Fosamax
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
29-05-2024
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Active ingredient:
Colecalciferol; Alendronate sodium; Calcium carbonate
Available from:
Merck Sharp & Dohme Australia Pty Ltd
Class:
Medicine Listed (Export Only)
Summary of Product characteristics
FSM-032010s
PRODUCT INFORMATION
FOSAMAX
®
(ALENDRONATE SODIUM)
TABLETS
FOSAMAX PLUS
TM
(ALENDRONATE SODIUM/COLECALCIFEROL)
FOSAMAX PLUS D-CAL
TM
(ALENDRONATE SODIUM/COLECALCIFEROL/CALCIUM)
FOSAMAX tablets contain alendronate sodium.
FOSAMAX PLUS tablets contain alendronate sodium and colecalciferol
(vitamin D
3
).
FOSAMAX PLUS D-Cal is a combination pack containing FOSAMAX PLUS
(alendronate sodium and
colecalciferol [vitamin D3]) in addition to BoneCal® tablets
(calcium carbonate).
Alendronate sodium is described chemically as:
(4-amino-1-hydroxybutylidene) bisphosphonic acid
monosodium salt trihydrate.
The empirical formula is C4H12NNaO7P2•3H2O. The formula weight
is 325.12. The CAS Registry
Number is 121268-17-5. The structural formula is:
Colecalciferol
The chemical name of colecalciferol
is (3β,5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-trien-3-ol. The
empirical
formula of colecalciferol is C
27
H
44
O and its molecular weight is 384.6. The CAS Registry Number
is 67-
97-0. The structural formula is:
CH
2
H
HO
CH
3
H
H
CH
3
H
CH
3
H
3
C
® Registered Trademark of Merck Sharp & Dohme Corp., a
subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA.
TM Trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck
& Co., Inc., Whitehouse Station, NJ, USA.
FSM-MF-032010s
2
Calcium Carbonate
Calcium carbonate is described chemically as carbonic acid calcium
salt (1:1). The empirical formula of
calcium carbonate is CaCO
3
and its molecular weight is 100.09. The CAS Registry Number
is 471-34-1.
DESCRIPTION
Alendronate sodium, MSD is a bisphosphonate that acts as a potent,
specific inhibitor of osteoclast-
mediated bone resorption. Bisphosphonates are synthetic analogs of
pyrophosphate that bind to the
hydroxyapatite found in bone.
Alendronate is a white, crystalline, nonh
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