Dosing & Uses
Dosage Forms & Strengths
L-methylfolate/pyridoxal 5′-phosphate/methylcobalamin
capsule
- 3mg/35mg/2mg
Diabetic Peripheral Neuropathy
Medical food for the clinical dietary management of endothelial dysfunction associated with diabetic peripheral neuropathy
1 capsule PO BID, or 2 capsules qDay
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
Adverse Effects
Frequency Not Defined
L-methylfolate
- Allergic reactions
Pyridoxal 5′-phosphate
- Acne
- Skin reactions
- Allergic reactions
- Photosensitivity
- Nausea
- Vomiting
- Abdominal pain
- Loss of appetite
- Increased liver function test results
- Paresthesia
- Somnolence
- Nausea
- Headaches
Methylcobalamin
- Mild transient diarrhea
- Polycythemia vera
- Itching
- Transitory exanthema
- Edema
Warnings
Contraindications
Hypersensitivity to ingredients
Cautions
Contains milk, soy, and carmine
Daily folic acid administration (>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 & Lactation
Pregnancy Category: C
Lactation: Unknown whether distributed in breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Provides nutritional requirements needed to restore metabolic processes associated with diabetic neuropathy to maintain blood flow by increasing nitric oxide resulting in vasodilation
L-methylfolate: Primary biologically active isomer of folic acid and the primary form of folate in circulation; folic acid is a precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions
Pyridoxal 5′-phosphate (PLP): Active form of vitamin B6
Methylcobalamin: One of 2 forms of biologically active vitamin B12
Absorption
Peak plasma time: 1.3 hr
Peak plasma concentration: 129 ng/mL
AUC: 383 mcg•h/mL
Distribution
Protein bound: 56%
Vd: Wide distribution, RBC levels of folate remain elevated for periods in excess of 40 days following discontinuation of supplementation
Elimination
Half-life: 3 hr
Excretion: Primarily in urine
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
PoDiaPN oral - | 35-5-2-300 mg capsule | ![]() |
Copyright © 2010 First DataBank, Inc.
Patient Handout
vitamin B6-methyltetrahydrofolate-mecobalamin-ALA oral
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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