Description

1. Description & Composition

Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin (a synthetic form of Vitamin B12) for intramuscular or subcutaneous injection.

• Active Ingredient: Each mL contains 1,000 mcg of cyanocobalamin.

• Inactive Ingredients:

  • Sodium Chloride (0.9%) as a tonicity agent.

  • Benzyl Alcohol (1.5%) as a preservative.

• Appearance: Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder.

• pH: The solution’s pH is adjusted during manufacturing to a range of 4.5–7.0

2. Clinical Pharmacology

• Mechanism of Action: Vitamin B12 is essential for growth, cell reproduction, hematopoiesis (blood cell formation), and the synthesis of nucleoproteins and myelin.

• Absorption & Distribution: Cyanocobalamin is rapidly absorbed from intramuscular and subcutaneous injection sites, reaching peak plasma levels within 1 hour after injection. It is transported via specific binding proteins (transcobalamin I and II) to various tissues, with the liver being the main storage organ.

• Excretion: Within 48 hours of an injection (100 or 1,000 mcg), 50 to 98% of the dose may appear in the urine, with the majority excreted within the first eight hours.

3. Important Precautions & Warnings

• Allergies: Inform your doctor if you are allergic to cyanocobalamin, hydroxocobalamin, cobalt, or any other vitamins.

• Leber’s Disease: Cyanocobalamin is not recommended for patients with Leber’s hereditary optic neuropathy, as it may cause optic nerve damage.

• Pregnancy & Breastfeeding: Consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

• Alcohol Use: Inform your doctor if you consume large amounts of alcohol.

• Kidney Disease: Patients with kidney disease should use this medication with caution.

4. Potential Side Effects

Common side effects may include:

• Pain, redness, or swelling at the injection site

• Mild diarrhea

• Itching or a feeling of swelling all over the body