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| <!--Clinical Trials Experience--> | | <!--Clinical Trials Experience--> |
| |clinicalTrials=6.1 Clinical Studies Experience | | |alcohol=Alcohol-Acetylcysteine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. |
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| 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.
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| 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.
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| Loading Dose/Infusion Rate Study
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| 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.
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| 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 (Section 5) and CLINACAL STUDIES - Loading Dose/InfusionRate Study (Section 14)
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| |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
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| <!--Drug Interactions-->
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| |drugInteractions=* Drug
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| :* Description
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| <!--Use in Specific Populations-->
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| |useInPregnancyFDA=* '''Pregnancy Category'''
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| |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
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| There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
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| |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
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| |useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
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| |useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
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| |useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
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| |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
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| |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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| |useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
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| |useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
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| |useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
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| |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
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| <!--Administration and Monitoring-->
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| |administration='''Administration Instructions (Three-Bag Method: Loading, Second and Third Dose)'''
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| *Dosing for Patients who weigh 5 kg to 20 kg (Table 1):
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| *Loading Dose: 150 mg/kg diluted in 3 mL/kg of diluent* administered over 1 hr
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| *Second Dose: 50 mg/kg diluted in 7 mL/kg of diluent* administered over 4 hrs
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| *Third Dose: 100 mg/kg diluted in 14 mL/kg of diluent* administered over 16 hrs
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| [[File:Acetylcysteine t 1.png|600px|thumbnail|left]]
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| {{clear}}
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| *See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction
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| *Dosing for patients who weigh 21 kg to 40 kg (Table 2):
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| *Loading Dose: 150 mg/kg diluted in 100 mL of diluent* administered over 1 hr
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| *Second Dose: 50 mg/kg diluted in 250 mL of diluent* administered over 4 hrs
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| *Third Dose: : 100 mg/kg diluted in 500 mL of diluent* administered over 16 hrs
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| [[File:Acetylcysteine t 2.png|600px|thumbnail|left]]
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| {{clear}}
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| *See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction.
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| *Dosing for patients who weigh 41 kg to 100 kg (Table 3):
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| *Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered over 1 hr
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| *Second Dose: 50 mg/kg diluted in 500 mL of diluent* administered over 4 hrs
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| *Third Dose: 100 mg/kg diluted in 1,000 mL of diluent administered over 16 hrs
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| [[File:Acetylcysteine t 3.png|600px|thumbnail|left]]
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| {{clear}}
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| '''Patients Weighing More Than 100 kg'''
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| *No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg. The dose of Acetylcysteine Injection recommended in these patients should be a loading dose of 15,000 mg infused over a period of one hour followed by a first maintenance dose of 5,000 mg over 4 hours and a second maintenance dose of 10,000 mg over 16 hours (Table 3).
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| '''Continued Therapy beyond 21 Hours'''
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| *While there is no clinical trial data to support infusions beyond 21 hours there is literature that supports continued infusion of acetylcysteine in some rare instances. 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 infusion of N-acetylcysteine beyond 21 hours. Acetaminophen levels and ALT/AST & INR should be checked before the end of the 21-hour infusion. If acetaminophen levels are still detectable, or in cases in which the ALT/AST are still increasing or the INR remains elevated, the infusion should be continued, and the treating physician should contact a US regional poison center at 1-800-222-1222, or alternatively, a “special health professional assistance line for acetaminophen overdose” at 1-800-525-6115 for assistance with dosing recommendations.
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| '''Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction'''
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| *The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as clinically needed. If the volume of the infusion is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure and death.
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| *As Acetylcysteine Injection is hyperosmolar (2600 mOsmol/L), caution is advised when the diluent volume is decreased as the hyperosmolarity of the solution is increased. See Table 4 below for examples.
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| [[File:Acetylcysteine t 4.png|600px|thumbnail|left]]
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| {{clear}}
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| *Single dose vial, preservative-free, discard unused portion. If vial was previously opened, do not use for intravenous administration.
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| *Stability studies indicate that the diluted solution is stable for 24 hours at controlled room temperature.
