Acetylcysteine (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Overview
Acetylcysteine (injection) is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Acetaminophen overdose
- Dosing Information
- Dosage
Administration of anesthesia for procedure
- Dosing Information
- Dosage
Atelectasis, Due to mucous obstruction
- Dosing Information
- Dosage
Bronchopulmonary disease, acute
- Dosing Information
- Dosage
Complication of surgical procedure - Respiratory complication
Cystic fibrosis, Pulmonary complications; Adjunct
Diagnostic procedure on lower respiratory tract
Disease of respiratory system, chronic
Tracheostomy care
Off-Label Use and Dosage (Adult)
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 Acetylcysteine (injection) in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetylcysteine (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Acetaminophen overdose
- Dosing Information
- Dosage
Administration of anesthesia for procedure
Atelectasis, Due to mucous obstruction
Bronchopulmonary disease, acute
Complication of surgical procedure - Respiratory complication
Cystic fibrosis, Pulmonary complications; Adjunct
Diagnostic procedure on lower respiratory tract
Disease of respiratory system, chronic
Tracheostomy care
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 Acetylcysteine (injection) in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetylcysteine (injection) in pediatric patients.
Contraindications
The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses and administered over a total of 21 hours. Please refer to the guidelines below for dose preparation based upon patient weight. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction (see Tables 1 and 2).
Warnings
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See full prescribing information for complete Boxed Warning.
ConditionName:
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- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Acetylcysteine (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Acetylcysteine (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Acetylcysteine (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Acetylcysteine (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Acetylcysteine (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Acetylcysteine (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Acetylcysteine (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Acetylcysteine (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Acetylcysteine (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Acetylcysteine (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Acetylcysteine (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Acetylcysteine (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Acetylcysteine (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Acetylcysteine (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Acetylcysteine (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Acetylcysteine (injection) Administration in the drug label.
Monitoring
There is limited information regarding Acetylcysteine (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Acetylcysteine (injection) and IV administrations.
Overdosage
There is limited information regarding Acetylcysteine (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Acetylcysteine (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Acetylcysteine (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Acetylcysteine (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Acetylcysteine (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Acetylcysteine (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Acetylcysteine (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Acetylcysteine (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Acetylcysteine (injection) How Supplied in the drug label.
Storage
There is limited information regarding Acetylcysteine (injection) 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 Acetylcysteine (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Acetylcysteine 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 Acetylcysteine (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Acetylcysteine (injection) 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.