ACETADOTE PACKAGE INSERT PDF

Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. N-acetyl derivative of L-cysteine, abbreviated as NAC; possesses a strong odor, often described as rotten eggs Used orally or parenterally as an antidote for acetaminophen overdose to prevent hepatotoxicity Used via inhalation as a mucolytic agent to treat and reduce COPD exacerbations. If the infusion is extended beyond 21 hours, the treating physician should contact either the US poison center or a special health professional assistance line for APAP overdose for assistance with dosing recommendations. The manufacturer recommends lavage before administering acetylcysteine treatment if activated charcoal was administered; activated charcoal adsorbs acetylcysteine in vitro and may reduce its effectiveness. Any dose vomited within 1 hour of administration must be repeated.

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If you are a consumer or patient please visit this version. ACETADOTE is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with an acute ingestion or from repeated supratherapeutic ingestion RSI 1.

Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion. Recommended Adult and Pediatric Dosage 2. Repeated Supratherapeutic Acetaminophen Ingestion 2.

Patients with a previous hypersensitivity reaction to acetylcysteine 4. ACETADOTE is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion RSI.

The following recommendations are related to acute acetaminophen ingestion. For recommendations related to repeated supratherapeutic exposure see Dosage and Administration 2. The critical ingestion-treatment interval for maximal protection against severe hepatic injury is between 0 — 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:. The nomogram may underestimate the hepatotoxicity risk in patients with chronic alcoholism, malnutrition, or CYP2E1 enzyme inducing drugs e. 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.

Figure 1. 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 :. The acetaminophen concentration was in the non-toxic range, but time of ingestion was unknown or less than 4 hours:. 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 ACETADOTE concentration.

Visually inspect for particular 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.

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:. Limited information is available regarding the dosing requirements of patients that weigh more than kg. 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. For specific ACETADOTE dosage and administration information in patients with RSI, consider contacting your regional poison center at , or alternatively, a special health professional assistance line for acetaminophen overdose at One patient with asthma developed bronchospasm and died after intravenous administration of acetylcysteine. Acute flushing and erythema of the skin may occur in patients receiving acetylcysteine intravenously.

These reactions usually occur 30 to 60 minutes after initiating the infusion and often resolve spontaneously despite continued infusion of acetylcysteine. If a reaction to acetylcysteine involves more than simply flushing and erythema of the skin, it should be treated as a hypersensitivity reaction. To avoid fluid overload, the volume of diluent should be reduced as needed [see Dosage and Administration 2 ]. If volume is not adjusted fluid overload can occur, potentially resulting in hyponatremia, seizure and death.

To avoid fluid overload, use the recommended dilution shown in Tables 2 , 3 and 4 [see Dosage and Administration 2. 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. The incidence of drug-related adverse reactions occurring within the first 2 hours following acetylcysteine administration is presented in Table 5. 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 and This study evaluated adult cases and pediatric cases.

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. 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. No adverse developmental outcomes due to acetylcysteine were observed.

There are no data on the presence of acetylcysteine in human milk, the effects on the breastfed infant, or the effects on milk production. 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.

An hour after the infusion started, the patient complained of generalized heat sensation and body pain and developed widespread urticaria and hypotension.

The second acetylcysteine infusion was withheld and the patient was treated for anaphylaxis. Despite treatment the patient subcomed to the acute inflammatory reaction and died. Symptoms of acute toxicity in the animals were ataxia, hypoactivity, labored respiration, cyanosis, loss of righting reflex and convulsions.

Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine N-acetyl-L-cysteine,. Acetylcysteine has the following structural formula:.

The pH of the solution ranges from 6. Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. Acetylcysteine probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite of acetaminophen.

The mean clearance CL for acetylcysteine was 0. The steady-state volume of distribution Vd ss following administration of an intravenous dose of acetylcysteine was 0. Acetylcysteine i.

Cysteine is further metabolized to form glutathione and other metabolites. These changes are not considered to be clinically meaningful. Long-term studies in animals have not been performed to evaluate the carcinogenic potential of acetylcysteine. Acetylcysteine was not genotoxic in the Ames test or the in vivo mouse micronucleus test. A randomized, open-label, multi-center clinical study was conducted in Australia in patients with acetaminophen poisoning to compare the rates of hypersensitivity reactions between two rates of infusion for the intravenous acetylcysteine loading dose.

One hundred nine subjects were randomized to a minute infusion rate and seventy-one subjects were randomized to a 60 minute infusion rate. A subgroup of 58 subjects 33 in the minute infusion group; 25 in the minute infusion group was treated within 8 hours of acetaminophen ingestion. An open-label, observational database contained information on patients who sought treatment for acetaminophen overdose over a year period.

A total of patients received acetylcysteine treatment. The actual number of hepatotoxicity outcomes may be higher than what is reported here. For patients with multiple admissions for acetaminophen overdose, only the first overdose treated with intravenous acetylcysteine was examined.

Hepatotoxicity may have occurred in subsequent admissions. Evaluable data were available from a total of pediatric patients less than 16 years of age who were admitted for poisoning following ingestion of acetaminophen, of whom 23 were treated with intravenous acetylcysteine. There were no deaths of pediatric patients. None of the pediatric patients receiving intravenous acetylcysteine developed hepatotoxicity while two patients not receiving intravenous acetylcysteine developed hepatotoxicity.

The number of pediatric patients is too small to provide a statistically significant finding of efficacy; however the results appear to be consistent to those observed for adults.

It is available as follows:. The color change does not affect the quality of the product. Advise patients and caregivers that hypersensitivity reactions related to administration and infusion may occur during and after ACETADOTE treatment, including hypotension, wheezing, shortness of breath and bronchospasm [see Warnings and Precautions 5.

For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at , or alternatively, a special health professional assistance line for acetaminophen overdose at DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Approval: Obtain an acetaminophen concentration to determine need for continued treatment.

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 ACETADOTE immediately and continue treatment for a total of three doses over 21 hours. If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known: Administer a loading dose of ACETADOTE immediately Obtain acetaminophen concentration to determine need for continued treatment 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 ACETADOTE 2.

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