Alendronate and Cholecalciferol

Alendronate and Cholecalciferol is a combination prescription medication used to treat and prevent osteoporosis. 

• Alendronate and Cholecalciferol are available under various brand names: Fosamax Plus D 

Common side effects of Alendronate and Cholecalciferol include:

• mild heartburn, stomach upset.
• diarrhea, gas, constipation.
• mild joint or back pain; or
• headache.

Serious side effects of Alendronate and Cholecalciferol include:

• hives. 
• difficulty breathing. 
• swelling of the face, lips, tongue, or throat.
• chest pain, new or worsening heartburn.
• 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 the thigh or hip; or
• jaw pain, numbness, or swelling.

Rare side effects of Alendronate and Cholecalciferol include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet, effervescent

• 70 mg (generic, Binosto)

Solution, oral

• 70 mg/75 mL (generic, Fosamax)

Osteoporosis, fracture risk reduction (males and postmenopausal females): 

Adult dosage

Oral

• Take the alendronate and cholecalciferol tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.
• Take the tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking this medicine.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Alendronate and Cholecalciferol have severe interactions with the following drugs:
  • human parathyroid hormone, recombinant
• Alendronate and Cholecalciferol have serious interactions with no other drugs.
• Alendronate and Cholecalciferol have moderate interactions with the following drugs:
  • aluminum hydroxide
  • calcium acetate
  • calcium carbonate
  • calcium chloride
  • calcium citrate
  • calcium gluconate
  • deferasirox
  • magnesium supplement
  • nizatidine
  • selenium
  • sodium bicarbonate
  • sodium citrate/citric acid
  • sodium sulfate/? magnesium sulfate/potassium chloride
  • sodium sulfate/potassium sulfate/magnesium sulfate
  • sucroferric oxyhydroxide
  • dimagnesium citrate anhydrous
  • voclosporin
  • zinc
• Alendronate and Cholecalciferol have minor interactions with at least 39 other drugs.

Contraindications

• You should not take this medicine if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.
• Do not take this medicine tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Alendronate and Cholecalciferol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Alendronate and Cholecalciferol?”

Cautions

• You should not take this medicine if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.
• Do not take this medicine tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.
• In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use alendronate and cholecalciferol, the more likely you are to develop this condition.
• Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Pregnancy and Lactation

• It is not known whether alendronate and cholecalciferol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
• Lactation
  • It is not known whether alendronate and cholecalciferol pass into breast milk or if they could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.