Pyridoxine (injection)

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# Overview
Pyridoxine (injection) is a nutritive agent of the vitamin B family that is FDA approved for the treatment 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)
- 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 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.
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- Dosage: 25 to 50 mg orally once daily for 9 months  in combination with Isoniazid (INH) Isoniazid 5 mg/kg/day orally or intramuscularly for 9 months (ie, for 270 doses); maximum dose, 300 mg/day 

### NonGuideline-Supported Use
- Dosage: 60 mg/day for 4 weeks
- Dosage: 5 g IV diluted in 500 mL of 5% dextrose
- Dosage: 30 milligrams/day

# 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
- Dosage: 25 to 50 mg orally once daily for 9 months  in combination with Isoniazid (INH) Isoniazid 5 mg/kg/day orally or intramuscularly for 9 months (ie, for 270 doses); maximum dose, 300 mg/day 

### NonGuideline-Supported Use
- Dosage: 6 mg (4.6-10.0 US 1998 RDA).
- Dosage
Week 1: 100 mg/day PO q24h
Week 2-5: 300 mg/day PO q24h
- Week 1: 100 mg/day PO q24h
- Week 2-5: 300 mg/day PO q24h

# 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
- 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.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 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.
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
- 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.

### 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

## Mechanism of Action
- Natural substances that have vitamin B6 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 B6 are pyridoxal phosphate (codecarboxylase) and pyridoxamine phosphate.  Riboflavin is required for the conversion of pyridoxine phosphate to pyridoxal phosphate.
Vitamin B6 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.

## Structure
- The chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl) pyridine hydrochloride. The structural formula is:

## Pharmacodynamics
There is limited information regarding Pyridoxine (injection) Pharmacodynamics in the drug label.

## Pharmacokinetics
- The total adult body pool consists of 16 to 25 mg of pyridoxine.  Its half-life appears to be 15 to 20 days.  Vitamin B6 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 B6 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.

## 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

## Storage
- Store at 20 to 25C (68 to 77F) .

# Images

## Drug Images

## Package and Label Display Panel

# 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
- Aminoxin
- Pyri-500
- Rodex
- Vitabee 6

# Look-Alike Drug Names
There is limited information regarding Pyridoxine (injection) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price