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| *Note: The color of Acetylcysteine Injection may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.
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| '''Renal Impairment'''
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| *No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.
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| '''Hepatic Impairment'''
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| *Although there was a threefold increase in acetylcysteine plasma concentrations in patients with hepatic cirrhosis, no data are available to determine if a dose adjustment in these patients is required. The published medical literature does not indicate that the dose of acetylcysteine in patients with hepatic impairment should be reduced.
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| |monitoring=*There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
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| * Description
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| <!--IV Compatibility-->
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| |IVCompat=* There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
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| <!--Overdosage-->
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| |overdose=* There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
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| <!--Pharmacology-->
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| <!--Drug box 2-->
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| |drugBox=[[File:Acetylcysteine wiki.png|600px|thumbnail|left]]
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| {{clear}}
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| |mechAction=* The viscosity of pulmonary mucous secretions depends on the concentrations of mucoprotein and to a lesser extent deoxyribonucleic acid (DNA). The latter increases with increasing purulence owing to the presence of cellular debris. The mucolytic action of acetylcysteine is related to the sulfhydryl group in the molecule. This group probably “opens” disulfide linkages in mucous thereby lowering the viscosity. The mucolytic activity of acetylcysteine is unaltered by the presence of DNA, and increases with increasing pH. Significant mucolysis occurs between pH 7 and 9.
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| * Acetylcysteine undergoes rapid deacetylation in vivo to yield cysteine or oxidation to yield diacetylcystine.
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| * Occasionally, patients exposed to the inhalation of an acetylcysteine aerosol respond with the development of increased airways obstruction of varying and unpredictable severity. Those patients who are reactors cannot be identified a priori from a random patient population. Even when patients are known to have reacted previously to the inhalation of an acetylcysteine aerosol, they may not react during a subsequent treatment. The converse is also true; patients who have had inhalation treatments of acetylcysteine without incident may still react to a subsequent inhalation with increased airways obstruction. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization. If bronchospasm progresses, the medication should be discontinued immediately.
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| '''Mechanism of Action'''
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| '''Acetaminophen Overdose:'''
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| * Acetaminophen is absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose. It is extensively metabolized in the liver to form principally the sulfate and glucoronide conjugates which are excreted in the urine. A small fraction of an ingested dose is metabolized in the liver by isozyme CYP2E1 of the cytochrome P-450 mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite. The toxic metabolite preferentially conjugates with hepatic glutathione to form nontoxic cysteine and mercapturic acid derivatives, which are then excreted by the kidney. Recommended therapeutic doses of acetaminophen are not believed to saturate the glucuronide and sulfate conjugation pathways and therefore are not expected to result in the formation of sufficient reactive metabolite to deplete glutathione stores. However, following ingestion of a large overdose, the glucuronide and sulfate conjugation pathways are saturated resulting in a larger fraction of the drug being metabolized via the cytochrome P-450 pathway and therefore, the amount of acetaminophen metabolized to the reactive intermediate increases. The increased formation of the reactive metabolite may deplete the hepatic stores of glutathione with subsequent binding of the metabolite to protein molecules within the hepatocyte resulting in cellular necrosis.
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| '''Acetylcysteine Intravenous Treatment:'''
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| * Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. It is most effective when given early, with benefit seen principally in patients treated within 8-10 hours of the overdose. Acetylcysteine likely 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.
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| |structure=* Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), and available as sterile, unpreserved solutions (not for injection).
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| * Acetylcysteine is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. Chemically, it is N-acetyl-L-cysteine.
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| * The compound is a white crystalline powder which melts at 104°−110°C and has a very slight odor. The structural formula for acetylcysteine is as follows:
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| [[File:Structural formula acetylcysteine.jpg|600px|thumbnail|left]]
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| {{clear}}
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| * Molecular weight: 163.19
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| * Each mL of the 10% solution contains acetylcysteine 100 mg; edetate disodium, dihydrate 0.25 mg.
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| * Each mL of the 20% solution contains acetylcysteine 200 mg; edetate disodium, dihydrate 0.5 mg.
