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PYRIDOXINE HYDROCHLORIDE injection

PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  

Drug UPDATES:   [Drug information (pdf)]  
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

 

Usual Diluents top of page

NS,  D5W

May also be administered undiluted by direct injection.

Standard Dilutions   [Amt of drug] [Infusion vol] [Infusion rate] top of page

[5 grams ]  [Remove 50 mL from 100mL bag ]  [5-30 minutes*]

Final concentration: 50 mg/mL. Protect from light.
*Depending on indication.

Sample protocols
Isoniazid overdose
Package insert: In poisoning caused by ingestion of more than 10 g of INH, an equal amount of pyridoxine should be given - 4 g intravenously followed by 1 g intramuscularly every 30 minutes.  

Other:  5 grams IV over 10 minutes. If the seizures stop before 10 minutes, the remainder of the initial dose should be given over 4 hours.  May repeat dose once, if seizures persist or recur

Hydrazine/ Gyromitra mushroom POISONING:
Oral via NG: 25 mg/kg (Maximum single dose: 5 g)
IIV: Initial dose of 25 mg/kg IV over 30 - 60 minutes (Maximum single dose: 5 g) Dose may be repeated if necessary.

Ethylene glycol toxicity:
50mg IV every 6 hours (or 100mg daily other sources) until ethylene glycol and glycolic acid levels are undetectable.


Great reference:
hhttps://iwkpoisoncentre.ca/pyridoxine-adult.html

Lheureux P, Penaloza A, Gris M. Pyridoxine in clinical toxicology: a review. Eur J Emerg Med. 2005 Apr;12(2):78-85.

Abstract
Pyridoxine (vitamin B6) is a co-factor in many enzymatic pathways involved in amino acid metabolism: the main biologically active form is pyridoxal 5-phosphate. Pyridoxine has been used as an antidote in acute intoxications, including isoniazid overdose, Gyromitra mushroom or false morrel (monomethylhydrazine) poisoning and hydrazine exposure. It is also recommended as a co-factor to improve the conversion of glyoxylic acid into glycine in ethylene glycol poisoning. Other indications are recommended by some sources (for example crimidine poisoning, zipeprol and theophylline-induced seizures, adjunct to d-penicillamine chelation), without significant supporting data. The value of pyridoxine or its congener metadoxine as an agent for hastening ethanol metabolism or improving vigilance in acute alcohol intoxication is controversial. This paper reviews the various indications of pyridoxine in clinical toxicology and the supporting literature. The potential adverse effects of excessive pyridoxine dosage will also be summarized.

WARNINGS  top of page

DESCRIPTION  top of page

Description:

Pyridoxine Hydrochloride Injection, USP is a sterile solution of pyridoxine hydrochloride in Water for Injection. Each mL contains 100 mg pyridoxine hydrochloride and 0.5% chlorobutanol anhydrous (chloral deriv.). pH adjusted with sodium hydroxide if necessary (2.0 to 3.8).

Pyridoxine hydrochloride is a colorless or white crystal or a white crystalline powder. One gram dissolves in 5 mL of water. It is stable in air and is slowly affected by sunlight.

The chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl) pyridine hydrochloride.

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:

CLINICAL PHARMACOLOGY:

Natural substances that have vitamin B 6 activity are pyridoxine in plants and pyridoxal or pyridoxamine in animals. All 3 are converted to pyridoxal phosphate by the enzyme pyridoxal kinase. The physiologically active forms of vitamin B 6 are pyridoxal phosphate (codecarboxylase) and pyridoxamine phosphate. Riboflavin is required for the conversion of pyridoxine phosphate to pyridoxal phosphate.

Vitamin B 6 acts as a coenzyme in the metabolism of protein, carbohydrate, and fat. In protein metabolism, it participates in the decarboxylation of amino acids, conversion of tryptophan to niacin or to serotonin (5-hydroxtryptamine), deamination, and transamination and transulfuration of amino acids. In carbohydrate metabolism, it is responsible for the breakdown of glycogen to glucose-1-phosphate.

The total adult body pool consists of 16 to 25 mg of pyridoxine. Its half-life appears to be 15 to 20 days. Vitamin B 6 is degraded to 4-pyridoxic acid in the liver. This metabolite is excreted in the urine.

The need for pyridoxine increases with the amount of protein in the diet. The tryptophan load test appears to uncover early vitamin B 6 deficiency by detecting xanthinurea. The average adult minimum daily requirement is about 1.25 mg. The ‘‘Recommended Dietary Allowance’’ of the National Academy of Sciences is estimated to be as much as 2.2 mg for adults and 2.5 mg for pregnant and lactating women. The requirements are more in persons having certain genetic defects or those being treated with isonicotinic acid hydrazide (INHJ) or oral contraceptives.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE:
 

Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following:

Inadequate dietary intake.

Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives.

Inborn errors of metabolism, e.g., vitamin B 6 dependent convulsions or vitamin B 6 responsive anemia.

The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.

CONTRAINDICATIONS top of page

Contraindications:

A history of sensitivity to pyridoxine or to any of the ingredients in Pyridoxine Hydrochloride Injection, USP is a contraindication.

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS:

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions:

General
Single deficiency, as of pyridoxine alone, is rare. Multiple vitamin deficiency is to be expected in any inadequate diet. Patients treated with levodopa should avoid supplemental vitamins that contain more than 5 mg pyridoxine in the daily dose.
Women taking oral contraceptives may exhibit increased pyridoxine requirements.
Drug Interactions
Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Pregnancy
Pregnancy Category A-The requirement for pyridoxine appears to be increased during pregnancy. Pyridoxine is sometimes of value in the treatment of nausea and vomiting of pregnancy.
Nursing Mothers
The need for pyridoxine is increased during lactation. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pyridoxine hydrochloride is administered to a nursing woman.
Usage in Children
Safety and effectiveness in children have not been established.

ADVERSE REACTIONS top of page

ADVERSE REACTIONS:

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Paresthesia, somnolence, and low serum folic acid levels have been reported.

 Drug information

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION:

Pyridoxine Hydrochloride Injection may be administered intramuscularly or intravenously. In cases of dietary deficiency, the dosage is 10 to 20 mg daily for 3 weeks. Follow-up treatment is recommended daily for several weeks with an oral therapeutic multivitamin preparation containing 2 to 5 mg pyridoxine. Poor dietary habits should be corrected, and an adequate, well balanced diet should be prescribed.

The vitamin B 6 dependency syndrome may require a therapeutic dosage of as much as 600 mg a day and a daily intake of 30 mg for life.

In deficiencies due to INH, the dosage is 100 mg daily for 3 weeks followed by a 30 mg maintenance dose daily.

In poisoning caused by ingestion of more than 10 g of INH, an equal amount of pyridoxine should be given - 4 g intravenously followed by 1 g intramuscularly every 30 minutes.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED  top of page

DOSAGE FORMS AND STRENGTHS:

Pyridoxine Hydrochloride Injection, USP is supplied as:

Product Code Unit of Sale Strength Each
1801 NDC 63323-180-01
Unit of 25
100 mg per mL NDC 63323-180-00
1 mL fill, in a 2 mL multiple dose vial

Storage and Stability top of page

PROTECT FROM LIGHT.

Use only if solution is clear and seal intact.

Sterile.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Disclaimer

The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. Read the disclaimer

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