L-METHYL-MC- levomefolate calcium, riboflavin, pyridoxine hydrochloride, and cyanocobalamin tablet, coated

L-Methyl-MC by

Drug Labeling and Warnings

L-Methyl-MC by is a Other medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

A medical food for the dietary management of hyperhomocysteinemia.

Description

Each round coated blue colored tablet contains:

Dietary Ingredients:
L-methylfolate Calcium	6 mg
Riboflavin	5 mg
Pyridoxine (as Pyridoxine HCl)	50 mg
Cyanocobalamin	1 mg

Ingredients

Microcrystalline Cellulose, Pyridoxine HCl,Opadry II Blue #40L10890 (Polydextrose, Hypromellose HPMC 2910, FD&C Blue #1 Aluminum Lake, Triacetin, Titanium Dioxide, Peg 8000). Stearic Acid (Vegetable Source), Croscarmellose Sodium, L-methylfolate Calcium, Riboflavin, Silicon Dioxide, Magnesium Stearate (Vegetable Source), Opadry II Clear #Y-19-7483, (Hypromellose HPMC 2910, Maltodextrin, Peg 400), Cyanocobalamin.

L-Methyl-MC Tablets do not contain sugar, lactose, yeast or gluten.

Indication and Usage

L-Methyl-MC Tablets are indicated for the distinct nutritional requirements of individuals under medical supervision for hyperhomocysteinemia; with particular emphasis for individuals diagnosed with or at risk for mild to moderate: cognitive impairment1, vascular dementia2, or Alzheimer's disease3.

Precautions

Folates, when administered as a single agent in doses above 0.1mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in L-Methyl-MC Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution4. A safe upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing L-Methyl-MC Tablets.

Adverse Reactions

While allergic sensitization has been reported following both oral and parenteral administration of folic acid, allergic sensitization has not been reported with the use of L-Methylfolate Calcium. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cyanocobalamin. Transient headaches have been reported infrequently with the use of L-Methyl-MC Tablets. If headaches should occur with the use of L-Methyl-MC Tablets consult with your medical practitioner.

Contraindications

Known hypersensitivity to any of the components in the product is a contraindication.

Drug Interactions

L-Methyl-MC Tablets added to other drugs

High dose folic acid may result in decreased serum levels for pyrimethamine and first-generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce first generation anticonvulsants effectiveness and/or increasing the frequency of seizures in susceptible patients. While the concurrent use of folic acid and first generation anticonvulsants or pyrimethamine may result in decreased efficacy of anticonvulsants, no such decreased effectiveness has been reported with the use of L-methylfolate. Nevertheless, caution should be used when prescribing L-METHYL-MC TABLETS among patients who are receiving treatment with first generation anticonvulsants or pyrimethamine. Pyridoxine should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Capecitabine (Xeloda®) toxicity may increase with the addition of leucovorin (5-formyltetrahydrofolate) (folate).

Drugs added to L-METHYL-MC TABLETS

Antibiotics may alter the intestinal microflora and may decrease the absorption of cyanocobalamin. Cholestyramine, colchicines or colestipol may decrease the enterohepatic reabsorption of cyanocobalamin. Metformin, para-aminosalicylic acid and potassium chloride may decrease the absorption of cyanocobalamin. Nitrous oxide can produce a functional cyanocobalamin deficiency. Several drugs are associated with lowering serum folate levels or reducing the amount of active folate available. First generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate) and lamotrigine (a second-generation anticonvulsant) may decrease folate plasma levels. Information on other second-generation anticonvulsants impact on folate levels is limited and cannot be ruled out. Methotrexate, alcohol (in excess), sulfasalazine, cholestyramine, colchicine, colestipol, L-dopa, methylprednisone, NSAIDs (high dose), pancreatic enzymes (pancrelipase, pancratin), pentamidine, pyrimethamine, smoking, triamterene, and trimethoprim may decrease folate plasma levels. Warfarin can produce significant impairment in folate status after a 6 month therapy.

Patient Information

L-Methyl-MC Tablets is a medical food for use only under medical supervision.

Dosage and Administration

Usual adult dose is one to two tablets daily or as directed by your medical practitioner. L-Methyl-MC Tablets is not recommended for use with children under the age of twelve.

How Supplied

Available as a round coated blue colored tablet. Debossed with "V360" on one side and blank on the other. Commercial product is supplied in bottles of 90 tablets (76439-360-901). Use under medical/physician supervision.

1 Virtus Pharmaceuticals, LLC does not represent this product code to be a National Drug Code (NDC) number. Instead, Virtus Pharmaceuticals, LLC has assigned a product code 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).

Patents

Some or all of the following-patents may apply:

U.S. Patent No. 5,563,126
U.S. Patent No. 5,795,873
U.S. Patent No. 5,997,915
U.S. Patent No. 6,011,040
U.S. Patent No. 6,207,651
U.S. Patent No. 6,254,904
U.S. Patent No. 6,297,224
U.S. Patent No. 6,528,496
and other pending patent applications.

References

1 Lehmann M, Regland B, Blennow K, and Gottfries CG: Vitamin B12-B6-Folate Treatment Improves Blood-Brain Barrier Function in Patients with Hyperhomocysteinaemia and Mild Cognitive Impairment. Dementia and Geriatric Cognitive Disorders 2003;16:145-150.

2 Nilsson K, Gustafson L, and Hultberg B: Improvement of cognitive functions after cobalamin/folate supplementation in elderly patients with dementia and elevated plasma homocysteine. International Journal of Geriatric Psychiatry 2001;16:609-614.

3 Seshadri S, Beiser A, Selhub J, Jacques PF, Rosenberg IH, D'Agostino RB, Wilson PWF, and Wolf PA: Plasma Homocysteine As A Risk Factor For Dementia And Alzheimer's Disease. New England Journal of Medicine 2002:Vol346, No. 7:476-483.

4 Lederle FA: Oral cobalamin for pernicious anaemia: medicine's best kept secret. JAMA 1991;265:94-95.

SPL UNCLASSIFIED SECTION

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619

PC0296-00
Revised 11/14

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

76439-360-90

L-METHYL-MC

TABLETS

RX
90 Tablets
Made in the USA

INGREDIENTS AND APPEARANCE

L-METHYL-MC 
levomefolate calcium, riboflavin, pyridoxine hydrochloride, and cyanocobalamin tablet, coated

Product Information
Product Type	MEDICAL FOOD	Item Code (Source)	NHRIC:76439-360
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Levomefolate Calcium (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC)	Levomefolate Calcium	6 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	5 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	50 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	1 mg

Inactive Ingredients
Ingredient Name	Strength
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Polydextrose (UNII: VH2XOU12IE)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
Aluminum Oxide (UNII: LMI26O6933)
Triacetin (UNII: XHX3C3X673)
Titanium Dioxide (UNII: 15FIX9V2JP)
Polyethylene Glycol 8000 (UNII: Q662QK8M3B)
Stearic Acid (UNII: 4ELV7Z65AP)
Croscarmellose Sodium (UNII: M28OL1HH48)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Magnesium Stearate (UNII: 70097M6I30)
Maltodextrin (UNII: 7CVR7L4A2D)
Polyethylene Glycol 400 (UNII: B697894SGQ)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	V360
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:76439-360-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
MEDICAL FOOD		02/09/2015

Labeler - Virtus Pharmaceuticals (969483143)