Label: L-METHYLFOLATE CALCIUM- levomefolate calcium tablet, coated

  • NDC Code(s): 76439-358-90, 76439-359-30, 76439-359-90
  • Packager: Virtus Pharmaceuticals
  • Category: MEDICAL FOOD
  • DEA Schedule: None
  • Marketing Status: MEDICAL FOOD

Drug Label Information

Updated September 17, 2015

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    L-METHYLFOLATE CALCIUM Tablets is a medical food dispensed by prescription for the clinical dietary management of the metabolic imbalances associated with depression and schizophrenia. Use under medical supervision.

    Each L-METHYLFOLATE CALCIUM 7.5mg tablet contains 7.5 mg of L-METHYLFOLATE CALCIUM

    Each L-METHYLFOLATE CALCIUM 15mg tablet contains 15mg of L-METHYLFOLATE CALCIUM .

    L-METHYLFOLATE CALCIUM Tablets 7.5mg Dietary Ingredients

    Dibasic Calcium Phosphate Dihydrate, Silicified Microcrystalline Cellulose 90, Silicified Microcrystalline Cellulose HD 90, Opadry II Blue 85F90748 (Polyvinyl Alcohol, Titanium Dioxide [color], PEG 3350, Talc and FD&C Blue #2[color]), L-METHYLFOLATE CALCIUM, Magnesium Stearate (Vegetable Source), and Carnauba Wax.

    L-METHYLFOLATE CALCIUM 7.5mg tablets do not contain sugar, lactose, yeast or gluten.

    L-METHYLFOLATE CALCIUM 15mg Tablets Dietary Ingredients

    Dibasic Calcium Phosphate Dihydrate, Silicified Microcrystalline Cellulose 90, Opadry II Orange 85F43102, (Polyvinyl Alcohol, PEG 3350, Talc, Titanium Dioxide [color], FD&C Yellow #6[color], FD&C Yellow #5[color], FD&C Red #40[color] and FD&C Blue #2[color]), L-METHYLFOLATE CALCIUM, Magnesium Stearate (Vegetable Source), and Carnauba Wax.

    L-METHYLFOLATE CALCIUM 15mg tablets do not contain sugar, lactose, yeast or gluten.

    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.

    L-METHYLFOLATE CALCIUM Tablets is a medical food dispensed by prescription.

  • CLINICAL PHARMACOLOGY

    L-METHYLFOLATE CALCIUM Tablets is a medical food, which consists of a proprietary biologically active folate, derived from food sources.

  • INDICATIONS AND USAGE

    ADJUNCTIVE USE IN MAJOR DEPRESSIVE DISORDER L-METHYLFOLATE CALCIUM Tablets is indicated for the distinct nutritional requirements of individuals who have suboptimal L-METHYLFOLATE CALCIUM Tablets levels in the cerebrospinal fluid, plasma, and/or red blood cells and have major depressive disorder (MDD) with particular emphasis as adjunctive support for individuals who are on an antidepressant.2-5

    ADJUNCTIVE USE IN SCHIZOPHRENIA L-METHYLFOLATE CALCIUM Tablets is indicated for the distinct nutritional requirements of individuals who have or are at risk for hyperhomocysteinemia and have schizophrenia who present with negative symptoms and/or cognitive impairment, with particular emphasis as an adjunctive support for individuals who have stabilized on antipsychotics.2

    L-METHYLFOLATE CALCIUM Tablets is indicated regardless of MTHFR C677T polymorphism genotype.6

  • CONTRAINDICATIONS

    L-METHYLFOLATE CALCIUM Tablets 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 Tablets may be less likely than folic acid to mask vitamin B12 deficiency.7,8 Folate therapy alone is inadequate for the treatment of a B12 deficiency.

    A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed, (although not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of a precipitation of a mixed/manic episode in patients at risk for bipolar disorder. L-METHYLFOLATE CALCIUM Tablets is not an antidepressant; however, 5-MTHF has been shown to enhance antidepressant effects of known antidepressants.2 Caution is recommended in patients with a history of bipolar illness. Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder since mood elevation in this population is possible.

    Patient Information

    L-METHYLFOLATE CALCIUM Tablets is a medical food1 for use under medical supervision and direction.

    L-METHYLFOLATE CALCIUM Tablets is a medical food dispensed by prescription.

    Interaction with Drugs

    Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. No decrease in effectiveness of drugs has been reported with the use of L-METHYLFOLATE CALCIUM Tablets.

