Description

Cyanocobalamin (Vitamin B12) Vials 0.5 mg/ml, 1 ml, #10

Composition

Each 1 ml vial contains 0.5 mg (500 mcg) of Cyanocobalamin (Vitamin B12) as the active ingredient. Inactive ingredients may include sodium chloride, acetic acid, sodium acetate, benzyl alcohol (as a preservative), and sterile water for injection.

Description

Cyanocobalamin is a synthetic form of Vitamin B12, a water-soluble vitamin essential for hematopoietic, neurological, and metabolic functions. It supports red blood cell production, neurological function, and DNA synthesis.

Pharmacological Group

Belongs to the group of hematopoietic agents and vitamin supplements. Essential in the conversion of methylmalonyl-CoA to succinyl-CoA and the synthesis of methionine from homocysteine.

Indications

• Treatment and prevention of Vitamin B12 deficiency
• Pernicious anemia (Addison-Biermer disease)
• Macrocytic anemia due to B12 malabsorption (e.g. post-gastrectomy, Crohn’s disease)
• Neurological disorders associated with B12 deficiency
• Supportive therapy for certain congenital metabolic disorders (e.g. methylmalonic acidemia)

Mechanism of Action

Cyanocobalamin is converted to active forms (methylcobalamin and adenosylcobalamin) in the body, where it functions as a cofactor in essential enzymatic reactions required for DNA synthesis, neurological function, and erythropoiesis.

Dosage and Administration

• Typical dose for deficiency treatment: 1000 mcg intramuscularly once daily for 1–2 weeks, followed by weekly injections, then monthly maintenance doses
• Prophylactic use: 1000 mcg IM monthly for patients with chronic malabsorption or after gastric surgery
• Only to be administered under the supervision of a healthcare provider

Contraindications

• Hypersensitivity to Cyanocobalamin, cobalt, or any component of the formulation
• Leber’s disease (hereditary optic nerve atrophy)—risk of optic nerve damage

Side Effects

• Common: Injection site pain, redness, diarrhea, mild itching or rash
• Less common: Hypokalemia (during initial treatment), allergic reactions, dizziness
• Rare: Anaphylaxis, thromboembolism, polycythemia vera exacerbation

Interactions

• Decreased absorption or effect with: Chloramphenicol, colchicine, metformin, neomycin, proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. ranitidine)
• Concurrent folic acid use may mask hematologic symptoms of B12 deficiency while allowing progression of neuropathy

Precautions

• Use with caution in patients with folate deficiency, iron deficiency, or polycythemia vera
• Monitor potassium levels during initial therapy due to risk of hypokalemia
• Not effective for optic neuropathy in Leber’s disease and may worsen condition

Overdose

No specific antidote exists. Vitamin B12 has low toxicity, but extremely high doses may cause acneiform eruptions or rosacea-like symptoms. Discontinue use and provide supportive treatment if overdose is suspected.

Pregnancy and Lactation

• Pregnancy: Cyanocobalamin is considered safe and is classified under FDA Pregnancy Category C. It is often used to correct deficiencies during pregnancy.
• Lactation: Excreted into breast milk. Safe for use under medical supervision.

Storage

• Store at 15–25°C (59–77°F)
• Protect from light
• Do not freeze
• Keep out of reach of children

Disposal

Dispose of unused solution and empty vials in accordance with local regulations. Do not reuse vials. Consult a pharmacist or local disposal authority for guidance.

Scientific References

• National Institutes of Health. “Cyanocobalamin.” StatPearls. 2023.
• NIH Office of Dietary Supplements – Vitamin B12 Fact Sheet