L-Methylfolate/Pyridoxal 5’-Phosphate/Methylcobalamin

L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin is used as a medical food for the clinical dietary management of endothelial dysfunction associated with diabetic peripheral neuropathy.

• L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin is available under the following different brand names: Metanx.

L-methylfolate/pyridoxal 5-phosphate/methylcobalamin is a combination of three vitamins of the B group. L-methylfolate is the active form of vitamin B9, also known as folate, pyridoxal 5-phosphate is the active form of vitamin B6 and methylcobalamin is one of the two active forms of vitamin B12. The combination of B vitamins is a prescription medical food used under a physician’s supervision, to treat peripheral diabetic neuropathy.

Peripheral diabetic neuropathy is a kind of nerve damage caused by excessive sugar levels in patients with type 2 diabetes mellitus. The combination of three water-soluble vitamins B9, B6, and B12 is specifically formulated to provide the nutritional supplements required to improve peripheral blood flow and reduce nerve damage and neuropathy in patients with diabetes.

L-methylfolate is a coenzyme crucial for many cellular functions including metabolism of amino acids, DNA and RNA synthesis, and the synthesis and growth of all cells, particularly, red blood cells. Pyridoxal 5-phosphate is a coenzyme involved in protein synthesis, has multiple functions, and is essential for normal brain development and for keeping the nervous system and immune system healthy. Methylcobalamin is another micronutrient that is important for the healthy functioning of the nervous system, formation of red blood cells, and DNA synthesis.

The three B vitamins are naturally available in many foods, but diabetic patients with neuropathy often require supplemental amounts. Good dietary sources of folate include leafy green vegetables, legumes, eggs, beef liver, fruits, and vegetables. Vitamin B6-rich foods include fish, beef liver and other organ meats, potatoes, and other starchy vegetables, and fruit (other than citrus). Vitamin B12 sources include fish, meat, poultry, eggs, dairy, and B12 fortified products such as breakfast cereals.

Warnings

Do not take L-methylfolate/pyridoxal 5-phosphate/methylcobalamin if you are hypersensitive to any of its components

L-methylfolate/pyridoxal 5-phosphate/methylcobalamin contains milk, soy, and carmine; avoid or use with caution if you have intolerance or allergy to any of these products

Doses of folic acid higher than 0.1 mg/day may mask B12 deficiency pernicious anemia while irreversible nerve damage continues to progress; folic acid is the synthetic form of folate and L-methylfolate may be less likely than folic acid to mask vitamin B12 deficiency

Dosages of L-Methylfolate/Pyridoxal 5’-Phosphate/Methylcobalamin:

Dosage Forms and Strengths

Capsule

• 3mg/35mg/2mg

Dosage Considerations – Should be Given as Follows:

Diabetic Peripheral Neuropathy

• A medical food for the clinical dietary management of endothelial dysfunction associated with diabetic peripheral neuropathy
• 1 capsule orally twice daily, or 2 capsules once daily
• Safety and efficacy not established in pediatric patients

Side effects of L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin include:

• L-methylfolate
  • Allergic reactions
• Pyridoxal 5′-phosphate
  • Acne
  • Skin reactions
  • Allergic reactions
  • Sensitivity to sunlight (photosensitivity)
  • Nausea
  • Vomiting
  • Abdominal pain
  • Loss of appetite
  • Increased liver function test results
  • Numbness and tingling
  • Drowsiness
  • Nausea
  • Headaches
• Methylcobalamin
  • Mild transient diarrhea
  • Polycythemia vera
  • Itching
  • Transitory skin rash
  • Fluid retention (edema)

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin has no listed severe interactions with other drugs.
• L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin has no listed serious interactions with other drugs.
• L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin has no listed moderate interactions with other drugs.
• L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin has no listed mild interactions with other drugs.
   

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
This medication contains L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin. Do not take Metanx if you are allergic to L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to ingredients

Effects of Drug Abuse
No information available

Short-Term Effects

See "What Are Side Effects Associated with Using L-Methylfolate/Pyridoxal 5’-Phosphate/Methylcobalamin?”

Long-Term Effects

See "What Are Side Effects Associated with Using L-Methylfolate/Pyridoxal 5’-Phosphate/Methylcobalamin?”

Cautions

• Contains milk, soy, and carmine
• Daily folic acid administration (greater than 0.1 mg/day), may obscure detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations); L-methylfolate may be less likely than folic acid to mask vitamin B12 deficiency

Pregnancy and Lactation

• Use L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is unknown whether L-methylfolate/pyridoxal 5’-phosphate/methylcobalamin is distributed in breast milk. Consult your doctor before breastfeeding.

What else should I know about L-methylfolate pyridoxal/5-phosphate/methylcobalamin?

• Take L-methylfolate/pyridoxal 5-phosphate/methylcobalamin exactly as prescribed
• Keep safely out of reach of children
• Seek medical help immediately if you develop severe allergic reactions