    L-METHYLFOLATE CALCIUM Tablets contains folate, which may have interactions the following:

    • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, 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 this AED in the blood and allowing breakthrough seizures to occur.9,10,12,15
    • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.11
    • Dihydrofolate Reductase Inhibitors (DHFRI): DHFIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.12
    • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.13
    • Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin,14
    • 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.12
    • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. 12
    • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylpredinisolone. 12
    • Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts. 12
    • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. 12
    • Metformin treatment in patients with type 2 diabetes decreases serum folate.16,17
    • Warfarin can produce significant impairment in folate status after a 6-month therapy.18
  • ADVERSE REACTIONS

    Allergic reactions have been reported following the use of oral L-METHYLFOLATE CALCIUM Tablets.

  • DOSAGE AND ADMINISTRATION

    The usual adult dose is 7.5mg to 15mg given daily with or without food or as directed under medical supervision.

  • HOW SUPPLIED

    L-METHYLFOLATE CALCIUM Tablets is a medical food dispensed by prescription

    7.5mg Bottle of 30 Product Code # 76439-359-301

    Use under medical/physician supervision.

    Bottle of 90 Product Code # 76439-359-901

    Use under medical/physician supervision.

    A light blue, round, coated, tablet debossed on one side with "V359" and blank on the other.

    15mg Bottle of 90 Product Code # 76439-358-901

    Use under medical/physician supervision.

    An orange, oval, coated, caplet debossed on one side with "V358" and blank on the other.


    1
    Virtus Pharmaceuticals, LLC does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirements of pharmacy and health insurance computer systems

    Storage

    Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF) (See USP). Protect from heat, light and moisture.

  • PATENTS

    Some or all of the following patents may apply: U.S. Patent No. 6,011,040 U.S. Patent No. 6,441,168B1 and other pending patent applications

  • REFERENCES

    1. United States Food and Drug Administration Title 21 Code of Federal Regulations 101.9(j) (8).
    2. Godfrey PSA et al. The Lancet. 1990;336:392-5.
    3. Passeri M et al. Aging Clin Exp Res. 1993; 5(1):63-71.
    4. Guaraldi GP et al. 1993;5(2):101-5.
    5. Di Palma C et al. Is Curr Ther Res. 1994; 55 (5): 559-68.
    6. Willems FF et al. Br J Pharmacol.2004;141 (5):825-30.
    7. Akoglu B et al. Euro J Clin Nutrition. 2007; 1–6.
    8. Scott JM and Weir DG. The Lancet. 1981; 2: 337-40.
    9. Hernandez-Diaz. N Engl J Med. 2000; 343: 1608-14.
    10. Morrell M. Curr. 2002; 2(2):31–34.
    11. Capecitabine Package Insert; Roche Laboratories, 2000
    12. Natural Standard Research Collaboration (NIH). Folate (folic acid) Monograph 2009
    13. .Amiburu A, et al. J. Physiol. Biochem., 57 (2), 71-80, 2001
    14. Chanson A, et al. JEADV 2008, 22:94-100
    15. Tatum IV W et al. Arch Intern Med. 2004; 164: 137-45.
    16. Wulffele MG, et al. Journal of Internal Medicine 2003; 254: 455-463.
    17. Desouza C, et al. Drugs 2002; 62(4): 605-16.
    18. Sobczyriska-Malefora A et al. Blood Coagul Fibrinolysis 2009 Jun; 20(4):297-302
  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Virtus Pharmaceuticals, LLC
    Tampa, FL 33619

    PC0294-00
    Revised 11/14

  • PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label

    VIRTUS
    PHARMACEUTICALS

    76439-358-90

    L-Methylfolate
    Calcium
    15 mg

    RX
    90 Tablets

    Made in USA

    PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 7.5 mg Tablet Bottle Label

    VIRTUS
    PHARMACEUTICALS

    76439-359-90

    L-Methylfolate
    Calcium
    7.5 mg

    RX
    90 Tablets

    Made in USA

    PRINCIPAL DISPLAY PANEL - 7.5 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    L-METHYLFOLATE CALCIUM 
    levomefolate calcium tablet, coated
    Product Information
    Product TypeMEDICAL FOODItem Code (Source)NHRIC:76439-358
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVAL (caplet) Size24mm
    FlavorImprint Code V358
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:76439-358-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    MEDICAL FOOD01/08/2015
    L-METHYLFOLATE CALCIUM 
    levomefolate calcium tablet, coated
    Product Information
    Product TypeMEDICAL FOODItem Code (Source)NHRIC:76439-359
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColorBLUE (Light blue) Scoreno score
    ShapeROUNDSize14mm
    FlavorImprint Code V359
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:76439-359-3030 in 1 BOTTLE
    2NHRIC:76439-359-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    MEDICAL FOOD02/09/2015
    Labeler - Virtus Pharmaceuticals (969483143)