Carglumic acid: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|genericName=Carglumic acid
|aOrAn=a
|aOrAn=a
|drugClass=hyperammonemia Agent
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication= acute hyperammonemia in patients with NAGS deficiency, maintenance therapy for chronic hyperammonemia in patients with NAGS deficiency
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=[[abdominal pain]], [[diarrhea]], [[vomiting]], [[anemia]],  [[infectious disease]] , [[headache]],  [[infection]] of [[ear]] , [[nasopharyngitis]], [[tonsillitis]], [[fever]]
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=1.1    Acute hyperammonemia in patients with NAGS deficiency
Carbaglu® is indicated as an adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).  During acute hyperammonemic episodes concomitant administration of Carbaglu with other ammonia lowering therapies such as alternate pathway medications, hemodialysis, and dietary protein restriction are recommended.


* Dosing Information
1.2    Maintenance therapy for chronic hyperammonemia in patients with NAGS deficiency
 
Carbaglu® is indicated for maintenance therapy in pediatric and adult patients for chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).  During maintenance therapy, the concomitant use of other ammonia lowering therapies and protein restriction may be reduced or discontinued based on plasma ammonia levels.
:* 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=====


|offLabelAdultGuideSupport=
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)-->
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|offLabelAdultNoGuideSupport=
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====


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

Revision as of 14:45, 30 March 2015

Carglumic 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];

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Overview

Carglumic acid is a hyperammonemia Agent that is FDA approved for the treatment of acute hyperammonemia in patients with NAGS deficiency, maintenance therapy for chronic hyperammonemia in patients with NAGS deficiency. Common adverse reactions include abdominal pain, diarrhea, vomiting, anemia, infectious disease , headache, infection of ear , nasopharyngitis, tonsillitis, fever.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

1.1 Acute hyperammonemia in patients with NAGS deficiency Carbaglu® is indicated as an adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). During acute hyperammonemic episodes concomitant administration of Carbaglu with other ammonia lowering therapies such as alternate pathway medications, hemodialysis, and dietary protein restriction are recommended.

1.2 Maintenance therapy for chronic hyperammonemia in patients with NAGS deficiency Carbaglu® is indicated for maintenance therapy in pediatric and adult patients for chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). During maintenance therapy, the concomitant use of other ammonia lowering therapies and protein restriction may be reduced or discontinued based on plasma ammonia levels.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Carglumic acid in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Carglumic acid 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

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Carglumic acid 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

  • 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 Carglumic acid in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Carglumic acid during labor and delivery.

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Carglumic acid in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Carglumic acid in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Carglumic acid in the drug label.

Pharmacology

There is limited information regarding Carglumic acid Pharmacology in the drug label.

Mechanism of Action

Structure

File:Carglumic acid01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Carglumic acid in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Carglumic acid in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Carglumic acid in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Carglumic acid in the drug label.

How Supplied

Storage

There is limited information regarding Carglumic acid Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Carglumic acid in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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