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 other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking ibandronate?
You should not use this medication if you are allergic to ibandronate, or if you have low
blood levels of calcium (hypocalcemia).
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 (the tube that connects your
mouth and stomach). You will need to stay upright for at least 60 minutes after taking this medication.
If you have any of these other conditions, you may need a dose adjustment or special tests to
safely use this medication:
Some people using medicines similar to ibandronate 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. It is not known whether ibandronate is harmful to an unborn
baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant
during treatment.
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 take ibandronate?
Use ibandronate exactly as it was prescribed for you. Do not use the medication in larger
amounts or for longer than recommended by your doctor. Follow the directions on your prescription
label.
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. Your
doctor, nurse, or other healthcare professional will give you the ibandronate 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 on a regular basis. It is important that you not miss any scheduled visits to
your doctor.
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 ibandronate tablets at room temperature away from moisture and heat.
What happens if I miss a dose of ibandronate?
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 once a month:
Call your doctor for
instructions if you miss an appointment for your injection.
Where can I get more information about ibandronate?
Your pharmacist has information about ibandronate written for health professionals that you may read.
What are the possible side effects of ibandronate?
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 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:
-
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.
What is the most important information I should know about ibandronate?
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 (the tube that connects your
mouth and stomach). You will need to stay upright for at least 60 minutes after taking this medication.
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.
Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral
water) when taking an ibandronate tablet.
For at least the first 60 minutes after taking an ibandronate 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 ibandronate 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 problems.
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.
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.
Do not lie down for at least 1 hour (60 minutes) after you take an ibandronate tablet.
What other drugs will affect ibandronate?
Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, iron or other
minerals can interfere with how your body absorbs ibandronate. If you use these other medicines, do
not that take them for at least 60 minutes after taking an ibandronate tablet.
Before using ibandronate, 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.
This list is not complete and there may be other drugs that can interact with ibandronate. 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.
What happens if I have an overdose of ibandronate?