Enlyte
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS: This product contains iron. EnLyte® should not be used by individuals at risk for iron overload (including transfusional overload) or other conditions for which iron is contraindicated.
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
INDICATIONS AND USAGE: EnLyte® is indicated for the distinct nutritional requirements of individuals who have suboptimal folates levels in the cerebrospinal fluid, plasma and/or red blood cells, and require a maintenance level. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias 12 (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin13, pregnancy, infancy, childhood or other related folate-malabsorption complications of an inborn or environmental origin.14,43
EnLyte® is not a drug, but may be used as monotherapy (“rescue” therapy) or adjunctive therapy as determined by your licensed medical practitioner. The adjunctive use of EnLyte® enables medical practitioners to combine therapeutic modalities (dietary management and drug therapy).18,19 In patients with suboptimal folate levels – and as determined by your licensed medical practitioner, EnLyte® may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or vascular nature such as may be found with depression; or EnLyte® may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or methylation metabolic imbalance as may be found with depressed patients.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: EnLyte® is an orally-administered prescription folate-containing product for the clinical dietary management of depression related to suboptimal folate levels associated with metabolic imbalances in transformylation and/or methylation biochemistry.1-8,20
Folate appears to enhance synthesis and/or regeneration of tetrahydrobiopterin (BH4), which is an essential cofactor in the biosynthesis of monoamine neurotransmitters serotonin, dopamine and norepinephrine.15,16,17 Additionally, folate may normalize elevated homocysteine levels and reduce the risk of neural tube defects. Elevated homocysteine has been observed among women with neural tube defect (NTD)-affected pregnancies.36 The protective effect of DeltaFolateTM in EnLyte® comes in supplying an array of folate-derivatives in combination with folate coenzymes, cofactors and co-metabolites that decrease the risk of bioavailability-interference such as might occur with inborn or environmental folate-malabsorption. This allows the folate substrate, THF, to be utilized in transformylation and/or methylation biochemistry.1-8,14
EnLyte® can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
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| INGREDIENTS:*Each oval, annatto-colored MULTIPHASIC soft gelatin capsule contains the following dietary ingredients: | |
| FeGC as ferrous glycine cysteinate (1.5mg elemental iron) from pure amino acid chelate† | 13.6 |
| PS-DHA as phosphatidylserine-docosahexaenoic acid from PS-DHA-Ca† | 6.4 mg |
| PS-EPA as phosphatidylserine-eicosapentaenoate acid from PS-EPA-Ca† | 800 mcg |
| DeltaFolateTM‡ (16 mg) comprised of - | |
| Formyltetrahydrofolic acid | 2.5 mg |
| Controlled-release citrated-pteroylmonoglutamic acid§ , USP | 1 mg |
| L-methylfolate magnesium¶ | 7 mg |
| Citrates § (citric acid, sodium citrates) | 5.5 mg |
| ALSO CONTAINS*: The following distinct dietary ingredients as necessary cofactors, coenzymes and co-metabolites for advanced folate supplementation: | |
| Phosphatidylserine# | 12 mg |
| Ascorbates [as 24 mg magnesium ascorbate and 1 mg zinc ascorbate] | 25 mg |
| Thiamine pyrophosphate | 25 mcg |
| Flavin adenine dinucleotide (FAD) | 25 mcg |
| Nicotinamide adenine dinucleotide hydride (NADH) | 25 mcg |
| Pyridoxal 5’ phosphate (P5P) | 25 mcg |
| Adenosylcobalamin | 50 mcg |
| Betaine (trimethylglycine) | 500 mcg |
| L-threonate magnesium | 1 mg |
Sources
Enlyte Manufacturers
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Jaymac Pharmaceuticals Llc
![Enlyte (Leucovorin, Folic Acid, Levomefolate Magnesium, Ferrous Cysteine Glycinate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, Phosphatidyl Serine, Pyridoxal 5-phosphate, Flavin Adenine Dinucleotide, Nadh, Cobamamide, Cocarboxylase (Thiamine Pyrophosphate), Magnesium Ascorbate, Zinc Ascorbate, Magnesium L-threonate And Betaine) Capsule, Delayed Release Pellets [Jaymac Pharmaceuticals Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Enlyte | Jaymac Pharmaceuticals Llc
DOSAGE AND ADMINISTRATION: The recommended dose is one softgel daily or as directed under medical supervision to achieve a satisfactory folate-maintenance level. Some individuals may require larger doses as determined by a licensed medical practitioner.
EnLyte® is best absorbed when taken on an empty stomach. During times of medication transition, the amount of EnLyte® may be increased as per direction of your licensed medical practitioner in order to achieve a “rescue” effect.
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