Acidron 4 mg/5 ml (IV Infusion)

Indications

• Hypercalcaemia of malignancy
• Bone metastases associated with solid tumours
• Osteolytic lesions associated with multiple myeloma
• Corticosteroid-induced osteoporosis
• Increase bone mass in men with osteoporosis
• Osteoporosis in postmenopausal women
• Paget's disease of bone
• Prophylaxis of postmenopausal osteoporosis

Pharmacology

• Belongs to the class of nitrogen-containing bisphosphonates
• Acts primarily on bone
• Inhibits osteoclast-mediated bone resorption
• Has high affinity for mineralized bone
• Rapidly distributed to bone when intravenously administered
• Targets the enzyme farnesyl pyrophosphate synthase in the osteoclast
• Possesses anti-tumour activity, anti-angiogenic activity, and anti-pain activity
• Excreted unchanged via the kidney

Dosage

• Recommended dosage for hypercalcemia of malignancy is 4 mg as a single-dose intravenous infusion
• Recommended dosage for multiple myeloma and bone metastases of solid tumors is 4 mg infused every 3-4 weeks

Administration

• Requires dilution with 100 ml of calcium-free infusion solution
• Must not be mixed with calcium or other divalent cation-containing infusion solutions
• Infusion duration must be at least 15 minutes
• If refrigerated, solution must be allowed to reach room temperature before administration

Interaction

• Administered concomitantly with commonly used anticancer agents, diuretics, antibiotics, and analgesics without interactions
• Caution advised when administered with aminoglycosides or thalidomide
• Concomitant use with loop diuretics increases the risk of hypocalcemia
• Caution indicated when used with other potentially nephrotoxic drugs

Contraindications

• Hypersensitivity to the active substance or any bisphosphonates
• Severe renal impairment (Creatinine clearance <30 ml/min)
• Pregnancy and lactation

Side Effects

• Headache
• Nausea
• Anorexia
• Fatigue
• Osteonecrosis of jaw
• Anemia
• Bone pain
• Constipation
• Fever
• Vomiting
• Flu-like syndrome
• Hypocalcemia
• Myalgia
• Arthralgia
• Hypophosphataemia

Pregnancy & Lactation

• Contraindicated during pregnancy and in breast-feeding women
• Not recommended for use in children and adolescents below 18 years of age

Precautions & Warnings

• Patients must be appropriately hydrated prior to administration
• Serum levels of calcium, phosphate, magnesium, and potassium should be carefully monitored
• Careful renal function monitoring should be considered
• Hydration can be achieved by drinking two glasses of fluid before and after the infusion

Use in Special Populations

• Not recommended in patients with severe renal impairment (Creatinine clearance <30 ml/min)
• No dose adjustment necessary in patients with creatinine clearance >60 ml/min

Overdose Effects

• May cause hypocalcemia, hypophosphatemia, and hypomagnesemia
• Correction may require intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate

Therapeutic Class

• Bisphosphonate preparations

Reconstitution

• Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%

Storage Conditions

• Store below 30°C prior to opening
• Protect from moisture and light
• Must be kept out of the reach and sight of children

Related Brands

• Zoletrust 4 mg/5 ml (IV Infusion) - drug-international-ltd
• Adronic 4 mg/5 ml (IV Infusion) - aristopharma-ltd