Acidron concentrated solution for IV infusion: Each vial contains Zoledronic Acid INN 4mg/5ml.
Acidron ® is the preparation of Zoledronic Acid which belongs to the class of nitrogen containing bisphosphonates and acts primarily on bone. 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 Acidron® is rapidly distributed to bone. The main molecular target of Acidron® in the osteoclast is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms. There was no accumulation of the active substance in plasma after multiple doses given every 28 days. Acidron® is not metabolized and is excreted unchanged via the kidney.
Route: Intravenous (IV infusion only)
Hypercalcemia of malignancy:
Maximum recommended dose is 4 mg as a single-dose IV infusion over at least 15 minutes. Re-treatment may be considered after a minimum of 7 days if serum calcium does not normalize.
Multiple myeloma & bone metastases of solid tumors:
4 mg infused every 3–4 weeks. Supplement with oral calcium 500 mg and vitamin D 400 IU daily.
Renal impairment:
Preparation & Administration:
Dilute with 100 mL calcium-free solution (0.9% NaCl or 5% Glucose). Infuse over not less than 15 minutes. Do not mix with divalent cation solutions.
Aminoglycosides cause additive hypocalcemic effects; loop diuretics increase hypocalcemia risk; nephrotoxic agents (NSAIDs, aminoglycosides) worsen renal impairment; anti-angiogenic agents increase osteonecrosis of the jaw risk.
Zoledronic acid is contraindicated in patients with known hypersensitivity to zoledronic acid or any of its components. It is also contraindicated in patients with severe renal impairment (creatinine clearance< 30 ml/min), pregnancy and lactation.
Common: Headache, nausea, anorexia, fatigue, anemia, bone pain, constipation, fever, vomiting, flu-like syndrome, hypocalcemia, myalgia, arthralgia, hypophosphatemia. Rare: Osteonecrosis of jaw.
Overdose
Clinical experience with acute over dosage is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcemia, reversal may be achieved with supplemental oral calcium and/or an infusion of calcium.
Category D (Contraindicated). Zoledronic acid can cause fetal harm including hypocalcemia and skeletal abnormalities; strictly contraindicated during pregnancy. Lactation: Contraindicated; discontinue nursing or discontinue drug.
Store below 30°C in a cool, dry place. Protect from light. Keep away from the reach of children.