MedPath

Pyridoxine

Generic Name
Pyridoxine
Brand Names
Alertonic, Animi-3 With Vitamin D, Bonjesta, Citranatal B-calm Kit, Citranatal Harmony, Concept Ob, Diclectin, Diclegis, Folbic, Foltabs, Fortaplex, Infuvite, Infuvite Pediatric, Irospan 24/6 Kit, Isotamine B, Mvc-fluoride, Mvi Pediatric, Natafort, Neo-bex, Pregvit, Tandem Plus, Vitafol-one
Drug Type
Small Molecule
Chemical Formula
C8H11NO3
CAS Number
65-23-6
Unique Ingredient Identifier
KV2JZ1BI6Z

Overview

Pyridoxine is the 4-methanol form of vitamin B6, an important water-soluble vitamin that is naturally present in many foods. As its classification as a vitamin implies, Vitamin B6 (and pyridoxine) are essential nutrients required for normal functioning of many biological systems within the body. While many plants and microorganisms are able to synthesize pyridoxine through endogenous biological processes, animals must obtain it through their diet. More specifically, pyridoxine is converted to pyridoxal 5-phosphate in the body, which is an important coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, and aminolevulinic acid. It's important to note that Vitamin B6 is the collective term for a group of three related compounds, pyridoxine, pyridoxal, and pyridoxamine, and their phosphorylated derivatives, pyridoxine 5'-phosphate, pyridoxal 5'-phosphate and pyridoxamine 5'-phosphate. Although all six of these compounds should technically be referred to as vitamin B6, the term vitamin B6 is commonly used interchangeably with just one of them, pyridoxine . Vitamin B6, principally in its biologically active coenzyme form pyridoxal 5'-phosphate, is involved in a wide range of biochemical reactions, including the metabolism of amino acids and glycogen, the synthesis of nucleic acids, hemogloblin, sphingomyelin and other sphingolipids, and the synthesis of the neurotransmitters serotonin, dopamine, norepinephrine and gamma-aminobutyric acid (GABA) . Pyridoxine is used medically for the treatment of vitamin B6 deficiency and for the prophylaxis of isoniazid-induced peripheral neuropathy (due to Isoniazid's mechanism of action which competitively inhibits the action of pyridoxine in the above-mentioned metabolic functions). It is also used in combination with Doxylamine (as the commercially available product Diclectin) for the treatment of nausea and vomiting in pregnancy.

Indication

Pyridoxine is indicated for the treatment of vitamin B6 deficiency and for the prophylaxis of Isoniazid-induced peripheral neuropathy. It is also approved by Health Canada for the treatment of nausea and vomiting in pregnancy in a combination product with Doxylamine (as the commercially available product Diclectin).

Associated Conditions

  • Back pain
  • Dizziness
  • Fever
  • Headache
  • Hepatic; Functional Disturbance
  • Hepatitis
  • Iron Deficiency Anemia (IDA)
  • Ketosis
  • Macrocytic anemia
  • Menière's Disease
  • Menstrual Distress (Dysmenorrhea)
  • Metabolic Acidosis
  • Motion Sickness
  • Myalgia
  • Nausea and vomiting
  • Neuralgia, Sciatic
  • Neuritis
  • Neurological Conditions caused by B Vitamin Deficiency
  • Secondary anemia
  • Toothache
  • Toxinfectious state
  • Trigeminal Neuralgia (TN)
  • Vitamin B1 deficiency
  • Vitamin B12 Deficiency
  • Vitamin B6 Deficiency
  • Vitamin Deficiency
  • Minor aches and pains
  • Minor pain

Clinical Trials

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AvPAK
50268-677
ORAL
10 mg in 1 1
4/12/2022
CarWin Pharmaceutical Associates, LLC
15370-105
ORAL
1.5 mg in 1 1
1/10/2024
MISSION PHARMACAL COMPANY
0178-0812
ORAL
25 mg in 1 1
5/3/2010
Method Pharmaceuticals, LLC
58657-164
ORAL
1.05 mg in 1 1
12/9/2023
Exeltis USA, Inc.
0642-7473
ORAL
2.5 mg in 1 1
2/14/2023
Marnel Pharmaceuticals, Inc.
0682-3001
ORAL
25 mg in 1 1
5/2/2014
Centurion Labs, LLC
23359-105
ORAL
20 mg in 1 1
1/22/2024
PureTek Corporation
59088-193
ORAL
20 mg in 1 1
1/11/2023
BonGeo Pharmaceuticals, Inc.
52796-174
ORAL
1.8 mg in 1 1
2/2/2024
Sandoz Inc
54643-9023
INTRAVENOUS
1 mg in 5 mL
10/28/2016

