Acetylcysteine Injection

Name: Acetylcysteine Injection

What are some things I need to know or do while I take Acetylcysteine Injection?

  • Tell all of your health care providers that you take acetylcysteine injection. This includes your doctors, nurses, pharmacists, and dentists.
  • The drug may change color when the bottle is opened.
  • There may be a bad odor to this medicine. This most often goes away fast.
  • Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
  • If you weigh less than 88 pounds (40 kilograms) or you have to watch how much fluid you take in, talk with your doctor. The chance of too much fluid in the body may be raised with acetylcysteine injection. Too much fluid in the body could lead to low blood sodium levels, seizures, and death.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Acetylcysteine Injection?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about acetylcysteine injection, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about acetylcysteine injection. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using acetylcysteine injection.

Review Date: October 4, 2017

Acetylcysteine Injection Dosage and Administration

Pre-Treatment Assessment and Testing Following Acute Acetaminophen Ingestion

The following recommendations are related to acute acetaminophen ingestion. For recommendations related to repeated supratherapeutic exposure see Dosage and Administration (2.5).

  1. Assess the history and timing of acetaminophen ingestion as an overdose.
    • The reported history of the quantity of acetaminophen ingested as an overdose is often inaccurate and is not a reliable guide to therapy.
  2. Obtain the following laboratory tests to monitor hepatic and renal function and electrolyte and fluid balance: aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, international normalized ratio (INR), creatinine, blood urea nitrogen (BUN), blood glucose, and electrolytes.
  3. Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion. Acetaminophen concentrations obtained earlier than 4 hours post-ingestion may be misleading as they may not represent maximum acetaminophen concentrations.
  4. If the time of acute acetaminophen ingestion is unknown:
    • Administer a loading dose of acetylcysteine immediately [see Dosage and Administration (2.4)].
    • Obtain an acetaminophen concentration to determine need for continued treatment [see Dosage and Administration (2.2)].
  5. If the acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour time interval after acetaminophen ingestion or there is clinical evidence of acetaminophen toxicity:
    • Administer a loading dose of acetylcysteine immediately and continue treatment for a total of three doses over 21 hours [see Dosage and Administration (2.4)].
  6. If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known:
    • Administer a loading dose of acetylcysteine immediately [see Dosage and Administration (2.4)]
    • Obtain an acetaminophen concentration to determine need for continued treatment [see Dosage and Administration (2.2)].
  7. If the patient presents less than 8 hours after ingestion and the time of acute acetaminophen ingestion is known and the acetaminophen concentration is known:
    • Use the Rumack-Matthew nomogram (Figure 1) to determine whether or not to initiate treatment with acetylcysteine [see Dosage and Administration (2.2)].

Nomogram for Estimating Potential for Hepatotoxicity from Acute Acetaminophen Ingestion and Need for Acetylcysteine Treatment

Acetylcysteine is an antidote for acetaminophen overdose. 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.

If the timing of the acute acetaminophen ingestion is known and the results of the acetaminophen assay are available within 8 hours:

  • Refer to the Rumack-Matthew nomogram (see Figure 1) to determine whether or not to initiate treatment with acetylcysteine.
  • Initiation of acetylcysteine depends on the plasma or serum acetaminophen concentration and also the clinical presentation of the patient.

The nomogram may underestimate the hepatotoxicity risk in patients with chronic alcoholism, malnutrition, or CYP2E1 enzyme inducing drugs (e.g., isoniazid), and consideration should be given to treating these patients even if the acetaminophen concentrations are in the nontoxic range.

Loading Dose

For patients whose acetaminophen concentrations are at or above the “possible” toxicity line (dotted line in nomogram):

  • Administer a loading dose of acetylcysteine [see Dosage and Administration (2.4)].

For patients with an acute overdose from an extended-release acetaminophen, if the acetaminophen concentration at 4 hours post ingestion is below the possible toxicity line then obtain a second sample for acetaminophen concentration 8 to 10 hours after the acute ingestion. If the second value is at or above the “possible” toxicity line (dotted line in nomogram):

  • Administer a loading dose of acetylcysteine [see Dosage and Administration (2.4)].

For patients whose values are below the “possible” toxicity line, but time of ingestion was unknown or sample was obtained less than 4 hours after ingestion:

  • Administer a loading dose of acetylcysteine [see Dosage and Administration (2.4)].

