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Active Pharma Ingredients / 19 Sep 2026

CALCOBUTROL

Generic Name: CALCOBUTROL

ABSTRACT -

Calcobutrol is the excipient/chelating component used in gadobutrol (Gadovist/Gadavist), a macrocyclic gadolinium-based contrast agent (GBCA) approved for MRI enhancement of the CNS, body, and cardiac structures. As a macrocyclic chelate, gadobutrol has a high thermodynamic and kinetic stability, reducing gadolinium release and associated deposition concerns. It enables enhanced visualisation of lesions that disrupt the blood-brain barrier.

DOSAGE -

Gadobutrol 1.0 mmol/mL solution: 0.1 mmol/kg body weight IV bolus for standard CNS and body MRI; up to 0.3 mmol/kg for perfusion studies.

SIDE EFFECTS - 

  • Nausea
  • Headache
  • Injection site warmth or discomfort
  • Dizziness
  • Taste disturbance

ALLERGIC REACTIONS -

These symptoms may indicate an allergic reaction and require immediate medical attention.

  • Anaphylaxis (rare but reported)
  • Urticaria
  • Pruritus
  • Bronchospasm

DRUG INTERACTIONS-

  • No significant pharmacokinetic drug interactions identified
  • Caution in patients receiving nephrotoxic drugs — renal clearance of Gd dependent on GFR
  • NSAIDs may aggravate renal impairment post-injection

PREAUTONS–

  • Nephrogenic systemic fibrosis (NSF) risk in severe renal impairment — screen eGFR
  • History of prior GBCA hypersensitivity — caution and pre-treatment
  • Pregnancy: use only if clearly necessary
  • Breastfeeding: interrupt for 24 hours after administration

WARNINGS –

  • Gadolinium deposition in brain and other tissues — clinical significance under evaluation
  • NSF risk in acute kidney injury or severe CKD — avoid GBCAs or use with extreme caution
  • Resuscitation equipment must be available during and after injection

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