Zometa

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|Zometa

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ZOLEDRONIC ACID (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Zometa

In Canada—

  • Zometa

Category

  • Antihypercalcemic
  • Bone resorption inhibitor

Description

Zoledronic acid (ZOE-le-dron-ik AS-id) is used to treat hypercalcemia (high levels of blood calcium) that may occur in patients with some types of cancer. It is also used to treat cancer called multiple myeloma (tumors formed by the cells of the bone marrow) or certain types of bone metastases (the spread of cancer).

This medicine may also be used for other conditions as determined by your doctor.

This medicine is to be administered only by or under the supervision of your doctor. It is available in the following dosage form:

  • Parenteral
  • Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For zoledronic acid, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to zoledronic acid or other medications used to treat a high blood calcium or osteoporosis. Also tell your doctor and pharmacist if you are allergic to any other substances, such as other drugs, foods, preservatives, or dyes.

Pregnancy—Zoledronic acid has not been studied in pregnant women. However, studies in animals have shown that zoledronic acid causes birth defects. Women of childbearing age should avoid becoming pregnant. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether zoledronic acid passes into breast milk. However, zoledronic acid is not recommended during breast-feeding, because it may cause bone problems in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of zoledronic acid in children with use in adults. Because of bone problems, this medicine should only be used in children if the benefit outweighs the risk.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. However, because kidney problems occur more often in older adults, kidney function will need to be monitored.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of zoledronic acid. Make sure you tell your doctor if you have any other medical problems, especially:

  • Previous allergic reaction to zoledronic acid or other drugs —May cause severe reaction
  • Asthma—Certain types of asthma may be worsened by zoledronic acid
  • Heart disease—May be worsened by zoledronic acid
  • Kidney disease—May be worsened by zoledronic acid
  • Cancer or
  • Cancer treatment or
  • Dental procedures or surgery or
  • Poor dental hygiene—May put you at risk for a serious jaw problem
  • Dehydration (not enough water or fluids in your body)—May increase risk of severe kidney problems
  • Liver problems—Safety of this medicine not known in patients with liver problems.

Proper Use of This Medicine

Dosing—The dose of zoledronic acid will be different for different patients. Follow your doctor"s orders . The following information includes only the average doses of zoledronic acid.

  • For intravenous dosage form
    • For treating multiple myeloma and bone metastases and,
    • For treating hypercalcemia (too much calcium in the blood):
      • Adults—4 milligrams (mg) in a solution to be injected into a vein in not less than 15 minutes.
      • Children—Use and dose must be determined by your doctor.

Note:

Your health care professional my also give you vitamins containing Vitamin D and calcium

Your doctor may adjust your dose for kidney problems. Take the dose that your doctor instructs you to take.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits after you have received zoledronic acid. If your condition has improved, your progress must still be checked. The results of laboratory tests or the occurrence of certain symptoms will tell your doctor if your condition is coming back and if a second treatment is needed.

Tell your doctor right away if you experience symptoms of agitation, blood in urine, coma, confusion, decreased urine output, depression, dizziness, headache, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of face, ankles, or hands, or unusual tiredness or weakness. These could be a sign of serious kidney problems.

It is important that you check with your doctor before having any dental procedures or surgeries done while you are receiving zoledronic acid. Tell your doctor right away if you experience jaw tightness, swelling, numbing, or pain or a loose tooth. It could be the sign of a serious jaw disease.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Agitation; black, tarry stools; blurred vision; chest pain; chills; coma; confusion; convulsions; cough; depression; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position; dizziness; fever; irregular heartbeat; irritability; lack or loss of strength; lethargy; lower back or side pain; mood or mental changes, confusion; muscle pain or cramps ; muscle trembling or twitching, shaking of hands, arms, feet, legs, or face; nausea or vomiting; numbness and tingling around mouth, fingertips, or feet; painful or difficult urination; pale skin; rapid weight gain; seizures; shortness of breath, difficult or labored breathing; skin rash, cracks in skin at the corners of mouth, soreness or redness around fingernails and toenails; sore throat; sores, ulcers, or white spots on lips or mouth; stupor; sudden sweating; swollen glands; tightness in chest; trouble breathing with exercise; unusual bleeding or bruising; unusual tiredness or weakness; wheezing

Incidence not known—occurred during clinical practice

Decreased frequency/amount of urine; heavy jaw feeling; increased blood pressure; increased thirst; loosening of a tooth; pain, swelling, or numbness in the mouth or jaw; swelling of face, hands, fingers, lower legs, ankles; troubled breathing; weight gain

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Abdominal pain; anxiety, nervousness, restlessness or irritability; bad, unusual or unpleasant (after) taste; back pain; bladder pain, bloody or cloudy urine; blistering, crusting, irritation, itching, or reddening of skin; bone pain; burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings; change in taste; cracked, dry scaly skin; cracked lips; constipation; dehydration; diarrhea; difficulty swallowing; discouragement; dry mouth; ear congestion; fear or nervousness; feeling sad, or empty; frequent urge to urinate; hair loss, or thinning hair; headache; hyperventilation; irregular heartbeats; joint pain, or swollen joints; loss of appetite; loss of interest, or pleasure; loss of voice; muscle pain, stiffness or difficulty in moving; pain, swelling, or redness in joints; partial loss of feeling; nasal congestion, or runny nose; seeing, hearing, or feeling things that are not there; sleepiness or unusual drowsiness; sleeplessness, trouble sleeping, unable to sleep; swelling; swelling of leg; swelling or inflammation of the mouth; thirst; trouble concentrating; unusually cold, shivering; vomiting; weight loss; white spots on lips, tongue, or inside mouth

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, zoledronic acid is used in certain patients with the following medical conditions:

  • Bone loss, in men, from taking certain medicines for prostate cancer.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Developed: 10/15/2001
Revised: 08/10/2005

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Typical mistypes for Zometa
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