For patients whose values are below the “possible” toxicity line and time of ingestion is known and the sample was obtained more than 4 hours after ingestion, do not administer acetylcysteine because there is minimal risk of hepatotoxicity.

Figure 1. Rumack-Matthew Nomogram for Estimating Potential for Hepatotoxicity for Acetaminophen Poisoning – Plasma or Serum Acetaminophen Concentration versus Time (hours) Post-acetaminophen Ingestion

(Adapted from Rumack and Matthew, Pediatrics 1975; 55: 871-876)

Maintenance Dose

Determine need for continued treatment with acetylcysteine after the loading dose. Choose ONE of the following based on the acetaminophen concentration:

The acetaminophen concentration is above the possible toxicity line according to the nomogram (see Figure 1):

  • Continue acetylcysteine treatment with the maintenance dose for a total of three separate doses over an infusion period of 21 hours [see Dosage and Administration (2.4)].
  • Monitor hepatic and renal function and electrolytes throughout treatment.

The acetaminophen concentration could not be obtained:

  • Continue acetylcysteine treatment with the maintenance dose for a total of three separate doses over an infusion period of 21 hours [see Dosage and Administration (2.4)].
  • Monitor hepatic and renal function and electrolytes throughout treatment.

For patients whose acetaminophen concentration is below the “possible” toxicity line (see Figure 1) and time of ingestion is known and the sample was obtained more than 4 hours after ingestion:

  • Discontinue acetylcysteine.

The acetaminophen concentration was in the non-toxic range, but time of ingestion was unknown or less than 4 hours:

  • Obtain a second sample for acetaminophen concentration and consider the patient's clinical status to decide whether or not to continue acetylcysteine treatment.
  • If there is any uncertainty as to patient's risk of developing hepatotoxicity, it is recommended to administer a complete treatment course.

Continued Therapy After Completion of Loading and Maintenance Doses

In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease; the absorption and/or the half-life of acetaminophen may be prolonged. In such cases, consideration should be given to the need for continued treatment with acetylcysteine beyond a total of three separate doses over a 21-hour infusion period.

Acetaminophen levels and ALT/AST and INR should be checked after the last maintenance dose. If acetaminophen levels are still detectable, or if the ALT/AST are still increasing or the INR remains elevated, dosing should be continued and the treating physician should contact a US regional poison center at 1-800-222-1222, alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115 for assistance with dosing recommendations, or 1-800-932-5676 for additional information.

Preparation and Storage of Acetylcysteine Diluted Solution Prior to Administration

Because acetylcysteine is hyperosmolar (2,600 mOsmol/L), acetylcysteine must be diluted in sterile water for injection, 0.45% sodium chloride injection (1/2 normal saline), or 5% dextrose in water prior to intravenous administration [see Warnings and Precautions (5.2)]. Dilution in these three solutions results in different osmolarity of the solution for intravenous administration (see Table 1 for examples of different osmolarity of the solution depending on the type of solution and the acetylcysteine concentration).

Visually inspect for particulate matter and discoloration prior to administration. The color of the diluted solution ranges from colorless to a slight pink or purple once the stopper is punctured (the color change does not affect the quality of the product). The diluted solution can be stored for 24 hours at room temperature. Discard unused portion. If a vial was previously opened, do not use for intravenous administration.

Table 1. Examples of Acetylcysteine Concentration and Osmolarity in Three Solutions

* Adjust osmolarity to a physiologically safe level (generally not less than 150 mOsmol/L in pediatric patients).

Acetylcysteine Concentration Osmolarity
Sterile Water for Injection ½ Normal Saline D5W
7 mg/mL 91 mOsmol/L* 245 mOsmol/L 343 mOsmol/L
24 mg/mL 312 mOsmol/L 466 mOsmol/L 564 mOsmol/L

Recommended Dosage in Adults and Pediatrics for Acute Acetaminophen Ingestion

Acetylcysteine is for intravenous administration only.

