Zoledronic Acid, belongs to a group of medicines called bisphosphonates. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone.
The active ingredient in Adronic is Zoledronic Acid, which belongs to a group of medicines called bisphosphonates. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic Acid is rapidly distributed to bone. Zoledronic Acid is not metabolized and is excreted unchanged via the kidney.
Adronic 4 Concentrated Solution for IV Infusion:
Each vial contains Zoledronic Acid Monohydrate BP 4.264 mg equivalent to Zoledronic Acid 4 mg supplied as 5 ml concentrated solution for IV infusion.
Zoledronic Acid is a bisphosphonate indicated for the treatment of:
• Hypercalcemia of malignancy.
• 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.
Limitation of use: The safety and efficacy of Zoledronic Acid have not been established for use in hyperparathyroidism or nontumor-related hypercalcemia.
Preparation & Administration:
Zoledronic Acid 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. Zoledronic Acid concentrate should be diluted in 100 ml of sterile 0.9% Sodium Chloride USP or 5% Dextrose Injection USP following proper aseptic technique, and administered to the patient by infusion. Undiluted concentrate should not be stored in a syringe, to avoid inadvertent injection. No dose adjustment is required in patients with creatinine clearance ≥60 ml/min. To prepare reduced doses for patients with a baseline creatinine clearance less than or equal to 60 ml/min, the volume should be withdrawn according to the specifications outlined in the table below.
| Recommended doses for patients with baseline creatinine clearance <60 ml/min | |
| Baseline creatinine clearance (ml/min) | Dose |
| >60 | 4 mg (5ml) |
| 50-60 | 3.5 mg (4.4 ml) |
| 40-49 | 3.3 mg (4.1 ml) |
| 30-39 | 3 mg (3.8 ml) |
Limited pharmacokinetic data are available for Zoledronic acid in patients with severe renal impairment (creatinine clearance less than 30 ml/min). The withdrawn concentrate must be diluted in 100 ml 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 2-8°C. 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.
Contraindicated in patients with known hypersensitivity to Zoledronic Acid.
Pregnancy: Zoledronic Acid may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Nursing mothers: It is not known whether Zoledronic Acid is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Zoledronic Acid, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Zoledronic Acid binds to bone long-term and may be released over weeks to years.
Pediatric use: Zoledronic Acid is not indicated for use in children.
Geriatric use: No significant differences in response rate or adverse reactions have been observed in patients aged 65 years or older receiving Zoledronic Acid as compared to younger patients. Because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.
The most common adverse events (greater than 25%) are nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea.
Aminoglycosides may have an additive effect to lower serum calcium for prolonged periods. Concomitant use of Loop diuretics with Zoledronic Acid may increase the risk of hypocalcemia.
Adronic 4 Concentrated Solution for IV Infusion: Each box contains one vial of Zoledronic Acid Monohydrate BP equivalent to Zoledronic Acid 4 mg with 1 bottle of 100 ml Sodisol intravenous Infusion (Sodium chloride BP 0.9%) 1 Infusion set, 1 butterfly needle, 1 Disposable Syringe (10 ml), 1 Alcohol Pad, 1 First Aid Bandage & 1 Hanger.
FR
DE