|Dosage Form||Package Information||Links|
|CAPSULE||30 CAPSULE in 1 BOTTLE (64661-711-30)||Label Information|
EnLyte® is an orally administered prescription hematinic drugfor therapeutic use formulated for adult macrocytic anemia patients â€“ including pernicious anemia and folate deficiency, ages 12 and up, who are under specific direction and monitoring of cobalamin and folate status by a physician. EnLyte® may be useful in patients at risk of depression due to a deficiency of cobalamin and/or folate. EnLyte® may be taken by women of childbearing age. EnLyte® may be taken by geriatric patients where compliance is an issue.
|Cobalamin intrinsic factor complex||1 NF Units*|
|ALSO CONTAINS (15 mg DFE folate):|
|Formylfolic acid||2.5 mgâ€|
|Reduced folic acid, DHF||1 mg1|
|L-methylfolic acid||7 mgâ€¡|
FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron3) [colorant], 25 mg ascorbates3,4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates) [stabilizers], at least 23.33 mg phospholipid-omega3 complex5 [marine lipids], 500 mcg betaine (trimethylglycine) [acidifier], 1 mg magnesium l-threonate [stabilizer].
OTHER EXCIPIENTS: Annatto [colorant], flavin adenine dinucleotide6 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], nicotinamide adenine dinucleotide hydride6 (NADH), pyridoxal 5â€™ phosphate6 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate6, ubidecarenone [antioxidant], yellow beeswax.
3 30% daily value (DV) of VITAMIN C, and 10% DV IRON.
4 NOT a significant source of magnesium and zinc.
5 Contains at least 12 mg phosphatidylserine (PS) â€“ of which approximately 6.4 mg as PS-DHA-Ca, and less than 1% EPA (<800 mcg PS-EPA-Ca)
6 Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6.
Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.
Cobalamin [treatment]; Folate[prevention]; Intrinsic Factor[facilitator].
Cobalamin deficiency results in megaloblastic anemia, GI lesions, and neurological damage that begins with an inability to produce myelin and is followed by gradual degeneration of the axon and nerve head. cobalamin has hematopoietic activity apparently identical to that of the anti-anemia factor in purified liver extract.
[Cobalamin] / [Intrinsic factor]
Gastrointestinal absorption of cobalamin depends on the presence of sufficient intrinsic factor. Intrinsic factor deficiency causes pernicious anemia - which may be associated with subacute combined degeneration of the spinal cord.
Folate deficiency results in megaloblastic anemia. Folate stimulates specifically the production of red blood cells, white blood cells, and platelets in persons suffering from certain megaloblastic anemias.
Folic acid, formylfolic acid and l-methylfolic acid metabolism results in the creation of tetrahydrofolic acid by different pathways. Both formylfolic acid and l-methylfolic acid acid do not require dihydrofolate reductase (DHR), however folic acid does.
[Folate] / [Cobalamin]
Cobalamin is essential for the synthesis of methionine from homocysteine - a reaction which also requires folate. In the absence of cobalamin, tetrahydrofolate cannot be regenerated from 5-methyltetrahydrofolate, and a functional folate deficiency occurs (ie, â€œmethyl trap hypothesisâ€).
Inborn errors of metabolism (IEMs) - such as methyltetrahydrofolate reductase (MTHFR), may also inhibited cobalamin intracellular conversion due to impaired ability to metabolize folic acid.
EnLyte® is indicated in the treatment of macrocytic anemias resulting from cobalamin deficiency - including pernicious anemia, and the prevention of folate deficiency.
EnLyte® is indicated as a primary and adjunctive treatment in megaloblastic anemia associated with tropical and non-tropical sprue, in anemias of nutritional origen, pregnancy, alcoholism, infancy and childhood as well as pernicious anemia patients having idiosyncrasy or sensitivity to parenteral administration (or when parental therapy is refused).
EnLyte® is indicated in the maintenance of normal hematologic status (hematopoiesis) as well as supplement for other cobalamin deficiencies, including:
Requirements of cobalamin and/or folate in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
0.1 mg or more of folic acid daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. The safe tolerable limit for folic acid (in preparations) is 1 mg [emphasis added].
Folic acid is not a substitute for vitamin B12 - although it may improve vitamin B12-deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12-deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Specifically, vitamin B12 deficiency allowed to progress over 3 months may produce permanent degenerative lesions of the spinal cord - as observed when folate therapy is used as the only hematopoietic agent.
Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.
A dietary deficiency of only vitamin B12 is rare; multiple vitamin deficiency is expected in any dietary deficiency. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy.
Colchicine, para-aminosalicylic acid, and heavy alcohol intake for longer than 2 weeks may produce malabsorption of cobalamin.
The adult dose is one capsule daily preferably on an empty stomach.
As a general rule - in patients with Addisonian Pernicious Anemia, treatment will be required for the remainder of the patientâ€™s life. Reticulocyte plasma count, cobalamin and folate must be obtained prior to treatment.
Do not exceed recommended dose. Call your medical practitioner about side effects. You may report side effects by calling 337.662-5962.
Store at 20°-25°C (68°-77°F). Protect from light and moisture as contact with moisture may produce surface discoloration and/or erosion.
Rx Only [DRUG]
Caution: Federal law prohibits dispensing without a prescription.
KEEP OUT OF THE REACH OF CHILDREN.
Tamper Evident:Do not use if seal is broken or missing.
7 Lower case.
JayMac Pharmaceuticals, LLC; Sunset, LA 70584.
MANUFACTURED AND/OR PACKAGED IN USA/CANADA.
US Patent No 7,935,365; and other patent applications pending.
EnLyte® is a registered mark of JayMac Pharmaceuticals. DeltaFolateâ„¢ is a use-trademark of JayMac Pharmaceuticals.
Revision 3(November 14, 2018
[1 NF Units]
[2.5mgF-THf, 1mg PteGlu, 7mgMe-THf]
â€‹as extrinsic/intrinsic factor complex plus folate
â€‹SOFTGELS (30ct BOTTLE)
Presciption Hematinic Drug
â€‹For Therapeutic Use
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
|Labeler - Jaymac Pharmaceuticals LLC (830767260)|
|Registrant - Jaymac Pharmaceuticals LLC (830767260)|