Clinical medicine profile
Hydroxocobalamin
Antidote [EPC]
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- Contraindications Hydroxocobalamin Injection is contraindicated in patients with known hypersensitivity to hydroxocobalamin, vitamin B12 preparations, cobalt, benzyl alcohol, or any component of the formulation.
- Hypersensitivity reactions, including anaphylactic shock and serious allergic reactions, have been reported following parenteral administration of hydroxocobalamin and other vitamin B12 products.
- Administration to patients with hereditary optic nerve atrophy (Leber’s disease) may result in severe and rapid optic nerve atrophy.
Precautions
- Warnings and Precautions Hypersensitivity reactions, including anaphylactic shock, rash, pruritus, urticaria, and edema, have been reported following parenteral administration of vitamin B12 products, including hydroxocobalamin.
- Patients with known sensitivity to hydroxocobalamin, cobalt, benzyl alcohol, or any component of the formulation may be at increased risk for serious allergic reactions.
- This product contains benzyl alcohol as a preservative.
- Benzyl alcohol has been associated with serious and fatal adverse reactions, including “gasping syndrome,” in premature infants and neonates.
- Administer under appropriate medical supervision.
- Monitor patients for signs and symptoms of hypersensitivity during administration.
- Do not use if the solution is cloudy, discolored, or contains particulate matter.
- Use aseptic technique during handling and administration.
- Protect from light.
- Not for intravenous administration.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
I.M. Initially repeated 5 times at 2-3 days interval then maintenance dose of 1g every 3 months
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Fat-soluble vitamins and potassium need care in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Vitamin A toxicity hepatic; niacin hepatotoxicity at high dose.
Use, effects & interactions
Indications
- Prophylaxis and treatment Vitamin B12deficiency
- treatment of pernicious anaemia Clinical selection for Hydroxocobalamin should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Antidote [EPC].
- Confirm site-specific dose, duration and monitoring before prescribing.
Adverse effects
- Adverse Reactions The following adverse reactions have been reported with hydroxocobalamin injection and other parenteral vitamin B12 products: Hypersensitivity reactions including anaphylactic shock, urticaria, rash, pruritus, flushing, and edema Injection site pain, erythema, and injection site reactions Headache and dizziness Nausea and diarrhea Fever and chills Rare cases of hypokalemia during intensive treatment of severe megaloblastic anemia Serious hypersensitivity reactions, including anaphylaxis, may occur in sensitive patients.
- To report suspected adverse reactions, contact Xseer Pharmaceuticals at (888) 658-8005 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Drug interactions
Open multi-drug checker ↗- ||| A form of vitamin B12 that is retained in the blood longer than cynanocobalamin
- ||| Cyanocobalamin and hydroxocobalamin are synthetic forms of Vitamin B12.
- Cyanocobalamin and hydroxocobalamin have similar indications but hydroxocobalamin may be preferred for treatment of B12 deficiency since optic neuropathies may degenerate with administration of cyanocobalamin.
Mechanism & disposition
It acts as a coenzyme for various metabolic functions such as protein synthesis and fat and carbohydrate metabolism.
Read complete mechanism
It acts as a coenzyme for various metabolic functions such as protein synthesis and fat and carbohydrate metabolism. Vitamins and minerals act as cofactors, antioxidants, structural elements or hormone precursors (e.g. vitamin D endocrine axis). Pharmacological high-dose effects differ from nutritional repletion.
Days–weeks for repletion
Depends on stores and ongoing intake
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
depends on GI integrity, food matrix and binders (e.g. calcium/iron interactions). Fat-soluble vitamins (A,D,E,K) accumulate; water-soluble generally renally cleared.
Pregnancy, lactation & diet
Folic acid preconception/first trimester critical. Iron/folate common in ANC. Avoid excess vitamin A.
Maternal repletion often appropriate; avoid megadoses.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.