Each vial contains Zoledronic acid monohydrate equivalent to Zoledronic acid anhydrous 4 mg as sterile freeze dried powder for reconstitution with 5ml of Sterile Water for Injection IP
Zoledronic is prescribed for:
Hypercalcemia of Malignancy - Zoledronic (zoledronic acid) Injection is prescribed for the treatment of hypercalcemia of malignancy.
Multiple Myeloma and Bone Metastases of Solid Tumors - Zoledronic is prescribed for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.
Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Hypercalcemia of Malignancy
Consideration should be given to the severity of as well as the symptoms of tumor-induced hypercalcemia when considering use of Zoledronic (zoledronic acid) Injection.
Vigorous saline hydration alone may be sufficient to treat mild, asymptomatic hypercalcemia.
The maximum recommended dose of Zoledronic in hypercalcemia of malignancy (albumin-corrected serum calcium* ? 12 /dL [3.0 mmol/L]) is 4 mg.
The 4- dose must be given as a single-dose intravenous infusion over no less than 15 minutes.
Patients should be adequately rehydrated prior to administration of Zoledronic.
Retreatment with Zoledronic 4 may be considered if serum calcium does not return to normal or remain normal after initial treatment.
It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose.
Renal function must be carefully monitored in all patients receiving Zoledronic and possible deterioration in renal function must be assessed prior to treatment with Zoledronic.
Multiple Myeloma and Metastatic Bone Lesions From Solid Tumors
The recommended dose of Zoledronic in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 infused over 15 minutes every three or four weeks.
Duration of treatment in the clinical studies was 15 months for prostate cancer, 12 months for breast cancer and multiple myeloma, and 9 months for other solid tumors.
Patients should also be administered an oral calcium supplement of 500 and a multiple vitamin containing 400 IU of Vitamin D daily.
Serum creatinine should be measured before each Zoledronic dose and treatment should be withheld for renal deterioration.
In the clinical studies, renal deterioration was defined as follows:
- For patients with normal baseline creatinine, increase of 0.5 /dL
- For patients with abnormal baseline creatinine, increase of 1.0 /dL
In the clinical studies, Zoledronic treatment was resumed only when the creatinine returned to within 10% of the baseline value.
Vials of Zoledronic concentrate for infusion contain overfill allowing for the withdrawal of 5 mL of concentrate (equivalent to 4 zoledronic acid).
This concentrate should immediately be diluted in 100 mL of sterile 0.9% of Sodium Chloride, USP, or 5% Dextrose Injection, USP.
Do not store undiluted concentrate in a syringe, to avoid inadvertent injection.
The dose must be given as a single intravenous infusion over no less than 15 minutes.
If not prescribed immediately after dilution with infusion media, for microbiological integrity, the solution should be refrigerated at 2 o C - 8 o C (36 o F- 46 o F).
The refrigerated solution should then be equilibrated to room temperature prior to administration.
The total time between dilution, storage in the refrigerator, and end of administration must not exceed 24 hours.
Zoledronic must not be mixed with calcium-containing infusion solutions, such as Lactated Ringerís solution, and should be administered as a single intravenous solution in a line separate from all other drugs.
Method of administration
Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of Zoledronic should not exceed 4 and the duration of infusion should be no less than 15 minutes.
There must be strict adherence to the intravenous administration recommendations for Zoledronic in order to decrease the risk of deterioration in renal function.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Zoledronic injection is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulations of Zoledronic.
- Vial of 10 ml;