MedlinePlus Drug Information: Ibandronate

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Ibandronate

(i ban' droh nate)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?	What side effects can this medication cause? What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know? Brand names

IMPORTANT WARNING: Return to top

[Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates and http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm.

[Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.

FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast (zoledronic acid). Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.

Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Bisphosphonates and http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm.

Why is this medication prescribed? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Ibandronate is used to prevent and treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change of life,' end of menstrual periods). Ibandronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).

How should this medicine be used? Return to top

Ibandronate comes as a tablet to take by mouth. The 2.5-mg tablet is usually taken once a day in the morning on an empty stomach and the 150-mg tablet is usually taken once a month in the morning on an empty stomach. The 150-mg tablet should be taken on the same date each month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ibandronate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ibandronate may not work properly and may damage the esophagus (tube between the mouth and stomach) or cause sores in the mouth if it is not taken according to the following instructions. Tell your doctor if you do not understand, you do not think you will remember, or you are unable to follow these instructions:

You must take ibandronate just after you get out of bed in the morning, before you eat or drink anything. Never take ibandronate at bedtime or before you wake up and get out of bed for the day.
Swallow the tablets with a full glass (6 to 8 ounces, about 1 cup) of plain water. Never take ibandronate with tea, coffee, juice, milk, mineral water, sparkling water, or any liquid other than plain water.
Swallow the tablets whole; do not split, chew, or crush them. Do not suck on the tablets.
After you take ibandronate, do not eat, drink, or take any other medications (including vitamins or antacids) for at least 60 minutes. Do not lie down for at least 60 minutes after you take ibandronate. Sit upright or stand upright for at least 60 minutes.

Ibandronate controls osteoporosis but does not cure it. Ibandronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take ibandronate even if you feel well. Do not stop taking ibandronate without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow? Return to top

Before taking ibandronate,

tell your doctor and pharmacist if you are allergic to ibandronate or any other medications, or any of the ingredients in ibandronate tablets. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Naprosyn, Aleve) cancer chemotherapy; and oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
if you are taking any oral medications, including supplements, vitamins, or antacids, take them at least 60 minutes after you take ibandronate.
tell your doctor if you are unable to sit upright or stand upright for at least 60 minutes and if you have or have ever had a low level of calcium in your blood. Your doctor may tell you not to take ibandronate.
tell your doctor if are undergoing radiation therapy and if you have or have ever had anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); difficulty swallowing; heartburn; ulcers or other problems with your stomach or esophagus; cancer; any type of infection, especially in your mouth; problems with your mouth, teeth, or gums; any condition that stops your blood from clotting normally; or dental or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.Also tell your doctor if you plan to become pregnant at any time in the future, because ibandronate may remain in your body for many years after you stop taking it. Call your doctor if you become pregnant during or after your treatment.
you should know that ibandronate may cause serious problems with your jaw, especially if you have dental surgery or treatment while you are taking the medication.A dentist should examine your teeth and perform any needed treatments before you start to take ibandronate. Be sure to brush your teeth and clean your mouth properly while you are taking ibandronate. Talk to your doctor before having any dental treatments while you are taking this medication.
talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.

What special dietary instructions should I follow? Return to top

You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking ibandronate. Your doctor will tell you which foods and drinks are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor may prescribe or recommend a supplement.

What should I do if I forget a dose? Return to top

If you forget to take the daily 2.5-mg tablet, do not take it later in the day.Skip the missed dose and continue your regular dosing schedule the next morning. Do not take two tablets of ibandronate on the same day.

If you forget to take the once-monthly 150-mg tablet, and your next scheduled day to take ibandronate is more than 7 days away, take one tablet the morning after you remember. Then return to taking one tablet each month on the regularly scheduled date. If you forget to take the once-monthly 150-mg tablet and your next scheduled day to take ibandronate is 7 or fewer days away, skip the dose and wait for your next scheduled day. You should not take two 150-mg tablets of ibandronate within 1 week.

If you are not sure what to do if you miss a dose of ibandronate, call your doctor.

What side effects can this medication cause? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Ibandronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

nausea
stomach pain
diarrhea
constipation
back pain
bone, joint, or muscle pain
pain in the arms or legs
weakness
dizziness
headache
flu-like symptoms
fever, sore throat, chills, cough, and other signs of infection
frequent or urgent need to urinate
painful urination

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately before you take any more ibandronate:

new or worsening heartburn
difficulty swallowing
pain on swallowing
chest pain
rash
painful or swollen gums
loosening of the teeth
numbness or heavy feeling in the jaw
poor healing of the jaw
eye pain

Ibandronate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine? Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose Return to top

In case of overdose, give the victim a full glass of milk and call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. Do not allow the victim to lie down and do not try to make the victim vomit. Do not lie down.

Symptoms of overdose may include:

nausea
stomach pain
heartburn

What other information should I know? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor. Your doctor may order certain tests to check your body's response to ibandronate.

Before having any bone imaging study, tell your doctor and health care personnel that you are taking ibandronate

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Boniva®

Last Revised - 10/01/2007
Last Reviewed - 10/01/2005

American Society of Health-System Pharmacists, Inc. Disclaimer