Vitamin B6 (Pyridoxine)

Pharmacologic Category

Vitamin, Water Soluble

Dosing: Adult

Pyridoxine deficiency: IM, IV: 10 to 20 mg/day for 3 weeks, followed by daily oral therapy for several weeks. Doses up to 600 mg/day may be needed with pyridoxine dependency syndrome.

Ethylene glycol poisoning (off-label use): Note: Cofactors are adjunctive to antidotal therapy and should never be used alone.

IV: 100 mg per day until the intoxication has resolved (Howland 2015)

Gyromitrin-containing mushroom (false morel) overdose/toxicity (treatment/prophylaxis) (off-label use): IV: 25 mg/kg over 15 to 30 minutes; repeat dose as needed to control seizures (Diaz 2005; Lheureux 2005)

Nausea and vomiting of pregnancy (off-label use): Oral: 10 to 25 mg 3 to 4 times a day. May be given alone or in combination with doxylamine. Adjust dose based on severity of symptoms (ACOG 189 2018).

Neurological toxicities (ie, seizures, coma) associated with isoniazid overdose (prevention) (off-label use): IV: Asymptomatic patients who present within 2 hours of ingesting a potentially toxic amount of isoniazid should receive a prophylactic dose of pyridoxine (Hernon 2015). Dosing recommendations are the same as for the treatment of symptomatic patients.

Neurological toxicities (ie, seizures, coma) associated with isoniazid overdose (treatment) (off-label use): IV:

Acute ingestion of known amount: Initial: A total dose of pyridoxine equal to the amount of isoniazid ingested (maximum dose: 5 g); administer at a rate of 0.5 to 1 g/minute until seizures stop or the maximum initial dose has been administered; may repeat every 5 to 10 minutes as needed to control persistent seizure activity and/or CNS toxicity. If seizures stop prior to the administration of the calculated initial dose, infuse the remaining pyridoxine over 4 to 6 hours (Howland 2015; Morrow 2006).

Acute ingestion of unknown amount: Initial: 5 g; administer at a rate of 0.5 to 1 g/minute; may repeat every 5 to 10 minutes as needed to control persistent seizure activity and/or CNS toxicity (Howland 2015; Morrow 2006).

Peripheral neuropathy associated with isoniazid therapy for Mycobacterium tuberculosis (prevention): Oral: 25 to 50 mg/day (CDC [Kaplan 2009]).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

Pyridoxine deficiency; treatment:

Children: Oral, IM, IV: 5 to 25 mg/day for 3 weeks, then 2.5 to 5 mg/day in multivitamin product (Kliegman 2007).

Adolescents: Oral, IM, IV: 10 to 20 mg/day for 3 weeks, then 2 to 5 mg/day (usual dosage found in multivitamin products) (Kliegman 2007).

Pyridoxine-dependent seizures, treatment: Limited data available:

Infants and Children:

Initial: Acute, active seizure: Note: Administration should occur in intensive care unit due to possible apnea episodes (may require intubation); with oral administration, therapeutic response and adverse effect (ie, apnea) may be delayed in presentation; monitor patients closely (Stockler 2011).

IV (preferred): 100 mg/dose; may repeat dose over the course of 30 minutes (Stockler 2011).

Oral (when IV not feasible): 30 mg/kg/day for several days (Stockler 2011).

Maintenance: Oral: Usual dose: 15 to 30 mg/kg/day not to exceed 500 mg/day (Baxter 1999; NORD 2017; Stockler 2011).

Drug-induced deficiency (cycloserine, isoniazid, penicillamine); chronic use:

Isoniazid/Cycloserine:

Prevention: Note: Recommended for patients at risk: Exclusively breastfed infants, meat- and milk-deficient diet, nutritional deficiency, pregnant adolescents, HIV-infected patients (HHS [OI pediatric 2019]); Red Book [AAP 2018]).

Infants and Children: Oral: 1 to 2 mg/kg once daily; maximum daily dose: 50 mg/day (HHS [OI pediatric 2019]).

