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Folic acid

Generic Name
Folic acid
Brand Names
Animi-3 With Vitamin D, Citranatal B-calm Kit, Citranatal Harmony, Concept Ob, EnBrace HR, EnLyte, Ferralet 90, Folbic, Foltabs, Hematogen, Infuvite, Infuvite Pediatric, Irospan 24/6 Kit, Magnebind 400 Rx, Mvc-fluoride, Mvi Pediatric, Natafort, Nicomide, Pregvit, Tandem Plus, Vitafol-one
Drug Type
Small Molecule
Chemical Formula
C19H19N7O6
CAS Number
59-30-3
Unique Ingredient Identifier
935E97BOY8

Overview

Folic acid, also known as folate or Vitamin B9, is a member of the B vitamin family and an essential cofactor for enzymes involved in DNA and RNA synthesis. More specifically, folic acid is required by the body for the synthesis of purines, pyrimidines, and methionine before incorporation into DNA or protein. Folic acid is particularly important during phases of rapid cell division, such as infancy, pregnancy, and erythropoiesis, and plays a protective factor in the development of cancer. As humans are unable to synthesize folic acid endogenously, diet and supplementation is necessary to prevent deficiencies. For example, folic acid is present in green vegetables, beans, avocado, and some fruits. In order to function within the body, folic acid must first be reduced by the enzyme dihydrofolate reductase (DHFR) into the cofactors dihydrofolate (DHF) and tetrahydrofolate (THF). This important pathway, which is required for de novo synthesis of nucleic acids and amino acids, is disrupted by anti-metabolite therapies such as Methotrexate as they function as DHFR inhibitors to prevent DNA synthesis in rapidly dividing cells, and therefore prevent the formation of DHF and THF. When used in high doses such as for cancer therapy, or in low doses such as for Rheumatoid Arthritis or psoriasis, Methotrexate impedes the body's ability to create folic acid. This results in a deficiency of coenzymes and a resultant buildup of toxic substances that are responsible for numerous adverse side effects. As a result, supplementation with 1-5mg of folic acid is recommended to prevent deficiency and a number of side effects associated with MTX therapy including mouth ulcers and gastrointestinal irritation. Leucovorin (also known as folinic acid) supplementation is typically used for high-dose MTX regimens for the treatment of cancer. Levoleucovorin and leucovorin are analogs of tetrahydrofolate (THF) and are able to bypass DHFR reduction to act as a cellular replacement for the co-factor THF. There are also several antiepileptic drugs (AEDs) that are associated with reduced serum and red blood cell folate, including Carbamazepine (CBZ), Phenytoin (PHT), or barbiturates. Folic acid is therefore often provided as supplementation to individuals using these medications, particularly to women of child-bearing age. Inadequate folate levels can result in a number of health concerns including cardiovascular disease, megaloblastic anemias, cognitive deficiencies, and neural tube defects (NTDs). Folic acid is typically supplemented during pregnancy to prevent the development of NTDs and in individuals with alcoholism to prevent the development of neurological disorders, for example.

Background

Folic acid, also known as folate or Vitamin B9, is a member of the B vitamin family and an essential cofactor for enzymes involved in DNA and RNA synthesis. More specifically, folic acid is required by the body for the synthesis of purines, pyrimidines, and methionine before incorporation into DNA or protein. Folic acid is particularly important during phases of rapid cell division, such as infancy, pregnancy, and erythropoiesis, and plays a protective factor in the development of cancer. As humans are unable to synthesize folic acid endogenously, diet and supplementation is necessary to prevent deficiencies. For example, folic acid is present in green vegetables, beans, avocado, and some fruits. In order to function within the body, folic acid must first be reduced by the enzyme dihydrofolate reductase (DHFR) into the cofactors dihydrofolate (DHF) and tetrahydrofolate (THF). This important pathway, which is required for de novo synthesis of nucleic acids and amino acids, is disrupted by anti-metabolite therapies such as Methotrexate as they function as DHFR inhibitors to prevent DNA synthesis in rapidly dividing cells, and therefore prevent the formation of DHF and THF. When used in high doses such as for cancer therapy, or in low doses such as for Rheumatoid Arthritis or psoriasis, Methotrexate impedes the body's ability to create folic acid. This results in a deficiency of coenzymes and a resultant buildup of toxic substances that are responsible for numerous adverse side effects. As a result, supplementation with 1-5mg of folic acid is recommended to prevent deficiency and a number of side effects associated with MTX therapy including mouth ulcers and gastrointestinal irritation. Leucovorin (also known as folinic acid) supplementation is typically used for high-dose MTX regimens for the treatment of cancer. Levoleucovorin and leucovorin are analogs of tetrahydrofolate (THF) and are able to bypass DHFR reduction to act as a cellular replacement for the co-factor THF. There are also several antiepileptic drugs (AEDs) that are associated with reduced serum and red blood cell folate, including Carbamazepine (CBZ), Phenytoin (PHT), or barbiturates. Folic acid is therefore often provided as supplementation to individuals using these medications, particularly to women of child-bearing age. Inadequate folate levels can result in a number of health concerns including cardiovascular disease, megaloblastic anemias, cognitive deficiencies, and neural tube defects (NTDs). Folic acid is typically supplemented during pregnancy to prevent the development of NTDs and in individuals with alcoholism to prevent the development of neurological disorders, for example.

Indication

Folic acid is indicated for the treatment of folic acid deficiency, megaloblastic anemia, and in anemias of nutritional origins, pregnancy, infancy, or childhood.

Associated Conditions

  • Anaemia folate deficiency
  • Folate deficiency
  • Iron Deficiency (ID)
  • Iron Deficiency Anemia (IDA)
  • Latent Iron Deficiency
  • Neural Tube Defects (NTDs)
  • Vitamin Deficiency
  • Methotrexate toxicity

Clinical Trials

Not Applicable
Completed
Posted: 2023/07/13
Sponsor:
Near East University...
Phase 2
Not yet recruiting
Posted: 2023/05/17
Sponsor:
Wuhan Union Hospital...
Phase 2
Not yet recruiting
Posted: 2023/03/20
Sponsor:
Liaoning Tumor Hospi...

FDA Approved Products

Folic Acid
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2023/09/27
NDC:68071-3513
Se-Natal 19 Chewable
Manufacturer:Seton Pharmaceuticals
Route:ORAL
Strength:1 mg in 1 1
Approved: 2019/01/07
NDC:13925-117
Nicotinamide
Manufacturer:Acella Pharmaceuticals, LLC
Route:ORAL
Strength:850 ug in 1 1
Approved: 2023/10/11
NDC:42192-374
FOLIC ACID
Manufacturer:Aphena Pharma Solutions - Tennessee, LLC
Route:ORAL
Strength:1 mg in 1 1
Approved: 2024/03/20
NDC:71610-803
Folic Acid
Manufacturer:Preferred Pharmaceuticals Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2023/12/12
NDC:68788-8557

Singapore Approved Products

SOLUVIT N FOR INFUSION
Manufacturer:Fresenius Kabi SSPC
Form:INJECTION, POWDER, FOR SOLUTION
Strength:0.4 mg/vial
Online:Yes
Approved: 1990/11/14
Approval:SIN05209P

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