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Zometa

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Overview

What is Zometa?

Zometa contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:

Zoledronic acid is a white crystalline powder. Its molecular formula is CHNOP•HO 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 is available in 100 mL bottles as a sterile liquid ready-to-use solution for intravenous infusion and in 5 mL vials as a sterile liquid concentrate solution for intravenous infusion.

Inactive Ingredients:



What does Zometa look like?



What are the available doses of Zometa?

4 mg per 100 mL single-use ready-to-use bottle ()

4 mg per 5 mL single-use vial of concentrate ()

What should I talk to my health care provider before I take Zometa?

How should I use Zometa?

Zometa is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3.0 mmol/L] using the formula: cCa in mg/dL=Ca in mg/dL + 0.8 (4.0 g/dL - patient albumin [g/dL]).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.


What interacts with Zometa?

Sorry No Records found


What are the warnings of Zometa?

Sorry No Records found


What are the precautions of Zometa?

Sorry No Records found


What are the side effects of Zometa?

Sorry No records found


What should I look out for while using Zometa?

Hypersensitivity to Zoledronic Acid or Any Components of Zometa

Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported .


What might happen if I take too much Zometa?

Clinical experience with acute overdosage of Zometa is limited. Two patients received Zometa 32 mg over 5 minutes in clinical trials. Neither patient experienced any clinical or laboratory toxicity. Overdosage may cause clinically significant hypocalcemia, hypophosphatemia, and hypomagnesemia. Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.

In an open-label study of zoledronic acid 4 mg in breast cancer patients, a female patient received a single 48-mg dose of zoledronic acid in error. Two days after the overdose, the patient experienced a single episode of hyperthermia (38°C), which resolved after treatment. All other evaluations were normal, and the patient was discharged seven days after the overdose.

A patient with non-Hodgkin’s lymphoma received zoledronic acid 4 mg daily on four successive days for a total dose of 16 mg. The patient developed paresthesia and abnormal liver function tests with increased GGT (nearly 100 unit/L, each value unknown). The outcome of this case is not known.

In controlled clinical trials, administration of Zometa 4 mg as an intravenous infusion over 5 minutes has been shown to increase the risk of renal toxicity compared to the same dose administered as a 15-minute intravenous infusion. In controlled clinical trials, Zometa 8 mg has been shown to be associated with an increased risk of renal toxicity compared to Zometa 4 mg, even when given as a 15-minute intravenous infusion, and was not associated with added benefit in patients with hypercalcemia of malignancy .


How should I store and handle Zometa?

4 milligram per 100 milliliter single-use ready-to-use bottleCarton of 1 bottle……………………………………………………………………………...NDC 0078-0590-61Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 5 milliliter single-use vial of concentrateCarton of 1 vial……………………………………………………………………………..NDC 0078-0387-25Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 100 milliliter single-use ready-to-use bottleCarton of 1 bottle……………………………………………………………………………...NDC 0078-0590-61Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 5 milliliter single-use vial of concentrateCarton of 1 vial……………………………………………………………………………..NDC 0078-0387-25Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 100 milliliter single-use ready-to-use bottleCarton of 1 bottle……………………………………………………………………………...NDC 0078-0590-61Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 5 milliliter single-use vial of concentrateCarton of 1 vial……………………………………………………………………………..NDC 0078-0387-25Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 100 milliliter single-use ready-to-use bottleCarton of 1 bottle……………………………………………………………………………...NDC 0078-0590-61Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 5 milliliter single-use vial of concentrateCarton of 1 vial……………………………………………………………………………..NDC 0078-0387-25Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 100 milliliter single-use ready-to-use bottleCarton of 1 bottle……………………………………………………………………………...NDC 0078-0590-61Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 5 milliliter single-use vial of concentrateCarton of 1 vial……………………………………………………………………………..NDC 0078-0387-25Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 100 milliliter single-use ready-to-use bottleCarton of 1 bottle……………………………………………………………………………...NDC 0078-0590-61Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].4 milligram per 5 milliliter single-use vial of concentrateCarton of 1 vial……………………………………………………………………………..NDC 0078-0387-25Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The principal pharmacologic action of zoledronic acid is inhibition of bone resorption. Although the antiresorptive mechanism is not completely understood, several factors are thought to contribute to this action. , zoledronic acid inhibits osteoclastic activity and induces osteoclast apoptosis. Zoledronic acid also blocks the osteoclastic resorption of mineralized bone and cartilage through its binding to bone. Zoledronic acid inhibits the increased osteoclastic activity and skeletal calcium release induced by various stimulatory factors released by tumors.

Non-Clinical Toxicology
Hypersensitivity to Zoledronic Acid or Any Components of Zometa

Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported .









































Zometa contains the same active ingredient as found in Reclast (zoledronic acid). Patients being treated with Zometa should not be treated with Reclast or other bisphosphonates.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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