Adolescents: Oral: 25 to 50 mg/day (ATS/CDC/IDSA [Nahid 2016]); HHS [OI adult 2019]).

Penicillamine (in Wilson Disease patients): Limited data available: Children and Adolescents: Oral: 25 to 50 mg/day (Roberts 2008).

Acute isoniazid ingestion:

Treatment of isoniazid-induced seizures and/or coma: IV: Children and Adolescents:

Acute ingestion of known amount: Initial: A total dose of pyridoxine equal to the amount of isoniazid ingested (maximum dose: 70 mg/kg up to 5 g); administer at a rate of 0.5 to 1 g/minute until seizures stop or the maximum initial dose has been administered; may repeat every 5 to 10 minutes as needed to control persistent seizure activity and/or CNS toxicity. If seizures stop prior to the administration of the calculated initial dose, infuse the remaining pyridoxine over 4 to 6 hours (Howland 2015; Morrow 2006).

Acute ingestion of unknown amount: Initial: 70 mg/kg (maximum dose: 5 g); administer at a rate of 0.5 to 1 g/minute; may repeat every 5 to 10 minutes as needed to control persistent seizure activity and/or CNS toxicity (Howland 2015; Morrow 2006; Santucci 1999)

Prevention of isoniazid-induced seizures and/or coma: IV: Children: Asymptomatic patients who present within 2 hours of ingesting a potentially toxic amount of isoniazid should receive a prophylactic dose of pyridoxine (Hernon 2015). Dosing recommendations are the same as for the treatment of symptomatic patients.

Acute intoxication; mushroom ingestion (genus Gyromitra): Children and Adolescents: IV: 25 mg/kg/dose; repeat as necessary to a maximum total dose of 15 to 20 g (Berger 2005).

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Use: Labeled Indications

Pyridoxine deficiency: Treatment and prevention of pyridoxine (vitamin B6) deficiency.

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

Ethylene glycol poisoningLevel of Evidence [C]

The American Academy of Clinical Toxicology guidelines recognize the lack of human clinical data for this use and consider pyridoxine as an adjunctive cofactor therapy in ethylene glycol poisoning without a formal or evidence-based recommendation, especially in patients who may have vitamin deficiencies (eg, patients with alcoholism) Ref.

Gyromitrin-containing mushroom (false morel) overdose/toxicity (treatment/prophylaxis)Level of Evidence [C]

Clinical experience suggests the utility of pyridoxine in the treatment of seizures from acute gyromitrin-containing mushroom toxicity Ref. Additional data may be necessary to further define the role of pyridoxine in this condition.

Nausea and vomiting of pregnancyLevel of Evidence [C, G]

Clinical experience suggests the utility of pyridoxine in the treatment of nausea and vomiting of pregnancy Ref.

Based on the American Society of Obstetricians and Gynecologists and the Society of Obstetricians and Gynaecologists of Canada practice guidelines, pyridoxine alone or in combination with doxylamine is a safe and effective treatment for nausea and vomiting of pregnancy and should be considered a first-line pharmacologic therapy Ref.

Neurological toxicities (ie, seizures, coma) associated with isoniazid overdose (prevention)Level of Evidence [C]

Clinical experience suggests the utility of pyridoxine in the prevention of isoniazid-induced neurologic toxicities Ref. Additional data may be necessary to further define the role of pyridoxine in this condition.

Neurological toxicities (ie, seizures, coma) associated with isoniazid overdose (treatment)Level of Evidence [C]

Data from a single case report suggests that pyridoxine may be beneficial for the treatment of isoniazid-induced seizures and/or coma Ref. Clinical experience also suggests the utility of pyridoxine in the treatment of isoniazid-induced seizures and/or coma Ref. Additional data may be necessary to further define the role of pyridoxine in this condition.

Peripheral neuropathy associated with isoniazid therapy for Mycobacterium tuberculosis (prevention)Level of Evidence [G]

Based on the Department of Health and Human Services (DHHS) Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, pyridoxine is effective and recommended in the prevention of peripheral neuropathy associated with isoniazid therapy for Mycobacterium tuberculosis.

