L-Methyl MC NAC (Page 2 of 2)

REFERENCES:

  1. Wu A, Chanarin I, Levi AJ. Macrocytosis of chronic alcoholism. The Lancet. 1974;1:829-31.
  2. Hallert C, Tobiasson P, Walan A. Serum folate determinations in tracing adult coeliacs. Scand J Gastroenterol. 1981; 16:263-67.
  3. De-Regil LM, Fernández-Gaxiola AC, Dowswell T, et al. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD007950. doi: 10.1002/14651858.CD007950.pub2.
  4. Federal Register Notice of April 9, 1971 (36 FR 6843).
  5. The Federal Register Notice of August 2, 1973 (38 FR 20750).
  6. The Federal Register Notice of October 17, 1980 (45 FR 69044).
  7. The Federal Register Notice of August 2, 1973 (38 FR 20750).
  8. Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6 , and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000.
  9. The Federal Register Notice of March 5, 1996 (61 FR 8760).
  10. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000.
  11. Code of Federal Regulations Title 21 Section 172.345.
  12. Code of Federal Regulations Title 21 Section 101.9(j)(8).
  13. Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7.

INDICATIONS AND USAGE:

L-Methyl-MC NAC is indicated for the distinct nutritional requirements of patients in need of dietary supplementation-specifically suboptimal folate or maintenance-level needs, as determined by a licensed medical practitioner.

L-Methyl-MC NAC should be administered under the supervision of a licensed medical practitioner.

PATIENT INFORMATION: L-Methyl-MC NAC 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 serum folate levels have occurred in some patients taking pancreatic extracts, such a 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.

Drugs which may interact with vitamin B12 (Methylcobalamin):

  • Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride may decrease the absorption of vitamin B12 .
  • Nitrous oxide can produce a functional vitamin B12 deficiency

PREGNANCY and NURSING MOTHERS

L-Methyl-MC NAC is not intended for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. This product contains B vitamins. Talk with your medical practitioner before using L-Methyl-MC NAC if pregnant or lactating.

DOSAGE AND ADMINISTRATION: Usual adult dose is one tablet daily or as prescribed by a licensed medical practitioner.

L-Methyl-MC NAC is not recommended for use in children under the age of twelve.

HOW SUPPLIED: L-Methyl-MC NAC is supplied as oval, coated, white tablets debossed “V208″ on top, dispensed in bottles of 90 tablets.

NDC: 76439-208 -901


1
This product is a prescription-folate with or without other dietary ingredients that — due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) — or similar product code, as required by pedigree reporting requirements and supply-chain control as well as — in some cases, for insurance-reimbursement applications.

This product may — under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable.

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.

Call your medical practitioner about side effects. You may report side effects by calling 813-283-1344.

KEEP THIS OUT OF REACH OF CHILDREN.

Rx

Prescription Dietary Supplement

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

Virtus PHARMACEUTICALS

Rev 11/12013

PRINCIPAL DISPLAY PANEL — 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

NDC 76439-208 -90

L-METHYL-MC NAC

TABLETS Prescription Dietary Supplement

Rx

90 Tablets

Made in the USA

PRINCIPAL DISPLAY PANEL -- 90 Tablet Bottle Label
(click image for full-size original)
L-METHYL MC NAC
levomefolate calcium, methylcobalamin and acetylcysteine tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76439-208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 6 mg
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 2 mg
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 600 mg
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
GLUTATHIONE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE (TYPE H)
CROSCARMELLOSE SODIUM
STEARIC ACID
MAGNESIUM STEARATE
SILICON DIOXIDE
TITANIUM DIOXIDE
POWDERED CELLULOSE
HYPROMELLOSES
POLYETHYLENE GLYCOLS
MICROCRYSTALLINE WAX
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code V208
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76439-208-90 90 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/09/2014
Labeler — Virtus Pharmaceuticals LLC (969483143)

Revised: 04/2014 Virtus Pharmaceuticals LLC

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