Acetylcysteine (injection): Difference between revisions

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{{Drugbox|
{{DrugProjectFormSinglePage
|IUPAC_name = (''R'')-2-acetamido-3-mercaptopropanoic acid
|authorTag=<!--Overview-->
| image = Acetylcysteine.svg
|aOrAn=a
| image2 = Acetylcysteine 3D.png
|hasBlackBoxWarning=Yes
| CAS_number=616-91-1
|adverseReactions=<!--Black Box Warning-->
| ATC_prefix=R05
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| ATC_suffix=CB01
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
| ATC_supplemental={{ATC|S01|XA08}} {{ATC|V03|AB23}}
 
| PubChem=12035
* Content
| DrugBank=n/a
 
| C=5 | H=9 | N=1 | O=3 | S=1
<!--Adult Indications and Dosage-->
| molecular_weight = 163.19
 
| bioavailability = 6–10% (oral) <br /> <3% (topical)
<!--FDA-Labeled Indications and Dosage (Adult)-->
| metabolism = [[hepatic]]
|fdaLIADAdult======Condition1=====
| elimination_half-life = 5.6 hours (adults)</br> 11 hours (neonates)
 
| excretion = [[renal]]
* Dosing Information
| licence_EU =  
 
| licence_US = acetylcysteine
:* Dosage
| pregnancy_category = B2 ([[Australia|Aus]])
 
| legal_status = Schedule 4 ([[Australia|Aus]])<br />[[Over-the-counter substance|OTC]] or [[Prescription drug|Rx]] ([[U.S.]])
=====Condition2=====
| routes_of_administration= inhalation, [[IV]], oral
 
}}
* Dosing Information
{{CMG}}
 
__NOTOC__
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Oral
 
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
|overdose====Acute Overdose===
 
====Signs and Symptoms====


* Description


==Overview==
====Management====


'''Acetylcysteine''' ([[International Nonproprietary Name|rINN]]; {{pronEng|ˌæsɛtəlˈsɪstiːn, əˌsɛtəl-}}), also known as '''''N''-acetylcysteine''' or '''''N''-acetyl-L-cysteine''' (abbreviated '''NAC'''), is a pharmacological agent used mainly as a [[mucolytic]] and in the management of [[paracetamol]] (acetaminophen) overdose. For these indications, it is available under the trade names '''ACC''' ([[Sandoz|Hexal AG]]), '''Mucomyst''' ([[Bristol-Myers Squibb]]), '''Acetadote''' (Cumberland Pharmaceuticals), '''Fluimucil''' ([[Zambon]]),  '''Parvolex''' ([[GlaxoSmithKline|GSK]]), '''Lysox''' ([[Menarini]]) and '''Mucolysin''' ([[Sandoz]]).
* Description


==Dosage forms==
===Chronic Overdose===
Acetylcysteine is available in different dosage forms for different indications:
*Solution for inhalation (Mucomyst, Mucosil) – inhaled for mucolytic therapy or ingested for nephroprotective effect (to protect the kidneys)
*[[intravenous therapy|IV]] injection (Parvolex, Acetadote) – treatment of paracetamol/acetaminophen overdose
*Oral solution – various indications


The IV injection and inhalation preparations are, in general, prescription only, whereas the oral solution is available [[over-the-counter substance|over the counter]] in many countries.
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


==Clinical use==
<!--Pharmacology-->
===Mucolytic therapy===
Inhaled acetylcysteine is indicated for mucolytic ("mucus-dissolving") therapy as an adjuvant in respiratory conditions with excessive and/or thick mucus production. Such conditions include [[emphysema]], [[bronchitis]], [[tuberculosis]], [[bronchiectasis]], [[amyloidosis]], [[pneumonia]]. It is also used post-operatively, as a diagnostic aid, and in [[tracheostomy]] care. It may be considered ineffective in [[cystic fibrosis]] (Rossi, 2006).  However, a recent paper in the Proceedings of the National Academy of Sciences reports that high-dose oral N-acetylcysteine modulates inflammation in cystic fibrosis and has the potential to counter the intertwined redox and inflammatory imbalances in CF (Tirouvanziam et al., 2006). Oral acetylcysteine may also be used as a mucolytic in less serious cases.