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
NUTRIHEALTH NEUROVIT FORTE TABLET
SIN10260P
TABLET, FILM COATED
250 mg
10/14/1998
IBERET-FOLIC-500 TABLET
SIN05447P
TABLET, FILM COATED
5 mg
2/19/1991
NEUROBION TABLET
SIN06258P
TABLET, SUGAR COATED
200 mg
6/21/1991
NEUROBION INJECTION
SIN06262P
INJECTION
100 mg/3 ml
6/21/1991
VITAMIN B FORTE TABLET
SIN07635P
TABLET, FILM COATED
250 mg
2/4/1994
NEUROSANBE TABLET
SIN11606P
TABLET, FILM COATED
200 mg
8/3/2001
NEUROBION TABLET (OTC)
SIN15098P
TABLET, SUGAR COATED
200 mg
10/13/2016
DANEURON TABLET
SIN12077P
TABLET, FILM COATED
200 mg
9/17/2002
ENZYPLEX TABLET
SIN06211P
ENTERIC COATED TABLET
5 mg
5/3/1991
NEURO-B TABLET
SIN10891P
TABLET, FILM COATED
200 mg
4/23/1999

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Energy Multi
453128
Medicine
A
6/21/2024
Cellula-T oral powder jar
43995
Hong Sp & Hs
Medicine
A
4/13/1993
Caruso's St John's Wort
286553
Medicine
A
3/9/2017
Men's Multi
326959
Medicine
A
12/2/2019
BLACKMORES SUPERKIDS MULTI CHEWABLES
289492
Medicine
A
5/30/2017
Super B Complex tablets
126510
Medicine
A
3/28/2006
BLACKMORES B+C TABLETS
215811
Medicine
A
10/9/2013
Wealthy Health Bio-Maxi B Excellent Stress Relief Formula with Herbs
139048
Medicine
A
5/21/2007
MaxN-Fuze Multivitamins
288444
Max Health & Living Australia Pty Ltd
Medicine
A
5/1/2017
METAGENICS ZINC DRINK
64051
Medicine
A
4/27/1998

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
STRESS B COMPLEX WITH C AND E TAB
02008947
Tablet - Oral
5 MG / TAB
12/31/1993
C-APNTO-B6 VITAMINS W MAGNESIUM TAB
00748218
Tablet - Oral
250 MG / TAB
12/31/1989
MOR-VITES TAB
pharmetics (2011) inc
01911236
Tablet - Oral
1 MG
12/31/1992
LIQUI B COMPLEX PLUS
twin laboratories inc.
01984411
Liquid - Oral
10 MG / ML
12/31/1995
B6 250 CAPLET 250MG
health-wise nutrition inc.
02005190
Tablet - Oral
250 MG / TAB
11/13/1996
MATERNITY ONE MULTIVITAMIN WITH MINS CAPLET
swiss herbal remedies ltd.
01918052
Tablet - Oral
50 MG
12/31/1991
VITOGEN MULTIPLE VITAMINS TAB
stanley pharmaceuticals, a division of vita health products inc.
00244341
Tablet - Oral
1 MG / TAB
12/31/1966
GLYCO LITE ECT
dynamic nutritional associates
00548987
Tablet (Enteric-Coated) - Oral
33 MG
12/31/1981
CHILDREN'S VITAMINS W IRON CHEWABLE
vita health products inc
00787116
Tablet - Oral
1 MG
12/31/1990
STRESS TAB
vita health products inc
00537128
Tablet - Oral
5 MG
12/31/1981

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
BECOZYME C FORTE COMPRIMIDOS RECUBIERTOS
Bayer Hispania S.L.
40869
COMPRIMIDO RECUBIERTO
Sin Receta
Commercialized
CEMIDON B6 150 MG/25 MG COMPRIMIDOS
Chiesi España S.A.U.
40689
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
CEMIDON B6 50 MG/15 MG COMPRIMIDOS
Chiesi España S.A.U.
38394
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
HIDROPOLIVIT A MINERAL COMPRIMIDOS MASTICABLES
Laboratorios Menarini S.A.
44019
COMPRIMIDO MASTICABLE
Sin Receta
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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