Pyridoxine (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Pyridoxine (injection) is a nutritive agent of the vitamin B family that is FDA approved for the {{{indicationType}}} of inadequate dietary intake, drug-induced deficiency, as from isoniazid (INH) or oral contraceptives, inborn errors of metabolism, e.g., vitamin B6 dependent convulsions or vitamin B6 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.. Common adverse reactions include decreased folic acid, paresthesia and somnolence.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Dietary Deficiency
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.
Vitamine B6 Dependency Syndrome
The vitamin B6 dependency syndrome may require a therapeutic dosage of as much as 600 mg a day and a daily intake of 30 mg for life.
Drug-Induced Deficiency
In deficiencies due to INH, the dosage is 100 mg daily for 3 weeks followed by a 30 mg maintenance dose daily.
Poisoning
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pyridoxine hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pyridoxine hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Pyridoxine (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pyridoxine hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pyridoxine hydrochloride in pediatric patients.
Contraindications
A history of sensitivity to pyridoxine or to any of the ingredients in Pyridoxine Hydrochloride Injection, USP is a contraindication.
Warnings
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.
Adverse Reactions
Clinical Trials Experience
Paresthesia, somnolence, and low serum folic acid levels have been reported.
Postmarketing Experience
There is limited information regarding Pyridoxine (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Pyridoxine (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Pyridoxine (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pyridoxine (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pyridoxine (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pyridoxine (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Pyridoxine (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Pyridoxine (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Pyridoxine (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pyridoxine (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pyridoxine (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pyridoxine (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pyridoxine (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pyridoxine (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Pyridoxine (injection) Administration in the drug label.
Monitoring
There is limited information regarding Pyridoxine (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Pyridoxine (injection) and IV administrations.
Overdosage
Pyridoxine given to animals in amounts of 3 to 4 g/kg of body weight produces convulsions and death. In man, a dose of 25 mg/kg of body weight is well tolerated.
Pharmacology
There is limited information regarding Pyridoxine (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Pyridoxine (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Pyridoxine (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pyridoxine (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Pyridoxine (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Pyridoxine (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Pyridoxine (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Pyridoxine (injection) How Supplied in the drug label.
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Images
Drug Images
{{#ask: Page Name::Pyridoxine (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Pyridoxine (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Pyridoxine (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Pyridoxine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Pyridoxine (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Pyridoxine (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.