Hydroxocobalamin
Regulatory sources consulted
- AEMPS CIMA: https://cima.aemps.es/cima/dochtml/ft/88743/FT_88743.html
- Professional Clinical Knowledge
- AEMPS CIMA · nº registro 88743 ↗
Approved indications
- Treatment of pernicious anemia (due to lack or inhibition of intrinsic factor).
- Prophylaxis and treatment of other megaloblastic anemias due to vitamin B12 deficiency.
- Antidote for acute cyanide poisoning (high-dose formulation, e.g., 5g IV).
Contraindications
Absolute
- Hypersensitivity to hydroxocobalamin, cobalt, or any of the excipients.
Clinical warnings
- Major warning · Administration of vitamin B12 may mask symptoms of subacute combined degeneration of the spinal cord. The diagnosis of deficiency should be confirmed before starting treatment. — AEMPS CIMA
- Major warning · The formulation for cyanide poisoning (high dose) can cause a transient and severe increase in blood pressure and a reddish discoloration of the skin and urine (chromaturia). — Clinical Knowledge
Drug interactions
- ModerateChloramphenicolS01AA01
Mechanism: Chloramphenicol may antagonize the hematopoietic response to vitamin B12.
Recommendation: Monitor the patient's hematological response if administered concomitantly.
AEMPS CIMA
- LowOral contraceptivesG03A
Mechanism: Oral contraceptives may reduce serum concentrations of vitamin B12.
Recommendation: Generally not clinically significant, but monitoring B12 levels may be considered with long-term use.
AEMPS CIMA
Adverse events
Common (≥1%)
injection site pain · nausea · headache · dizziness · chromaturia (with high doses)
Rare but serious
anaphylactic reactions · angioedema · severe hypertension (with high doses)
Pregnancy and lactation
Pregnancy: No adverse effects are expected when administered at recommended doses for anemia, as it is an essential vitamin. Lactation: It is excreted in breast milk in amounts not expected to have adverse effects on the infant.