
Drometa4 mg/5 ml
Incepta Pharmaceuticals Ltd.
Approved Indication Zoledronic Acid [For hypercalcemia] is indicated for the treatment of hypercalcemia of malignancy (HCM) and more.
Zoledronic Acid [For hypercalcemia] is indicated for the treatment of hypercalcemia of malignancy (HCM), defined as an albumin-corrected serum calcium level of ≥12 mg/dL (3 mmol/L). It is used to rapidly lower dangerously elevated calcium levels caused by certain cancers (e.g. squamous cell carcinomas, breast cancer, multiple myeloma, and other tumors producing humoral or local osteolytic hypercalcemia).
Zoledronic acid, as a molecule, is also used at different doses and dosing schedules for osteoporosis prevention/treatment, Paget's disease of bone, and to reduce skeletal-related events in bone metastases from solid tumors or multiple myeloma. These are separate regimens and are not the hypercalcemia-of-malignancy indication covered by Zoledronic Acid [For hypercalcemia]; do not substitute one dosing schedule for another.
| Parameter | Recommendation |
|---|---|
| Dose | 4 mg as a single intravenous infusion |
| Infusion time | Over no less than 15 minutes |
| Retreatment | May be considered if serum calcium does not return to normal or does not remain normal, but only after a minimum of 7 days has elapsed, to allow full response to the initial dose and renal function recovery |
No dose adjustment of Zoledronic Acid [For hypercalcemia] is generally required for mild-to-moderate renal impairment when treating hypercalcemia of malignancy. In patients with severe renal impairment, the decision to use Zoledronic Acid [For hypercalcemia] should be individualized, weighing the risk of further renal deterioration against the risk of leaving life-threatening hypercalcemia untreated. Serum creatinine should be checked prior to each dose.
Zoledronic Acid [For hypercalcemia] is not indicated for use in pediatric patients; safety and efficacy have not been established (see Pediatric Use).
Zoledronic Acid [For hypercalcemia] is contraindicated in patients with:
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