Usage
This combination medication is prescribed for the treatment and prevention of nutritional deficiencies, particularly those involving iron, vitamin B12, folic acid, and vitamin D3. These deficiencies can arise from various factors like poor diet, malabsorption, pregnancy, alcoholism, or certain medications. It’s specifically indicated for conditions such as:
- Iron deficiency anemia: Characterized by low levels of iron, essential for hemoglobin synthesis and oxygen transport.
- Megaloblastic anemia: Caused by vitamin B12 or folic acid deficiency, impacting red blood cell production.
- Pernicious anemia: A specific type of megaloblastic anemia due to impaired vitamin B12 absorption.
- Nutritional deficiencies in pregnancy: To support fetal development and prevent neural tube defects.
- Other conditions requiring supplementation: For example, patients with malabsorption syndromes, those on certain medications interfering with nutrient absorption, or individuals with increased nutritional needs.
Pharmacological Classification: This combination falls under the category of nutritional supplements and hematinics.
Mechanism of Action: This combination works by replenishing deficient nutrients essential for various physiological processes.
- Cyanocobalamin (Vitamin B12): Crucial for red blood cell formation, neurological function, and DNA synthesis. It converts to active forms, methylcobalamin, and adenosylcobalamin, within the body.
- Ferrous Ascorbate (Iron): A key component of hemoglobin, transporting oxygen throughout the body. Ascorbic acid enhances iron absorption.
- Folic Acid (Vitamin B9): Necessary for DNA synthesis, red blood cell production, and fetal development. It works synergistically with vitamin B12.
- Vitamin D3 (Cholecalciferol): Helps maintain blood calcium and phosphorus levels and aids in bone mineralization.
Alternate Names
There is no single international nonproprietary name (INN) for this combination. It’s often referred to by its component ingredients. Brand names vary regionally and may include names like Ferotwo-XT (Biofield Pharma, India). Always verify the composition when using brand names.
How It Works
Pharmacodynamics: The effects on the body are primarily hematological and metabolic. Iron increases hemoglobin levels, correcting anemia. Vitamin B12 and folic acid stimulate erythropoiesis, leading to increased red blood cell counts. Vitamin D3 regulates calcium homeostasis, supporting bone health.
Pharmacokinetics:
- Absorption: Iron absorption is enhanced by ascorbic acid and occurs primarily in the duodenum and jejunum. Vitamin B12 absorption requires intrinsic factor and happens in the ileum. Folic acid is absorbed in the jejunum. Vitamin D3 is absorbed in the small intestine.
- Metabolism: Iron is incorporated into hemoglobin. Vitamin B12 and folic acid are converted to active forms. Vitamin D3 is metabolized in the liver and kidneys.
- Elimination: Iron is primarily lost through blood loss. Excess vitamin B12 is excreted in urine. Folic acid is excreted in urine and bile. Vitamin D3 metabolites are excreted in bile and feces.
Mode of Action: At the cellular level, iron becomes part of the heme molecule in hemoglobin. Vitamin B12 and folic acid are coenzymes in DNA synthesis and red blood cell maturation. Vitamin D3 acts on nuclear receptors, influencing gene transcription related to calcium homeostasis.
Dosage
Dosage depends on the individual patient’s specific needs, the severity of the deficiency, and the formulation used. Always follow the prescribed dosage.
Standard Dosage
Adults: A common dosage is one tablet daily containing a combination of ferrous ascorbate (100 mg elemental iron), folic acid (1.5 mg), cyanocobalamin (15 mcg), and vitamin D3 (200 IU).
Children: Dosage in children should be determined by a pediatrician, considering age, weight, and the specific deficiency being addressed.
Special Cases:
- Elderly Patients: Dosage may need adjustment based on renal function and other comorbidities.
- Patients with Renal Impairment: Dosage adjustments are crucial, as renal dysfunction can affect drug clearance and increase the risk of toxicity. Consult dosage guidelines specific to renal function, typically based on estimated glomerular filtration rate (eGFR).
- Patients with Hepatic Dysfunction: Monitor closely, as liver disease can impact drug metabolism. Dosage adjustments may be necessary.
- Patients with Comorbid Conditions: Consider other medical conditions like diabetes, cardiovascular disease, and gastrointestinal disorders when determining dosage.
Clinical Use Cases Dosage in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations is not relevant for this combination medication, as it is used to address nutritional deficiencies.
Dosage Adjustments Individualize dosing based on the patient’s clinical picture. This includes renal and hepatic function, other comorbidities, and response to therapy. Therapeutic drug monitoring may be beneficial in certain situations.