Level of Evidence Definitions

Level of Evidence Scale

Clinical Practice Guidelines

Opportunistic Infections:

DHHS, Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, October 2014 [Note: Information contained within this monograph is pending revision based on these more recent guidelines]

Administration: IM

Administer IM or IV.

Administration: IV

Administer IM or IV.

Gyromitrin-containing mushroom (false morel) overdose/toxicity (treatment/prophylaxis) (off-label use): Administer dose over 15 to 30 minutes (Lheureux 2005).

Isoniazid toxicity (off-label use): Initial doses should be administered at a rate of 0.5 to 1 g/minute. If the parenteral formulation is not available, anecdotal reports suggest that pyridoxine tablets may be crushed and made into a slurry and given at the same dose orally or via nasogastric (NG) tube (Hernon 2015). Oral administration is not recommended for acutely poisoned patients with seizure activity.

Administration: Injectable Detail

pH: 2 to 3.8

Administration: Oral

Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. ER tablets should be swallowed whole. Do not break, crush, or chew. IR tablet, capsule, and injectable formulations are available. If safety and efficacy can be effectively monitored, no change in formulation or administration is required after bariatric surgery. Bariatric vitamin supplementation is recommended on a lifelong basis after surgery; may consider integration of daily pyridoxine regimen into the bariatric vitamin in appropriate clinical scenarios.

Administration: Pediatric

Oral: Administer without regard to meals.

Isoniazid acute ingestion/poisoning: If the parenteral formulation is not available, anecdotal reports suggest that pyridoxine tablets may be crushed and made into a slurry and administered at the same dose orally or via NG tube (Boyer 2006) or an extemporaneous compounded solution may be used. Oral administration is not recommended for acutely poisoned patients with seizure activity.

Parenteral: May be administered IM or slow IV; seizures have been precipitated following large IV doses.

Isoniazid toxicity: Initial IV doses should be administered at a rate of 500 to 1,000 mg/minute.

Dietary Considerations

Dietary adequate Intake (AI) (IOM 1998):

1 to 6 months: 0.1 mg/day

7 to 12 months: 0.3 mg/day

Dietary recommended daily allowance (RDA) (IOM 1998):

1 to 3 years: 0.5 mg

4 to 8 years: 0.6 mg

9 to 13 years: 1 mg

14 to 18 years: Females: 1.2 mg; Males: 1.3 mg

19 to 50 years: 1.3 mg

≥51 years: Females: 1.5 mg; Males: 1.7 mg

Pregnancy: 1.9 mg

Lactation: 2 mg

Storage/Stability

Injection: Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Oral: Store at room temperature. Avoid excessive heat or moisture.

Compatibility

See Trissel’s IV Compatibility Database

Open Trissel's IV Compatibility

Extemporaneously Prepared

1 mg/mL Oral Solution

A 1 mg/mL oral solution may be made using pyridoxine injection. Withdraw 100 mg (1 mL of a 100 mg/mL injection) from a vial with a needle and syringe; add to 99 mL simple syrup in an amber bottle. Label "refrigerate". Stable for 30 days refrigerated.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations, 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat or prevent low vitamin B6.

• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Fatigue

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Burning

• Numbness feeling

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

International issues:

Contraindications

Hypersensitivity to pyridoxine or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Neuropathy: Severe, permanent peripheral neuropathies have been reported; neurotoxicity is more common with long-term administration of large doses (in adults: >2 g/day) (Albin 1987).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal impairment. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register 2002). See manufacturer’s labeling.

Other warnings/precautions:

• Dependence/withdrawal: Doses >200 mg/day may cause dependence and withdrawal.

• Pharmacy supply of emergency antidotes: Guidelines suggest that at least 8 to 24 g be stocked. This is enough to treat 1 patient weighing 100 kg for an initial 8- to 24-hour period. In areas where tuberculosis is common and isoniazid toxicity is more likely, hospitals should consider stocking 24 g. This is enough to treat 1 patient for 24 hours (Dart 2018).

