Zandra 5 mg/100 ml

Description

Indications:
Zandra is indicated for:

• Treatment and prevention of postmenopausal osteoporosis.
• Increasing bone mass in men with osteoporosis.
• Treatment and prevention of glucocorticoid-induced osteoporosis.
• Treatment of Paget’s disease of bone in men and women.

Limitations of Use: The optimal duration of use has not been determined. For patients at low risk of fracture, consider discontinuation after 3 to 5 years of use.

Always consult a registered physician before use.

Pharmacology:
Zandra contains Zoledronic Acid, a bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to mineralized bone with high affinity, particularly at sites of high bone turnover. The drug targets the enzyme farnesyl pyrophosphate synthase in osteoclasts, leading to a long duration of action due to its strong binding to bone mineral.

Dosage:

• Postmenopausal Osteoporosis (Treatment):
  • 5 mg intravenous infusion once a year over at least 15 minutes.
• Postmenopausal Osteoporosis (Prevention):
  • 5 mg intravenous infusion once every 2 years over at least 15 minutes.
• Osteoporosis in Men:
  • 5 mg intravenous infusion once a year over at least 15 minutes.
• Glucocorticoid-Induced Osteoporosis:
  • 5 mg intravenous infusion once a year over at least 15 minutes.
• Paget’s Disease of Bone:
  • 5 mg intravenous infusion over at least 15 minutes. Re-treatment may be considered based on serum alkaline phosphatase levels or symptoms.

Calcium and Vitamin D Supplementation:

• Paget’s Disease: Patients should take 1500 mg elemental calcium daily and 800 IU vitamin D daily, especially in the 2 weeks following Zandra administration.
• Osteoporosis: Patients should ensure adequate dietary intake of calcium (1200 mg daily) and vitamin D (800–1000 IU daily).

Administration:

• Administer as an intravenous infusion over no less than 15 minutes.
• Ensure patients are adequately hydrated before administration.
• Inspect the solution for particulate matter or discoloration before use.
• Follow the infusion with a 10 mL normal saline flush.
• Do not mix with calcium-containing solutions. Administer through a separate infusion line.
• If refrigerated, allow the solution to reach room temperature before use.

Contraindications:

• Hypocalcemia.
• Severe renal impairment (creatinine clearance <35 mL/min).
• Hypersensitivity to Zoledronic Acid or any component.

Side Effects:

• Common: Fever, muscle pain, headache, joint pain, limb pain.
• Serious: Flu-like symptoms, nausea, vomiting, diarrhea, eye inflammation, osteonecrosis of the jaw, atypical femur fractures.

Precautions and Warnings:

• Monitor serum calcium, phosphate, and magnesium levels. Supplement as needed.
• Assess renal function before each dose. Avoid use in severe renal impairment.
• Perform routine oral exams to monitor for osteonecrosis of the jaw.
• Evaluate patients with thigh or groin pain for atypical femur fractures.
• Discontinue use if severe bone, joint, or muscle pain occurs.

Drug Interactions:

• Aminoglycosides: May prolong hypocalcemia.
• Loop Diuretics: May increase the risk of hypocalcemia.
• Nephrotoxic Drugs: Use with caution. Monitor renal function.

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:

• Pediatric Use: Not indicated for children.
• Geriatric Use: Monitor renal function closely.
• Renal Impairment: Contraindicated in severe renal impairment (creatinine clearance <35 mL/min).
• Hepatic Impairment: No dosage adjustment required.

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