L-METHYLFOLATE CALCIUM- levomefolate calcium tablet, coated
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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:
|Serving Size: 1 tablet||Servings Per Container: 90|
|Amount Per Serving||% Daily Value|
|L-Methylfolate Calcium*, or 6(S)-5-MTHF-Ca||15 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.
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:
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).
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.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
L-Methylfolate Calcium 15 mg is a prescription dietary supplement to be used only under licensed medical supervision.
Drugs which may interact with folate include:
Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate.
The usual adult dose is 15 mg daily with or without food or as directed by a licensed medical practitioner.
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)
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
Prescription Dietary Supplement
90 ct. Bottle (90 tablets)
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
MADE IN USA
levomefolate calcium tablet, coated
|Labeler - Virtus Pharmaceuticals (969483143)|