-93-5;
Empirical formula: C
7
H
8
CIN
3
O
4
S
2
; MW: 297.73
DESCRIPTION
STADA Irbesartan HCT 150/12.5 tablets contain 150 mg of irbesartan and
12.5mg of
hydrochlorothiazide.
_Product Information _
_Page _
_STADA Irbesartan HCT 150mg-12.5mg, 300mg-12.5mg & 300mg-25mg tablets
_
_ _
_STADA Irbesartan HCT PI 091112A _
_ _
_ _
_2_
STADA Irbesartan HCT 300/12.5 tablets contain 300 mg of irbesartan and
12.5mg of
hydrochlorothiazide.
STADA Irbesartan HCT 300/25 tablets contain 300 mg of irbesartan and
25mg of
hydrochlorothiazide.
Irbesartan is a white to off-white powder. It is a relatively
non-polar compound with a
partition coefficient (octanol-water) of 10.1 at a pH of 7.4. It is
slightly soluble in
alcohol and methylene chloride and practically insoluble in water.
Hydrochlorothiazide is a white crystalline powder. It is slightly
soluble in water but
freely soluble in sodium hydroxide solution.
STADA Irbesartan HCT tablets also contain the inactive ingredients
povidone k,
magnesium stearate microcrystalline cellulose, lactose, croscarmellose
sodium,
colloidal anhydrous silica, hydrogenated castor oil, and maize starch.
PHARMACOLOGY
Pharmacodynamics and mechanism of action
Irbesartan is a specific antagonist of angiotensin II receptors (AT
1
subtype).
Angiotensin II is an important component of t