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Ibandronate (oral/injection)

Generic name: ibandronate (oral/injection) [eye-BAN-dro-nate]
Brand Names: Boniva Bondronat
Dosage Forms: Intravenous Solution (3 mg/3 ml), Oral Tablet (150 mg).
Drug class: bisphosphonates

What is Ibandronate?

Ibandronate, also known as bis FOS for short (bis FOS), is a medicine that affects the formation and breakdown of bones in the body. This medicine can help prevent fractures and slow down bone loss.Ibandronate can be used to treat or even prevent osteoporosis after menopause.Ibandronate can be used in other ways not mentioned in this guide.

Side effects of Ibandronate

If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, wheezing or difficulty breathing, swelling of your lips, face, tongue, or throat.

Ibandronate can cause serious side effects. If you experience:

  • Heartburn: chest pain that is new or worsening
  • Having difficulty swallowing can be painful.
  • Pain or burning in the ribs or back
  • Heartburn that is severe, or burning pains in the upper stomach;
  • A new or unusual pain in the thigh or your hip
  • Jaw pain, numbness, or swelling
  • Muscle pain or severe joint, bone, or muscle pain
  • Low calcium levels can cause muscle contractions, numbness, or tingling (around the mouth, fingers, and toes).

Ibandronate can cause the following side effects:

  • Heartburn, stomach pain, diarrhea;
  • Joint pain, back pain, or muscle pain.
  • You may experience pain in the arms or legs.
  • Headache
  • Fever, chills, tiredness, flu-like symptoms

There may be other side effects. To seek medical advice regarding side effects, contact your primary healthcare provider or call 1-800-FDA-1088 to report them.

Warnings

If you have severe renal disease or low calcium levels in your blood, you should avoid using ibandronate.You should not take ibandronate if your esophagus is infected or if it's impossible to stand or sit up straight for 60 minutes following the tablet.

Ibandronate may cause serious adverse effects in your stomach or esophagus. If you experience chest pain, heartburn that is new or worsening, or difficulty swallowing, stop taking ibandronate immediately and contact your doctor.

Call your doctor immediately if you experience muscle spasms or numbness (in your hands, feet, or mouth) or have severe joint, bone, or muscle pain.

Before you take this drug

Ibandronate should not be used if:

  • Severe kidney disease
  • Low calcium levels (hypocalcemia)

If you are experiencing esophageal problems or cannot stand or sit up for 60 minutes, do not take a tablet. Ibandronate may cause serious problems with the stomach or esophagus. After taking ibandronate, you must remain upright for 1 hour.

Tell your doctor about any of the following to ensure that ibandronate will be safe for you:

  • Trouble swallowing
  • You may have digestive problems or stomach pain.
  • Hypocalcemia;
  • A dental issue (you may require a dental examination before using ibandronate);
  • Kidney disease
  • Malabsorption is a condition where your body has difficulty absorbing nutrients from food.

This medicine can cause bone loss in the jaw (osteonecrosis). The symptoms include numbness or pain in the jaw, red or swelling gums, loose or missing teeth, and slow healing following dental work. This condition is more likely to occur if you continue using ibandronate.

If you've had chemotherapy, radiation, or steroids, it may increase your risk of osteonecrosis. Some other risk factors are blood clotting problems, anemia (low red blood cell count), and pre-existing dental problems.Speak to your doctor about any risks or benefits associated with using this medication.

Ibandronate is not known to harm unborn babies. Inform your doctor if you are pregnant or planning to become pregnant.Ibandronate is not known to pass into breast milk or to harm a baby who is nursing. You should tell your doctor if a child is breastfed.

How to take Ibandronate?

Do not alter the instructions on your prescription. Use this medication only as directed. Do not exceed the recommended dose or extend its use beyond what is necessary.

Ibandronate is taken as a tablet once a month. Ibandronate is injected into a vein via an IV every three months.Ibandronate can be taken by mouth at home. However, a healthcare professional must administer the injection.

Take the ibandronate tablets first thing in the morning. At least 60 minutes prior to eating or drinking anything or taking any other medication. The medicine should be taken on the same date each month, first thing in the morning.

Take the ibandronate tablets along with 6 to 8 ounces of plain water. Avoid coffee, tea, or soda. Also, avoid mineral water and juice. Avoid drinking or eating anything but plain water.You should not chew or crush an ibandronate tablet. Instead, swallow it whole.

Do not take ibandronate for at least 60 minutes (1 hour) after taking the tablet.

  • You should not recline or lie down.
  • Take no other medicines, including vitamins or antacids.

Ibandronate can cause dental problems. Brush and floss regularly. Tell your dentist that you use ibandronate before you have any dental work done (especially surgery).

Ibandronate may be part of a comprehensive treatment programme that includes diet changes, exercise, and testing of bone mineral density, as well as calcium and vitamin supplements. You should follow your doctor's advice.Store away from heat and moisture at room temperature.The length of treatment will be determined by your doctor. Ibandronate can be given only for 3–5 years.

Details on dosage

Adult dose for osteoporosis:

Oral:
Take 150 mg once a week on the same date each month.
IV Injection:
Every three months, inject 3 mg IV over 15–30 seconds.
Comments:
The IV injection shouldn't be given more than once every three months.
Before administering each IV injection, check serum creatinine.
Perform a routine oral exam prior to administering an IV injection.
Uses: To treat and prevent postmenopausal osteoporosis and increase BMD (bone mineral density) to reduce vertebral fractures.

Adult dose for prevention of osteoporosis:

Oral:
Take 150 mg once a week on the same date each week.
IV Injection:
Every three months, inject 3 mg IV over 15–30 seconds.
Comments:
The IV injection shouldn't be given more than once every three months.
Before administering each IV injection, check serum creatinine.
Perform a routine oral exam prior to administering an IV injection.
Uses: To treat and prevent postmenopausal osteoporosis and increase BMD (bone mineral density) to reduce vertebral fractures.

What happens if I miss the dose?

Ibandronate Tablets: Do not take the tablet later in the day if you forgot to take it in the morning. Do not take the missed dose until the morning after. Return to your normal monthly schedule and choose your dose day. Wait until your next scheduled dose, if it is less than seven days away. Skip the missed dose. Do not take more than two (2) doses within a week.Ibandronate Injections: If you miss your appointment, call your doctor to get instructions.

What happens if I overdose?

If you have taken oral ibandronate, drink a glass of milk. Seek emergency medical care or call 1-800-222-1222. Do not make yourself vomit or lie down.

Overdoses are unlikely because ibandronate is administered by healthcare professionals in a medical environment.

What should be avoided?

Ibandronate should not be taken within 60 minutes of taking it. Vitamins, calcium, and antacids are all included. Ibandronate can be made less absorbable by your body if you take certain medicines.

Try to stop smoking or avoid it. Smoking reduces your bone density and increases the risk of fractures.Avoid excessive alcohol consumption. Bone loss can be caused by excessive alcohol consumption.

Interaction with other drug

Tell your doctor if you are taking any new medications or if you will stop using any of your current ones.

  • Aspirin
  • Nsaids are nonsteroidal anti-inflammatory medications. These include ibuprofen, naproxen, celecoxib (Advil), diclofenac (Aleve), indomethacin (Indomethacin), meloxicam (Meloxicam), and many others.

This list is incomplete. Ibandronate may interact with other drugs, such as prescription and OTC medications, vitamins, and herbal products. This medication guide does not list all possible interactions. Speak to your doctor about your best schedule of other medications.

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