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| * The solutions also contain sodium hydroxide and may contain hydrochloric acid for pH adjustment, pH 7.0 (6.0 to 7.5). Acetylcysteine Solution, USP is oxygen sensitive.
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| * Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine Injection contains the following inactive ingredients: 0.5 mg/mL disodium edetate, sodium hydroxide (used for pH adjustment), and water for injection, USP.
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| |PD=* There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
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| <!--Pharmacokinetics-->
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| |PK='''Distribution:'''
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| * The steady-state volume of distribution (Vdss) and the protein binding for acetylcysteine were reported to be 0.47 liter/kg and 83%, respectively.
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| '''Metabolism:'''
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| *Acetylcysteine may form cysteine, disulfides and conjugates in vivo (N, N'-diacetylcysteine, N-acetylcysteine-cysteine, N-acetylcysteine- glutathione, N-acetylcysteine-protein, etc). Based on published data, it was reported that after an oral dose of 35S-acetylcysteine, about 22% of total radioactivity was excreted in urine after 24 hours. No metabolites were identified.
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| '''Elimination:'''
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| *After a single intravenous dose of acetylcysteine, the plasma concentration of total acetylcysteine declined in a poly-exponential decay manner with a mean terminal half-life (T1/2) of 5.6 hours. The mean clearance (CL) for acetylcysteine was reported to be 0.11 liter/hr/kg and renal CL constituted about 30% of total CL.
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| '''Special Populations:'''
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| *Gender: Adequate information is not available to assess if there are differences in pharmacokinetics (PK) between males and females.
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| *Pediatric: The mean elimination T1/2 of acetylcysteine is longer in newborns (11 hours) than in adults (5.6 hours). Pharmacokinetic information is not available in other age groups.
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| *Pregnant Women: In four pregnant women with acetaminophen toxicity, oral or I.V. acetylcysteine was administered at the time of delivery. Acetylcysteine was detected in the cord blood of 3 viable infants and in cardiac blood of a fourth infant sampled at autopsy [see Pregnancy (8.1)].
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| *Hepatic Impairment: In subjects with severe liver damage, i.e., cirrhosis due to alcohol (with Child-Pugh score of 7 to 13), or primary and/or secondary biliary cirrhosis (with Child-Pugh score of 5 to 7), mean T1/2 increased by 80% while mean CL decreased by 30% compared to the control group.
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| *Renal Impairment: Pharmacokinetic information is not available in patients with renal impairment.
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| *Geriatric Patients: Adequate information on acetylcysteine PK in geriatric patients is not available.
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| <!--Nonclinical Toxicology-->
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| |nonClinToxic='''Carcinogenesis & Mutageneis & Impairment of Fertility'''
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| *Long-term studies in animals have not been performed to evaluate the carcinogenic potential of acetylcysteine.
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| *Acetylcysteine was not genotoxic in the Ames test or the in vivo mouse micronucleus test. It was, however, positive in the in vitro mouse lymphoma cell (L5178Y/TK+/-) forward mutation test.
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| *Treatment of male rats with acetylcysteine at an oral dose of 250 mg/kg/day for 15 weeks (0.1 times the recommended human dose of 300 mg/kg) did not affect the fertility or general reproductive performance.
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| <!--Clinical Studies-->
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| |clinicalStudies='''Loading Dose/Infusion Rate Study'''
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| *A randomized, open-label, multi-center clinical study was conducted in Australia to compare the rates of anaphylactoid reactions between two rates of infusion for the intravenous acetylcysteine loading dose. One hundred nine subjects were randomized to a 15 minute infusion rate and seventy-one subjects were randomized to a 60 minute infusion rate. The loading dose was 150 mg/kg followed by a maintenance dose of 50 mg/kg over 4 hours and then 100 mg/kg over 16 hours. Of the 180 patients, 27% were male and 73% were female. Ages ranged from 15 to 83 years, with the mean age being 29.9 years (±13.0).
