Olmesartan/HCT Sandoz 20/25 olmesartan medoxomil/hydrochlorothiazide 20/25 mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olmesartan medoxomil, Quantity: 20 mg; hydrochlorothiazide, Quantity: 25 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Hydrochlorothiazide,Olmesartan medoxomil

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; purified water; hyprolose; microcrystalline cellulose; hypromellose; magnesium stearate; titanium dioxide; iron oxide yellow; macrogol 4000

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: 20/25 mg film coated tablets are yellow film coated, oval shaped, biconvex tablets debossed with L400 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-02-05

Summary of Product characteristics

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PRODUCT INFORMATION
OLMESARTAN / HCT SANDOZ 20/12.5, 20/25, 40/12.5, 40/25 TABLETS
NAME OF THE MEDICINE
OLMESARTAN / HCT SANDOZ contains the active ingredients olmesartan
medoxomil and
hydrochlorothiazide (HCTZ).
Olmesartan medoxomil is a prodrug, hydrolysed to olmesartan during
absorption from the
gastrointestinal tract. Olmesartan is a selective AT
1
subtype angiotensin II receptor
antagonist. HCTZ is a thiazide diuretic.
Olmesartan medoxomil (CAS no. 144689-63-4) is described chemically as
2,3-dihydroxy-2-
butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[
_p_
-(
_o_
-1H-tetrazol-5-ylphenyl) benzyl]
imidazole-5-carboxylate, cyclic 2,3-carbonate.
Its empirical formula is C
29
H
30
N
6
O
6
and its structural formula is:
HCTZ (CAS no. 58-93-5) is described chemically as
6-chloro-3,4-dihydro-2
_H_
-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide.
The empirical formula is C
7
H
8
ClN
3
O
4
S
2
and the structural formula is:
DESCRIPTION
Olmesartan medoxomil is a white to light yellowish-white powder or
crystalline powder with a
molecular weight of 558.59. It is practically insoluble in water and
sparingly soluble in
methanol.
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_Version 01_
HCTZ is a white, or almost white, crystalline powder, with a molecular
weight of 297.7.
HCTZ is very slightly soluble in water, soluble in acetone, sparingly
soluble in alcohol.
It dissolves in dilute solutions of alkali hydroxides.
OLMESARTAN / HCT SANDOZ is available for oral use as film-coated
tablets containing
20/12.5 mg, 20/25 mg, 40/12.5 mg, or 40/25 mg olmesartan
medoxomil/HCTZ.
OLMESARTAN / HCT SANDOZ tablets also contain the following inactive
ingredients:
+cellulose - microcrystalline, lactose monohydrate, hyprolose,
magnesium stearate,
hypromellose and OPADRY complete film coating system 03F82788 Yellow.
PHARMACOLOGY
PHARMACODYNAMI