FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population.
Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.
Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.13
Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
L-Methyl-MC NAC is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.
L-Methyl-MC NAC should be administered under the supervision of a licensed medical practitioner. Each oval, coated, white tablet contains the following dietary ingredients:
Serving Size: 1 tablet | Servings Per Container: 90 | |
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Amount Per Serving | % Daily Value | |
|
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L-Methylfolate Calcium*, or 6(S)-5-MTHF-Ca | 6 mg | † |
Methylcobalamin | 2 mg | † |
N-Acetylcysteine | 600 mg | † |
Other Ingredients: Sodium Citrate Dihydrate, Vitamin C (Ascorbic Acid), Citric Acid, Glutathione, DiCalcium Phosphate Microcrystalline Cellulose, Hydroxypropyl Cellulose (Modified Cellulouse), Croscarmellose Sodium. Stearic Acid, Magnesium Stearate, Silicon Dioxide, Titanium Dioxide, Cellulose, Hydroxypropylmethyl Cellulose (Modified Cellulose), Food Glaze, Polyethylene Glycol, Micro wax and other ancillary ingredients as needed to ensure product stability.
Since additives, preservatives, bioavailability enhances, colors and flavors of natural origin are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the market place and ensure the highest therapeutic target, safety and quality.
Sources
L-methyl Mc Nac Manufacturers
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Virtus Pharmaceuticals Llc
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