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Zoledronic acid

Pronunciation

Generic Name: zoledronic acid (ZOE-le-DRON-ik AS-id)
Brand Name: Reclast

Zoledronic acid is used for:

Treating and preventing osteoporosis (weak bones) in women who are past menopause. It is also used to help build bone in men with osteoporosis. It is also used to treat and prevent osteoporosis in certain patients treated with corticosteroids (eg, prednisone). It may also be used to treat Paget disease or for other conditions as determined by your doctor.

Zoledronic acid is a bisphosphonate. It works by decreasing the breakdown of bone. This reduces the amount of calcium that is released into the blood from bones and helps to lower your blood calcium level.

Do NOT use zoledronic acid if:

  • you are allergic to any ingredient in zoledronic acid or to any other bisphosphonate (eg, alendronate)
  • you have severe kidney problems or recent worsening of kidney function
  • you have low blood calcium levels
  • you are using another medicine that contains zoledronic acid

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using zoledronic acid:

Some medical conditions may interact with zoledronic acid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had asthma or other breathing problems from taking aspirin
  • if you have a history of kidney problems, low blood calcium levels, blood clotting problems, anemia, asthma, or bone infection
  • if you have a history of thyroid or parathyroid problems or if you have had thyroid or parathyroid surgery
  • if you have poor nutrition, nutrient absorption problems (eg, malabsorption syndrome), have had sections of your intestines removed, or are unable to take calcium or vitamin D supplements
  • if you have low blood volume, recent vomiting or diarrhea, decreased appetite, or if you are dehydrated
  • if you have cancer or have had or will be receiving radiation or chemotherapy
  • if you have poor dental hygiene or other dental problems, or have planned dental surgery (eg, tooth extraction)

Some MEDICINES MAY INTERACT with zoledronic acid. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aminoglycoside antibiotics (eg, gentamicin) or diuretics (eg, furosemide) because the risk of low blood calcium levels or kidney problems may be increased
  • Corticosteroids (eg, prednisone) because the risk of jawbone problems may be increased
  • Medicines that may harm the kidney (eg, amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) or thalidomide because the risk of kidney problems may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

This may not be a complete list of all interactions that may occur. Ask your health care provider if zoledronic acid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use zoledronic acid:

Use zoledronic acid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Zoledronic acid comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get zoledronic acid refilled.
  • Zoledronic acid is usually given as an injection at your doctor's office, hospital, or clinic.
  • Drink at least 2 full glasses (16 oz/480 mL) of fluid (eg, water) within a few hours before you receive zoledronic acid, as directed by your doctor.
  • Do not use zoledronic acid if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • If you miss a dose of zoledronic acid, contact your doctor right away.

Ask your health care provider any questions you may have about how to use zoledronic acid.

Important safety information:

  • Zoledronic acid may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use zoledronic acid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Follow the diet and exercise program given to you by your health care provider. Talk to your doctor about taking a calcium and vitamin D supplement while you use zoledronic acid.
  • Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones.
  • It is important to avoid becoming dehydrated while you are using zoledronic acid. Check with your doctor for instructions.
  • Certain fractures of the thigh bone (femur) have been reported in patients using bisphosphonates. It is unknown if bisphosphonates contributed to the fractures. Contact your doctor right away if you experience hip, thigh, or groin pain. Discuss any questions or concerns with your doctor.
  • You may develop flu-like symptoms, mild fever, muscle or joint aches, or headache after you receive zoledronic acid. If this occurs, a mild pain reliever (eg, acetaminophen) may help to relieve these symptoms.
  • Zoledronic acid may cause jawbone problems in some patients. Your risk may be greater the longer you take zoledronic acid or if you have cancer, poor dental hygiene, ill-fitting dentures, or certain other conditions (eg, anemia, blood clotting problems, dental problems, infections). Your risk may also be greater if you have certain dental procedures or you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use zoledronic acid. Ask your doctor any questions you may have about dental treatment while you use zoledronic acid.
  • Proper dental care is important while you are using zoledronic acid. Brush and floss your teeth and visit the dentist regularly.
  • Certain dental procedures should be avoided if possible while you are using zoledronic acid. Check with your doctor and dentist before having any dental treatments while using zoledronic acid.
  • Worsening of asthma has been reported in patients taking medicines like this one. Discuss any questions or concerns with your doctor.
  • Lab tests, including kidney function, complete blood cell counts, and blood electrolyte levels (eg, calcium, magnesium, phosphate), may be performed while you use zoledronic acid. These tests may be used to monitor your condition or check for side effects. Your doctor may also want to evaluate you periodically while you use zoledronic acid to assess the need to continue treatment. Be sure to keep all doctor and lab appointments.
  • Use zoledronic acid with caution in the ELDERLY, especially those with kidney problems; they may be more sensitive its effects.
  • Zoledronic acid should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use zoledronic acid if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. It is not known if zoledronic acid is found in breast milk. Do not breast-feed while you are using zoledronic acid.

Possible side effects of zoledronic acid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; mild back, joint, or muscle pain; mild flu-like symptoms (eg, mild fever, muscle aches); mild itching, pain, or redness at the injection site; nausea; stomach pain or upset; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; eye pain, redness, or swelling; fever, chills, or persistent sore throat; irregular heartbeat; jaw pain or swelling; mental or mood changes (eg, depression); muscle cramps or spasms; numbness or tingling (especially around the mouth); severe bone, joint, or muscle pain (especially in the hip, groin, or thigh); severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or diarrhea; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; irregular heartbeat; mental or mood changes; muscle cramps; numbness or tingling (especially around the mouth).

Proper storage of zoledronic acid:

Zoledronic acid is usually handled and stored by a health care provider. If you are using zoledronic acid at home, store zoledronic acid as directed by your pharmacist or health care provider. Keep zoledronic acid out of the reach of children and away from pets.

General information:

  • If you have any questions about zoledronic acid, please talk with your doctor, pharmacist, or other health care provider.
  • Zoledronic acid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take zoledronic acid or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about zoledronic acid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to zoledronic acid. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using zoledronic acid.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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