Levomefolate Calcium And Algal

Levomefolate Calcium And Algal Manufacturers

• Method Pharmaceuticals, Llc
  

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  Levomefolate Calcium And Algal | Method Pharmaceuticals, Llc

  

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  The usual adult dose is one or two capsule(s) daily with or without food or as directed by a licensed medical practitioner.

  FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. About 70% of food folate and cellular folate is comprised of L-methylfolate. It is the primary form of folate in circulation, and is also the form transported across membranes – particularly across the blood brain barrier – into peripheral tissues. In the cell, L-methylfolate is used in the remethylation of homocysteine to form methionine and tetrahydrofolate (THF). L-methylfolate is converted into functional, metabolically active coenzyme forms for use in the body, and supplies the active folate substrate, THF for use in transformylation and methylation biochemistry.1

  Folates are known for reducing the incidence of fetal neural tube defects (NTDs).2,3,4 NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development.4,5 During the first four weeks of pregnancy, when many women do not even realize that they have conceived, adequate maternal folate intake is reported to reduce the risk of NTDs. Folate is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry. Folate is involved in transformylation and methylation metabolism as well as, indirectly, succinylation metabolism (through the “methyl trap” hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate.4 Other ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intake may affect the magnitude of risk reduction or participate in a co-protective effect with folate.4,5 

  It is reported that L-methylfolate supplementation increases BH4 synthesis through a pterin “salvage pathway”, which converts sepiapterin/dihydrobiopterin (BH2) to BH4 through the enzymatic activity of dihydrofolate reductase (DHFR). Additionally, it is reported that L-methylfolate (L-MTHF) may enhance or even “stand in” for BH4. BH4 can also be regenerated from quinonoid dihydrobiopterin by dihydropteridine reductase (DHPR) and synthesized de novo by conversion from guanosine triphosphate (GTP). BH4 functions as a cofactor for the enzymes responsible for the production of monoamine neurotransmitters (serotonin, epinephrine, dopamine). BH4 is the cofactor for conversion of phenylalanine to tyrosine. Tyrosine is then converted into DOPA, and eventually to norepinephrine and epinephrine. The conversion of tryptophan to serotonin also requires BH4.

  FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 establish that increased folate is a proper supplement in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood.6,7 Folate metabolism may be affected by malabsorption issues that differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states “The agency concluded that the scientific literature did not support the superiority of any one source of folate over others, and that the data were insufficient to provide a basis for stating that a specific amount of folate is more effective than another amount" [emphasis added].1 The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically 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. Oral preparations supplying more than 0.8 mg of folate per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated.7”

  "Patients should be kept under supervision of a licensed practitioner and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased [emphasis added].7” In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote “... high intakes of folate may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added].8”

  Summary: This product is a dietary management / prescription folate that, due to advanced folate levels, requires administration under the care of a licensed medical practitioner. The "Rx" on the label is to ensure prescription dispensing and that the product is administered under the supervision of a licensed medical practitioner due to the increased risk associated with masking of B12 deficiency (pernicious anemia). The "Rx" status and a National Drug Code (NDC), or similar Product Code, facilitate pedigree reporting requirements and supply-chain control as well as, in some cases, insurance-reimbursement applications.

  These statements have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.

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