Levomefolate Mecobalamin Pyridoxal 5 phosphate

Levomefolate Mecobalamin Pyridoxal 5 phosphate Brand Names

Elfolate Plus | Folast | Foltanx | Metanx | Neurpath-B | VitaCirc-B

What is Levomefolate Mecobalamin Pyridoxal 5 phosphate

In the US, medical foods are defined under 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)).

Medical foods are specially formulated and processed products that must be administered enterally under the supervision of a physician and are intended for the dietary management of a disease or condition for which distinctive nutritional requirements are determined by medical evaluation.

Medical foods are intended for patients who have limited or impaired capacity to ingest, digest, absorb, or metabolize nutrients, or who have medically determined nutrient requirements that cannot be met by the modification of the normal diet alone.

Medical foods do not have to undergo review or approval by the FDA, and individual medical food products do not have to be registered with FDA.

Consequently, scientific data supporting claimed benefit(s) are not always available for medical foods as they are for traditional pharmaceuticals.

Consumers should also note that rigid quality control standards are not required for medical foods and substantial variability can occur in both the potency and the purity of these products. Monographs on medical foods are included in CP when reliable clinical data are available

Indications

  • diabetic neuropathy
  • hyperhomocysteinemia

For nutritional supplementation to aid in the management of diabetic neuropathy

Side Effects

  1. diarrhea
  2. headache
  3. nausea
  4. paresthesias
  5. polycythemia

Somnolence, nausea, headache, and paresthesias have been reported with pyridoxal-5-phosphate, which is in levomefolate; mecobalamin; pyridoxal-5-phosphate. Mecobalamin has been associated with mild, transient diarrhea.

Monitoring Parameters

  • laboratory monitoring not necessary

Contraindications

  • breast-feeding
  • children
  • infants
  • neonates
  • pernicious anemia
  • pregnancy
  • vitamin B12 deficiency

Interactions

There are no drug interactions associated with Levomefolate Mecobalamin Pyridoxal 5 phosphate products.

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