"Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.
But the panel backed off giving any sp"...
(alendronate sodium) Tablets, Oral Solution
FOSAMAX (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclastmediated 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.
FOSAMAX tablets for oral administration contain 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 70 mg of free acid, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate.
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: sodium citrate dihydrate and citric acid anhydrous as buffering agents, sodium saccharin, artificial raspberry flavor, and purified water. Added as preservatives are sodium propylparaben 0.0225% and sodium butylparaben 0.0075%.
What are the possible side effects of alendronate (Fosamax)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using alendronate and call your doctor at once if you have any of these serious side effects:
- chest pain;
- difficulty or pain when swallowing;
- pain or burning under the ribs or in the back;
- severe heartburn, burning pain in your upper stomach, or coughing up blood;
- new or worsening heartburn;
- fever, body aches, flu symptoms;
- severe joint, bone, or muscle...
What are the precautions when taking alendronate sodium (Fosamax)?
Before taking alendronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: disorders of the esophagus (such as esophageal stricture or achalasia), trouble swallowing, trouble standing or sitting upright for at least 30 minutes, low calcium levels, stomach/intestinal disorders (such as ulcers).
Infrequently, people taking bisphosphonates have had serious jawbone problems (osteonecrosis). Poor dental hygiene, poorly fitting dentures, or having certain dental work...
Last reviewed on RxList: 5/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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