"Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.
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Boniva Patient Information including How Should I Take
In this Article
- What is ibandronate (Boniva)?
- What are the possible side effects of ibandronate (Boniva)?
- What is the most important information I should know about ibandronate (Boniva)?
- What should I discuss with my healthcare provider before using ibandronate (Boniva)?
- How should I use ibandronate (Boniva)?
- What happens if I miss a dose (Boniva)?
- What happens if I overdose (Boniva)?
- What should I avoid while taking ibandronate (Boniva)?
- What other drugs will affect ibandronate (Boniva)?
- Where can I get more information?
What should I discuss with my healthcare provider before using ibandronate (Boniva)?
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 you can safely take ibandronate, tell your doctor if you have any of these other conditions:
- a vitamin D deficiency;
- kidney disease;
- an ulcer in your stomach or esophagus; or
- trouble swallowing.
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 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 (Boniva)?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. 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. 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. Visit your doctor regularly.
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.
Additional Boniva Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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