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Fosamax Plus D™
(alendronate sodium/cholecalciferol)
Tablets
See: Foasmax
FOSAMAX PLUS D contains alendronate sodium, a bisphosphonate, and
cholecalciferol (vitamin D3).
Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of
osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of
pyrophosphate that bind to the hydroxyapatite found in bone.
Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene)
bisphosphonic acid monosodium salt trihydrate.
The empirical formula of alendronate sodium is C4H12NNaO7P2•3H2O and its formula
weight is 325.12.
Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble
in water, very slightly soluble in alcohol, and practically insoluble in
chloroform.
Cholecalciferol (vitamin D3) is a secosterol that is the natural precursor of
the calcium-regulating hormone calcitriol (1,25 dihydroxyvitamin D3).
The chemical name of cholecalciferol is
(3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol. The empirical formula of
cholecalciferol is C27H44O and its molecular weight is 384.6.
Cholecalciferol is a white, crystalline, odorless powder. Cholecalciferol is
practically insoluble in water, freely soluble in usual organic solvents, and
slightly soluble in vegetable oils.
FOSAMAX PLUS D for oral administration contains 91.37 mg of alendronate
monosodium salt trihydrate, the molar equivalent of 70 mg of free acid, and 70
or 140 mcg of cholecalciferol, equivalent to 2800 or 5600 International Units (IU)
vitamin D, respectively. Each tablet contains the following inactive
ingredients: microcrystalline cellulose, lactose anhydrous, medium chain
triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon
dioxide, magnesium stearate, butylated hydroxytoluene, modified food starch, and
sodium aluminum silicate.
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