Zometa

DRUG DESCRIPTION

Zometa contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoelastic bone resorption. Zoledronic acid is designated chemically as (l-Hydroxy-2-imidazol-l-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is

Zometa« (zoledronic acid for inj) 
  (zolcdronic acid)  Structural Formula Illustration

Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2ĚH2O and its molar mass is 290.1g/Mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0.

Zometa (zoledronic acid for inj) is available in vials as a sterile liquid concentrate solution for intravenous infusion. Each 5-mL vial contains 4.264 mg of zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid on an anhydrous basis.

Inactive Ingredients: mannitol, USP, as bulking agent, water for injection and sodium citrate, USP, as buffering agent.

What are the possible side effects of zoledronic acid (Reclast, Zometa)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;
  • muscle spasms, numb or tingly feeling (especially around your mouth);
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising, unusual weakness;
  • severe joint, bone, or muscle pain;...

Read All Potential Side Effects and See Pictures of Zometa

What are the precautions when taking zoledronic acid for inj (Zometa)?

Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, risedronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, loss of too much body water (dehydration), aspirin-sensitive asthma.

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your...

Read All Potential Precautions of Zometa


Zometa Consumer (continued)

SIDE EFFECTS: Dizziness, headache, or flu-like symptoms (such as fever, chills, muscle/joint aches) may occur. If any of these effects persist or worsen, 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 right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, jaw pain, eye/vision problems, numbness/tingling, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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.

PRECAUTIONS: Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, risedronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, loss of too much body water (dehydration), aspirin-sensitive asthma.

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

It is unknown if this drug passes into breast milk. Because it may harm a nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Zometa Patient Information Including Side Effects

Brand Names: Reclast, Zometa

Generic Name: zoledronic acid (Pronunciation: zole DRO nik AS sid)

  • What is zoledronic acid (Zometa)?
  • What are the possible side effects of zoledronic acid (Zometa)?
  • What is the most important information I should know about zoledronic acid (Zometa)?
  • What should I discuss with my healthcare provider before receiving zoledronic acid (Zometa)?
  • How is zoledronic acid given (Zometa)?
  • What happens if I miss a dose (Zometa)?
  • What happens if I overdose (Zometa)?
  • What should I avoid while receiving zoledronic acid (Zometa)?
  • What other drugs will affect zoledronic acid (Zometa)?
  • Where can I get more information?

What is zoledronic acid (Zometa)?

Zoledronic acid (sometimes called zoledronate) is in a group of medicines called bisphosphonates (bis FOS fo nayts). Zoledronic acid inhibits the release of calcium from bones.

Zoledronic acid is used to treat Paget's disease, and high blood levels of calcium caused by cancer (hypercalcemia of malignancy). Zoledronic acid also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body.

Zoledronic acid is also used to treat or prevent osteoporosis in postmenopausal women, and to increase bone mass in men with osteoporosis. Zoledronic acid is used to treat or prevent osteoporosis in people who will be taking certain steroid medicines for 12 months or longer.

Zoledronic acid may also be used for other purposes not listed in this medication guide.

What are the possible side effects of zoledronic acid (Zometa)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;
  • muscle spasms, numb or tingly feeling (especially around your mouth);
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising, unusual weakness;
  • severe joint, bone, or muscle pain; or
  • bronchospasm (wheezing, chest tightness, trouble breathing).

Less serious side effects may include:

  • cough;
  • loss of appetite, nausea, vomiting;
  • diarrhea, constipation;
  • headache, tired feeling;
  • mild joint or muscle pain; or
  • redness or swelling where the needle was placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about zoledronic acid (Zometa)?

Do not receive zoledronic acid without telling your doctor if you have had an allergic reaction to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with zoledronic acid. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to zoledronic acid have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Avoid having any type of dental surgery while you are being treated with zoledronic acid. It may take longer than normal for you to recover.

Related Drug Centers
  • Zometa
  • Reclast


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