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| *A subgroup of 58 subjects (33 in the 15-minute treatment group; 25 in the 60-minute treatment group) was treated within 8 hours of acetaminophen ingestion. No hepatotoxicity occurred within this subgroup; however with 95% confidence, the true hepatotoxicity rates could range from 0% to 9% for the 15-minute treatment group and from 0% to 12% for the 60-minute treatment group.
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| '''Observational Study'''
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| * An open-label, observational database contained information on 1,749 patients who sought treatment for acetaminophen overdose over a 16-year period. Of the 1,749 patients, 65% were female, 34% were male and less than 1% was transgender. Ages ranged from 2 months to 96 years, with 71.4% of the patients falling in the 16 to 40 year old age bracket. A total of 399 patients received acetylcysteine treatment. A post-hoc analysis identified 56 patients who (1) were at high or probable risk for hepatotoxicity (APAP greater than 150 mg/L at the four hours line according to the Australian nomogram) and (2) had a liver function test. Of the 53 patients who were treated with intravenous acetylcysteine (300 mg/kg intravenous acetylcysteine administered over 20 to 21 hours) within 8 hours, two (4%) developed hepatotoxicity (AST or ALT greater than 1,000 U/L). Twenty-one of 48 (44%) patients treated with acetylcysteine after 15 hours developed hepatotoxicity. 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.
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| * Evaluable data were available from a total of 148 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. Of the 23 patients who received intravenous acetylcysteine treatment, 3 patients (13%) had an adverse reaction (anaphylactoid reaction, rash and flushing, transient erythema). 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.
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| *Postmarketing Safety Study
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| <!--How Supplied-->
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| |howSupplied=* Acetylcysteine Injection is available as a 20% solution (200 mg/mL) in 30 mL single dose glass vials. Each single dose vial contains 6 g/30 mL (200 mg/mL) of Acetylcysteine. Acetylcysteine Injection is sterile and can be used for intravenous administration.
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| [[File:Acetyl cysteine how supplied.png|600px|thumbnail|left]]
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| {{clear}}
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| *Do not use previously opened vials for intravenous administration.
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| *Note: The color of Acetylcysteine Injection may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.
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| *The stopper in the Acetylcysteine Injection vial is formulated with a synthetic base-polymer and does not contain Natural Rubber Latex, Dry Natural Rubber, or blends of Natural Rubber.
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| <!--Patient Counseling Information-->
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| |storage=*Store unopened vials at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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| |packLabel=[[File:Acetylcysteine pdp.jpg|600px|thumbnail|left]]
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| {{clear}}
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| [[File:Acetylcysteine pdp2.jpg|600px|thumbnail|left]]
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| {{clear}}
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| [[File:Acetylcysteine label.png|600px|thumbnail|left]]
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| {{clear}}
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| |fdaPatientInfo=*Sensitivity to acetylcysteine: Patients should be advised to report to their physician any history of sensitivity to acetylcysteine.
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| * Asthma: Patients should be advised to report to their physician any history of asthma [see WARNINGS AND PRECAUTIONS (5)]
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| * For all questions concerning adverse reactions associated with the use of this product or for Inquiries concerning our products, please contact us at 1-800-551-7176.
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| * 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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| <!--Precautions with Alcohol-->
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| |alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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| <!--Brand Names-->
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| |brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
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| <!--Look-Alike Drug Names-->
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| |lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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| <!--Drug Shortage Status-->
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| |drugShortage=
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| }} | | }} |
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| |fileName=No image.jpg
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| |fileName={{PAGENAME}}11.png
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| {{LabelImage
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| |fileName={{PAGENAME}}11.png
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| }}
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| <!--Pill Image-->
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| <!--Label Display Image-->
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| <!--Category-->
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| [[Category:Drug]]
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
ConditionName:
See full prescribing information for complete Boxed Warning.
|
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)
Condition1
Condition2
Condition3
Condition4
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Acetylcysteine (injection) in adult patients.
Non–Guideline-Supported Use
Condition1
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)
Condition1
Condition2
There is limited information regarding FDA-Labeled Use of Acetylcysteine (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Acetylcysteine (injection) in pediatric patients.
Non–Guideline-Supported Use
Condition1
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.
|
Precautions
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.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.