Pyridoxine (oral)

Pyridoxine (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Pyridoxine (oral) is a nutritive agent of the vitamin B family that is FDA approved for the treatment of inadequate dietary intake. Common adverse reactions include paresthesia and somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• As a dietary supplement for adults, take one tablet daily with a full glass of water, preferably after a meal.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pyridoxine (oral) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pyridoxine (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Pyridoxine (oral) 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 (oral) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pyridoxine (oral) in pediatric patients.

Contraindications

There is limited information regarding Pyridoxine (oral) Contraindications in the drug label.

Warnings

• Keep out of reach of children.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Pyridoxine (oral) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Pyridoxine (oral) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Pyridoxine (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Pyridoxine (oral) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pyridoxine (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pyridoxine (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pyridoxine (oral) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Pyridoxine (oral) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Pyridoxine (oral) in geriatric settings.

Gender

There is no FDA guidance on the use of Pyridoxine (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pyridoxine (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pyridoxine (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pyridoxine (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pyridoxine (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pyridoxine (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Pyridoxine (oral) Administration in the drug label.

Monitoring

There is limited information regarding Pyridoxine (oral) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Pyridoxine (oral) and IV administrations.

Overdosage

There is limited information regarding Pyridoxine (oral) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

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.

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 (oral) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Pyridoxine (oral) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Pyridoxine (oral) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Pyridoxine (oral) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Pyridoxine (oral) How Supplied in the drug label.

Storage

• Store in a cool, dry place, tightly closed.

Images

Drug Images

{{#ask: Page Name::Pyridoxine (oral) |?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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL 25 MG

NDC 61748-092-30

PYRIDOXINE SUPPLEMENT25 mg USP (Vitamin B-6) 30 TABLETS {{#ask: Label Page::Pyridoxine (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Pyridoxine (oral) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Pyridoxine (oral) 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 (oral) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Pyridoxine (oral) 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.