Alendronicdrug info
alendronic acid 0.933 MG/ML Oral Solution
What it is used for
1 INDICATIONS & USAGE Alendronate Sodium Oral Solution is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women Treatment to increase bone mass in men with osteoporosis Limitations of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.
1.1 Treatment of
Osteoporosis in Postmenopausal Women Alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
1.3 Treatment to
Increase Bone Mass in Men with Osteoporosis Alendronate sodium is indicated for treatment to increase bone mass in men with osteoporosis.
1.6 Important
Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of alendronate for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 29, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Alendronate Sodium Oral Solution 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 C 4 H 12 NNaO 7 P 2 ·3H 2 O and its formula weight is 325.12.
The structural formula is: Alendronate sodium USP is a white powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each bottle of the oral solution contains 91.35 mg of alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg of free acid. Each bottle also contains the following inactive ingredients: citric acid (anhydrous), methylparaben, propylparaben, purified water, raspberry flavor, saccharin sodium and sodium citrate dihydrate. structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 29, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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