ibandronate

Pronunciation

Generic Name: ibandronate (eye BAN dro nate)
Brand Name: Boniva, Bondronat

What is ibandronate?

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

Ibandronate is used to treat or prevent osteoporosis in women after menopause.

Ibandronate may also be used for purposes not listed in this medication guide.

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

You should not use this medication if you are allergic to ibandronate, or if you have severe kidney disease, low blood levels of calcium (hypocalcemia), or a problem with your esophagus (the tube that connects your mouth and stomach).

Slideshow: Flashback: FDA Drug Approvals 2013

Do not take an ibandronate tablet if you cannot sit upright or stand for at least one full hour. Ibandronate can cause serious problems in the stomach or esophagus. You will need to stay upright for at least 60 minutes after taking this medication.

What should I discuss with my healthcare provider before using ibandronate?

You should not use this medication if you are allergic to ibandronate, or if you have severe kidney disease, low blood levels of calcium (hypocalcemia), or a problem with your esophagus (the tube that connects your mouth and stomach).

Do not take an ibandronate tablet if you cannot sit upright or stand for at least one full hour. Ibandronate can cause serious problems in the stomach or esophagus. You will need to stay upright for at least 60 minutes after taking this medication.

To make sure ibandronate is safe for you, tell your doctor if you have:

  • a vitamin D deficiency;

  • kidney disease;

  • an ulcer in your stomach or esophagus; or

  • trouble swallowing.

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 ibandronate, 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.

FDA pregnancy category C. It is not known whether ibandronate 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 ibandronate 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 use ibandronate?

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

Ibandronate tablets are taken either once each day or once each month. Ibandronate intravenous solution is given as an injection into one of your veins once every three (3) months. A healthcare provider will give you this injection. Ibandronate tablets can be taken at home.

Take the ibandronate tablet first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything or take any other medicine. If you take an ibandronate tablet only once a month, take it on the same day each month and always first thing in the morning.

Take each ibandronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an ibandronate tablet.

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

After taking an ibandronate tablet, carefully follow these instructions:

  • Do not lie down or recline for at least 60 minutes after taking ibandronate.

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

  • Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes after taking ibandronate. 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 often. You may not need to take ibandronate for longer than 3 to 5 years.

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

Ibandronate 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 take ibandronate 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 two (2) tablets in one day.

If you take ibandronate tablets once a month: If you forget to take ibandronate 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 monthly schedule on your chosen dose day. If your next scheduled dose is less than 7 days away, wait until then to take the medicine and skip the missed dose. Do not take two (2) tablets in one week.

If you receive ibandronate injections every 3 months: Call your doctor for instructions if you miss an appointment for your injection.

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 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 ibandronate?

Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes before or after taking an ibandronate tablet.

Avoid milk and other dairy products for at least 60 minutes after taking ibandronate (except in the case of overdose as stated above).

Ibandronate 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 ibandronate 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;

  • 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:

  • back pain, headache;

  • redness or swelling of your eyes;

  • diarrhea;

  • flu symptoms;

  • redness or swelling where the medicine was injected;

  • nausea or upset stomach; or

  • pain in your arms or legs.

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)

Ibandronate Dosing Information

Usual Adult Dose for Osteoporosis:

2.5 mg orally once daily
150 mg orally once monthly on the same day each month
3 mg by bolus intravenous injection over 15 to 30 seconds every three months.

Duration: For patients at low risk for fracture, consider discontinuation after 3 to 5 years of treatment. An optimum duration of treatment has not been determined.

Comments:
Oral ibandronate should be administered with 6 to 8 ounces of plain water at least 60 minutes before the first food, beverage or medication of the day. Beverages other than water, food, and certain medications reduce the absorption of ibandronate. Plain water is the only drink that should be taken with ibandronate. Some mineral waters may have a higher concentration of calcium and therefore should not be used.

Patients should remain upright (standing or sitting) for at least 60 minutes following administration of oral ibandronate.

Usual Adult Dose for Prevention of Osteoporosis:

2.5 mg orally once daily
150 mg orally once monthly on the same day each month
3 mg by bolus intravenous injection over 15 to 30 seconds every three months.

Duration: For patients at low risk for fracture, consider discontinuation after 3 to 5 years of treatment. An optimum duration of treatment has not been determined.

Comments:
Oral ibandronate should be administered with 6 to 8 ounces of plain water at least 60 minutes before the first food, beverage or medication of the day. Beverages other than water, food, and certain medications reduce the absorption of ibandronate. Plain water is the only drink that should be taken with ibandronate. Some mineral waters may have a higher concentration of calcium and therefore should not be used.

Patients should remain upright (standing or sitting) for at least 60 minutes following administration of oral ibandronate.

What other drugs will affect ibandronate?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ibandronate, 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 ibandronate, 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 ibandronate.
  • 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: 9.03. Revision Date: 2013-05-30, 4:01:10 PM.

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