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Vitamin B6 (pyridoxine): Drug information

Vitamin B6 (pyridoxine): Drug information
(For additional information see "Vitamin B6 (pyridoxine): Patient drug information" and see "Vitamin B6 (pyridoxine): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Neuro-K-250 T.D. [OTC] [DSC];
  • Neuro-K-250 Vitamin B6 [OTC] [DSC];
  • Neuro-K-50 [OTC] [DSC];
  • Neuro-K-500 [OTC] [DSC]
Pharmacologic Category
  • Vitamin, Water Soluble
Dosing: Adult
Pyridoxine deficiency

Pyridoxine deficiency:

Dietary deficiency:

IM, IV: 10 to 20 mg daily for 3 weeks, followed by daily oral therapy (2 to 5 mg per day which can be obtained from a multivitamin product) for several weeks.

Oral: 25 to 100 mg daily for 1 to 2 weeks (DiBaise 2019; ESPEN [Berger 2022]).

Pyridoxine-dependency syndromes:

Initial: Acute, active seizure:IV: 100 mg as a single dose; repeat as needed at 5- to 10-minute intervals up to a total dose of 500 mg (Vossler 2020).

Maintenance: Oral: 200 to 500 mg daily (maximum: 500 mg/day) (Coughlin 2021; Stockler 2011).

Ethylene glycol poisoning

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 2019).

Gyromitrin-containing mushroom overdose/toxicity

Gyromitrin-containing mushroom (false morel) overdose/toxicity (treatment/prophylaxis) (off-label use): Note: Dosing recommendations are based on the use of pyridoxine for the treatment and prevention of neurological toxicities associated with isoniazid overdose (Goldfrank 2019).

IV: 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 2019; Morrow 2006).

Hydrazine toxicity

Hydrazine toxicity (off-label use): Note: Optimal dose has not been established; dosing recommendations are based on the use of pyridoxine for the treatment and prevention of neurological toxicities associated with isoniazid overdose (Howland 2019).

IV: 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 2019; Morrow 2006; Nagappan 2000).

Nausea and vomiting, pregnancy associated

Nausea and vomiting, pregnancy-associated (off-label use): Note: Indicated as monotherapy in conjunction with nonpharmacologic measures for nausea alone; combination with doxylamine may be considered when nausea persists despite nonpharmacologic measures and pyridoxine monotherapy or as initial therapy for more severe symptoms (eg, nausea with vomiting) (ACOG 2018).

Oral: 12.5 to 25 mg 3 to 4 times per day as monotherapy or in combination with doxylamine (ACOG 2018; Smith 2022).

Neurological toxicities associated with isoniazid overdose

Neurological toxicities (ie, seizures, coma) associated with isoniazid overdose (off-label use): Note: As isoniazid poisonings are rare, hospitals may not have sufficient quantities of parenteral pyridoxine available for IV administration (preferred); pyridoxine tablets may be crushed and made into a slurry and given at the same dose orally or via NG tube (Bateman 2016; Hernon 2019).

Treatment:

Acute ingestion of known amount: IV: 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 2019; Morrow 2006).

Acute ingestion of unknown amount: IV: 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 2019; Morrow 2006).

Prevention: IV: Asymptomatic patients who present within 2 hours of ingesting a potentially toxic amount of isoniazid should receive a prophylactic dose of pyridoxine (Hernon 2019). Dosing recommendations are the same as for the treatment of symptomatic patients.

Peripheral neuropathy associated with isoniazid therapy for Mycobacteriumtuberculosis

Peripheral neuropathy associated with isoniazid therapy for Mycobacterium tuberculosis (prevention):

Daily isoniazid regimen: Oral: 25 to 50 mg/day (CDC [Kaplan 2009]).

Weekly isoniazid/rifapentine regimen: Oral: 50 mg once weekly (HHS [adult OI 2020]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney 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

(For additional information see "Vitamin B6 (pyridoxine): Pediatric drug information")

Pyridoxine deficiency; treatment

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 (Gal 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) (Gal 2007).

Pyridoxine-dependent seizures, treatment

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; chronic use

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

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

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).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney 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.

Dosing: Older Adult

Refer to adult dosing.

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 [DSC] [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 [DSC]

Neuro-K-500: 500 mg [DSC]

Neuro-K-250 Vitamin B6: 250 mg [DSC]

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

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

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

Solution, Injection, as hydrochloride:

Generic: 100 mg/mL (30 mL)

Administration: Adult

Oral: Administer preferably with food and liquid. 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.

Injection: Administer IM or IV.