Dosage Regimen

The total recommended dosage of acetylcysteine is 300 mg/kg given intravenously as 3 separate, sequential doses (i.e., 3-bag method to administer the loading, second, and third doses). The total recommended infusion time for 3 doses is 21 hours. For the recommended weight-based dosage and weight-based dilution in patients who weigh:

  • 5 to 20 kg (see Table 2)
  • 21 to 40 kg (see Table 3)
  • 41 kg or greater (see Table 4)
Table 2. Recommended Acetylcysteine Dosage and Dilution for Patients 5 kg to 20 kg

* Dilute acetylcysteine in one of the following three solutions: sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water.

** Recommended dosing for those less than 5 kg has not been studied.

Body Weight Bag 1 (Loading Dose) Bag 2 (Second Dose) Bag 3 (Third Dose)
150 mg/kg in 3 mL/kg of diluent* infused over 1 hour 50 mg/kg in 7 mL/kg of diluent* infused over 4 hours 100 mg/kg diluted in 14 mL/kg of diluent* infused over 16 hours
Loading Dose Diluent Volume Second Dose Diluent Volume Third Dose Diluent Volume
5 kg** 750 mg 15 mL 250 mg 35 mL 500 mg 70 mL
10 kg 1,500 mg 30 mL 500 mg 70 mL 1,000 mg 140 mL
15 kg 2,250 mg 45 mL 750 mg 105 mL 1,500 mg 210 mL
20 kg 3,000 mg 60 mL 1,000 mg 140 mL 2,000 mg 280 mL
Table 3. Recommended Acetylcysteine Dosage and Dilution for Patients 21 kg to 40 kg

* Dilute acetylcysteine in one of the following three solutions: sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water.

Body Weight Bag 1 (Loading Dose) Bag 2 (Second Dose) Bag 3 (Third Dose)
150 mg/kg in 100 mL of diluent* infused over 1 hour 50 mg/kg in 250 mL of diluent* infused over 4 hours 100 mg/kg in 500 mL of diluent* infused over 16 hours
21 kg 3,150 mg 1,050 mg 2,100 mg
30 kg 4,500 mg 1,500 mg 3,000 mg
40 kg 6,000 mg 2,000 mg 4,000 mg
Table 4. Recommended Acetylcysteine Dosage and Dilution for Patients 41 kg or Greater

* Dilute acetylcysteine in one of the following three solutions: sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water.

** No specific studies have been conducted to evaluate the necessity of dose adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg.

Body Weight Bag 1 (Loading Dose) Bag 2 (Second Dose) Bag 3 (Third Dose)
150 mg/kg in 200 mL of diluent* infused over 1 hour 50 mg/kg in 500 mL of diluent* infused over 4 hours 100 mg/kg in 1,000 mL of diluent* infused over 16 hours
41 kg 6,150 mg 2,050 mg 4,100 mg
50 kg 7,500 mg 2,500 mg 5,000 mg
60 kg 9,000 mg 3,000 mg 6,000 mg
70 kg 10,500 mg 3,500 mg 7,000 mg
80 kg 12,000 mg 4,000 mg 8,000 mg
90 kg 13,500 mg 4,500 mg 9,000 mg
≥100 kg** 15,000 mg 5,000 mg 10,000 mg

Recommendations for Repeated Supratherapeutic Acetaminophen Ingestion

Repeated supratherapeutic acetaminophen ingestion (RSI) is an ingestion of acetaminophen at dosages higher than those recommended for extended periods of time. The risk of hepatotoxicity and the recommendations for treatment of acute acetaminophen ingestion (i.e., the Rumack-Matthew nomogram) do not apply to patients with RSI. Therefore, obtain the following information to guide acetylcysteine treatment for RSI:

  • Acetaminophen serum or plasma concentrations. A reported history of the quantity of acetaminophen ingested is often inaccurate and is not a reliable guide to therapy.
  • Laboratory tests to monitor hepatic and renal function and electrolyte and fluid balance: AST, ALT, bilirubin, INR, creatinine, BUN, blood glucose, and electrolytes.

For specific acetylcysteine dosage and administration information in patients with RSI, consider contacting your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

Adverse Reactions

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the literature the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 21%, and they most commonly occur during the initial loading dose of acetylcysteine.

Loading Dose/Infusion Rate Study

In a randomized, open-label, multi-center clinical study conducted in Australia in patients with acetaminophen poisoning, the rates of hypersensitivity reactions between a 15-minute and 60-minute intravenous infusion for the 150 mg/kg loading dose of acetylcysteine were compared.

