L-methylfolate/pyridoxal 5-phosphate/methylcobalamin

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 (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 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.

• 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 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

Common side effects of L-methylfolate/pyridoxal 5-phosphate/methylcobalamin include:

L-methylfolate

• Allergic reactions

Pyridoxal 5-phosphate

• Nausea
• Vomiting
• Loss of appetite
• Abdominal pain
• Headaches
• Drowsiness (somnolence)
• Tingling or prickling sensations (paresthesia)
• Elevated liver function test results
• Allergic reactions
• Skin reactions
• Acne
• Light sensitivity (photosensitivity)

Methylcobalamin

• Temporary widespread skin rash (exanthema)
• Itching
• Swelling (edema)
• Excessive red blood cells (polycythemia vera)

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.

Capsule

• 3mg/35mg/2mg

Adult:

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

Pediatric:

• Safety and efficacy not established

• In case of overdose of L-methylfolate/pyridoxal 5-phosphate/methylcobalamin or if you develop severe hypersensitivity symptoms, seek medical help immediately or contact Poison Control.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

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

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no well-controlled studies on use of L-methylfolate/pyridoxal 5-phosphate/methylcobalamin during pregnancy; use with caution if potential benefits outweigh potential fetal risks
• It is not known if L-methylfolate/pyridoxal 5-phosphate/methylcobalamin is excreted in breast milk; use with caution

• 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