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Alendronate and cholecalciferol

 
  Generic Name: Alendronate and cholecalciferol (a LEN dro nayt and KOL e cal SIF er ol)
 
  Brand Names: 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 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 other purposes not listed in this medication guide.

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

Do not take an alendronate and cholecalciferol tablet if you cannot sit upright or stand for at least 30 minutes. This medicine 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 the medicine.

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 each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an alendronate and cholecalciferol tablet.

For at least the first 30 minutes after taking this medicine, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

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.

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

Do not take an alendronate and cholecalciferol tablet if you cannot sit upright or stand for at least 30 minutes. This medicine 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 the medicine.

Before using alendronate and cholecalciferol, 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.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take alendronate and cholecalciferol.

Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take alendronate and cholecalciferol?

Take this medication exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor.

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. Do not miss any scheduled appointments.

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 this medication 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 take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. 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 nausea, heartburn, stomach pain, diarrhea, 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. Do not lie down for at least 30 minutes after you take this medicine.

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 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 swelling.

Less serious side effects may include:

  • mild heartburn, nausea, or stomach upset;

  • diarrhea, gas, or constipation;

  • mild joint or back pain; or

  • headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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?

Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs alendronate and cholecalciferol. If you use these other medicines, do not that take them for at least 30 minutes after taking an alendronate and cholecalciferol tablet.

Before using alendronate and cholecalciferol, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

There may be other drugs that can interact with alendronate and cholecalciferol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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.
  • 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 1996-2006 Cerner Multum, Inc. Version: 2.03. Revision Date: 4/12/2009 4:45:47 PM.;
 
 
 
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