L-METHYLFOLATE CALCIUM- levomefolate calcium tablet, coated

L-Methylfolate Calcium by

Drug Labeling and Warnings

L-Methylfolate Calcium by is a Other medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

NDC: 63629-5411-1: 30 Tablets in a BOTTLE

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

L- Methylfolate 15mg Caplets

INGREDIENTS AND APPEARANCE

L-METHYLFOLATE CALCIUM 
levomefolate calcium tablet, coated

Product Information
Product Type	MEDICAL FOOD	Item Code (Source)	NHRIC:63629-5411(NDC:76439-358)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLATE CALCIUM	15 mg

Inactive Ingredients
Ingredient Name	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
POLYVINYL ALCOHOL, UNSPECIFIED (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
Color	ORANGE	Score	no score
Shape	OVAL (caplet)	Size	24mm
Flavor		Imprint Code	V358
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:63629-5411-1	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
MEDICAL FOOD		01/08/2015

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK, RELABEL