L-methylfolate/pyridoxal 5'-phosphate/methylcobalamin (Rx)

Brand and Other Names:Metanx
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Dosing & Uses

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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

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Interactions

Interaction Checker

and L-methylfolate/pyridoxal 5'-phosphate/methylcobalamin

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                    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
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                    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

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                    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.

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                    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

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                    Images

                    BRAND FORM. UNIT PRICE PILL IMAGE
                    PoDiaPN oral
                    -
                    35-5-2-300 mg capsule

                    Copyright © 2010 First DataBank, Inc.

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                    Patient Handout

                    Patient Education
                    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) 2021 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.

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                    Formulary

                    FormularyPatient Discounts

                    Adding plans allows you to compare formulary status to other drugs in the same class.

                    To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                    Adding plans allows you to:

                    • View the formulary and any restrictions for each plan.
                    • Manage and view all your plans together – even plans in different states.
                    • Compare formulary status to other drugs in the same class.
                    • Access your plan list on any device – mobile or desktop.

                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    Tier Description
                    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
                    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                    ST Step Therapy
                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                    OR Other Restrictions
                    Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.