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Methylfolate, methylcobalamin, and acetylcysteine: Drug information

Methylfolate, methylcobalamin, and acetylcysteine: Drug information
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For additional information see "Methylfolate, methylcobalamin, and acetylcysteine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • CerefolinNAC;
  • Metafolbic Plus;
  • Metafolbic Plus RF [DSC]
Pharmacologic Category
  • Medical Food
Dosing: Adult
Medical food

Medical food: Oral: One tablet daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

See Methylfolate and Acetylcysteine monographs.

Contraindications

Hypersensitivity to methylfolate, methylcobalamin, and acetylcysteine, or any component of the formulation.

Warnings/Precautions

Disease-related concerns:

• Anemia: Monotherapy: Not appropriate for monotherapy with pernicious, aplastic, or normocytic anemias when anemia is present with vitamin B12 deficiency.

• Pernicious anemia: Doses >0.1 mg/day of folic acid may obscure pernicious anemia with continuing irreversible nerve damage progression.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral:

Cerefolin NAC: L-methylfolate 6 mg, methylcobalamin 2 mg, N-acetylcysteine 600 mg, and Schizochytrium algae [contains soy; gluten free, lactose free, yeast free]

Metafolbic Plus: L-methylfolate 6 mg, methylcobalamin 2 mg, and N-acetylcysteine 600 mg [gluten free, lactose free, sugar free, yeast free]

Metafolbic Plus RF: L-methylfolate 6 mg, methylcobalamin 2 mg, N-acetylcysteine 600 mg, and Schizochytrium algae [DSC] [contains soy; gluten free, yeast free]

Generic: L-methylfolate 6 mg, methylcobalamin 2 mg, and N-acetylcysteine 600 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Cerefolin Brain Wellness Oral)

6-2-600 mg (per each): $7.91

Tablets (Cerefolin NAC Oral)

6-90.314-2-600 mg (per each): $7.54

Tablets (Metafolbic Plus Oral)

6-2-600 mg (per each): $2.66

Tablets (Metafolbic Plus RF Oral)

6-90.314-2-600 mg (per each): $3.80

Tablets (Methylfol-Algae-B12-Acetylcyst Oral)

6-90.314-2-600 mg (per each): $3.75

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Use: Labeled Indications

Medical food: For use in patients with mild to moderate cognitive impairment who present with increased risk for neurovascular oxidative stress and/or hyperhomocysteinemia; and/or decreased methylfolate and/or vitamin B12 levels.

Note: A medical food is formulated to be administered enterally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods are not drugs and, therefore, are not subject to any FDA regulatory requirements that specifically apply to drugs (eg, requirement for written/oral prescription prior to dispensing, premarket review or approval, proof of safety and efficacy).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Charcoal, Activated: May decrease serum concentration of Acetylcysteine. Risk C: Monitor

Chloramphenicol (Systemic): May decrease therapeutic effects of Vitamin B12. Risk C: Monitor

Fluorouracil Products: Folic Acid may increase adverse/toxic effects of Fluorouracil Products. Risk C: Monitor

Fosphenytoin-Phenytoin: Folic Acid may decrease serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor

Green Tea: May decrease serum concentration of Folic Acid. Risk C: Monitor

Pafolacianine: Coadministration of Folic Acid and Pafolacianine may alter diagnostic results. Risk X: Avoid

PHENobarbital: Folic Acid may decrease serum concentration of PHENobarbital. Risk C: Monitor

Primidone: Folic Acid may decrease serum concentration of Primidone. Additionally, folic acid may decrease concentrations of active metabolites of primidone (e.g., phenobarbital). Risk C: Monitor

Pyrimethamine: Folic Acid may decrease therapeutic effects of Pyrimethamine. Management: Folic acid doses greater than 2.5 mg per day should be avoided due to the potential for sulfadoxine/pyrimethamine treatment failure. Consider limiting folic acid use to no more than 0.4 mg per day for women of child-bearing age. Risk D: Consider Therapy Modification

Raltitrexed: Folic Acid may decrease therapeutic effects of Raltitrexed. Risk X: Avoid

Sulfadoxine: Folic Acid may decrease therapeutic effects of Sulfadoxine. Management: Folic acid doses greater than 2.5 mg per day should be avoided due to the potential for sulfadoxine/pyrimethamine treatment failure. Consider limiting folic acid use to no more than 0.4 mg per day for women of child-bearing age. Risk D: Consider Therapy Modification

SulfaSALAzine: May decrease serum concentration of Folic Acid. Risk C: Monitor

Breastfeeding Considerations

According to the manufacturer, use should be avoided in lactating patients. Also refer to the Acetylcysteine monograph for additional information.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (IN) India: Nexfolin | Tetrafol Nac;
  • (PR) Puerto Rico: L methyl mc nac
  1. CerefolinNAC (methylfolate, methylcobalamin, acetylcysteine) [prescribing information]. Covington, LA: Alfasigma USA Inc; February 2017.
  2. Metafolbic Plus (methylfolate, methylcobalamin, acetylcysteine) [prescribing information]. Shreveport, LA: Nestlé Health Science-Pamlab Inc; November 2016.
  3. Metafolbic Plus RF (methylfolate, methylcobalamin, acetylcysteine) [prescribing information]. Shreveport, LA: Nestlé Health Science-Pamlab Inc; November 2016.
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