Side Effects
Common Side Effects:
- Gastrointestinal disturbances (nausea, vomiting, constipation, diarrhea, dark stools, stomach upset)
- Allergic reactions (skin rash)
- Metallic taste in the mouth (with iron supplementation)
Long-Term Effects: Long-term use can lead to iron overload in susceptible individuals.
Adverse Drug Reactions (ADR): Report any significant adverse events to the appropriate pharmacovigilance system.
Contraindications
- Hypersensitivity to any of the components.
- Iron overload disorders (hemochromatosis, hemosiderosis).
- Anemias not caused by iron, B12, or folate deficiency.
- Untreated pyelonephritis.
- Acute liver disease.
- Leber’s hereditary optic neuropathy (caution with cyanocobalamin).
Drug Interactions
- Antacids, tetracycline antibiotics, quinolone antibiotics, bisphosphonates, levodopa, and levothyroxine can decrease iron absorption.
- Anti-seizure medications (phenytoin, phenobarbital) may interact with the combination.
- Alcohol reduces folic acid absorption.
- Consult drug interaction databases for a comprehensive list.
Pregnancy and Breastfeeding
- Pregnancy: Generally considered safe when clinically indicated. Essential for preventing neural tube defects.
- Breastfeeding: Present in breast milk. Consult a physician regarding safety and potential effects on the infant.
Drug Profile Summary
- Mechanism of Action: Replenishes deficiencies in iron, vitamin B12, folic acid, and vitamin D3.
- Side Effects: GI disturbances, allergic reactions, metallic taste.
- Contraindications: Hypersensitivity, iron overload, certain anemias.
- Drug Interactions: Antacids, antibiotics, alcohol.
- Pregnancy & Breastfeeding: Generally safe in pregnancy; consult regarding breastfeeding.
- Dosage: Individualized based on deficiency and patient factors.
- Monitoring Parameters: Hemoglobin, red blood cell indices, iron studies, vitamin B12 levels, folate levels, vitamin D levels.
Popular Combinations
This combination is frequently prescribed on its own. Occasionally, other B vitamins or minerals might be added depending on the clinical situation.
Precautions
- Screen for allergies, metabolic disorders, and organ dysfunction.
- Monitor renal and hepatic function in patients with underlying disease.
- Evaluate iron stores before initiating iron supplementation.
- Counsel patients on potential side effects and drug interactions.
- Advise against alcohol consumption with this combination.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Cyanocobalamin + Ferrous Ascorbate + Folic Acid + Vitamin D3?
A: The dosage is individualized based on the patient’s specific deficiency and clinical condition. A common adult dose is one tablet daily containing 100 mg elemental iron (as ferrous ascorbate), 1.5 mg folic acid, 15 mcg cyanocobalamin, and 200 IU vitamin D3. Pediatric and special population dosing should be determined by a physician.
Q2: What are the common side effects?
A: Common side effects include gastrointestinal issues like nausea, constipation, diarrhea, dark stools, and stomach upset.
Q3: Are there any contraindications?
A: Yes, contraindications include hypersensitivity to any component, iron overload disorders, and anemias not caused by iron, B12, or folate deficiency.
Q4: Can this combination be used during pregnancy and breastfeeding?
A: It is generally considered safe during pregnancy and is often prescribed to prevent neural tube defects. Consult a physician regarding use during breastfeeding.
Q5: What are the potential drug interactions?
A: This combination can interact with various medications, including antacids, certain antibiotics (tetracyclines, quinolones), and levothyroxine. It is important to review all concomitant medications with the patient.
Q6: How should I monitor a patient on this medication?
A: Monitor hemoglobin, red blood cell indices, iron studies, vitamin B12 levels, folate levels, and vitamin D levels as clinically indicated.
Q7: Can this combination be used in patients with renal impairment?
A: Dosage adjustments are crucial in patients with renal impairment. Consult dosage guidelines based on eGFR to minimize the risk of toxicity.
Q8: Are there any specific dietary recommendations while taking this medication?
A: A balanced diet is recommended. Advise patients to avoid taking the medication with dairy products, tea, or coffee, as these can interfere with iron absorption. Encourage adequate hydration.
Q9: What should I do if a patient experiences side effects?
A: Evaluate the severity and nature of the side effects. Mild GI issues may resolve with continued use or can be managed with dietary adjustments. Discontinue the medication and consult a physician if severe or persistent side effects occur.
Q10: How is iron deficiency diagnosed?
A: Iron deficiency is diagnosed through blood tests, including complete blood count (CBC), serum iron, ferritin, transferrin saturation, and total iron-binding capacity (TIBC).
