L-Methyltetrahydrofolate Calcium + Methylcobalamin + Pyridoxal-5-phosphate

Usage

• This combination is prescribed for the treatment and management of nutritional deficiencies, especially those related to folate (vitamin B9), vitamin B12, and vitamin B6. It is also used as an adjunctive therapy in conditions like peripheral neuropathy (particularly diabetic peripheral neuropathy), elevated homocysteine levels, megaloblastic anemia (due to folate deficiency), vitamin B12 deficiency anemia, and cognitive disorders (e.g., dementia, memory loss). Some studies suggest its use for depression and autism spectrum disorders, but more research is needed.
• Pharmacological Classification: Nutritional supplement/Medical food.
• Mechanism of Action: This combination provides the active forms of these essential B vitamins, which are crucial for various metabolic processes, including DNA synthesis, red blood cell formation, nerve function, and homocysteine regulation.

Alternate Names

• L-Methylfolate Calcium + Methylcobalamin + Pyridoxal 5-Phosphate
• L-5-Methyltetrahydrofolate Calcium + Mecobalamin + Pyridoxal 5-Phosphate
• L-Methylfolate + Methylcobalamin + Pyridoxal-5-Phosphate + Vitamin D3 (when combined with Vitamin D3)
• Brand Names: Folinow, L-Myofur, Carryvit, Fol-XT, Mybro-LMF, Metanx (when combined with algae-S powder/Schizochytrium)

How It Works

• Pharmacodynamics: L-Methyltetrahydrofolate calcium, the active form of folate, is vital for DNA and RNA synthesis, amino acid metabolism, and converting homocysteine to methionine. Methylcobalamin, a form of vitamin B12, is essential for nerve function, red blood cell formation, and DNA synthesis. It also plays a role in converting homocysteine to methionine and fatty acid metabolism. Pyridoxal-5-phosphate, the active form of vitamin B6, participates in numerous enzymatic reactions, particularly protein metabolism and neurotransmitter synthesis.
• Pharmacokinetics: All three components are well-absorbed in the gastrointestinal tract. They are metabolized in the liver and other tissues, with excretion primarily via the kidneys.
• Mode of Action: These vitamins act as coenzymes in various metabolic pathways. L-methylfolate is essential for one-carbon transfer reactions. Methylcobalamin is a cofactor for methionine synthase, which converts homocysteine to methionine. Pyridoxal-5-phosphate acts as a cofactor for numerous enzymes involved in amino acid metabolism and neurotransmitter synthesis.
• Receptor binding, Enzyme inhibition, or Neurotransmitter modulation: These vitamins primarily function as coenzymes and do not directly bind to receptors or inhibit enzymes in the classical sense. However, they modulate various metabolic pathways indirectly, influencing neurotransmitter synthesis and other physiological processes.
• Elimination Pathways: Primarily renal excretion, with some metabolic breakdown in the liver.

Dosage

Dosage is determined by the patient’s age, health condition, severity of the deficiency, and other individual factors. A doctor should always determine the appropriate dosage and treatment duration.

Standard Dosage

Adults:

The standard dosage depends on the specific product formulation. Typically, tablets or capsules are administered orally once daily. Injectable solutions are available for intramuscular or subcutaneous administration, strictly under medical supervision.

Children:

Safety and efficacy haven’t been established in children. Use only under the guidance of a physician, who will determine the dosage based on age and weight.

Special Cases:

• Elderly Patients: Dosage adjustments may be needed based on renal function.
• Patients with Renal Impairment: Reduce the dose or increase monitoring frequency based on the degree of impairment.
• Patients with Hepatic Dysfunction: Dosage adjustments may be necessary.
• Patients with Comorbid Conditions: Individualized dosing considerations for patients with conditions like diabetes or cardiovascular disease may be required.

Clinical Use Cases

This combination is not typically used in acute medical settings like intubation, surgical procedures, mechanical ventilation, ICU care, or emergency situations.

Dosage Adjustments

Consider dose modifications in patients with renal or hepatic impairment, metabolic disorders, or genetic polymorphisms affecting drug metabolism. Consult a healthcare professional for adjustments.

