Gamma-aminobutyric acid: Difference between revisions

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Ammu Susheela (talk | contribs)
nocaptcha, Administrators
14,466 edits
No edit summary
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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{Ammu}}
|genericName=[[gamma.-aminobutyric acid]]
|aOrAn=a
|aOrAn=a
|drugClass=[[anxiolytic]]
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=epilepsy
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=[[hypersensitivity]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Line 12: Line 15:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=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.
 
|offLabelAdultGuideSupport=
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=epilepsy, tardive dyskinesia, spasicity
 
|fdaLIADPed=
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
Line 82: Line 28:


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Hypersensitivity to GABA
 
|warnings=* WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====


 
|postmarketing=Visual defects with vigabatrin administration
 
flushing, euphoria, anxiety
 
increased blood pressure and heart rate
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=* Drug
:* Description
:* Description
Line 266: Line 67:
|administration=* Oral
|administration=* Oral


* Intravenous
 
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


Line 321: Line 122:


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* GABA PHENOLIC ®<ref>{{Cite web | title =GABA PHENOLIC - .gamma.-aminobutyric acid liquid | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01416ec2-130a-4c93-8b60-d16d8827084d }}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Revision as of 19:14, 2 April 2015

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]

Disclaimer

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Overview

Gamma-aminobutyric acid is a 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

epilepsy, tardive dyskinesia, spasicity

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

  • Hypersensitivity to GABA

Warnings

  • WARNINGS: If pregnant or breast-feeding, ask a health professional before use.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

Visual defects with vigabatrin administration flushing, euphoria, anxiety increased blood pressure and heart rate

Drug Interactions

  • Drug
  • Description

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

  • Oral

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Gamma-aminobutyric acid01.png
This image is provided by the National Library of Medicine.

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

Storage

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

Images

Drug Images

{{#ask: Page Name::Gamma-aminobutyric acid |?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::Gamma-aminobutyric acid |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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 ®[1]

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. ↑ "GABA PHENOLIC - .gamma.-aminobutyric acid liquid".

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