Gamma-aminobutyric acid

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Gamma-aminobutyric acid
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: Ammu Susheela, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Gamma-aminobutyric acid is an anxiolytic that is FDA approved for the treatment of epilepsy. Common adverse reactions include hypersensitivity.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. * Consult a physician for use in children under 12 years of age.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Gamma-aminobutyric acid in adult patients.

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Gamma-aminobutyric acid in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Gamma-aminobutyric acid in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Gamma-aminobutyric acid in pediatric patients.

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Gamma-aminobutyric acid in the drug label.

Postmarketing Experience

Drug Interactions

There is limited information regarding Gamma-aminobutyric acid Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Gamma-aminobutyric acid in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Gamma-aminobutyric acid during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to specific gender populations.

Race

There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Gamma-aminobutyric acid in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Gamma-aminobutyric acid in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Gamma-aminobutyric acid in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Gamma-aminobutyric acid in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Gamma-aminobutyric acid in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Gamma-aminobutyric acid in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Gamma-aminobutyric acid in the drug label.

Pharmacology

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Template:Chembox header2 | gamma-Aminobutyric acid
Identifiers
3D model (JSmol)
ChEBI
ChEMBL
ChemSpider
DrugBank
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KEGG
MeSH gamma-Aminobutyric+Acid
UNII
Properties
C4H9NO2
Molar mass 103.120 g/mol
Hazards
Template:Chembox header2 | Except where noted otherwise, data are given for
materials in their standard state
(at 25 °C, 100 kPa)
Infobox disclaimer and references

Mechanism of Action

There is limited information regarding Gamma-aminobutyric acid Mechanism of Action in the drug label.

Structure

There is limited information regarding Gamma-aminobutyric acid Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Gamma-aminobutyric acid in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Gamma-aminobutyric acid in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Gamma-aminobutyric acid in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Gamma-aminobutyric acid in the drug label.

How Supplied

There is limited information regarding Gamma-aminobutyric acid How Supplied in the drug label.

Storage

There is limited information regarding Gamma-aminobutyric acid Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Gamma-aminobutyric acid in the drug label.

Precautions with Alcohol

  • Alcohol-Gamma-aminobutyric acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • GABA PHENOLIC ®[2]

Look-Alike Drug Names

There is limited information regarding Gamma-aminobutyric acid 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.

  1. ↑ Dawson RMC, Elliot DC, Elliot WH, Jones KM, ed. (1959). Data for Biochemical Research. Oxford: Clarendon Press.[page needed]
  2. ↑ "GABA PHENOLIC - .gamma.-aminobutyric acid liquid".

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