Side Effects

Common Side Effects

• Nausea
• Stomach upset
• Diarrhea
• Gastrointestinal discomfort
• Skin reactions (rash, itching)
• Headache
• Insomnia

Rare but Serious Side Effects

• Allergic reactions (hypersensitivity, anaphylaxis)
• Polycythemia vera (excessive red blood cells)
• Edema (fluid retention)

Long-Term Effects

Chronic complications from prolonged use are rare, but monitoring is advised.

Adverse Drug Reactions (ADR)

Clinically significant ADRs are infrequent. Report any adverse reaction to the prescribing physician immediately.

Contraindications

• Hypersensitivity to any component.
• Pernicious anemia or other B12 absorption issues (without medical supervision).
• Milk, soy, or carmine intolerance/allergies (in some formulations).

Drug Interactions

• Anti-epileptic drugs (phenytoin, phenobarbital, primidone, carbamazepine) - High-dose folic acid may decrease anticonvulsant efficacy and increase seizure risk, but this hasn’t been observed with L-methylfolate. However, caution is advised.
• Levodopa - Pyridoxal-5-phosphate antagonizes its action, but can be used with carbidopa/levodopa combinations.
• Proton pump inhibitors (omeprazole, lansoprazole) and H2 receptor antagonists (ranitidine, cimetidine).
• Methotrexate
• Antibiotics - May reduce methylcobalamin absorption.
• Alcohol - Limit consumption to ensure maximum absorption of nutrients.

Pregnancy and Breastfeeding

Use only if prescribed by a doctor. Discuss potential risks and benefits with your doctor before starting this medication. The effects on the fetus and drug excretion in breast milk are not fully established.

Drug Profile Summary

• Mechanism of Action: Corrects folate, vitamin B12, and vitamin B6 deficiencies, supporting red blood cell formation, nerve function, DNA synthesis, and homocysteine metabolism.
• Side Effects: Nausea, stomach upset, diarrhea, skin reactions, headache, insomnia. Rare but serious: allergic reactions, polycythemia vera, edema.
• Contraindications: Hypersensitivity, pernicious anemia, specific ingredient intolerances.
• Drug Interactions: Anti-epileptics, levodopa, proton pump inhibitors, H2 receptor antagonists, methotrexate, antibiotics, alcohol.
• Pregnancy & Breastfeeding: Use with caution and only under medical supervision.
• Dosage: Varies based on formulation, age, condition. Typically oral tablets/capsules once daily. Injectables available under medical supervision.
• Monitoring Parameters: Complete blood count, homocysteine, B vitamin levels, liver function tests (if indicated).

Popular Combinations

This combination can be further combined with other vitamins and minerals like Vitamin D3 and DHA, depending on patient needs.

Precautions

• General Precautions: Pre-screening for allergies, metabolic disorders, organ dysfunction.
• Pregnant Women/Breastfeeding Mothers: Consult a physician.
• Children & Elderly: Consult a physician for appropriate dosing and monitoring.
• Lifestyle Considerations: Limit alcohol intake.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for L-Methyltetrahydrofolate Calcium + Methylcobalamin + Pyridoxal-5-phosphate?

A: The dosage varies according to individual patient needs, age, and health status. Please refer to the Dosage section above or consult product labeling and a physician for personalized recommendations.

Q2: Can this combination be used in children?

A: Consult a pediatrician for guidance on pediatric use, as safety and efficacy haven’t been established.

Q3: What are the signs of hypercalcemia?

A: Signs include nausea, vomiting, confusion, muscle weakness, constipation, and increased thirst.

Q4: Can I take this medication if I’m pregnant or breastfeeding?

A: Consult a physician. Use during pregnancy and lactation should be considered only when the benefits outweigh the risks.

Q5: What are the common side effects?

A: Common side effects include nausea, stomach upset, diarrhea, skin reactions, headache, and insomnia.

Q6: What should I do if I miss a dose?

A: Take the missed dose as soon as you remember, unless it’s almost time for your next dose. Do not double the dose.

Q7: How should this medication be stored?

A: Store in a cool, dry place away from direct sunlight and out of reach of children. Do not freeze.

Q8: Does this medication interact with other medications I’m taking?

A: Yes, potential drug interactions exist. Refer to the Drug interactions section above, and be sure to inform your doctor about all medications and supplements you are taking.

Q9: Can this combination help with peripheral neuropathy?

A: While it is often used as an adjunctive therapy for peripheral neuropathy, particularly in diabetic patients, it is important to consult with a physician to determine the appropriate course of treatment. Its effectiveness varies among individuals.