Alendronate Sodium Solution
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Uses
Alendronate Sodium Oral Solution 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) [see Clinical Studies (14.1)].
Alendronate Sodium Oral Solution is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].
The safety and effectiveness of alendronate for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
History
There is currently no drug history available for this drug.
Other Information
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. The structural formula is:
Alendronate sodium is a white, crystalline, nonhygroscopic 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), methyl paraben, propylparaben, raspberry blend, saccharin sodium, and sodium citrate.
Sources
Alendronate Sodium Solution Manufacturers
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Tagi Pharma, Inc.
![Alendronate Sodium Solution [Tagi Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Alendronate Sodium Solution | Tagi Pharma, Inc.
2.1 Treatment of Osteoporosis in Postmenopausal WomenThe recommended dosage is:
one bottle of 70 mg oral solution once weekly 2.3 Treatment to Increase Bone Mass in Men with OsteoporosisThe recommended dosage is:
one bottle of 70 mg oral solution once weekly 2.6 Dosing InstructionsAlendronate must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information (17.2)]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate [see Drug Interactions (7.1)]. Waiting less than 30 minutes, or taking alendronate with food, beverages (other than plain water) or other medications will lessen the effect of alendronate by decreasing its absorption into the body.
Alendronate should only be taken upon arising for the day. To facilitate gastric emptying alendronate oral solution should be followed by at least 2 oz (a quarter of a cup) of water. Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences [see Warnings and Precautions (5.1) and Patient Counseling Information (17.2)].
2.7 Recommendations for Calcium and Vitamin D SupplementationPatients should receive supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Dosing in Severe Renal ImpairmentAlendronate is not recommended for patients with creatinine clearance <35 mL/min due to lack of experience in this population [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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