EnLyte: Package Insert / Prescribing Info

EnLyte Description

EnLyte® is a medical food for use only under medical supervision to assist MTHFR SNP (IEMs) and methylation coenzyme cofactor deficiency patients in the clinical dietary management of depression and is specially formulated to meet the distinctive nutritional requirements for these patients.

Each EnLyte® softgel capsule contains: 50 mcg adenosylcobalamin (vitamin B12) and 15 mg DFE of reduced folates (from 7 mg l-methylfolate magnesium, 2.5 mg folinic acid, and 1 mg folic acid).

A recent study+ suggested that EnLyte® was effective in lowering homocystine levels in patients that are positive for MTHFR (methylenetetrahydrofolate reductase polymorphism).

+ClinicalTrials.gov identifier: NCT02709668, Correlation of Clinical Response With Homocysteine Reduction During Therapy With Reduced B Vitamins in Patients with MDD Who Are Posititive for MTHFR C677T or A1298C Polymorphism.

Ingredients: Olive oil, gelatin, glycerin, magnesium ascorbate, Sharp-PS® Gold (phosphatidylserine-DHA complex), yellow beeswax, purified water, sodium citrate, l-methylfolate magnesium, sunflower lecithin, folinic acid, citric acid, annatto extract, elemental iron (from ferrous glycine cysteinate), folic acid, zinc ascorbate, magnesium l-threonate, natural orange flavor, piperine, CoQ10 (ubidecarenone), betaine, vitamin B12 (adenosylcobalamin), FAD (flavin adenine dinucleotide), NADH (nicotinamide adenosine dinucleotide hydride), vitamin B6 (pyridoxal 5’ phosphate), vitamin B1 (thiamine pyrophosphate).

CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.

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.

Indications and Usage for EnLyte

CLINICAL DIETARY MANAGEMENT OF MAJOR DEPRESSIVE DISORDER.

Adverse Reactions/Side Effects

Allergic reactions have been reported following the use of oral folate. Mild transient diarrhea, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with B12.

Precautions

Folic acid, including reduced forms such as folinic acid, in daily doses above 0.1 mg may obscure the detection of B12 deficiency specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological issues. Folate therapy alone is inadequate for the treatment of a B12 deficiency and must be administered under the supervision of a licensed medical practitioner.

EnLyte Dosage and Administration

The usual dose is one EnLyte® softgel capsule given daily with or without food, or as directed under medical supervision. No age restrictions.

KEEP THIS OUT OF THE REACH OF CHILDREN.

Do not exceed the recommended dose.

How is EnLyte supplied

Oval, brownish orange softgel capsule with imprint ENL.

Storage and Handling

Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP).

Protect from heat, light and moisture.

(Tamper Evident: Do not use if seal is broken or missing.)

JAYMAC Pharmaceuticals LLC, 2085 I-49 S. Service Rd Sunset, LA 70584

MANUFACTURED AND/OR PACKAGED IN USA/INDIA

​Rev Nov 8 2023 (V9)

Warnings

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 SOFTGELS Bottle Label