This medication is used to treat a certain type of bone disease (Paget's disease) that causes abnormal and weak bones. Zoledronic acid is also used to treat bone loss (osteoporosis) in men and in women after menopause. It may also be used to treat or prevent osteoporosis in people who are taking corticosteroid medications (such as prednisone) for long periods. It works by slowing the breakdown of bone and keeping bones strong. It also helps to reduce the risk of broken bones (fractures). This medication belongs to a class of drugs known as bisphosphonates.

Another zoledronic acid product is used to treat bone problems that may occur with cancer. The 2 products should not be used together.

This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

This medication is given as a single dose by a health care professional. It is given slowly into a vein over at least 15 minutes. Health care professionals must follow all the manufacturer's instructions for properly preparing and giving this drug. Check this product visually for particles or discoloration before using. If either is present, do not use the liquid. If you have any questions about using this medication properly, consult your doctor or pharmacist.

Eat and drink normally on the day of treatment. Drink at least 2 glasses of fluid before treatment unless otherwise directed by your doctor. It is very important that you get plenty of fluids when you are given this medication.

Your doctor may direct you to take calcium and vitamin D each day. If you have Paget's disease, it is especially important that you take the directed amount of calcium and vitamin D during the 2 weeks after your zoledronic acid dose. Vitamin D and calcium are very important to prevent low levels of calcium in the blood. Tell your doctor immediately if you have any symptoms of low calcium such as numbness/tingling (especially around the lips/mouth) and muscle spasms.

The dosage is based on your medical condition and response to treatment. The usual maximum adult dose is 5 milligrams.

For the treatment of Paget's disease, this medication is given as a single dose and may be repeated based on your symptoms. For the treatment of osteoporosis, this medication is given as a single dose once a year.

Nausea, tiredness, flu-like symptoms (e.g., fever, chills, muscle/joint aches), dizziness, headache, or pain/redness/swelling at the injection site may occur. Most of these side effects are mild and occur within 3 days of treatment. Flu-like symptoms may be reduced by taking acetaminophen or ibuprofen after the treatment. If any of these effects worsen or last more than 4 days, tell 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 immediately if any of these unlikely but serious side effects occur: increased or severe bone/joint/muscle pain, jaw pain, unusual weakness, eye problems (e.g., redness/itching/swelling, sensitivity to light), muscle spasms, numb/tingling skin, sores in jaw/mouth, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates such as alendronate or risedronate; or if you have trouble breathing (wheezing) after taking aspirin; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low calcium levels in the blood, problem taking calcium/vitamin D supplements, recent or planned dental surgery (e.g., tooth removal), certain gut problems (malabsorption, surgery on the small intestine), kidney problems, treatment with zoledronic acid (e.g., for cancer), parathyroid/thyroid problems (e.g., hypoparathyroidism, thyroid/parathyroid surgery), severe loss of body water (dehydration).

Infrequently, serious jawbone problems (osteonecrosis) have occurred in people using this medication. Dental surgery, cancer, certain medications (chemotherapy, corticosteroids such as prednisone), or poor dental hygiene may increase the risk. See your dentist for a full examination/treatment before your dose of zoledronic acid. Tell your dentist that you will be using zoledronic acid, and make sure he or she knows of all your medications and medical history, especially of any cancer radiation treatments. Tell your doctor or dentist immediately if you have persistent jaw pain or sores in the mouth or jaw that do not heal.

This medication may cause severe kidney problems. Consult your doctor or pharmacist for more information. To help prevent harm to your kidneys, drink plenty of fluids unless otherwise directed by your doctor. (See also How to Use section.)

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for information on reliable forms of birth control.

It is not known whether this drug passes into breast milk. Because of possible harm to the nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: mineral supplements (especially those containing calcium, magnesium, or phosphorus), "water pills" (diuretics such as bumetanide, furosemide, hydrochlorothiazide).

Also tell your doctor or pharmacist of drugs that may be harmful to your kidneys such as: aminoglycoside antibiotics (e.g., gentamicin, tobramycin), amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen), tacrolimus, vancomycin.

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.

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. Canada residents can call a provincial poison control center.

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., calcium/phosphate/magnesium blood levels, bone density tests, kidney tests) will be performed to monitor your progress or check for side effects. Consult your doctor for more details.

Not applicable.

Store the unopened bottles at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. After opening, this product should be refrigerated between 36-46 degrees F (2-8 degrees C) and used within 24 hours. Discard any unused drug after 24 hours. 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 July 2009 Copyright(c) 2009 First DataBank, Inc.