Ibandronate - Medical Health Care Library Wiki


Main Article	Precautions	Side Effects	Forum

Ibandronate

	Original Author Healthocrates Staff
	Physician/Scientist No contributions yet. Be the first!
	Health Care Professional No contributions yet. Be the first!
	Contributing Member No contributions yet. Be the first!
	Add New Topic Tab

IMPORTANT WARNING:

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?

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?

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

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

What storage conditions are needed for this medicine?

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

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?

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.

Brand names

Boniva®

Notes:

[Watch page ]

EditText of this page (last edited March 11, 2008)