Patients should also be administered an oral calcium supplement of 500mg and a multiple vitamin containing 400IU of Vitamin D daily.

2.3 Preparation of Solution
Zometa must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs.

4 mg / 100 mL Single-Use Ready-to-Use Bottle

Bottles of Zometa ready-to-use solution for infusion contain overfill allowing for the administration of 100mL of solution (equivalent to 4mg zoledronicacid). This solution is ready-to-use and may be administered directly to the patient without further preparation. For single use only

To prepare reduced doses for patients with baseline CrCl less than or equal to 60 mL/min, withdraw the specified volume of the Zometa solution from the bottle (seeTable2) and replace with an equal volume of sterile 0.9%Sodium Chloride, USP, or 5%Dextrose Injection, USP. Administer the newly-prepared dose-adjusted solution to the patient by infusion. Follow proper aseptic technique. Properly discard previously withdrawn volume of ready-to-use solution - do not store or reuse.

Table 2: Preparation of Reduced Doses – Zometa ready-to-use bottle Remove and discard the following Zometa ready-to-use solution (mL) Replace with the following volume of sterile 0.9%Sodium Chloride, USP or 5%Dextrose Injection, USP (mL) Dose (mg)
12.0 12.0 3.5
18.0 18.0 3.3
25.0 25.0 3.0

If not used immediately after dilution with infusion media, for microbiological integrity, the solution should be refrigerated at 2°C - 8°C (36°F 46°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.

4mg / 5 mL Single-Use Vial

Vials of Zometa concentrate for infusion contain overfill allowing for the withdrawal of 5mL of concentrate (equivalent to 4mg zoledronicacid). This concentrate should immediately be diluted in 100mL of sterile 0.9%Sodium Chloride, USP, or 5%Dextrose Injection, USP, following proper aseptic technique, and administered to the patient by infusion. Do not store undiluted concentrate in a syringe, to avoid inadvertent injection.

To prepare reduced doses for patients with baseline CrCl less than or equal to 60 mL/min, withdraw the specified volume of the Zometa concentrate from the vial for the dose required (seeTable3).

Table 3: Preparation of Reduced Doses – Zometa concentrate Remove and Use
Zometa Volume (mL) Dose (mg)
4.4 3.5
4.1 3.3
3.8 3.0

The withdrawn concentrate must be diluted in 100mL of sterile 0.9%Sodium Chloride, USP, or 5%Dextrose Injection, USP.

If not used immediately after dilution with infusion media, for microbiological integrity, the solution should be refrigerated at 2°C-8°C (36°F-46°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 24hours.

2.4 Method of Administration
Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of Zometa shoul