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levomefolic acid

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Last Updated: 26 November 2020

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General | Latest Info

levomefolic acid

Clinical data
License dataUS DailyMed : estradiol_and_levomefolate_calcium Drospirenone,_ethinyl estradiol_and_levomefolate_calcium, US FDA : Beyaz
MedlinePlusa601050
Other namesEE/DRSP/LMF; EE/DRSP/THF; EE/DRSP/THFA; EE/DRSP/FH4; EE/DRSP/VB9
Pregnancy categoryUS : X (Contraindicated),
Routes of administrationBy mouth
Trade namesBeyaz, Safyral, Tydemy
Combination of
DrospirenoneProgestogen ; Progestin ; Antimineralocorticoid ; Antiandrogen
EthinylestradiolEstrogen
Levomefolic acidVitamin
Identifiers
(verify)
ChemSpiderNone
Legal status
Legal statusIn general: (Prescription only)

This factsheet has been created for sponsors who wish to list folate products on ARTG. It is intended to provide general information on the most commonly used folates and answer most frequently asked questions. Folate, or vitamin B9, is an essential vitamin required by the human body for normal growth and development as it plays a critical role in synthesis of DNA and RNA, and in metabolism of certain amino acids. The term folate is actually the generic name for a group of related compounds with similar nutritional properties. The three most commonly used forms are folic acid, calcium folinate and levomefolate salts. All three forms can be incorporated into the body's metabolic pathways and may provide sources of the same biologically active form of folate-compound known as 5-methyltetrahydrofolate or levomefolic acid.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Medical uses

Studies have shown its uses to be oral contraception, lessening premenstrual dysphoric Disorder, and treatment of moderate acne in women over 14 years of age who choose oral contraceptive for contraception. Five clinical trials were carried out for these labeled uses, including a one-year contraceptive efficacy study, two 3-cycle studies in women with premenstrual dysphoric Disorder, and two 6-cycle studies in women with moderate acne. Drug combination will also increase folate levels due to its extra ingredient, levomefolic Calcium. This is equivalent to folic Acid 0. 4 mg and will help prevent neural tube defects in case of accidental pregnancy while taking, or shortly after stopping the drug.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Vitamin B9

Folate is a generic term referring to both natural folates in food and folic acid, synthetic form used in supplements and fortify food. Folate is critical in metabolism of nucleic acid precursors and several amino acids, as well as in methylation reactions. Severe deficiency in either Folate or vitamin B 12 can lead to megaloblastic anemia, which causes fatigue, weakness, and shortness of breath. Improper Treatment of vitamin B 12-dependent megaloblastic anemia with high dose supplemental folic acid can potentially delay diagnosis of vitamin B 12 deficiency and thus leave individual at risk of developing irreversible brain damage. Folate status is influenced by the presence of genetic variations in Folate metabolism, particularly those found in 5 10-methylenetetrahydrofolate reductase gene. Inadequate Folate status during early pregnancy increases the risk of congenital anomalies. The introduction of mandatory folic acid fortification of refined grain products in the US in 1998 has reduced the prevalence of neural tube defects in newborns. Yet, Folate status is considered inadequate by the majority of women of childbearing age worldwide. Moreover, genetic factors might modify the risk of NTDs by increasing susceptibility to Folate deficiency during pregnancy. Several studies are currently investigating the role of folic acid supplementation in prevention of congenital anomalies other than NTDs. Folate deficiency and elevated concentrations of homocysteine in blood are associated with increased risk of cardiovascular disease. Although folic acid supplementation has been proven effective to control circulating homocysteine concentrations, effect of homocysteine lowering on incidence of CVD is still debate. Low Folate status has been linked to increased cancer risk. However, intervention trials with high doses of folic acid have not generally shown any benefit on cancer incidence. Prospective cohort studies have reported an inverse association between Folate status and colorectal cancer risk, especially among men. The relationship between folate status and cancer risk is however complex and requires further research. Folate is essential for brain development and function. Low Folate status and / or high homocysteine concentrations are associated with cognitive dysfunction in aging. Whether supplemental B-vitamins, including folic acid, will have long-term benefits in maintaining cognitive health is not yet know. Several autosomal recessive disorders affecting Folate transport and metabolism can be treated with high doses of folinic acid, Folate derivative. Folate is a water-soluble B-vitamin, which is also know as vitamin B 9 or folacin. Naturally occurring folates exist in many chemical forms; Folates are found in food, as well as in metabolically active forms in the human body. Folic acid is major synthetic form found in fortified foods and vitamin supplements. Other synthetic forms include folinic acid and levomefolic acid. Folic acid has no biological activity unless converted into folates. In following discussion, forms found in food or body are referred to as folates, while form found in supplements or fortified food is referred to as folic acid.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

What is folate?

There are four folate sources currently permitted for use in listed medicines via Permissible Ingredients Determination. These are folic acid, calcium folinate, levomefolate glucosamine, and levomefolate calcium. These ingredients are most commonly used in preparations indicated for reducing the risk of having child with spina bifida and / or neural tube defects. These indications are restrict representations and the sponsor must have advertising exemption for claim, or have a product that meets the requirements of folic acid advertising exemption. When sponsor wishes to make these indications, products must contain dose equivalent to 400-500 micrograms of folic acid and include the following statements on the label: 'Warning: Do not exceed state dose except on medical advice. If you have had a baby with neural tube defect / spina bifida-seek specific medical advice '; and 'Vitamins can only be of assistance if dietary vitamin intake is inadequate. ' or 'Vitamin supplements should not replace balanced diet'.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

What is folic acid?

Many foods are being fortified with folic acid to help consumers maintain good nutritional folate status. Also, dietary supplements that include folate typically provide it as FA. Yet this substance is manufactured folate that is known to be poorly used by the bodys folate enzyme system. The body has to use enzyme to make FA usable, and this enzyme conversion capacity is limit. Consequently, many people have unconverted FA in their bloodstream, which studies have linked to negative health effects. Methylfolate is the folate form most naturally preferred by the body, so much so that the intestinal lining has transport proteins that bind to it and selectively absorb it into blood. Similar proteins also move MF from circulation into brain tissue. But MF utilization can be blocked by FA coming from fortified foods or poorly formulated dietary supplements. Folic acid is not just poorly effective, it actually interferes with enzymes that are tasked with using MF and other folates coming from our foods. Folic acid consumption is a serious health issue. Bottom line: always choose supplements with Methylfolate instead of folic acid. Unlike folic acid, Methylfolate, when consume, does not have to be converted into active folatebeing already the body's most active folate form, it can be immediately used by our folate enzyme systems. One of the most common human gene mutations is the C677T mutation in enzyme MTHFR, whose function is to produce MF. More than 40 percent of individuals in some ethnic groups have this mutation, which is associated with impaired folate utilization. Taking MF by mouth bypasses this mutation: as premade authentic MF it doesnt need to be produced by MTHFR. For people with C677T or various other, less common MTHFR mutations, MF is a health breakthrough!

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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