- PRESCRIPTION REQUIRED
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
IBANDRONATE MONTHLY - ORAL
COMMON BRAND NAME(S): Boniva
USES: Ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause, as you age, or if you take corticosteroid medications (e.g., prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Ibandronate belongs to a class of medications called bisphosphonates.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet before starting this medication and each time you get a refill because new information may be available. Follow the instructions very closely to maximize the amount of drug absorbed and reduce the risk of injury to your esophagus. Consult your doctor or pharmacist if you have any questions. Take this medication by mouth, usually once a month on the same date each month, or as directed by your doctor. Choose the day of the month that best fits your schedule. Take this medication after getting up for the day, before taking your first food, beverage or other medication. Do not take it at bedtime or while you are still in bed. Take this medication with a full glass (6-8 ounces or 180-240 milliliters) of plain water. Do not take it with any other beverages. Do not chew or suck the tablet or keep it in your mouth to melt. Swallow the tablet whole. Then stay fully upright (sitting, standing or walking) for at least 60 minutes and do not lie down until after your first food of the day. Wait at least 60 minutes after taking ibandronate before you eat or drink anything other than plain water and before taking any other medication by mouth. Medications such as quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), sucralfate, and bismuth subsalicylate may interfere with the absorption of ibandronate. Calcium or iron supplements, vitamins with minerals, and antacids containing calcium, magnesium or aluminum, as well as foods such as dairy products (e.g., milk, yogurt), mineral water, and calcium-enriched juice, may also interfere with absorption. Do not take these products for at least 60 minutes after taking ibandronate. Take this medication regularly in order to get the most benefit from it. Remember to take it on the same day each month. It may help to mark your calendar with a reminder. Talk to your doctor about the risks and benefits of long-term use of this medication. Continue to take other medications for your condition as directed by your doctor.
SIDE EFFECTS: Stomach upset, diarrhea, pain in arms/legs, or mild flu-like symptoms (e.g., fatigue, muscle ache) may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, vision changes. This medication may infrequently cause irritation and ulcers in your stomach or esophagus. Seek immediate attention if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult or painful swallowing, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking ibandronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (e.g., alendronate, etidronate, pamidronate, risedronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have the following conditions: low blood calcium levels (hypocalcemia), inability to sit upright or stand for 60 minutes, severe kidney disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: disorders of the esophagus (e.g., esophageal stricture or achalasia), difficult or painful swallowing, kidney problems, stomach/intestinal disorders (e.g., ulcers). Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately. Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking ibandronate before your surgery. Ask for specific instructions about stopping or starting this medication. Caution is advised if you are pregnant or planning to become pregnant in the future. This medication may stay in your body for many years. Its effects on an unborn baby are not known. Discuss the risks and benefits with your doctor before starting treatment with ibandronate. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also the How to Use section. Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. This medication may affect the results of certain lab tests (bone-imaging agents). Be sure to tell your doctor or laboratory personnel that you are taking this medication. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
NOTES: Do not share this medication with others. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice. Laboratory and/or medical tests (e.g., bone density tests, x-rays, height, blood mineral levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you should miss a dose and your next scheduled dose is more than 7 days away, do not take the medication later in the day. Take it the next morning after you remember. Then continue taking your monthly dose in the morning on your originally chosen day of the month. If your next scheduled dose is only 1 to 7 days away, wait until your selected day to take the medication. Do not take two tablets within the same week to catch up. Consult your doctor or pharmacist if you have any questions.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.