• Vitamin deficiency: Single vitamin deficiency is rare; evaluate for other deficiencies.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Use with caution in patients with Parkinson's disease treated with levodopa.

Warnings: Additional Pediatric Considerations

Higher doses (oral doses >30 mg/kg/day) have been associated with sensory and rare motor neuropathies, both of which are potentially reversible (Stockler 2011). Neuropathies have also been described with chronic administration of doses as low as 50 mg/day; however, some patients do not experience neuropathy (at low or high doses), even after years of administration (McLachlan 1995; Stockler 2011).

Pregnancy Risk Factor

A

Pregnancy Considerations

Water soluble vitamins cross the placenta. Maternal pyridoxine plasma concentrations may decrease as pregnancy progresses and requirements may be increased in pregnant women (IOM 1998). Pyridoxine is used to treat nausea and vomiting of pregnancy (ACOG 189 2018; Neibyl 2010; Campbell [SOGC] 2016).

Breast-Feeding Considerations

Pyridoxine is present in breast milk and concentrations vary by maternal intake. Pyridoxine requirements are increased in breastfeeding women compared to non-breastfeeding women (IOM 1998). Possible inhibition of lactation at doses >600 mg/day when taken immediately postpartum (Foukas 1973). The manufacturer recommends that caution be exercised when administering pyridoxine injection to breastfeeding women.

Briggs' Drugs in Pregnancy & Lactation

• Pyridoxine

Adverse Reactions

Frequency not defined.

Central nervous system: Ataxia, drowsiness, headache, neuropathy, paresthesia, seizure (following very large IV doses)

Endocrine & metabolic: Acidosis, folate deficiency

Gastrointestinal: Nausea

Hepatic: Increased serum AST

Hypersensitivity: Hypersensitivity reaction

* See Cautions in AHFS Essentials for additional information.

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Altretamine: Pyridoxine may diminish the therapeutic effect of Altretamine. Specifically when altretamine is used in combination with Cisplatin the response duration may be diminished. Management: Consider avoiding concomitant use of pyridoxine in a altretamine/cisplatin regimen. Although pyridoxine may have beneficial effects on altretamine-associated neurotoxicity, it may reduce the duration of response to altretamine. Risk D: Consider therapy modification

Barbiturates: Pyridoxine may increase the metabolism of Barbiturates. Apparent in high pyridoxine doses (eg, 200 mg/day) Risk C: Monitor therapy

Fosphenytoin: Pyridoxine may increase the metabolism of Fosphenytoin. This is most apparent in high pyridoxine doses (e.g., 80 mg to 200 mg daily) Risk C: Monitor therapy

Levodopa-Containing Products: Pyridoxine may diminish the therapeutic effect of Levodopa-Containing Products. Management: The concomitant use of pyridoxine and levodopa (in the absence of a dopa decarboxylase inhibitor (DDI)) should be avoided. Use of a DDI (eg, carbidopa) with levodopa will essentially eliminate the risk of this interaction. Risk D: Consider therapy modification

Phenytoin: Pyridoxine may increase the metabolism of Phenytoin. This is most apparent in high pyridoxine doses (e.g., 80 mg to 200 mg daily) Risk C: Monitor therapy

Monitoring Parameters

For treatment of isoniazid or gyromitrin-containing mushroom toxicity: Anion gap, arterial blood gases, electrolytes, neurological exam, seizure activity

Reference Range

Over 50 ng/mL (SI: 243 nmol/L) (varies considerably with method). A broad range is ~25-80 ng/mL (SI: 122-389 nmol/L). HPLC method for pyridoxal phosphate has normal range of 3.5-18 ng/mL (SI: 17-88 nmol/L).

Advanced Practitioners Physical Assessment/Monitoring

Provide patient appropriate dietary instructions.

