Adronic 4 mg/5 ml vial

Description

Indications:
Adronic is indicated for:

• Hypercalcemia of malignancy.
• Bone metastases associated with solid tumors.
• Osteolytic lesions in multiple myeloma.
• Corticosteroid-induced osteoporosis.
• Increasing bone mass in men with osteoporosis.
• Osteoporosis in postmenopausal women.
• Paget’s disease of bone.
• Prophylaxis of postmenopausal osteoporosis.

Always consult a registered physician before use.

Pharmacology:
Adronic contains Zoledronic Acid, a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to mineralized bone with high affinity, reducing bone turnover and calcium release. Zoledronic Acid also exhibits anti-tumor, anti-angiogenic, and anti-pain properties, along with synergistic effects with other anti-cancer drugs. It is not metabolized and is excreted unchanged via the kidneys.

Dosage:

• Hypercalcemia of Malignancy:
  • Recommended dose: 4 mg as a single intravenous infusion.
  • Re-treatment may be considered after at least 7 days if serum calcium levels do not normalize.
• Multiple Myeloma and Bone Metastases:
  • Recommended dose: 4 mg infused every 3–4 weeks.
  • Supplement with 500 mg calcium and 400 IU vitamin D daily.
• Renal Impairment:
  • Not recommended for severe renal impairment (creatinine clearance <30 ml/min).
  • Dose adjustments based on creatinine clearance:

    • 60 ml/min: 4 mg

    • 50–60 ml/min: 3.5 mg
    • 40–49 ml/min: 3.3 mg
    • 30–39 ml/min: 3 mg

Administration:

• Dilute the required amount of Adronic concentrate with 100 ml of calcium-free infusion solution (0.9% sodium chloride or 5% glucose).
• Infuse over at least 15 minutes.
• Use immediately after preparation or store at 2–8°C for up to 24 hours. Allow to reach room temperature before administration.
• Do not mix with calcium-containing solutions.

Contraindications:

• Hypersensitivity to Zoledronic Acid or any component.
• Severe renal impairment (creatinine clearance <30 ml/min).
• Pregnancy and lactation.

Side Effects:

• Common: Headache, nausea, fatigue, bone pain, constipation, fever, vomiting, flu-like symptoms, hypocalcemia, myalgia, arthralgia, hypophosphatemia.
• Serious: Osteonecrosis of the jaw, anemia.

Precautions and Warnings:

• Ensure adequate hydration before administration, especially in elderly patients or those on diuretics.
• Monitor serum calcium, phosphate, magnesium, potassium, and creatinine levels regularly.
• Provide supplemental therapy for hypocalcemia, hypophosphatemia, or hypomagnesemia if needed.

Drug Interactions:

• Use caution with aminoglycosides, loop diuretics, and other nephrotoxic drugs.
• Concomitant use with thalidomide may increase the risk of renal dysfunction in multiple myeloma patients.

Overdose:

• Symptoms may include hypocalcemia, hypophosphatemia, and hypomagnesemia. Treat with intravenous calcium gluconate, potassium/sodium phosphate, or magnesium sulfate as needed.

Use in Special Populations:

• Pregnancy and Lactation: Contraindicated.
• Pediatric Use: Not recommended for children and adolescents under 18 years.
• Elderly Use: No dosage adjustment required, but monitor renal function closely.

Reconstitution:

• Dilute the required amount in 100 ml of 0.9% sodium chloride or 5% dextrose solution.

Storage Conditions:
Store below 30°C in a dry place, protected from light and moisture. Keep out of children’s reach.