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 NORPHAR
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Category

• Antihypercalcemic
• Bone resorption inhibitor

Description

Zometa / Zoledronic acid(zo-le-DRO-nik)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 cancers 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)

How ZOMETA Works

ZOMETA (zoledronic acid) injection belongs to a class of drugs called bisphosphonates (biss-foss-fon-ates) that slows the bone-destroying activity that occurs with bone metastases. Bisphosphonates directly work against the abnormal cells that cause the "wearing away" (resorption) of bone and help slow down the abnormal build-up of unstable bone. Bisphosphonates are used to help improve bone strength in many diseases associated with bone resorption, including cancer.

Other intravenous (IV) bisphosphonates have been used to treat breast cancer or multiple myeloma that has spread to the bone. After preparation, the infusion takes only 15 minutes. This convenience allows patients more time to do the things they enjoy.

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 Zometa / Zoledronic acid, the following should be considered:

Allergies- Tell your doctor if you have ever had any unusual or allergic reaction to Zometa / 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- Zometa / Zoledronic acid has not been studied in pregnant women. However, studies in animals have shown that Zometa / 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 Zometa / Zoledronic acid passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children- Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of Zometa / Zoledronic acid in children with use in adults.

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. There is no specific information comparing use of Zometa / Zoledronic acid in the elderly with use in other age groups.

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 Zometa / Zoledronic acid. Make sure you tell your doctor if you have any other medical problems, especially:

• Previous allergic reaction to Zometa / Zoledronic acid or other drugs -May cause severe reaction
• Asthma-Certain types of asthma may be worsened by Zometa / Zoledronic acid
• Heart disease-May be worsened by Zometa / Zoledronic acid
• Kidney disease-May be worsened by Zometa / Zoledronic acid

Proper Use of This Medicine

Dosing- The dose of Zometa / Zoledronic acid will be different for different patients. Follow your doctor's orders . The following information includes only the average doses of Zometa / 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.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits after you have received Zometa / 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.

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

Black, tarry stools; blurred vision; cancer progression; chest pain; chills; confusion; convulsions; cough; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position; fever; irregular heartbeat; lack or loss of strength; 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; 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; sudden sweating; swollen glands; tightness in chest; trouble breathing with exercise; unusual bleeding or bruising; unusual tiredness or weakness; wheezing; worsening of cancer

 

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; 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.