(meth il FO late)
Medical food for the nutritional requirements of patients with suboptimal L-methylfolate and have major depressive disorder or who have or are at risk for hyperhomocysteinemia and have 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).
Hypersensitivity to any component of the formulation
Medicinal food: Oral: 7.5-15 mg daily
Refer to adult dosing.
May be administered with or without food.
Store at controlled room temperature of 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F). Protect from heat, light, and moisture.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
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 [contains sodium caseinate, soy protein, soybean lecithin]
L-Methylfolate Formula 7.5: L-methylfolate 7.5 mg and Schizochytrium algae [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 [DSC], L-methylfolate 7.5 mg and Schizochytrium algae [DSC]
Tablet, Oral:
Deplin: 7.5 mg [DSC] [gluten free, lactose free, sugar free, yeast free; contains fd&c blue #2 (indigotine)]
Deplin: 15 mg [DSC] [gluten free, lactose free, sugar free, yeast free; contains fd&c blue #2 (indigotine), fd&c red #40, fd&c yellow #6 (sunset yellow), tartrazine (fd&c yellow #5)]
Elfolate: 7.5 mg, 15 mg
Generic: 7.5 mg, 15 mg
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
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 healthcare provider.
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.
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.