Vitamin B12 + Elemental Iron + Folic Acid

Allopathic
Indications
  • Treatment and prevention of nutritional anemias caused by deficiencies of vitamin B12, iron, and folic acid.
  • Vitamin B12 deficiency anemia (including pernicious anemia and dietary deficiency).
  • Iron deficiency anemia due to blood loss, malnutrition, pregnancy, or chronic diseases.
  • Folic acid deficiency anemia and prevention of neural tube defects during pregnancy.
  • Supportive therapy in malabsorption syndromes, chronic blood loss, post-surgical recovery, and chemotherapy-induced anemia.
  • Off-label: General fatigue and weakness related to combined vitamin and mineral deficiencies.
Dosage & Administration
  • Adults:
    • Vitamin B12: 1000 mcg daily orally or 1000 mcg intramuscularly monthly after initial correction.
    • Elemental Iron: 60–120 mg daily divided into 2-3 doses.
    • Folic Acid: 400–1000 mcg orally once daily.
  • Pregnant women:
    • Iron: 30–60 mg elemental iron daily.
    • Folic Acid: 400–800 mcg daily (higher doses for high-risk pregnancies).
    • Vitamin B12 as per clinical need.
  • Pediatrics: Dosage adjusted based on age, weight, and severity of deficiency; typically 3–6 mg/kg/day of elemental iron.
  • Elderly: Standard adult dosing with monitoring; dose adjustments as needed for renal/hepatic impairment.
  • Administration:
    • Oral preferred for maintenance and mild deficiency.
    • Vitamin B12 parenteral injections for severe deficiency or malabsorption.
    • Iron taken on empty stomach for better absorption but may be taken with food to reduce GI upset.
    • Avoid concomitant calcium or antacids with iron.
  • Duration: Until anemia correction; maintenance dosing as recommended.
Mechanism of Action (MOA)

Vitamin B12 functions as a coenzyme essential for DNA synthesis and neurological function by facilitating the conversion of homocysteine to methionine and methylmalonyl-CoA to succinyl-CoA, critical for myelin production and red blood cell formation. Elemental iron is a vital component of hemoglobin and myoglobin, enabling oxygen transport and storage. Folic acid acts as a methyl donor in nucleotide synthesis necessary for DNA replication and cell division. Together, these agents restore effective erythropoiesis and correct macrocytic and microcytic anemias by replenishing deficient cofactors.

Pharmacokinetics
  • Absorption:
    • Vitamin B12 absorption requires intrinsic factor in the terminal ileum; high oral doses allow passive absorption.
    • Iron is absorbed primarily in the duodenum and upper jejunum via active transport.
    • Folic acid is absorbed in the proximal small intestine.
  • Distribution:
    • Vitamin B12 is stored mainly in the liver.
    • Iron circulates bound to transferrin and is stored as ferritin.
    • Folic acid is distributed to tissues including liver and bone marrow.
  • Metabolism:
    • Vitamin B12 converted intracellularly to active forms (methylcobalamin, adenosylcobalamin).
    • Iron incorporated into hemoglobin or stored.
    • Folic acid metabolized to tetrahydrofolate derivatives.
  • Excretion:
    • Vitamin B12 eliminated via bile with enterohepatic recirculation.
    • Iron lost through sloughing of intestinal mucosa and blood loss.
    • Folic acid excreted mainly in urine.
  • Half-life:
    • Vitamin B12: weeks (due to storage).
    • Folic acid: approximately 3–4 hours.
Pregnancy Category & Lactation
  • Vitamin B12, iron, and folic acid are considered safe and essential during pregnancy and lactation.
  • Recommended for prevention of maternal anemia and fetal neural tube defects.
  • Secreted in breast milk; safe for breastfeeding infants.
  • Caution advised in case of excessive iron intake due to gastrointestinal discomfort.
Therapeutic Class
  • Hematinics and Nutritional Supplements
  • Vitamin B12: Water-soluble vitamin (cobalamin)
  • Iron: Mineral supplement
  • Folic Acid: Water-soluble vitamin (B9)
Contraindications
  • Hypersensitivity to any component (vitamin B12, iron, folic acid)
  • Hemochromatosis or iron overload disorders
  • Unexplained anemia without proper diagnosis
  • Severe liver dysfunction precluding iron use
Warnings & Precautions
  • Monitor for iron overload during prolonged therapy.
  • Differentiate vitamin B12 deficiency from folate deficiency to avoid masking neurological symptoms.
  • Use caution in infections due to possible iron promotion of bacterial growth.
  • Monitor hematologic parameters regularly.
  • Discontinue if hypersensitivity reactions occur.
Side Effects
  • Common:
    • Gastrointestinal upset (nausea, constipation, diarrhea) mainly due to iron.
    • Injection site reactions with vitamin B12 IM injections.
    • Mild allergic skin reactions.
  • Serious (rare):
    • Anaphylaxis with parenteral vitamin B12.
    • Iron toxicity or overload.
    • Peripheral neuropathy if vitamin B12 deficiency untreated.
Drug Interactions
  • Iron absorption decreased by antacids, calcium, tetracyclines, and proton pump inhibitors.
  • Vitamin B12 absorption reduced by metformin, proton pump inhibitors, and H2 blockers.
  • Folic acid may mask vitamin B12 deficiency symptoms.
  • Vitamin C enhances iron absorption.
  • No significant CYP450 interactions.
Recent Updates or Guidelines
  • Emphasis on folic acid supplementation during pregnancy to prevent neural tube defects by WHO and CDC.
  • Increased screening and treatment of vitamin B12 deficiency in at-risk populations recommended.
  • Iron dosing protocols updated to balance efficacy and minimize side effects.
  • Combined supplementation supported for mixed anemia treatment.
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F).
  • Protect from moisture, heat, and light.
  • Keep oral forms in tightly closed containers.
  • Injectable vitamin B12 protected from freezing and excessive heat.
  • Keep out of reach of children.