Hydroxocobalamin (Vitamin B12)
Brand names: Cobalin-H (IM), Neo-Cytamen (IM), Cyanokit (IV — cyanide antidote)
Hydroxocobalamin is an injectable form of vitamin B12 used to treat B12 deficiency, including pernicious anaemia and deficiency from malabsorption or dietary causes.
Adult dose
Paediatric dose
Dose adjustments
Not addressed in the retrieved SPC sections — §4.2 gives no renal-impairment dosing and §4.4 does not mention renal function.
Not addressed in the retrieved SPC sections — §4.2 gives no hepatic-impairment dosing and §4.4 does not mention hepatic function.
Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.
Contraindications
- [UK SPC §4.3] 'Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.'
- [US label cross-check, broader than the UK SPC] Known hypersensitivity to hydroxocobalamin, vitamin B12 preparations, cobalt, benzyl alcohol, or any component of the formulation.
- [US label cross-check, and DIRECTLY CONTRARY TO THE UK SPC §4.1, which lists Leber's atrophy as an indication] 'Administration to patients with hereditary optic nerve atrophy (Leber's disease) may result in severe and rapid optic nerve atrophy.'
Side effects
- [§4.8] Metabolism: initial hypokalaemia — potassium falls as B12 treatment drives cellular uptake during haematological recovery
- [§4.8] Cardiac: arrhythmias secondary to hypokalaemia, reported during initial therapy
- [§4.8] Blood: reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia
- [§4.8] Immune: hypersensitivity reactions including rash, itching and exanthema; anaphylaxis; antibodies to the hydroxocobalamin-transcobalamin II complex have developed during therapy
- [§4.8] Injection site reactions including pain, erythema, pruritus, induration and swelling
- [§4.8] Nervous system: headache, paraesthesia, tremor
- [§4.8] Gastrointestinal: nausea, vomiting, diarrhoea
- [§4.8] General: fever, chills, hot flushes, dizziness, malaise, pain
- [§4.8] Skin: acneiform and bullous eruptions
- [§4.8] Renal and urinary: chromaturia (discoloured urine)
- [§4.8] Note: 'There are no modern clinical studies available that can be used to determine the frequency of undesirable effects. Therefore, all the undesirable effects listed are classed as "frequency Not known".'
Interactions
- [§4.5, carried inside the fetched §4.4 text] Chloramphenicol — 'Parenteral chloramphenicol may attenuate the effect of hydroxocobalamin in anaemia.'
- [§4.5] Oral contraceptives — 'The serum concentration of hydroxocobalamin may be lowered.'
- [§4.5] 'The above interactions are unlikely to be of clinical significance but should be taken into account when performing assays for blood concentrations. Vitamin B 12 assays by microbiological techniques are invalidated by antimetabolites and most antibiotics.'
Monitoring
- Confirm the diagnosis of vitamin B12 deficiency BEFORE giving hydroxocobalamin — indiscriminate administration may mask the true diagnosis (§4.4)
- Plasma potassium during initial therapy — 'Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period' (§4.4)
- Regular monitoring of the blood is recommended (§4.4)
- Blood count response — the without-neurological-involvement regimen is given weekly 'until blood count is normal' (§4.2)
- Neurological improvement — the with-neurological-involvement regimen continues on alternate days 'as long as improvement continues' (§4.2)
- If megaloblastic anaemia fails to respond, investigate folate metabolism (§4.4)
- Assay interpretation: vitamin B12 assays by microbiological techniques are invalidated by antimetabolites and most antibiotics (§4.5)
Clinical monograph
How it works
It is converted to the active coenzymes methylcobalamin and adenosylcobalamin, which are required for DNA synthesis and red cell maturation and for normal neurological function.
Prescribing in practice
- Establish the diagnosis before treating, as folic acid given alone in B12 deficiency can correct the anaemia while allowing irreversible neurological damage to progress.
- It is given by intramuscular injection because oral absorption is unreliable in pernicious anaemia and other malabsorptive states.
- Initiate replacement promptly where neurological involvement is present, with more frequent loading before maintenance.
Monitoring
Check a full blood count and reticulocyte response after starting, and monitor potassium during early treatment of severe megaloblastic anaemia.
Counselling the patient
- Treatment for pernicious anaemia is usually lifelong and given as regular injections.
- Report any new tingling, numbness or balance problems.
- Attend for your scheduled maintenance injections to prevent relapse.
Evidence & guidelines
Hydroxocobalamin is recommended in NICE guidance on B12 deficiency as the standard parenteral replacement for pernicious anaemia and malabsorption.
Reference: BSH Guidelines on Cobalamin and Folate Deficiency 2014; NICE CG126; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.
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- Pre-op Medical Clearance · NICE NG45; ESC 2022
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