Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
Denovo: 15 mg [contains fd&c yellow #6 (sunset yellow), tartrazine (fd&c yellow #5)]
Deplin 7.5: L-methylfolate 7.5 mg and Schizochytrium algae [contains fd&c red #40, fd&c yellow #6 (sunset yellow), fd&c yellow #6 aluminum lake, sodium caseinate, soy protein, soybean lecithin]
Deplin 15: L-methylfolate 15 mg and Schizochytrium algae [contains fd&c red #40, fd&c yellow #6 (sunset yellow), sodium caseinate, soy protein, soybean lecithin]
L-Methylfolate Formula 15: L-methylfolate 15 mg and Schizochytrium algae [DSC] [contains sodium caseinate, soy protein, soybean lecithin]
L-Methylfolate Formula 7.5: L-methylfolate 7.5 mg and Schizochytrium algae [DSC] [contains sodium caseinate, soy protein, soybean lecithin]
L-Methylfolate Forte: L-methylfolate 7.5 mg and Schizochytrium algae [contains fd&c red #40, fd&c yellow #6 (sunset yellow), fd&c yellow #6 aluminum lake, sodium caseinate, soy protein, soybean lecithin]
L-Methylfolate Forte: L-methylfolate 15 mg and Schizochytrium algae [contains sodium caseinate, soy protein, soybean lecithin]
Generic: L-methylfolate 15 mg and Schizochytrium algae, L-methylfolate 7.5 mg and Schizochytrium algae [DSC]
Tablet, Oral:
Elfolate: 7.5 mg, 15 mg
Generic: 7.5 mg, 15 mg
Pharmacology
Mechanism of Action
Methylfolate, or L-methylfolate, is the active form of folate in the body, which can be transported into peripheral tissues and across the blood-brain barrier. Folate is necessary for formation of numerous coenzymes in many metabolic systems, particularly for purine, pyrimidine, and nucleoprotein synthesis, and maintenance in erythropoiesis; stimulates WBC and platelet production in folate deficiency anemia.
Use: Labeled Indications
Medical food for the nutritional requirements of patients with suboptimal L-methylfolate and who have major depressive disorder or schizophrenia
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).
Contraindications
Hypersensitivity to any component of the formulation
Dosage and Administration
Dosing: Adult
Medical food: Oral: 7.5 to 15 mg daily
Dosing: Geriatric
Refer to adult dosing.
Administration
Oral: May be administered with or without food.
Storage
Store at controlled room temperature of 15°C to 30°C (59°F to 86°F). Protect from heat, light, and moisture.
Methylfolate Images
Drug Interactions
CarBAMazepine: Methylfolate may decrease the serum concentration of CarBAMazepine. Monitor therapy
Cholestyramine Resin: May decrease the serum concentration of Methylfolate. Monitor therapy
Colestipol: May decrease the serum concentration of Methylfolate. Monitor therapy
Fosphenytoin: Methylfolate may decrease the serum concentration of Fosphenytoin. Monitor therapy
PHENobarbital: Methylfolate may decrease the serum concentration of PHENobarbital. Monitor therapy
Phenytoin: Methylfolate may decrease the serum concentration of Phenytoin. Monitor therapy
Primidone: Methylfolate may decrease the serum concentration of Primidone. Monitor therapy
Pyrimethamine: Methylfolate may diminish the therapeutic effect of Pyrimethamine. Monitor therapy
Raltitrexed: Methylfolate may diminish the therapeutic effect of Raltitrexed. Avoid combination
SulfaSALAzine: May decrease the serum concentration of Methylfolate. Monitor therapy
Valproate Products: Methylfolate may decrease the serum concentration of Valproate Products. Monitor therapy
Warnings/Precautions
Disease-related concerns:
- Anemia: Monotherapy: Not appropriate for monotherapy with pernicious or other megaloblastic anemias when anemia is present with vitamin B12 deficiency.
- Pernicious anemia: Doses >0.1 mg/day may obscure pernicious anemia with continuing irreversible nerve damage progression.
Other warnings/precautions:
- Medicinal food: Product is a medicinal food for use only under the supervision of a health care provider.
Patient Education
What is this drug used for?
- It is used to aid diet needs.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- A significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
