Label: L-METHYL-B6-B12- levomefolate calcium, pyridoxal 5-phosphate and methylcobalamin tablet, coated 

  • NDC Code(s): 76439-205-50, 76439-205-90
  • Packager: Virtus Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/12

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  • SPL UNCLASSIFIED SECTION

    Rx
    Prescription Dietary Supplement

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  • DESCRIPTION

    L-Methyl-B6-B12 is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.

    L-Methyl-B6-B12 should be administered under the supervision of a licensed medical practitioner.

    Each coated, round, purple tablet contains the following dietary ingredients:

    Supplement Facts
    Serving Size: 1 tablet    Servings Per Container: 90 (NDC* 76439-218-90)
    Serving Size: 1 tablet    Servings Per Container: 500 (NDC* 76439-218-50)
    Amount Per Serving % Daily Value
    *
    This product is a dietary supplement that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.
    contains less than 1% d-methylfolate.
    Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
    L-Methylfolate Calcium, or 6(S)-5-MTHF-Ca 3 mg
    Pyridoxal 5' Phosphate 35 mg
    Methylcobalamin 2 mg

    Other ingredients: Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid and film coat (FD&C blue #1 lake, FD&C red #3, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide).

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  • FOLATE REGULATION

    The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.

    Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle.

    Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.

    The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that:

     
    Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.

    Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).


    1
    It is not known whether or not l-methylfolate can obscure pernicious anemia above 0.1 mg doses, so caution is advised also with this form of folate.
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  • INDICATIONS AND USAGE

    L-Methyl-B6-B12 is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. L-Methyl-B6-B12 should be administered under the supervision of a licensed medical practitioner.

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  • CONTRAINDICATIONS

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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  • WARNINGS

    Caution is recommended in patients with a history of bipolar illness.

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  • PRECAUTIONS

    General

    Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin 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).

    Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.

    PATIENT INFORMATION

    L-Methyl-B6-B12 is a prescription dietary supplement to be used only under licensed medical supervision.

    DRUG INTERACTIONS

    Drugs which may interact with folate include:

    • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate.
    • Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants.
    • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
    • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
    • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
    • Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
    • Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
    • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
    • Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
    • L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.
    • Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
    • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
    • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
    • Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase.
    • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
    • Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.
    • Smoking and Alcohol: Reduced serum folate levels have been noted.
    • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
    • Metformin treatment in patients with type 2 diabetes decreases serum folate.
    • Warfarin can produce significant impairment in folate status after a 6-month therapy.
    • Folinic acid may enhance the toxicity of fluorouracil.
    • Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
    • Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

    Drugs which may interact with vitamin B12:

    • Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12.
    • Nitrous oxide can produce a functional vitamin B12 deficiency.

    Drugs which interact with vitamin B6:

    • Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

    PREGNANCY and NURSING MOTHERS

    L-Methyl-B6-B12 is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins in active form. Talk with your medical practitioner before using if pregnant or lactating.

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  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.

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  • DOSAGE AND ADMINISTRATION

    One tablet twice daily or as directed by a licensed medical practitioner.

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  • HOW SUPPLIED

    L-Methyl-B6-B12 tablets are coated, round, purple tablets debossed with "BP 0.3" on top and a bisect on bottom, and are supplied in bottles of 90 tablets and 500 tablets.

    NDC2 76439-218-90 (90 ct. bottle / 90 tablets)
    NDC2 76439-218-50 (500 ct. bottle / 500 tablets)


    2
    This product is a dietary supplement that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.

    STORAGE

    Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

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  • SPL UNCLASSIFIED SECTION

    Call your medical practitioner about side effects. You may report side effects by calling 813-283-1344.

    KEEP THIS OUT OF THE REACH OF CHILDREN.

    Rx

    Prescription Dietary Supplement
    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

    Manufactured for:
    Virtus Pharmaceuticals, LLC
    Tampa, FL 33619
    www.virtusRX.com
    MADE IN USA

    Rev. 2/2012

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  • PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

    VIRTUS
    PHARMACEUTICALS

    NDC 76439-218-90

    L-METHYL-B6-B12

    TABLETS Prescription Dietary Supplement

    Rx
    90 Tablets

    PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    L-METHYL-B6-B12 
    levomefolate calcium, pyridoxal 5-phosphate, and methylcobalamin tablet, coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-205
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Levomefolate Calcium (Levomefolic Acid) Levomefolate Calcium 15 mg
    Pyridoxal 5-Phosphate (Pyridoxal 5-Phosphate) Pyridoxal 5-Phosphate 35 mg
    Methylcobalamin (Methylcobalamin) Methylcobalamin 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    Croscarmellose sodium  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    calcium phosphate, dibasic, anhydrous  
    Silicon Dioxide  
    stearic acid  
    FD&C YELLOW NO. 6  
    ALUMINUM OXIDE  
    polyethylene glycols  
    polyvinyl alcohol  
    talc  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code BP;100
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76439-205-90 90 in 1 BOTTLE
    2 NDC:76439-205-50 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 03/15/2012
    Labeler - Virtus Pharmaceuticals (969483143)
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