The incidence of drug-related adverse reactions occurring within the first 2 hours following acetylcysteine administration is presented in Table 5. Overall, 17% of patients developed an acute hypersensitivity reaction (18% in the 15-minute infusion group; 14% in the 60-minute infusion group) [see Warnings and Precautions (5.1), Clinical Studies (14)].

Table 5. Incidence of Drug-Related Adverse Reactions Occurring Within the First 2 Hours Following Study Drug Administration by Preferred Term: Loading Dose/Infusion Rate Study

Unkn=Unknown

Treatment Group 15-mins 60-mins
Number of Patients n=109 n=71
Cardiac disorders 5 (5%) 2 (3%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Tachycardia NOS 4 (4%) 1 (1%) 2 (3%)
Gastrointestinal disorders 16 (15%) 7 (10%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Nausea 1 (1%) 6 (6%) 1 (1%) 1 (1%)
Vomiting NOS 2 (2%) 11 (10%) 2 (3%) 4 (6%)
Immune System Disorders 20 (18%) 10 (14%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Hypersensitivity reaction 2 (2%) 6 (6%) 11 (10%) 1 (1%) 4 (6%) 5 (7%) 1 (1%)
Respiratory, thoracic and mediastinal disorders 2 (2%) 2 (3%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Pharyngitis 1 (1%)
Rhinorrhea 1 (1%)
Rhonchi 1 (1%)
Throat tightness 1 (1%)
Skin & subcutaneous tissue disorders 6 (6%) 5 (7%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Pruritus 1 (1%) 2 (3%)
Rash NOS 3 (3%) 2 (2%) 3 (4%)
Vascular disorders 2 (2%) 3 (4%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Flushing 1 (1%) 1 (1%) 2 (3%) 1 (1%)

Safety Study

A large multi-center study was performed in Canada where data were collected from patients who were treated with intravenous acetylcysteine for acetaminophen overdose between 1980 and 2005. This study evaluated 4,709 adult cases and 1,905 pediatric cases. The incidence of hypersensitivity reactions in adult (overall incidence 8%) and pediatric (overall incidence 10%) patients is presented in Tables 6 and 7.

Table 6. Distribution of reported hypersensitivity reactions in adult patients receiving intravenous acetylcysteine
Incidence (%)
Reaction % of Patients (N=4,709)
Urticaria/Facial Flushing 6.1%
Pruritus 4.3%
Respiratory Symptoms* 1.9%
Edema 1.6%
Hypotension 0.1%
Anaphylaxis 0.1%
Table 7. Distribution of reported hypersensitivity reactions in pediatric patients receiving intravenous acetylcysteine

* Respiratory symptoms are defined as presence of any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, or bronchospasm.

Incidence (%)
Reaction % of Patients (N=1,905)
Urticaria/Facial Flushing 7.6%
Pruritus 4.1%
Respiratory Symptoms* 2.2%
Edema 1.2%
Anaphylaxis 0.2%
Hypotension 0.1%

Use in specific populations

Pregnancy

Risk Summary

Limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. Delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see Clinical Considerations]. Reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Acetaminophen and acetylcysteine cross the placenta. Delaying treatment in pregnant women with acetaminophen overdose and potentially toxic acetaminophen plasma levels may increase the risk of maternal and fetal morbidity and mortality.

Data

Animal Data

Reproduction studies have been performed following administration of acetylcysteine during the period of organogenesis in rats at oral doses up to 2,000 mg/kg/day (1.1 times the recommended total human intravenous dose of 300 mg/kg based on body surface area comparison) and in rabbits at oral doses up to 1,000 mg/kg/day (1.1 times the recommended total human intravenous dose of 300 mg/kg based on body surface area comparison). No adverse developmental outcomes due to acetylcysteine were observed.

Lactation

Risk Summary

There are no data on the presence of acetylcysteine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for acetylcysteine and any potential adverse effects on the breastfed child from acetylcysteine or from the underlying maternal condition.

Clinical Considerations

Based on the pharmacokinetic data, acetylcysteine should be nearly completely cleared 30 hours after administration. Breastfeeding women may consider pumping and discarding their milk for 30 hours after administration.

