Fosamax Plus D
"The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis."...
Fosamax Plus D
FOSAMAX® PLUS D
(alendronate sodium/cholecalciferol) Tablets
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.
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. The structural formula is:
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 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.
What are the possible side effects of alendronate and cholecalciferol (Fosamax Plus D)?
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 cholecalciferol and call your doctor at once if you have a serious side effect such as:
- chest pain;
- difficulty or pain when swallowing;
- pain or burning under the ribs or in the back;
- new or worsening heartburn;
- severe joint, bone, or muscle pain;
- new or unusual pain in your thigh or hip; or
- jaw pain, numbness,...
What are the precautions when taking alendronate sodium and cholecalciferol (Fosamax Plus D)?
Before taking alendronate/vitamin D3, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or to other vitamin D products; 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, kidney problems, stomach/intestinal disorders (such as ulcers).
Some people taking alendronate/vitamin D3 may have serious jawbone problems. Your doctor should check your mouth...
Last reviewed on RxList: 4/24/2015
This monograph has been modified to include the generic and brand name in many instances.
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