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Zoldonat 4mg - Zoledronic Acid Injection

Zoldonat 4mg is a bisphosphonate medication used to treat high calcium levels caused by cancer and bone complications in cancer patients. It helps strengthen bones and reduce fracture risk in patients with certain cancers.

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General Information:
Generic Name: Zoledronic Acid
Brand Name: Zoldonat
Packing: Vial (single-use)
Strength: 4mg/5ml
Manufacturer: Natco Pharma Ltd.
Form: Injection (concentrate for infusion)
Category: Bisphosphonates, Oncology
Product Intro:
Zoldonat 4mg is an injectable form of Zoledronic Acid, a potent bisphosphonate drug used to treat or prevent skeletal-related events in patients with multiple myeloma and solid tumor bone metastases. It also helps manage hypercalcemia of malignancy (high blood calcium due to cancer).

Uses:
  1. Treatment of hypercalcemia of malignancy
  2. Prevention of skeletal-related events in patients with bone metastases
  3. Management of multiple myeloma-related bone disease
  4. Osteolytic lesions in patients with metastatic breast cancer
  5. Bone loss prevention in prostate cancer patients receiving hormone therapy
  6. Treatment of osteoporosis in postmenopausal women (off-label in oncology)

Storage Instructions:
  1. Store at 2°C to 8°C (refrigerated)
  2. Do not freeze
  3. Protect from light and heat
  4. Use immediately after dilution
  5. Keep out of reach of children

How it Works (Mechanism of Action):
Zoledronic Acid inhibits osteoclast-mediated bone resorption by binding to bone hydroxyapatite. It suppresses the activity and survival of osteoclasts, which are responsible for bone breakdown. This helps in reducing bone loss, fractures, and calcium levels in patients with bone-involved cancers.

Side Effects:
Common Side Effects:
  1. Fatigue
  2. Flu-like symptoms (fever, chills, muscle aches)
  3. Bone or joint pain
  4. Headache
  5. Nausea and vomiting
  6. Hypocalcemia (low calcium levels)
Severe Side Effects:
  1. Osteonecrosis of the jaw (ONJ)
  2. Renal toxicity (kidney problems)
  3. Anaphylactic reactions
  4. Severe hypocalcemia
  5. Eye inflammation (uveitis, scleritis)
  6. Atypical femur fractures (rare)

Dosage (Typical Recommended Dose):
  1. 4 mg IV infusion over at least 15 minutes, once every 3–4 weeks depending on indication
  2. Dose adjustments are required in renal impairment
  3. Always follow the physician’s instructions based on cancer type and kidney function

Method of Administration:
  1. Administered via intravenous (IV) infusion
  2. Must be diluted in 100 ml normal saline or D5W
  3. Administer over a minimum of 15 minutes
  4. Ensure adequate hydration before and after administration

Precautions:
  1. Perform renal function tests before each dose
  2. Ensure dental examination before starting therapy to minimize risk of ONJ
  3. Monitor serum calcium, phosphate, and magnesium levels regularly
  4. Avoid use in patients with severe renal impairment (creatinine clearance <30 mL/min)
  5. Maintain good oral hygiene during therapy

Drug Interactions:
  1. Caution with nephrotoxic drugs (aminoglycosides, NSAIDs)
  2. Avoid concurrent use with loop diuretics (increased risk of hypocalcemia)
  3. May interact with other calcium-lowering agents
  4. Monitor digoxin levels if patient is hypocalcemic

Allergies:
  1. Contraindicated in patients with known hypersensitivity to Zoledronic Acid or other bisphosphonates
  2. Allergic reactions may include rash, swelling, difficulty breathing, dizziness

Overdose Information:
  1. Symptoms may include hypocalcemia, renal impairment, electrolyte disturbances
  2. Treatment is symptomatic and supportive
  3. IV calcium gluconate may be required in severe hypocalcemia

Missed Dose Instructions:
  1. If a dose is missed, reschedule the infusion as soon as possible
  2. Resume the regular dosing schedule thereafter
  3. Do not double the dose

Additional Notes:
  1. Patient should maintain adequate calcium and vitamin D intake
  2. Long-term use may require periodic bone density assessments
  3. Regular renal monitoring is essential to prevent toxicity
  4. Avoid invasive dental procedures during treatment unless absolutely necessary
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