Zoledronic Acid

Zoledronic Acid is used for:

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Treating osteoporosis (weak bones) in women who are past menopause. It is also used to treat Paget disease. It may also be used 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
• you have low calcium levels
• you are using another form of zoledronic acid

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

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 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, thyroid problems, parathyroid problems, or blood clotting problems
• if you have had thyroid or parathyroid surgery, or if you have had sections of your intestines removed
• if you have nutrient absorption problems, poor nutrition, dehydration, low blood volume, cancer, dental problems, anemia, or bone infection
• if you are receiving radiation or chemotherapy

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 loop diuretics (eg, furosemide) because the risk of low blood calcium levels 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 this medicine 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.

• An extra patient leaflet is available with Zoledronic Acid . Talk to your pharmacist if you have questions about this information.
• 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
• 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 .
• 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, ibuprofen) may help to relieve these symptoms.
• Zoledronic Acid may cause jaw bone problems in some patients. Your risk may be greater if you have cancer, poor dental hygiene, or certain other conditions (eg, anemia, blood clotting problems, infections, dental problems). Your risk may also be greater if 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 .
• 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 .
• 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. 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 taking 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 bone, joint, or muscle pain; mild flu-like symptoms (eg, mild fever, muscle aches); nausea; stomach pain or upset; tiredness; weakness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, 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; numbness or tingling (especially around the mouth); severe bone, joint, or muscle pain; severe or persistent dizziness or headache; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

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.

This information is a summary only. It does not contain all information about Zoledronic Acid . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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