Each annotto-colored, oval softgel capsule contains the following ingredients with piperine added for bioavailability enhancement:
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. The folic acid in EnLyte® is uniquely formulated with citrate buffers to achieve optimum absorption at the proximal jejunum. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate. Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle.
Folic acid, or any form of folate other than l-methylfolate – such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under a physician's supervision. The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern - while establishing that increased folate was proper therapy in megoblastic anemias; specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue.
The Federal Register Notice of August 2, 1973 (38 FR 20750) states that:
Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.
Folic acid, or any form of folate other than l-methylfolate – such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under a physician's supervision.
Folic acid may be added to medical foods – as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345)
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.
Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
Caution is recommended in patients with a history of bipolar illness. Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder since mood elevation in this population is possible.
Formyl-THF may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.
Folic acid has been shown to play a dual role in cancer development; low total folate2 intake increases risk of carcinogenesis, and high folic acid intake has been shown to promote carcinogenesis. Patients undergoing cancer treatment or who have a history of pre-cancerous neoplasms should consult their doctor to determine if EnLyte® is appropriate for them.
Pregnancy Category C (for formyl-THF)
Animal reproduction studies have not been conducted with formyl-THF. It is also not known whether formyl-THF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Formyl-THF is an active form of folic acid, and has vitamin B9 activity. Folinic acid, or citrovorum factor, has been on the market since the early 1950s, and is considered generally recognized as safe and effective for the treatment of folic acid deficiency.
It is not known whether formyl-THF is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when formyl-THF is administered to a nursing mother.
Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines or herbal/health supplements alongside EnLyte®.
Formyl-THF may enhance the toxicity of fluorouracil.
Allergic sensitization has been reported following both oral and parenteral administration of folate.
Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxal 5' phosphate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with methylcobalamin.
These are not all of the possible side effects with EnLyte®. It is important to always contact your doctor if you experience any side effects while on EnLyte®.
DOSAGE AND ADMINISTRATION
The recommended dose is one softgel daily or as prescribed by a physician.
Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.