Description
Ibandronate is used to treat and prevent osteoporosis (thinning of the bone) in women after menopause.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of ibandronate in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibandronate in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Dairy Food
- food
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia or
- Blood clotting problems or
- Cancer or
- Dental or tooth problems or
- Dental procedures (eg, dental implants, tooth extraction) or
- Infection or
- Poor oral hygiene or
- Surgery (eg, dental surgery)—May increase risk for severe jaw problems.
- Esophagus (the tube that runs from your throat to your stomach) problems (eg, achalasia, stricture) or
- Hypocalcemia (low calcium in the blood) or
- Inability to stand or sit upright for at least 60 minutes or
- Kidney disease, severe or
- Trouble with swallowing—Should not be used in patients with these conditions.
- Stomach or bowel problems (eg, Barrett's esophagus, duodenitis, gastritis, heartburn, inflammation of the esophagus, or ulcers)—Use with caution. May make these conditions worse.
Proper Use
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Make sure your doctor 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).
Take ibandronate with a full glass (6 to 8 ounces) of plain water on an empty stomach. It should be taken first thing in the morning at least 60 minutes before any food, beverage, or other medicines. Food and beverages (eg, mineral water, coffee, tea, milk, 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.
Swallow the tablet whole. Do not suck or chew on the tablet because it may cause throat irritation.
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.
It is important that you eat a well-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 after taking ibandronate. To do so may keep this medicine from working properly.
Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not. Do not stop using this medicine suddenly without asking your doctor.
Dosing
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For prevention and treatment of postmenopausal osteoporosis:
- Adults—2.5 milligrams (mg) once a day in the morning, or 150 mg once a month on the same date each month, taken at least 60 minutes before the first food, beverage, or medicine of the day other than water.
- Children—Use and dose must be determined by your doctor.
- For prevention and treatment of postmenopausal osteoporosis:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
For patients taking the medicine each day: If you miss a dose or forget to use your medicine in the morning, skip the missed dose and take your medicine the next morning. Do not take two tablets on the same day. Return to your regular schedule the next day.
For patients taking the medicine monthly: If you miss your dose and your next scheduled dose is more than 7 days away, take it the next morning after you remember. Return to your regularly scheduled day of the month for taking your next dose.
For patients taking the medicine monthly: If you miss your dose and your next scheduled dose is 1 to 7 days away, wait until then to take your medicine and skip the missed dose.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
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.
This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking this medicine and call your doctor. Some symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.
This medicine could lower the amount of calcium in your blood. Call your doctor right away if you develop any signs of low calcium levels, such as muscle spasms or twitching, or numbness or tingling in your fingers, toes, or lips.
It is important that you tell all of your health care providers that you are taking ibandronate. If you are having dental procedures while taking ibandronate, you may have an increased chance of getting a severe problem with your jaw. This may be more common if you use ibandronate for a long time.
Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.
This medicine may increase your risk of developing fractures of the thigh bone. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
This medicine may interact with the dye used for bone scans.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- difficult, burning, or painful urination
- difficulty with breathing
- fever or chills
- 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 the chest
Less common
- Bloody or cloudy urine
- body aches or pain
- congestion
- difficulty with swallowing
- dizziness
- dryness of the throat
- fast heartbeat
- frequent urge to urinate
- hives
- hoarseness
- itching
- numbness
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- runny nose
- skin rash
- tender, swollen glands in the neck
- tingling
- unusual tiredness or weakness
- voice changes
Incidence not known
- Abdominal or stomach cramps
- blurred vision or other change in vision
- bone, joint, or muscle pain, severe and occasionally incapacitating
- confusion
- convulsions
- eye redness
- eye tenderness
- heavy jaw feeling
- irregular heartbeats
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loosening of a tooth
- muscle cramps in the hands, arms, feet, legs, or face
- noisy breathing
- numbness and tingling around the mouth, fingertips, or feet
- pain, swelling, or numbness in the mouth or jaw
- sensitivity to light
- severe eye pain
- tearing
- tremor
- unusual pain in the thighs, groin, or hips
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Acid or sour stomach
- belching
- bone pain
- burning feeling in the chest or stomach
- heartburn
- indigestion
- loss of appetite
- pain or burning in the throat
- sores or ulcers
- stomach discomfort, upset, or pain
- tenderness in the stomach area
- vomiting
- white spots on the lips or tongue or inside the mouth
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- ear congestion
- headache
- loss of voice
- pain in the extremity (arms and legs)
Less common
- Cough
- difficulty having a bowel movement (stool)
- difficulty with moving
- discouragement
- feeling of constant movement of self or surroundings
- feeling sad or empty
- general feeling of discomfort or illness
- irritability
- joint pain
- lack or loss of strength
- lightheadedness
- loss of interest or pleasure
- muscle aches and pain
- muscle stiffness
- pain, swelling, or redness in the joints
- sensation of spinning
- shivering
- stuffy nose
- sweating
- tooth disorder
- trouble concentrating
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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