METANX� Capsules
DESCRIPTION
METANX� is a prescription medical food for use only
under the supervision of a physician for the clinical
dietary management of diabetic peripheral neuropathy
and is specially formulated to meet the distinctive
nutritional requirements for this condition.
Each METANX� capsule contains 3 mg of L-methylfolate
Calcium (as Metafolin�)*, 90.314 mg of Algae-S Powder
(Schizochytrium), 35 mg of Pyridoxal-5�-Phosphate and
2.0 mg of Methylcobalamin *CAS#151533-22-1
INGREDIENTS
Silicified Microcrystalline Cellulose, Algae-S Powder
[Schizochytrium Algal Oil (Vegetable Source), Glucose
Syrup Solids, Mannitol, Sodium Caseinate (Milk), Soy
Protein, High Oleic Sunflower Oil, 2% or less Sodium
Ascorbate, Tricalcium Phosphate, Tetrasodium
Diphosphate, Natural Flavors, Soy Lecithin, and Mixed
Natural Tocopherols and Ascorbyl Palmitate (as
antioxidants)], Pullulan, Pyridoxal 5�- Phosphate, Lmethylfolate
Calcium, Methylcobalamin, Titanium
Dioxide (color), Magnesium Stearate (Vegetable
Source), Caramel (color), Riboflavin USP, Shellac,
Propylene Glycol USP. Contains Milk and Soy
METANX� capsules do not contain lactose, yeast or
gluten.
METANX� is a prescription medical food for use only
under the supervision of a physician.
Medical foods are intended for a patient who has a
limited or impaired capacity to ingest, digest, absorb, or
metabolize ordinary foodstuffs or certain nutrients, or
who has other special medically determined nutrient
requirements, the dietary management of which cannot
be achieved by the modification of the normal diet
alone.1
This product is not an Orange Book product.
INDICATIONS AND USAGE
METANX� is indicated for the distinct nutritional
requirements of individuals with endothelial
dysfunction who present with loss of protective
sensation and neuropathic pain associated with diabetic
peripheral neuropathy.2-7
METANX� is indicated for the distinct nutritional
requirements of patients with endothelial dysfunction
and/or hyperhomocysteinemia who present with lower
extremity ulceration(s).8-11
CONTRAINDICATIONS
METANX� is contraindicated in patients with known
hypersensitivity to any of the components contained in
this product.
PRECAUTIONS
GENERAL
Folic acid, when administered in daily doses above
0.1mg, may obscure the 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 Calcium
may be less likely than folic acid to mask vitamin B12
deficiency.12,13
Folate therapy alone is inadequate for
the treatment of a B12 deficiency.
PATIENT INFORMATION
METANX� is a prescription medical food for use only
under the supervision of a physician.
ADVERSE REACTIONS
Allergic reactions have been reported following the use
of oral L-methylfolate Calcium.14
Acne, skin reactions,
allergic reactions, photosensitivity, nausea, vomiting,
abdominal pain, loss of appetite, increased liver
function test results, paresthesia, somnolence, nausea
and headaches have been reported with pyridoxal 5�-
phosphate.15 Mild transient diarrhea, itching, transitory
exanthema and the feeling of swelling of the entire
body has been associated with methylcobalamin.16
RECOMMENDED USE
The usual adult dose may be taken as one capsule twice
daily (1 capsule B.I.D.); or two capsules once daily (2
capsules QD); or as directed under medical supervision.