Hydroxocobalamin
Antidote [EPC]
What it is used for
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.
Warnings
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.
Possible side 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
Storage
Store as labelled. Keep out of reach of children.
No reviewed patient-education article is available. The fields shown are from the currently verified medicine record and unavailable fields are not inferred.