Fosamax Plus D (Alendronate Sodium & Cholecalciferol) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

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Paget's Disease »

What is Paget's disease?

Paget's disease is a chronic condition of bone characterized by disorder of the normal bone remodeling process. Normal bone has a balance of forces that act to lay down new bone and take up old bone. This relationship (referred to as "bone remodeling") is essential for maintaining the normal calcium levels in our blood. In bone affected by Paget's disease, the bone remodeling is disturbed and not synchronized. As a result, the bone that is formed is abnormal, enlarged, not as dense, brittle, and prone to breakage (fracture).

Paget's disease affects older skeletal bone of adults. It's estimated that 1% of adults in the U.S. have Paget's disease. There is also an extremely rare form of Paget's disease in children, referred to as juvenile Paget's disease. Paget's disease is also known as osteitis deformans.

What causes Paget's disease?

It is not known what causes Paget's disease. Recently, certain...

Read the Paget's Disease article »

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FOSAMAX PLUS D®
(alendronate sodium/cholecalciferol) Tablets

DRUG DESCRIPTION

FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 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. The structural formula is:

Alendronate sodium Structural Formula Illustration

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. The structural formula is:

Cholecalciferol Structural Formula Illustration

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 (alendronate sodium & cholecalciferol) 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 meg 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.

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 this medicine 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;
new or worsening heartburn;
severe joint, bone, or muscle pain; or
jaw pain, numbness, or...

Read All Potential Side Effects and See Pictures of Fosamax Plus D »

What are the precautions when taking alendronate sodium & 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, stomach/intestinal disorders (such as ulcers).

Infrequently, people taking bisphosphonates have had serious jawbone problems (osteonecrosis). Poor dental hygiene, poorly...

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Last reviewed on RxList: 3/11/2011
This monograph has been modified to include the generic and brand name in many instances.