alendronate and cholecalciferol

Generic Name: alendronate and cholecalciferol (a LEN dro nate and KOL e cal SIF er ol)
Brand Name: Fosamax Plus D

What is alendronate and cholecalciferol?

Alendronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Alendronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Cholecalciferol is a form of vitamin D, and is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Alendronate and cholecalciferol is used to treat and prevent osteoporosis.

Alendronate and cholecalciferol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about alendronate and cholecalciferol?

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.

Slideshow: Flashback: FDA Drug Approvals 2013

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.

What should I discuss with my healthcare provider before taking alendronate and cholecalciferol?

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.

To make sure alendronate and cholecalciferol is safe for you, tell your doctor if you have:

  • low blood calcium (hypocalcemia);

  • a cancer such as sarcoidosis, leukemia, lymphoma;

  • a vitamin D deficiency;

  • kidney disease; or

  • an ulcer in your stomach or esophagus.

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.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. 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.

It is not known whether alendronate and cholecalciferol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take alendronate and cholecalciferol?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Alendronate and cholecalciferol tablets are taken once each week. Choose the day of the week that best fits your schedule. Every week, take one alendronate and cholecalciferol tablet on your chosen day.

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.

Do not crush, chew, or suck the tablet. Swallow the pill whole.

After taking an alendronate and cholecalciferol tablet, carefully follow these instructions:

  • Do not lie down or recline for at least 30 minutes after taking alendronate and cholecalciferol.

  • Do not eat or drink anything other than plain water.

  • Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate and cholecalciferol. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. You may not need to take alendronate and cholecalciferol for longer than 3 to 5 years if you take it for osteoporosis.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate and cholecalciferol. You may need to stop using the medicine for a short time.

Alendronate and cholecalciferol is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you forget to take alendronate and cholecalciferol on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide. Overdose may also cause muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking alendronate and cholecalciferol?

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate and cholecalciferol.

Alendronate and cholecalciferol side effects

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:

  • 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 your thigh or hip; or

  • jaw pain, numbness, or swelling.

Common side effects may include:

  • mild heartburn, stomach upset;

  • diarrhea, gas, constipation;

  • mild joint or back pain; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Alendronate and cholecalciferol Dosing Information

Usual Adult Dose for Osteoporosis:

One tablet orally once weekly. Tablet should only be swallowed upon rising for the day with a full glass of water (6 to 8 ounces) and patients should not lie down for at least 30 minutes and until after their first food of the day.

What other drugs will affect alendronate and cholecalciferol?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with alendronate and cholecalciferol, especially:

  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with alendronate and cholecalciferol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about alendronate and cholecalciferol.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.04. Revision Date: 2013-07-17, 10:47:25 AM.

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