L-METHYLFOLATE CALCIUM- levomefolate calcium tablet, coated 
Virtus Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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L-Methylfolate Calcium 15 mg
Tablets

Rx

Prescription Dietary Supplement

DESCRIPTION

L-Methylfolate Calcium 15 mg is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.

L-Methylfolate Calcium 15 mg should be administered under the supervision of a licensed medical practitioner.

Each coated, oblong, orange tablet contains the following dietary ingredient:

Supplement Facts
Serving Size: 1 tabletServings Per Container: 90
Amount Per Serving% Daily Value
*
contains less than 1% d-methylfolate.
Daily Value 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-Ca15 mg                                    

Other ingredients: Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, and film coat (FD&C red #2, FD&C yellow #6 lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide).

This product contains FD&C Yellow #6 Lake.

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.

INDICATIONS AND USAGE

L-Methylfolate Calcium 15 mg is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. L-Methylfolate Calcium 15 mg should be administered under the supervision of a licensed medical practitioner.

CONTRAINDICATIONS

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

WARNINGS

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

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.

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 15 mg is not an antidepressant; however, folate has been shown to enhance antidepressant effects of known antidepressants. 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 15 mg 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.

PREGNANCY and NURSING MOTHERS

L-Methylfolate Calcium 15 mg is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains a B vitamin in reduced form. Talk with your medical practitioner before using if pregnant or lactating.

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.

DOSAGE AND ADMINISTRATION

The usual adult dose is 15 mg daily with or without food or as directed by a licensed medical practitioner.

HOW SUPPLIED

L-Methylfolate Calcium 15 mg tablets are coated, oblong, orange tablets debossed "BP" on top and "1000" on bottom, and are supplied in bottles of 90 tablets.

NDC2 76439-205-90 (90 ct. bottle / 90 tablets)


2
These products are dietary supplements that – due to increased folate levels (8/2/73 38 FR 20750), require 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.

KEEP THIS OUT OF REACH OF CHILDREN.

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

Call your medical practitioner about side effects.

You may report side effects by calling 813-283-1344.

L-Methylfolate Calcium 15 mg Tablets
Rx
Prescription Dietary Supplement
90 ct. Bottle (90 tablets)

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

Rev. 01/2012

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

NDC† 76439-205-90

L-Methylfolate
Calcium 15 mg

Prescription Dietary Supplement

Rx
90 Tablets

Made in USA

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
L-METHYLFOLATE CALCIUM 
levomefolate calcium tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:76439-205
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM15 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScoreno score
ShapeOVALSize24mm
FlavorImprint Code BP;100
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76439-205-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER03/15/2012
Labeler - Virtus Pharmaceuticals (969483143)

Revised: 8/2012
Document Id: a2ca9d47-8705-4817-94fd-4c64a13a2cb7
Set id: 2ebbba9c-9451-4b87-87b0-31546c37cef6
Version: 1
Effective Time: 20120802
 
Virtus Pharmaceuticals