Nursing Physical Assessment/Monitoring

Provide patient appropriate dietary instructions.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as hydrochloride:

Neuro-K-250 T.D.: 250 mg [corn free, rye free, starch free, sugar free, wheat free]

Solution, Injection, as hydrochloride:

Generic: 100 mg/mL (1 mL)

Tablet, Oral, as hydrochloride:

Neuro-K-50: 50 mg

Neuro-K-500: 500 mg

Neuro-K-250 Vitamin B6: 250 mg

Pyri 500: 500 mg

Generic: 25 mg, 50 mg, 100 mg, 250 mg

Tablet, Oral, as hydrochloride [preservative free]:

Generic: 25 mg, 50 mg, 100 mg [DSC]

Tablet Extended Release, Oral, as hydrochloride:

Generic: 200 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection, as hydrochloride:

Generic: 100 mg/mL (10 mL, 30 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• A11HA02

Generic Available (US)

May be product dependent

Pricing: US

Capsules (Neuro-K-250 T.D. Oral)

250 mg (per each): $0.10

Solution (Pyridoxine HCl Injection)

100 mg/mL (per mL): $18.24

Tablets (Pyridoxine HCl Oral)

25 mg (per each): $0.01

50 mg (per each): $0.08

100 mg (per each): $0.06

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Precursor to pyridoxal, which functions in the metabolism of proteins, carbohydrates, and fats; pyridoxal also aids in the release of liver and muscle-stored glycogen and in the synthesis of GABA (within the central nervous system) and heme

When used for the treatment of ethylene glycol poisoning, pyridoxine is theorized to increase the formation of glycine, a nontoxic metabolite (Barceloux 1999).

Pharmacodynamics/Kinetics

Absorption: Oral: Well absorbed (IOM 1998)

Metabolism: Hepatic to pyridoxal phosphate and pyridoxamine phosphate (active forms)

Half-life elimination: Biologic: 15 to 20 days

Excretion: Urine (as metabolites)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

B6; B6; Pyridoxine HCl; Pyridoxine Hydrochloride; Vitamin B6

References

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US Department of Health and Human Services (HHS) Panel on Adult and Adolescent Opportunistic Infection. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf. Updated November 21, 2019. Accessed March 5, 2020.

Vitamin B6 [prescribing information]. Long Island City: NY: Freeda Vitamins Inc; received June 2011.

Vitamin B-6 (pyridoxine) [prescribing information]. Livonia: MI: Rugby Laboratories; November 2019.

Brand Names: International

AFI-B6 (NO); B(6)-Vicotrat (DE); Becilan (FR); Bedoxine (BE, LU); Bedoyecta (MX); Beesix (ZA, ZW); Benadon (AR, AT, CH, ES, GB, IE, IT, PT, SE); Bexivit (GR); Biprin (CO); Bivit (IT); Burgerstein Vitamin B6 (CH); Comploment Continus (AE, BH, CH, CY, EG, IE, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Dermo 6 (FR); Dodemina (MX); Dolvifen (MX); Farmobion B6 (IT); Glutarase (IT); Heksavit (FI); Hexobion 100 (DE); Hysix (JP); Incremin con hierro (MX); M. V. I. 12 (MX); Memosprint (IT); Natele (MX); Nuro-B (MX); Pharmaton (MX); Pidopidon (JP); Piridoxina Austral (AR); Plivit B6 (HR); Poly-B con Vitamina C (MX); Pyricontin Continus (IN); Pyridoxin Recip[Tab.] (SE); Pyridoxin ”Dak” (DK); Pyridoxine Aguettant (FR); Pyridoxine Renaudin (FR); Pyridoxine-Labaz (LU); Pyrivitol (AT); Pyroxin (AU); Reisevit (AT); Sechvitan (JP); Tanvimil B6 (AR); Trineurovita (MX); Vit. B6 Agepha (AT); Vita-B6 (FI); Vitamin B6 (HU); Vitamin B6 Streuli (CH); Vitamine B6 Richard (FR); Vitaminum B6 (PL); Xanturenasi (IT)

Last Updated 5/29/20