CANDESARTAN HCTZ AGH 32/25 candesartan cilexetil 32 mg & hydrochlorothiazide 25 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

candesartan cilexetil, Quantity: 32 mg; hydrochlorothiazide, Quantity: 25 mg

Available from:

Alembic Pharmaceuticals Australia Pty Ltd

INN (International Name):

Candesartan cilexetil,Hydrochlorothiazide

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: hyprolose; macrogol 8000; lactose monohydrate; maize starch; carmellose calcium; magnesium stearate; iron oxide red

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

Product summary:

Visual Identification: Light pink, oval biconvex uncoated mottled tablets debossed with 'L3' & '04' on either side of break line on one side & break line on one other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 6 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2012-12-05

Summary of Product characteristics

Candesartan HCTZ Actavis
_Candesartan cilexetil & hydrochlorothiazide tablets _
_(16mg/12.5mg, 32mg/12.5mg & 32mg/25mg) _
PRODUCT INFORMATION
NAME OF THE MEDICINE
CANDESARTAN CILEXETIL
The
chemical
name
for
candesartan
cilexetil
is
(1_RS_)‐1‐[[(Cyclohexyloxy)carbonyl]oxy]ethyl
2‐
ethoxy‐1‐[[2′‐(1_H_‐tetrazol‐5‐yl)biphenyl‐4‐yl]methyl]‐1_H_‐benzimidazole‐7‐carboxylate.
Its structural
formula is:
C
33
H
34
N
6
O
6
Molecular weight: 611
CAS No.: 145040‐37‐5
HYDROCHLOROTHIAZIDE
The chemical name is
6‐chloro‐3,4‐dihydro‐2_H_‐1,2,4‐benzothiadiazine‐7‐sulfonamide
1,1‐dioxide.
Its structural formula is:
C
7
H
8
ClN
3
O
4
S
2
Molecular weight: 297.7
CAS No.: 58‐93‐5
DESCRIPTION
Candesartan cilexetil is a white or almost white powder and is
practically insoluble in water, freely
soluble in methylene chloride and slightly soluble in anhydrous
ethanol. Three polymorphic forms
have been identified; crystal form I, crystal form II and an amorphous
form. Crystalline form I is
used in Candesartan HCTZ Actavis.
Hydrochlorothiazide is a white, crystalline powder. It is very
slightly soluble in water, soluble in
acetone, sparingly soluble in ethanol (96 per cent). It dissolves in
dilute solutions of alkali
hydroxides.
Candesartan HCTZ Actavis– Product information
Page 2 of 16
Candesartan HCTZ Actavis tablets come in three strengths and contain
16 mg of candesartan
cilexetil
and
12.5 mg
of
hydrochlorothiazide,
32
mg
of
candesartan
cilexetil
and
12.5
mg
of
hydrochlorothiazide or 32 mg of candesartan and 25 mg of
hydrochlorothiazide. The tablets also
contain
lactose,
carmellose
calcium,
maize
starch,
macrogol
8000,
hydroxypropylcellulose,
magnesium stearate, Pigment Blend PB‐24880 Pink (ARTG 108327;
16/12.5 mg and 32/25 mg
tablets only) and yellow colouring (iron oxide yellow and lactose) in
the 32/12.5 mg tablets only.
The tablets are gluten free.
PHARMACOLOGY
Angiotensin II is the primary vasoactive hormone of the
renin‐angiotensin‐aldosterone system and
plays a signi