IBANDRONATE (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
- Bone resorption inhibitor
Description
Ibandronate (i-BAN-dro-nate) is usedto treat or prevent osteoporosis (thinning of the bone) in women after menopause.
This medicine is available only with your doctor's prescription, in thefollowing dosage forms:
Before Using This Medicine
In decidingto use a medicine, the risks of taking the medicine must be weighed againstthe good it will do. This is a decision you and your doctor will make. Foribandronate, the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to ibandronate. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.
Pregnancy?Ibandronate has not been studied in pregnant women.However, studies in animals have shown that ibandronate may causes birth defectsand other pregnancy problems. Before taking this medicine, make sure yourdoctor knows if you are pregnant or if you may become pregnant.
Breast-feeding?It is not known whether ibandronate passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.
Children?Studies on this medicine have been done only inadult patients and there is no specific information comparing use of ibandronatein children with use in other age groups.
Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary.
Tell your health care professional if you are taking any other prescriptionor nonprescription (over-the-counter [OTC]) medicine.
Other medical problems?The presence of other medicalproblems may affect the use of ibandronate. Make sure you tell your doctorif you have any other medical problems, especially:
- Hypocalcemia (low calcium levels in the blood)?Must be treatedfirst, before beginning treatment with ibandronate
- Inability to stand or sit upright for at least 60 minutes?Youshould not take this medicine because it could cause serious problems to youresophagus and stomach.
- Anemia or
- Blood clotting problems or
- Cancer or
- Cancer treatment or
- Dental or oral disease or
- Infection?May put you at risk for a serious jaw problem
- Asian or Caucasian race or
- Family history of osteoporosis or
- Other bone problems or
- Previous broken bone or
- Smoking or
- Thin body frame?These conditions may make it more difficultfor this medicine to prevent osteoporosis.
- Digestion problems?Taking ibandronate may be harmful to theesophagus, 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.
Proper Use of This Medicine
Make certainyour health care professional knows if you are on any special diet, such asa low-sodium or low-sugar diet. Your doctor may recommend that you eat a balanceddiet with an adequate amount of calcium and vitamin D (found in milk or otherdairy products).
Take ibandronate with a full glass (6 to 8 ounces)of plain water on an empty stomach. It should be taken in the morningat least 60 minutes before any food, beverage, or other medicines. Food andbeverages, such as mineral water, coffee, tea, or juice, will decrease theamount of ibandronate absorbed by the body. Waiting longer than 60 minuteswill allow more of the drug to be absorbed. Medicines such as antacids, calciumor 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 alsohelp prevent irritation to your esophagus.
Your doctor may recommend that you eat a balanced diet with an adequateamount of calcium and vitamin D (found in milk or other dairy products). However,do not take any food, beverages, or calcium or vitamin supplements within60 minutes or longer of taking ibandronate. To do so may keep this medicinefrom working properly.
For the injection: You will receive this medicinefrom a healthcare professional every 3 months. You should not receive thisinjection more often than every 3 months.
Dosing?The dose of ibandronate will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe 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):
- For treatment of postmenopausal osteoporosis (thinning of bone)
- Adults?2.5 mg once a day in the morning or 150 mg once a monthon the same date each month, taken at least 60 minutes before the first food,beverage, or medication. You should take ibandronate with six to eight ouncesof plain water.
- Children?Use and dose must be determined by your doctor.
- For prevention of postmenopausal osteoporosis (thinning of bone)
- Adults?2.5 mg once a day in the morning or 150 mg once a monthon the same date each month (if directed by your doctor), taken at least 60minutes before the first food, beverage, or medication. You should take ibandronatewith six to eight ounces of plain water.
- Children?Use and dose must be determined by your doctor.
Missed dose?For 2.5 mg tablet once a day?If you missa dose of this medicine, do not take it later in the day. Resume your schedulethe next morning. Do not double doses.
For 150 mg tablet once a month?If you miss a dose of this medicineand your next scheduled dose is more than 7 days away, take one tablet inthe morning. Resume your schedule the next month. If you miss a dose of thismedicine and your next scheduled dose is only 1 to 7 days away, you must waituntil your next scheduled dose. Resume your schedule the next month. Do notdouble doses. Do not take more than two tablets within the same week.
For injection every 3 months?If you miss a scheduled appointmentto receive a dose of this medicine, it should be rescheduled as soon as possible.Then, resume the schedule of every 3 months from the date of the last injection.
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 otherdamp 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 yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Itis important that your doctor check your progress at regular visits to makesure this medicine is working properly and watch for unwanted effects.
Tell your doctor right away if you develop symptoms of your esophagus beingirritated such as new or worsening difficulty swallowing, pain on swallowing,pain behind your breast bone, or heartburn.
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 antacids, calcium supplements, or other products containingaluminum, 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 ofplain water.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Check with your doctorimmediately if any of the following side effects occur:
More common
Bladder pain; bloody or cloudy urine; chest pain; cough producingmucus; difficulty breathing; difficult, burning, or painful urination; fever orchills; frequent urge to urinate; lower back or side pain; nervousness; pounding in the ears; shortness of breath; slow or fast heartbeat; sneezing; sore throat; tightness in chest; wheezing
Less common
Bloody or cloudy urine; body aches orpain; congestion; difficult,burning, or painful urination; difficulty swallowing; dizziness; dryness ofthroat; fast heartbeat; frequent urge to urinate; hives; hoarseness; itching; largeamount 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; voicechanges
Incidence unknown
Blurred vision or other change in vision; bone, joint, and/or muscle pain, severe and occasionally incapacitating; eye redness; eye tenderness; heavy jaw feeling; loosening of a tooth; pain, swelling, or numbness in the mouth or jaw; sensitivity to light; severe eye pain; tearing
Symptoms of overdose
Get emergency help immediately if any of the followingsymptoms 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; irregularheartbeats; loss of appetite; mood or mental changes; muscle cramps in hands, arms,feet, legs, or face; numbness and tingling aroundthe mouth, fingertips, or feet; pain or burning in throat; shortness of breath; stomach discomfort upset orpain; sores, ulcers; tendernessin stomach area; tremor; ulcer; unusual tiredness or weakness; upset stomach; vomiting; white spots on lips or tongue or inside the mouth
Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor are bothersome.
Less common
Abdominal or stomach pain; bleeding,blistering, burning, coldness, discoloration of skin, feeling of pressure,hive, infection, inflammation, itching, lumps, numbness, pain, rash, redness,scarring, soreness, stinging, swelling, tenderness, tingling, ulceration,or warmth at site; cough; difficulty having a bowel movement [stool]; difficultyin moving; discouragement; feeling of constant movement of self or surroundings; feeling sad or empty; general feeling of discomfortor illness; irritability; joint pain; lack or appetite; lack or loss of strength; loss of interest or pleasure; lightheadedness; muscleaches and pain; muscle pain or stiffness; nausea; pain, swelling, or redness injoints; sensation of spinning; shivering; sore throat; stuffy or runny nose; sweating; tiredness; tooth disorder; trouble concentrating; trouble sleeping; vomiting; weakness
Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.
Developed: 03/25/2004
Revised: 02/08/2006
