ACTONEL COMBI risedronate sodium 35mg and calcium carbonate 1250mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcium carbonate,risedronate sodium

Available from:

Theramex Australia Pty Ltd

INN (International Name):

Calcium carbonate,Risedronate sodium

Authorization status:

Registered

Summary of Product characteristics

ACTONEL
®
, ACTONEL COMBI & ACTONEL COMBI D PI V2 160511
1
PRODUCT INFORMATION
ACTONEL
®
, ACTONEL COMBI & ACTONEL COMBI D
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Risedronate, Calcium carbonate, Cholecalciferol
NON-PROPRIETARY NAME
Risedronate
Each Actonel tablet contains the equivalent of 5, 30, 35, 75 or 150 mg
of risedronate sodium. The
empirical formula for risedronate sodium is C
7
H
10
NO
7
P
2
Na. The chemical name of risedronate
sodium is [1-hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid)
monosodium salt.
Calcium Carbonate Tablet
Also contains 1250 mg calcium carbonate tablets. Each calcium tablet
contains 1250 mg calcium
carbonate, which is equivalent to 500 mg elemental calcium.
Calcium Carbonate/Cholecalciferol Sachet
Each sachet contains 2500 mg calcium carbonate and 22
µ
g (880 IU) cholecalciferol, which is
equivalent to 1000 mg elemental calcium and 22
µ
g (880 IU) vitamin D3. The terms cholecalciferol
and
vitamin
D3
are
equivalent.
The
chemical
name
of
cholecalciferol
is
(5Z,7E)-9,10-
secocholesta-5,7,10(19)-trien-3β-ol. Molecular formula: C
27
H
44
O.
CHEMICAL STRUCTURE
The chemical structure of risedronate sodium is the following:
Molecular Weight: 305.10
The CAS registry number is 115436-72-1
The chemical structure of cholecalciferol:
Molecular Weight: 384.6
The CAS registry number is 67-97-0
DESCRIPTION
Risedronate sodium is a fine, white to off-white, odourless,
crystalline powder. It is soluble in water
and in aqueous solutions and essentially insoluble in common organic
solvents.
Calcium carbonate is a white powder, practically insoluble in water,
with a relative molecular
weight of 100.1.
ACTONEL
®
, ACTONEL COMBI & ACTONEL COMBI D PI V2 160511
2
Cholecalciferol is a secosterol that is a natural precursor of the
calcium-regulating hormone
calcitriol (1,25-dihydroxyvitamin).
Risedronate
Each Actonel tablet contains risedronate sodium (5, 30, 35, 75 or 150
mg), lactose (5, 30 or 35 mg
tablets
only),
crospovidone,
magnesium
stearate,
microcrystalline
cellulose,
hydroxypropy