Acetylcysteine (injection)

Acetylcysteine (injection)
Black Box Warning
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: Deepika Beereddy, MBBS [2]

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Black Box Warning

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Overview

Acetylcysteine (injection) is an antioxidant, respiratory system agent that is FDA approved for the treatment of acetaminophen overdose, adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung), acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis), pulmonary complications of cystic fibrosis, tracheostomy care, pulmonary complications associated with surgery, use during anesthesia, post-traumatic chest conditions, atelectasis due to mucous obstruction, diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization). There is a Black Box Warning for this drug as shown here. Common adverse reactions include rash, urticaria/facial flushing and pruritus, diarrhea, nausea, vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acetaminophen overdose

Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Overdose incidences are divided into two types; Acute Ingestion or Repeated Supratherapeutic Ingestion (RSI). [see Dosage and Administration (2) and Acetaminophen Assays – Interpretation and Methodology -(Acute or Repeated Supratherapeutic Ingestion) (1.1, 1.2)].

On admission for suspected acetaminophen overdose, a serum blood sample should be drawn at least 4 hours after ingestion to determine the acetaminophen level and will serve as a basis for determining the need for treatment with acetylcysteine. If the patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately.

Acetylcysteine Injection should be administered within 8 hours from acetaminophen ingestion for maximal protection against hepatic injury for patients whose serum acetaminophen levels fall above the "possible" toxicity line on the Rumack-Matthew nomogram (line connecting 150 mcg/mL at 4 hours with 37.5 mcg/mL at 12 hours); [see Acetaminophen Assays – Interpretation and Methodology (1.1, 1.2)) ]. If the time of ingestion is unknown, or the serum acetaminophen level is not available, cannot be interpreted, or is not available within the 8 hour time interval from acetaminophen ingestion, Acetylcysteine Injection should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion of an overdose of acetaminophen, regardless of the quantity reported to have been ingested.

The aspartate aminotransferase (AST, SGOT), alanine aminotranferase (ALT, SGPT), bilirubin, prothrombin time, creatinine, blood urea nitrogen (BUN), blood glucose, and electrolytes also should be determined in order to monitor hepatic and renal function and electrolyte and fluid balance.

NOTE: The critical ingestion-treatment interval for maximal protection against severe hepatic injury is between 0 to 8 hours. Efficacy diminishes progressively after 8 hours and treatment initiation between 15 and 24 hours post-ingestion of acetaminophen yields limited efficacy. However, it does not appear to worsen the condition of patients and it should not be withheld, since the reported time of ingestion may not be correct.

1.1 Acetaminophen Assays Interpretation and Methodology – Acute Ingestion

The acute ingestion of acetaminophen in quantities of 150 mg/kg or greater may result in hepatic toxicity. However, the reported history of the quantity of a drug ingested as an overdose is often inaccurate and is not a reliable guide to therapy of the overdose. Therefore, plasma or serum acetaminophen concentrations, determined as early as possible, but no sooner than four hours following an acute overdose, are essential in assessing the potential risk of hepatotoxicity. If an assay for acetaminophen cannot be obtained, it is necessary to assume that the overdose is potentially toxic.

Interpretation of Acetaminophen Assays

When results of the plasma acetaminophen assay are available, refer to the nomogram in Figure 1 to determine if plasma concentration is in the potentially toxic range. Values above the line connecting 200 mcg/mL at 4 hours with 50 mcg/mL at 12 hours (probable line) are associated with a probability of hepatic toxicity if an antidote is not administered. If the predetoxification plasma level is above the line connecting 150 mcg/mL at 4 hours with 37.5 mcg/mL at 12 hours (possible line), continue with maintenance doses of acetylcysteine. It is better to err on the safe side and thus this line, defining possible toxicity, is plotted 25% below the line defining probable toxicity. If the predetoxification plasma level is below the line connecting 150 mcg/mL at 4 hours with 37.5 mcg/mL at 12 hours (possible line), there is minimal risk of hepatic toxicity, and Acetylcysteine treatment may be discontinued.

Estimating Potential for Hepatotoxicity: The following depiction of the Rumack- Matthew nomogram has been developed to estimate the probability that plasma levels in relation to intervals post-ingestion will result in hepatotoxicity.

The Rumack-Matthew nomogram may underestimate the risk for hepatotoxicity in some patients with risk factors such as chronic alcoholism, malnutrition, or CYP2E1 enzyme inducing drugs (e.g., isoniazid).

• 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

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: Content

• 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

Acetadote, Acys-5, Mucomyst.

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.