Ibandronate (Oral)

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.

It is important for your doctor to check your progress at regular visits to make sure this medicine is working properly and to look for unwanted effects.

This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking it and call your doctor. Some symptoms of esophagus damage are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food is 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 notice 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 to inform all of your health care providers that you are taking ibandronate. If you are having dental procedures while taking ibandronate, you may have a higher chance of getting a severe problem with your jaw. This may be more common if you use ibandronate for a long time.

Make sure to tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you experience 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 you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must weigh the risks of taking it against the benefits it may provide. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how ibandronate affects children. Safety and effectiveness have not been established.

Geriatric

Currently, studies have not shown any specific issues in elderly patients that would limit the usefulness of ibandronate.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In such cases, your doctor may want to adjust the dose, or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been highlighted for their potential significance but may not include everything.

Using this medicine with any of the following may raise the risk of certain side effects, which may be unavoidable in some situations. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding the use of food, alcohol, or tobacco.

• Dairy Food
• food

Other Medical Problems

Having other medical issues may influence how you can use this medicine. Be sure to tell your doctor if you have any additional medical problems, especially:

• Anemia or
• Blood clotting issues or
• Cancer or
• Dental or tooth issues or
• Dental procedures (e.g., dental implants, tooth extraction) or
• Infection or
• Poor oral hygiene or
• Surgery (e.g., dental surgery)—May increase the risk of severe jaw problems.

• Esophagus (the tube that connects your throat to your stomach) issues (e.g., achalasia, stricture) or
• Hypocalcemia (low calcium in the blood) or
• Inability to stand or sit upright for at least 60 minutes or
• Severe kidney disease or
• Difficulty swallowing—Should not be used in patients with these conditions.

• Stomach or bowel issues (e.g., Barrett's esophagus, duodenitis, gastritis, heartburn, esophageal inflammation, or ulcers)—Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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.

In the U.S.

• Boniva

Available Dosage Forms:

• Tablet

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

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.

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.