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

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.

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

Storage

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