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.
Background
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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/07/22 | Not Applicable | Recruiting | |||
2024/04/30 | Phase 2 | Completed | |||
2024/04/02 | Phase 1 | Completed | |||
2024/02/06 | Not Applicable | Recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2023/08/23 | Not Applicable | Completed | The First People's Hospital of Huzhou | ||
2023/08/16 | Phase 3 | Recruiting | |||
2022/03/21 | Phase 3 | Recruiting | |||
2021/08/27 | Not Applicable | Completed | |||
2021/08/17 | Phase 4 | Completed | Nasim Tabrizi | ||
2020/05/26 | Phase 3 | Completed | Xiaoke Wu |
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 |
---|---|---|---|---|---|
Vitamin B6 for Injection | 国药准字H20050816 | 化学药品 | 注射剂 | 7/20/2020 | |
Vitamin B6 for Injection | 国药准字H20051996 | 化学药品 | 注射剂 | 9/26/2019 | |
Vitamin B6 for Injection | 国药准字H20050152 | 化学药品 | 注射剂 | 8/5/2020 | |
Vitamin B6 for Injection | 国药准字H20153177 | 化学药品 | 注射剂 | 4/9/2020 | |
Vitamin B6 for Injection | 国药准字H20060448 | 化学药品 | 注射剂 | 8/17/2020 | |
Vitamin B6 for Injection | 国药准字H20051352 | 化学药品 | 注射剂 | 8/5/2020 | |
Vitamin B6 for Injection | 国药准字H20050234 | 化学药品 | 注射剂 | 7/10/2020 | |
Vitamin B6 for Injection | 国药准字H20051900 | 化学药品 | 注射剂 | 10/23/2020 | |
Vitamin B6 for Injection | 国药准字H20050817 | 化学药品 | 注射剂 | 7/2/2020 | |
Vitamin B6 for Injection | 国药准字H20153172 | 化学药品 | 注射剂 | 4/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
NEW-PAIN-Q CAP | N/A | N/A | N/A | 6/20/1990 | |
SUMITON CAPSULE (NEW FORMULA) | N/A | N/A | N/A | 6/17/2014 | |
CERNEVIT FOR INJ | N/A | N/A | N/A | 4/18/2008 | |
BIOCATALIN INJECTABLE SOLN (VET) | N/A | N/A | N/A | 8/9/1984 | |
CHLORAFORTE CAP | N/A | N/A | N/A | 6/2/1992 | |
TELING EYE DROPS | N/A | N/A | N/A | 12/8/1992 | |
WHARNIS (NEW FORMULA) CAPSULES | N/A | N/A | N/A | 11/29/2013 | |
TENDUM CAP | N/A | N/A | N/A | 8/24/2001 | |
HUAZIN INJ | N/A | N/A | N/A | 4/28/1982 | |
MULTIMAX SYRUP | N/A | N/A | N/A | 7/8/2014 |
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 |