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Generic Name: alendronate (a LEN dro nate)
Brand Names: Fosamax

What is alendronate?

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.

Alendronate is used to treat or prevent postmenopausal osteoporosis and steroid-induced osteoporosis. Alendronate is also used to treat Paget's disease of bone.

Alendronate may also be used for purposes other than those listed in this medication guide.

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

Do not take an alendronate 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.

Take the alendronate 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 tablet.

For at least the first 30 minutes after taking an alendronate tablet, 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 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?

Do not take an alendronate 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.

Before using alendronate, tell your doctor if you have:

• low blood calcium (hypocalcemia);

• a vitamin D deficiency;

• kidney disease; or

• an ulcer in your stomach or esophagus.

If you have any of these conditions, you may not be able to use alendronate, or you may need a dosage adjustment or special tests during treatment.

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?

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

Alendronate tablets are taken either once each day or once each week.

Take the alendronate tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take an alendronate tablet only once a week, take it on the same day each week and always first thing in the morning.

Take each alendronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an alendronate tablet. Do not crush, chew, or suck the alendronate tablet. Swallow the pill whole.

After taking an alendronate tablet, carefully follow these instructions:

• Do not lie down or recline for at least 30 minutes after taking alendronate.
• 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. 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. It is important that you not miss any scheduled visits to your doctor.

Alendronate 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 alendronate tablets at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take alendronate tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take take two (2) tablets in one day.

If you take alendronate tablets once a week: If you forget to take alendronate 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.

Symptoms of an alendronate overdose 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?

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking an alendronate tablet. Do not lie down for at least 30 minutes after you take an alendronate tablet.

Alendronate 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 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.

Continue using alendronate and talk with your doctor if you have any of these less serious side effects:

• mild heartburn or stomach upset;

• diarrhea, gas, or constipation;

• joint pain or swelling;

• swelling in your hands or feet;

• back pain; or

• dizziness, weakness, or headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect alendronate?

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

Before using alendronate, 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 affect alendronate. 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 has more information about alendronate written for health professionals that you may read.

What does my medication look like?

Alendronate is available with a prescription under the brand name Fosamax. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Fosamax 10 mg--white, round tablets with a bone image

• Fosamax 35 mg-white, oval tablets

• Fosamax 40 mg--white, triangular tablets

• Fosamax 70 mg-white, oval tablets

• Fosamax Oral Solution 70 mg-clear, colorless, raspberry-flavored solution

• 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: 6.04. Revision Date: 2/2/07 11:45:35 AM.