Ibandronate (Systemic)
   
Ibandronate (Systemic)
Description
Ibandronate (i-BAN-dro-nate) is used to treat or prevent osteoporosis (thinning of the bone) in women after menopause
This medicine is available only with your doctor's prescription, in the following dosage forms:
Special Considerations
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ibandronate, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to ibandronate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Diet
Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet. Your doctor may recommend that you eat a balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products).
Pregnancy
Ibandronate has not been studied in pregnant women. However, studies in animals have shown that ibandronate may causes birth defects and other pregnancy problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.
Breast-feeding
It is not known whether ibandronate passes into breast milk. However, this medicine has been reported to pass into the milk of lactating rats.
Children
Studies on this medicine have been done only in adult patients and there is no specific information comparing use of ibandronate in children with use in other age groups.
Older adults
This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Other medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.
Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other medical problems
The presence of other medical problems may affect the use of ibandronate. Make sure you tell your doctor if you have any other medical problems, especially:
• Hypocalcemia (low calcium levels in the blood)-Must be treated first, before beginning treatment with ibandronate
• Digestion problems-Taking ibandronate may be harmful to the esophagus, intestine, or stomach
• Esophagus problems or
• Intestine problems or
• Stomach problems-Ibandronate may make these conditions worse
• Kidney problems-The effects of ibandronate may be increased
Administration
Take ibandronate with a full glass (6 to 8 ounces) of plain water on an empty stomach . It should be taken in the morning at least 60 minutes before any food, beverage, or other medicines. Food and beverages, such as mineral water, coffee, tea, or juice, will decrease the amount of ibandronate absorbed by the body. Waiting longer than 60 minutes will allow more of the drug to be absorbed. Medicines such as antacids, calcium or vitamin supplements will also decrease the absorption of ibandronate.
Do not lie down for 60 minutes after taking ibandronate . This will help ibandronate reach your stomach faster. It will also help prevent irritation to your esophagus.
Your doctor may recommend that you eat a balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). However, do not take any food, beverages, or calcium or vitamin supplements within 60 minutes or longer of taking ibandronate. To do so may keep this medicine from working properly.
Dosing
The dose of ibandronate will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of ibandronate. If your dose is different, do not change it unless your doctor tells you to do so.
• For oral dosage form (tablets):
o For treatment of postmenopausal osteoporosis (thinning of bone)
§ Adults-2.5 mg once a day in the morning, taken at least 60 minutes before the first food, beverage, or medication. You should take ibandronate with six to eight ounces of plain water.
§ Children-Use and dose must be determined by your doctor.
o For prevention of postmenopausal osteoporosis (thinning of bone)
§ Adults-2.5 mg once a day in the morning, taken at least 60 minutes before the first food, beverage, or medication. You should take ibandronate with six to eight ounces of plain water.
§ Children-Dose must be determined by your doctor.
Missed dose
If you miss a dose of this medicine, do not take it later in the day. Resume your schedule the next morning. Do not double doses.
Storage
To store this medicine:
• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.
Precautions
It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and watch for unwanted effects.
Importance of not lying down for at least 60 minutes after taking ibandronate.
Importance of taking ibandronate at least 60 minutes before first food, beverage, or medication of the day.
Importance of taking antiacids, calcium supplements, or other product containing aluminum, iron, or magnesium at least 60 minutes after ibandronate.
Use of aspirin or nonsteroidal anti-inflammatory drugs (e.g. Aleve, Motrin) may increase your risk for stomach problems.
Do not chew or suck on the tablet. Swallow whole with 6 to 8 ounces of plain water.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Bladder pain; bloody or cloudy urine; chest pain; cough producing mucus; difficulty breathing; difficult, burning, or painful urination; fever or chills; frequent urge to urinate; lower back or side pain; shortness of breath; sneezing; sore throat; tightness in chest; wheezing.
Less common
Body aches or pain; congestion; difficulty swallowing; dizziness; dryness of throat; fast heartbeat; hives; hoarseness; itching; large amount of cholesterol in the blood; numbness; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; runny nose; skin rash; tender, swollen glands in neck; tingling; trouble in swallowing; unusual tiredness or weakness; voice changes.
Incidence unknown
Blurred vision or other change in vision; eye redness; eye tenderness; sensitivity to light; severe eye pain; tearing.
Symptoms of Overdose
Get emergency help immediately if any of the following symptoms of overdose occur
Abdominal cramps; acid or sour stomach; belching; bone pain; burning feeling in chest or stomach; chest pain; confusion; convulsions; difficulty in breathing; difficulty in swallowing; heartburn; indigestion; irregular heartbeats; loss of appetite; mood or mental changes; muscle cramps in hands, arms, feet, legs, or face; numbness and tingling around the mouth, fingertips, or feet; pain or burning in throat; shortness of breath; stomach discomfort upset or pain; sores, ulcers; tenderness in stomach area; tremor; ulcer; unusual tiredness or weakness; upset stomach; vomiting; white spots on lips or tongue or inside the mouth.
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.
More Common
Acid or sour stomach; belching; diarrhea; ear congestion; headache; heartburn; indigestion; loss of voice; pain in extremity (arms and legs); stomach discomfort, upset or pain.
Less common
Difficulty in moving; feeling of constant movement of self or surroundings; lack or loss of strength; lightheadedness; muscle pain or stiffness; pain, swelling, or redness in joints; sensation of spinning; tooth disorder; vomiting.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
June 04, 2004 
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