Zudronic Administration Protocol

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  • Zudronic Administration Protocol
  • Confirm indication & dose:
    • Osteoporosis: 5 mg once yearly.
    • Paget’s disease: Usually single infusion (5 mg); repeat only if relapse confirmed biochemically.
  • Check contraindications:
    • Hypocalcaemia, severe renal impairment (CrCl <35 mL/min), hypersensitivity to bisphosphonates.
  • Baseline labs (within 14 days, ideally same day):
    • Serum creatinine: (Avoid if CrCl < 35 mL/min; adjust hydration accordingly)
    • Serum Calcium: Must correct hypocalcemia before starting
    • Vitamin D (25-OH) (recommended): Supplement if low to reduce risk of hypocalcemia
    • Phosphate & Magnesium (optional): Important in patients with malnutrition or GI malabsorption
    • CBC (only if clinically indicated): Not routine, but considered in cancer patients
  • Dental Evaluation (Osteonecrosis of the Jaw – ONJ risk)
    • For all patients (especially cancer patients on high doses or repeated infusions), it’s best to do a dental check before starting therapy.
    • Any invasive dental work should ideally be completed before infusion.
    • Educate patient on maintaining good oral hygiene.

Before Infusion:

Ensure patient is adequately hydrated.

  • Low-risk patients (osteoporosis, normal renal function):
    • Instruct to drink ≥500 mL water in the 2–3 hours before infusion.
    • If oral intake is poor or patient is elderly/at risk for dehydration, give: 0.9% NaCl (Normal Saline) 100–250 mL IV over 15–30 min prior to Zudronic infusion.
  • High-risk patients (CKD, dehydration, hypercalcemia, oncology):
    • Pre-hydration: 250–500 mL NS IV over 30–60 minutes before infusion.
    • Post-hydration (optional): 250 mL NS IV over 30 minutes after infusion
  • Paracetamol:

1,000 mg (IV infusion in 100 ml over 15 min) IV 30-60 min before infusion to reduce flu-like reaction risk (fever, myalgia, headache).

If IV not available, give 650–1000 mg orally 1–2 hr. before infusion.

Note: Paracetamol does not prevent anaphylaxis — rare (<0.01%).

  • Antihistamines:

Chlorpheniramine maleate 10 mg IV slow push 30 min before infusion to reduce allergic reaction risk (give only if previous infusion caused urticaria/pruritus).

  • Corticosteroids:

Dexamethasone 4–8 mg IV 30 min before infusion to reduce severe acute-phase reactions (Reserved for high-risk or steroid-responsive patients).

  1. Verify product: 5 mg zoledronic acid in 100 mL solution, clear & particle-free.
  2. Use a dedicated IV line.
  3. Infuse over ≥15 minutes (never as bolus).
  4. Do not mix with Ringer’s lactate / calcium-containing solutions or other drugs.

Monitor:

  • Blood pressure, pulse, oxygen saturation every 15 minutes during infusion (especially in elderly, cardiac, or cancer patients).
  • Watch for infusion reactions: chills, fever, hypotension.

Flush after infusion:

  • Flush line with 10–20 mL 0.9% NaCl to clear any residual drug or give an additional 100 mL NS post-infusion if hydration is still needed.
  • Monitor patient for 30–60 min for any adverse reactions.
  • Monitor renal function and serum calcium if clinically indicated.
  • Advise oral hydration throughout the day (at least 1.5–2 L fluid, if not contraindicated).
  • Continue PCM 650 mg every 6–8 hours for next 24–48 hr. as needed.
  • Continue calcium + vitamin D supplementation unless contraindicated as needed.

Educate patient:

  • Flu-like symptoms possible in first 3 days — manage with paracetamol.
  • ONJ warning signs.
  • Drinking water, Blanket for chills, Chair or recliner (comfortable seating during infusion)
  • Educational leaflet / patient card.

Acute Hypocalcemia: (tingling, muscle cramps, tetany, seizures)

  • Calcium Gluconate 10%, 10 mL (≈ 1 g) IV slowly over 10 min, dilute in 50 mL NS if needed; may repeat as required
  • Monitor ECG; always have oral calcium + vitamin D ready for post-infusion support

Allergic Reaction / Anaphylaxis:  (rash, bronchospasm, hypotension)

  • *Adrenaline (Epinephrine) 1:1000, 0.5 mL (0.5 mg) IM into lateral thigh; repeat every 5–15 min if needed

First-line for life-threatening allergic reaction

  • *Hydrocortisone 100 mg IV slowly, Adjunct after adrenaline for ongoing allergic symptoms
  • *Chlorpheniramine maleate 10 mg slow IV (over 1–2 min) or deep IM for urticaria, itching, mild allergic features

Bronchospasm: (wheezing, difficulty breathing)

  • Salbutamol 5 mg via nebulizer with O₂, repeat as needed, use alongside adrenaline if due to anaphylaxis

Severe Hypotension / Shock

  • Normal Saline / Ringer’s Lactate, rapid bolus 500–1000 mL IV; reassess and repeat as needed, keep patient supine with legs elevated

Seizures

  • (from severe hypocalcemia) Diazepam, 5–10 mg IV slowly, treat underlying cause (calcium) immediately

Fever / Infusion Reaction

  • Paracetamol, 500–1000 mg orally or IV every 6–8 h (max 4 g/day), premedication can reduce post-infusion flu-like symptoms.
SPECIAL CAUTIONS:
  • Avoid use if CrCl < 35 mL/min (osteoporosis) or < 30 mL/min (cancer, as per many oncology protocols).
  • Pregnancy Category D — contraindicated unless benefits outweigh risks.
  • Lactation: avoid unless necessary.