Toxicity secondary to gyromitrin-containing mushrooms (false morel), hydrazine, or isoniazid (off-label uses): Initial doses should be administered IV 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 NG tube (Bateman 2016; Hernon 2019). Oral administration is not recommended for acutely poisoned patients with seizure activity.

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.

Use: Labeled Indications

Pyridoxine deficiency: Treatment and prevention of pyridoxine (vitamin B6) deficiency due to inadequate dietary intake, medication use (including isoniazid or oral contraceptives), or inborn errors of metabolism (eg, pyridoxine-dependent convulsions, pyridoxine-responsive anemia).

Use: Off-Label: Adult

Ethylene glycol poisoning; Gyromitrin-containing mushroom (false morel) overdose/toxicity (treatment/prophylaxis); Hydrazine toxicity; Nausea and vomiting, pregnancy-associated; Neurological toxicities (ie, seizures, coma) associated with isoniazid overdose, prevention; Neurological toxicities (ie, seizures, coma) associated with isoniazid overdose, treatment; Peripheral neuropathy associated with isoniazid therapy for Mycobacterium tuberculosis (prevention)

Medication Safety Issues
Sound-alike/look-alike issues:

Pyridoxine may be confused with paroxetine, pralidoxime, Pyridium

International issues:

Doxal [Brazil] may be confused with Doxil brand name for DOXOrubicin [U.S.]

Doxal: Brand name for pyridoxine/thiamine combination [Brazil], but also the brand name for doxepin [Finland]

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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

Contraindications

Injection: Hypersensitivity to pyridoxine or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Neuropathy: Severe, permanent peripheral neuropathies have been reported; risk may be increased with chronic use or higher doses (eg, >500 mg/day) (Albin 1987; Coughlin 2021).

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.

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

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).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Fosphenytoin-Phenytoin: Pyridoxine may decrease the serum concentration of Fosphenytoin-Phenytoin. 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

PHENobarbital: Pyridoxine may decrease the serum concentration of PHENobarbital. Risk C: Monitor therapy

Primidone: Pyridoxine may decrease serum concentrations of the active metabolite(s) of Primidone. Specifically, concentrations of phenobarbital may be reduced. Risk C: Monitor therapy

Pregnancy Considerations

Water soluble vitamins cross the placenta (IOM 1998).

Maternal pyridoxine plasma concentrations may decrease as pregnancy progresses and requirements may be increased in pregnant women (IOM 1998).

Pyridoxine is used to treat pregnancy-associated nausea and vomiting (ACOG 2018; Niebyl 2010; SOGC [Campbell 2016]). Pyridoxine is also recommended for the prevention of peripheral neuropathy associated with isoniazid therapy in pregnant patients treated for Mycobacterium tuberculosis (ATS/CDC/IDSA [Nahid 2016]).

Breastfeeding Considerations

Pyridoxine is present in breast milk (IOM 1998).

Breast milk concentrations vary by maternal intake. Pyridoxine requirements are increased in breastfeeding women compared to nonbreastfeeding women (IOM 1998). Possible inhibition of lactation at doses >600 mg/day when taken immediately postpartum (Foukas 1973). Although the manufacturer recommends that caution be exercised when administering pyridoxine injection to breastfeeding women; pyridoxine is considered compatible with breastfeeding (WHO 2002). Pyridoxine is recommended for the prevention of peripheral neuropathy associated with isoniazid therapy in breastfeeding patients treated for Mycobacterium tuberculosis (ATS/CDC/IDSA [Nahid 2016]).

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

Monitoring Parameters

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

For treatment of pyridoxine-dependency syndromes: Signs/symptoms of peripheral neuropathy; consider nerve conduction velocity test every 1 to 2 years in patients on chronic high doses (Coughlin 2021).

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).

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).

Pharmacokinetics

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)

Pricing: US

Solution (Pyridoxine HCl Injection)

100 mg/mL (per mL): $19.88

Tablets (Pyridoxine HCl Oral)

25 mg (per each): $0.01

50 mg (per each): $0.08

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.

Brand Names: International
  • AFI-B6 (NO);
  • B(6)-Vicotrat (DE);
  • Becilan (FR, GR);
  • Bedoxine (BE, LU);
  • Bedoyecta (MX);
  • Beesix (TW, ZA, ZW);
  • Benadon (AR, AT, CH, ES, GB, IE, IT, PT, SE);
  • Bendol (TW);
  • 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);
  • Hysix (JP);
  • Incremin con hierro (MX);
  • Lactosec (ZA);
  • 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);
  • Weta B6 (TW);
  • Xanturenasi (IT)


For country code abbreviations (show table)
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