Prescribing information (package insert) - Hydroxocobalamin Injection 1 mg/mL
Desription
Hydroxocobalamin Injection is a sterile, red-colored, preservative-containing injectable solution supplied as a multi-dose vial for intramuscular administration. Hydroxocobalamin is a naturally occurring form of vitamin B12 essential for normal hematopoiesis, neurologic function, and cellular metabolism.
Each mL contains:
Hydroxocobalamin .............................. 1 mg
Benzyl Alcohol .................................. 0.9%
Sodium Chloride ................................ 9 mg
Sterile Water for Injection .............. q.s.
The pH is adjusted with hydrochloric acid and/or sodium hydroxide to a target pH range of 4.0 to 7.5.
Hydroxocobalamin appears as dark red crystals or crystalline powder and is sparingly soluble in water. The solution should appear clear and red in color.
Storage and Handling
Store Hydroxocobalamin Injection at USP Controlled Room Temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).
Protect from light and freezing. Keep vial in carton until use.
Inspect solution visually prior to administration. Do not use if the solution is cloudy, discolored, or contains particulate matter.
Use aseptic technique when handling and withdrawing product from the multi-dose vial.
Components
Each mL contains Hydroxocobalamin 1 mg as the active pharmaceutical ingredient. Hydroxocobalamin is a naturally occurring form of vitamin B12 used for vitamin B12 replacement therapy and support of normal hematologic and neurologic function.
Benzyl Alcohol 0.9% as preservative
Sodium Chloride 9 mg for isotonicity
Sterile Water for Injection q.s. as solvent vehicle
The pH is adjusted with Hydrochloric Acid and/or Sodium Hydroxide to a pH range of 4.0 to 7.5.
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.
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
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.