Yes

Vitamin, Water Soluble

Prevents and treats vitamin B₆ deficiency, pyridoxine-dependent seizures in infants, adjunct to treatment of acute toxicity from isoniazid, cycloserine, or hydralazine overdose

A/C (if dose exceeds RDA recommendation)

Clinical effects on the fetus: Crosses the placenta; available evidence suggests safe use during pregnancy and breast-feeding

Breast-feeding/lactation: Crosses into breast milk; possible inhibition of lactation at doses >600 mg/day. American Academy of Pediatrics considers compatible with breast-feeding.

Hypersensitivity to pyridoxine or any component

Dependence and withdrawal may occur with doses >200 mg/day

<1%: Sensory neuropathy, seizures have occurred following I.V. administration of very large doses, headache, nausea, decreased serum folic acid secretions, increased AST, paresthesia, allergic reactions have been reported

Ataxia, sensory neuropathy with doses of 50 mg to 2 g daily over prolonged periods; acute doses of 70-357 mg/kg have been well tolerated

Decreased serum levels of levodopa, phenobarbital, and phenytoin

Protect from light

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

Absorption: Enteral, parenteral: Well absorbed from GI tract

Metabolism: Metabolized in 4-pyridoxic acid (active form), and other metabolites

Half-life: 15-20 days

Recommended daily allowance (RDA):

Children:

1-3 years: 0.9 mg

4-6 years: 1.3 mg

7-10 years: 1.6 mg

Adults:

Male: 1.7-2.0 mg

Female: 1.4-1.6 mg

Pyridoxine-dependent Infants:

Oral: 2-100 mg/day

I.M., I.V., S.C.: 10-100 mg

Dietary deficiency: Oral:

Children: 5-25 mg/24 hours for 3 weeks, then 1.5-2.5 mg/day in multiple vitamin product

Adults: 10-20 mg/day for 3 weeks

Drug-induced neuritis (eg, isoniazid, hydralazine, penicillamine, cycloserine): Oral:

Children:

Treatment: 10-50 mg/24 hours

Prophylaxis: 1-2 mg/kg/24 hours

Adults:

Treatment: 100-200 mg/24 hours

Prophylaxis: 25-100 mg/24 hours

Treatment of seizures and/or coma from acute isoniazid toxicity, a dose of pyridoxine hydrochloride equal to the amount of INH ingested can be given I.M./I.V. in divided doses together with other anticonvulsants; if the amount INH ingested is not known, administer 5 g I.V. pyridoxine

Treatment of acute hydralazine toxicity, a pyridoxine dose of 25 mg/kg in divided doses I.M./I.V. has been used

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).

Urobilinogen

None noted

May decrease the effects of levodopa and phenobarbital

No information available to require special precautions

No effects or complications reported

Take exactly as directed. Do not take more than recommended. Do not chew or crush extended release tablets. Do not exceed recommended intake of dietary B6 (eg, red meat, bananas, potatoes, yeast, lima beans, and whole grain cereals). You may experience burning or pain at injection site; notify prescriber if this persists.

Burning may occur at the injection site after I.M. or S.C. administration; seizures have occurred following I.V. administration of very large doses

Injection, as hydrochloride: 100 mg/mL (10 mL, 30 mL)

Tablet, as hydrochloride: 25 mg, 50 mg, 100 mg

Tablet, as hydrochloride, extended release: 100 mg

A 1 mg/mL oral solution was stable for 30 days when refrigerated when compounded as follows:

Keep in refrigerator

Nahata MC and Hipple TF, Pediatric Drug Formulations, 3rd ed, Cincinnati, OH: Harvey Whitney Books Co, 1997.

Albin RL, Albers JW, Greensberg HS, et al, "Acute Sensory Neuropathy - Neuronopathy From Pyridoxine Overdose," Neurology, 1987, 37(11):1729-32.

Chase P, Walter F, Vandenberghe D, et al, "Pyridoxine Does Not Prevent Hyperbaric Oxygen Toxicity Seizures in Rats," Clin Toxicol, 1995, 33(5):531.

de Zegher FD, Przyrembel H, Chalmers RA, et al, "Successful Treatment on Infantile Type I Primary Hyperoxaluria Complicated by Pyridoxine Toxicity," Lancet, 1985, 2(8451):392-3.

Glenn GM, Krober MS, Kelly P, et al, "Pyridoxine as Therapy in Theophylline-Induced Seizures," Vet Hum Toxicol, 1995, 37(4):342-5.

Harati Y and Niakan E, "Hydrazine Toxicity, Pyridoxine Therapy, and Peripheral Neuropathy," Ann Intern Med, 1986, 104(5):728-9.

Orlowski JP, Paganini EP, Pippenger CE, et al, "Treatment of a Potentially Lethal Dose Isoniazid Ingestion," Ann Emerg Med, 1988, 17(1):73-6.

Pauling L, "Sensory Neuropathy From Pyridoxine Abuse," N Engl J Med, 1984, 310(3):197-8.

Scharman EJ and Rosencrane JG, "Isoniazid Toxicity: A Survey of Pyridoxine Availability," Am J Emerg Med, 1994, 12(3):386-8.