INN monograph
Hydroxocobalamin
Antidote [EPC] · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Professional class pharmacology (Vitamin / mineral / nutritional supplement)
Kenya market
Wholesale / list prices where loaded
Risk first
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.
Point of care
Dosing
Adult
I.M. Initially repeated 5 times at 2-3 days interval then maintenance dose of 1g every 3 months
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Fat-soluble vitamins and potassium need care in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Vitamin A toxicity hepatic; niacin hepatotoxicity at high dose.
Safety
Drug interactions
- ||| 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.
Safety
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
Use
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.
Pharmacology
Mode of action
It acts as a coenzyme for various metabolic functions such as protein synthesis and fat and carbohydrate metabolism.
Full mechanism text
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.
ADME
Pharmacokinetics & PD
| Onset | Days–weeks for repletion |
|---|---|
| Duration | Depends on stores and ongoing intake |
| Route | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| Absorption | 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. |
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
Folic acid preconception/first trimester critical. Iron/folate common in ANC. Avoid excess vitamin A.
Lactation
Maternal repletion often appropriate; avoid megadoses.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Professional class pharmacology (Vitamin / mineral / nutritional supplement)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.