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Deplin

Last reviewed on RxList: 2/1/2018
Drug Description

DEPLIN® 7.5 Capsules

DEPLIN® 15 Capsules

DESCRIPTION

DEPLIN® is a prescription medical food for use only under the supervision of a physician for the clinical dietary management of depression and schizophrenia and is specially formulated to meet the distinctive nutritional requirement for these conditions.

Each DEPLIN® 7.5 capsule contains 7.5 mg of L-methylfolate (from Metafolin®) and 90.314 mg Algae-S powder (Schizochytrium). CAS#151533-22-1

Each DEPLIN® 15 capsule contains 15.0 mg of L-methylfolate (from Metafolin®) and 90.314 mg Algae-S powder (Schizochytrium). CAS#151533-22-1

Ingredients

DEPLIN® 7.5

Silicified Microcrystalline Cellulose, Algae-S Powder (Schizochytrium Algal Oil [Vegetable source], Glucose Syrup Solids, Mannitol, Sodium Caseinate (milk), Soy Protein, High Oleic Sunflower Oil, 2% or less Sodium Ascorbate, Tricalcium Phosphate, Tetrasodium Diphosphate, Natural Flavors, Soy Lecithin, and Mixed Natural Tocopherols and Ascorbyl Palmitate[as antioxidants]), Pullulan, L-methylfolate Calcium, Titanium dioxide [color], Magnesium Stearate (Vegetable Source), FD&C Yellow #6[color], FD&C Red #40[color], Propylene Glycol, Sodium Hydroxide, Povidone, FD&C Yellow #6 Aluminum Lake, Shellac. Contains Milk and Soy

DEPLIN® 15

Silicified Microcrystalline Cellulose, Algae-S Powder (Schizochytrium Algal Oil [Vegetable source], Glucose Syrup Solids, Mannitol, Sodium Caseinate (milk), Soy Protein, High Oleic Sunflower Oil, 2% or less Sodium Ascorbate, Tricalcium Phosphate, Tetrasodium Diphosphate, Natural Flavors, Soy Lecithin, and Mixed Natural Tocopherols and Ascorbyl Palmitate [as antioxidants]), Pullulan, L-methylfolate Calcium, Titanium Dioxide [color], Magnesium Stearate (Vegetable Source)], FD&C Yellow #6[color], FD&C Red #40[color], Propylene Glycol, Sodium Hydroxide, Povidone, Shellac. Contains Milk and Soy

DEPLIN® is a prescription medical food for use only under the supervision of a physician.

Medical foods are intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.1 This product is not an Orange Book product.

REFERENCES

1. United States Food and Drug Administration Title 21 Code of Federal Regulations 101.9(j) (8).

Side Effects & Drug Interactions

SIDE EFFECTS

Allergic reactions have been reported following the use of oral L-methylfolate.11

DRUG INTERACTIONS

No Information provided

REFERENCES

11. Natural Standard Research Collaboration (NIH). Folate (folic acid) Monograph 2009.

Warnings & Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

General

L-methylfolate (DEPLIN®) is not interchangeable with folic acid. Folic acid is not effective in some patients in impacting cerebral folate levels due to low rates of folic acid transport across the blood-brain barrier and/or low brain levels of the enzyme required to convert folic acid into a biological and functional form.7-9

Patients at risk for vitamin B12 deficiency should consult with their physician prior to taking L-methylfolate.10

REFERENCES

7. Visentin et al Annu Rev Physiol 2014 76:251-74.

8. Zhao et al Mol Aspects Med 2013 34: 373-85.

9. Molero-Luis et al Expert Rev Neurother 2015 15: 793-802.

10. Pietrzik et al Clin Pharmacokinet 2010 49: 535-48.

Overdosage & Contraindications

OVERDOSE

No Information provided

CONTRAINDICATIONS

DEPLIN® is contraindicated in patients with known hypersensitivity to any of the components contained in this product.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

No information provided.

Medication Guide

PATIENT INFORMATION

DEPLIN® is a prescription medical food for use only under the supervision of a physician.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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