Zolepex Special Precautions

Zoledronic acid must not be mixed or diluted with calcium-containing solution or other calcium-containing drug or product. Zoledronic acid should be administered through separate vented infusion lines apart from other drugs.
Patient should be appropriately hydrated prior to treatment with Zoledronic acid.
Overhydration should be avoided in patients at risk of cardiac failure. A urinary output should be maintained at 2 L per day throughout therapy with Zoledronic acid.
Patient should be monitored for hypercalcemia-related metabolic parameters including serum concentrations of calcium, phosphate, magnesium, and serum creatinine prior to each administration and throughout the treatment with Zoledronic acid. Hypercalcemia condition maybe associated with abnormal renal function. Hence renal function should be monitored in such patients.
Patients having hypercalcemia associated with malignancy after a post-treatment evaluation should be investigated at least 7 days after drug initiation. A second course of Zoledronic acid at the same dosage may be considered in case that the desired results are not achieved. If patients with hypercalcemia of malignancy experience a deterioration of renal function during therapy with Zoledronic acid, the possible risk of renal failure with subsequent doses of the drug must be carefully weighed against the potential benefits of treatment. No data is available to date on the safety and efficacy of more than one course of retreatment with Zoledronic acid in patients with hypercalcemia of malignancy.
If hypocalcemia, hypophosphatemia or hypomagnesemia occur, short-term supplemental therapy may be necessary.
Bisphosphonates has been associated with renal deterioration. The risk of adverse renal effect during parenteral therapy with bisphosphonates including Zoledronic acid depends on coexisting conditions associated with renal impairment such as dehydration, preexisting renal disease, concomitant therapy with other drugs such as other bisphosphonates or nephrotoxic drugs, or duration of IV infusion shorter than recommended.
Patients should consult the physician if severe pain of the jaw, muscle or joint pain occurs.
Patients should maintain good oral hygiene and should have a dental examination with preventive prior to treatment with this drug because of reported osteonecrosis found in patients treated with bisphosphonates including Zoledronic acid. Frequency of osteonecrosis of the jaw depends on pathological cancer (e.g. breast cancer, multiple myeloma) and pre-existing oral disease (e.g. tooth extractions, periodontitis, oral injuries, non-fixed denture). For patients who develop osteonecrosis of the jaw while on Zoledronic acid therapy, dental surgery may exacerbate the condition. There are no data available to suggest whether discontinuation of Zoledronic acid treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement by physician should be evaluated to determine patients risk and benefit so that treatment for each patient could be planned accordingly.