Pediatric Use

Safety and effectiveness of acetylcysteine in pediatric patients have not been established by adequate and well-controlled studies. Use of acetylcysteine in pediatric patients 5 kg and greater is based on clinical practice [see Dosage and Administration (2.4)].

Side effects

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the literature the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 20.8%, and they most commonly occur during the initial loading dose of acetylcysteine.

Loading Dose/Infusion Rate Study

The incidence of drug-related adverse reactions occurring within the first 2 hours following acetylcysteine administration reported in a randomized study in patients with acetaminophen poisoning is presented in Table 5 by preferred term. In this study patients were randomized to a 15-minute or a 60-minute loading dose regimen.

Within the first 2 hours following intravenous acetylcysteine administration, 17% developed an anaphylactoid reaction (18% in the 15-minute treatment group; 14% in the 60-minute treatment group) in this randomized, open-label, multi-center clinical study conducted in Australia to compare the rates of anaphylactoid reactions between two rates of infusion for the intravenous acetylcysteine loading dose [see WARNINGS and Clinical Studies - Loading Dose/Infusion Rate Study (Section 14)].

Table 5: Incidence of Drug-Related Adverse Reactions Occurring Within the First 2 Hours Following Study Drug Administration by Preferred Term: Loading Dose/Infusion Rate Study

Treatment Group 15-min 60-min
Number of Patients n=109 n=71
Cardiac disorders 5 (5%) 2 (3%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Tachycardia NOS   4 (4%) 1 (1%)     2 (3%)    
Gastrointestinal disorders 16 (15%) 7 (10%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Nausea Vomiting 1 (1%)   6 (6%)     1 (1%) 1 (1%)  
NOS   2 (2%) 11 (10%)     2 (3%) 4 (6%)  
Immune System Disorders 20 (18%) 10 (14%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Anaphylactoid reaction 2 (2%) 6 (6%) 11 (10%) 1 (1%)   4 (6%) 5 (7%) 1 (1%)
Respiratory, thoracic and mediastinal disorders 2 (2%) 2 (3%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Pharyngitis     1 (1%)          
Rhinorrhoea   1(1%)            
Rhonchi           1 (1%)    
Throat tightness           1 (1%)    
Skin & subcutaneous tissue disorders 6 (6%) 5 (7%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Pruritus   1 (1%)       2 (3%)    
Rash NOS   3 (3%) 2 (2%)     3 (4%)    
Vascular disorders 2 (2%) 3 (4%)
Severity: Unkn Mild Moderate Severe Unkn Mild Moderate Severe
Flushing   1 (1%) 1 (1%)     2 (3%) 1 (1%)  
Unkn=Unknown

Postmarketing Safety Study

A large multi-center study was performed in Canada where data were collected from patients who were treated with intravenous acetylcysteine for acetaminophen overdose between 1980 and 2005. This study evaluated 4709 adult cases and 1905 pediatric cases. The incidence of anaphylactoid reactions in adult (overall incidence 7.9%) and pediatric (overall incidence 9.5%) patients is presented in Tables 6 and 7.

Table 6: Distribution of reported reactions in adult patients receiving intravenous acetylcysteine

  Incidence (%)
Reaction % of Patients (n=4709)
Urticaria/Facial Flushing 6.1%
Pruritus 4.3%
Respiratory Symptoms* 1.9%
Edema 1.6%
Hypotension 0.1%
Anaphylaxis 0.1%

Table 7: Distribution of reported reactions in pediatric patients receiving intravenous acetylcysteine

  Incidence (%)
Reaction % of Patients (n=1905)
Urticaria/Facial Flushing 7.6%
Pruritus 4.1%
Respiratory Symptoms* 2.2%
Edema 1.2%
Anaphylaxis 0.2%
Hypotension 0.1%
*Respiratory symptoms are defined as presence of any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, or bronchospasm.

Patient information

Sensitivity to acetylcysteine: Patients should be advised to report to their physician any history of sensitivity to acetylcysteine [see CONTRAINDICATIONS].

Asthma

Patients should be advised to report to their physician any history of asthma [see WARNINGS AND PRECAUTIONS].

For all questions concerning adverse reactions associated with the use of this product or for inquiries concerning our products, please contact us at 1-877-484-2700.

For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

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