For this indication, acetylcysteine acts to reduce mucus viscosity by splitting [[disulfide bond]]s linking proteins present in the mucus (mucoproteins).
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*


===Paracetamol (Acetaminophen) overdose===
<!--Structure-->
Intravenous acetylcysteine is indicated for the treatment of [[paracetamol]] (acetaminophen) overdose. When paracetamol is taken in large quanities, a minor metabolite called N-methyl-p-benzoquinone imine ([[NAPQI]]) builds up.  It is normally [[Xenobiotic_metabolism#Phase_II_-_conjugation|conjugated]] by [[glutathione]], but when taken in excess (especially in alcoholics), the body's glutathione reserves are not sufficient to inactivate the toxic NAPQI.  This metabolite is then free to react with key hepatic enzymes, therefore damaging hepatocytes.  This may lead to severe liver damage and even death by [[fulminant]] [[liver failure]].
|structure=*


For this indication, acetylcysteine acts to augment the glutathione reserves in the body and, together with glutathione, directly bind to toxic metabolites. These actions serve to protect [[hepatocyte]]s in the liver from NAPQI toxicity.
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


Although both IV and oral acetylcysteine are equally effective for this indication, oral administration is uncommon, as it is poorly tolerated, owing to the high doses required (due to low oral [[bioavailability]]), very unpleasant taste and odour, and [[adverse drug reaction|adverse effect]]s (particularly nausea and vomiting). However, 3% to 6% of people given intravenous acetylcysteine show a severe, [[anaphylaxis]]-like allergic reaction, which may include extreme breathing difficulty (due to [[bronchospasm]]), [[hypotension|a decrease in blood pressure]], rash, [[angioedema]], and sometimes also nausea and vomiting (Kanter, 2006). Repeated overdoses will cause the allergic reaction to get worse and worse. Several studies have found this anaphylaxis-like reaction to occur more often in people given IV acetylcysteine despite serum levels of paracetamol not high enough to be considered toxic (Dawson et al., 1989; Bailey & McGuigan, 1998; Schmidt & Dalhoff, 2001; Lynch & Robertson, 2004).
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


In some countries, a specific intravenous formulation does not exist to treat [[paracetamol]] overdose. In these cases, the formulation used for inhalation may be used intravenously.
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


===Nephroprotective agent===
<!--Nonclinical Toxicology-->
Oral acetylcysteine is used for the prevention of [[radiocontrast]]-induced nephropathy (a form of [[acute renal failure]]). Some studies show that prior administration of acetylcysteine markedly decreases (90%) radiocontrast nephropathy (Tepel ''et al'' 2000), whereas others appear to cast doubt on its efficacy (Hoffman ''et al.'', 2004; Miner ''et al.'', 2004).  Worth considering is the newest data published in two papers in the ''New England Journal of Medicine''  and the ''Journal of the American Medical Association.''  The authors' conclusions in those papers were: 1) "Intravenous and oral N-acetylcysteine may prevent contrast-medium–induced nephropathy with a dose-dependent effect in patients treated with primary angioplasty and may improve hospital outcome." (Marenzi et al, 2006)
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
2) "Acetylcysteine protects patients with moderate chronic renal insufficiency from contrast-induced deterioration in renal function after coronary angiographic procedures, with minimal adverse effects and at a low cost" (Kay et al., 2003).


Acetylcysteine continues to be commonly used in individuals with [[chronic renal failure|renal impairment]] to prevent the precipitation of acute renal failure.
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


==Investigational==
<!--How Supplied-->
The following uses have not been well-established or investigated:
|howSupplied=*  
* NAC is undergoing [[clinical trial]]s in the [[United States]] for the treatment of [[obsessive-compulsive disorder]].<ref>[http://clinicaltrials.gov/ct/show/NCT00539513?order=2 N-Acetylcysteine Augmentation in Treatment-Refractory Obsessive-Compulsive Disorder - Full Text View - ClinicalTrials.gov<!-- Bot generated title -->]</ref> It is thought to counteract the [[glutamate]] hyperactivity in OCD.
* NAC has been shown to reduce cravings associated with chronic [[cocaine]] use in a study conducted at the [[Medical University of South Carolina]] (Mardikian ''et al'', 2007; LaRowe et al, 2007)
* It may reduce the incidence of [[chronic obstructive pulmonary disease]] (COPD) exacerbations (Pela ''et al.'', 1999)
* In the treatment of [[AIDS]], NAC has been shown to cause a "marked increase in immunological functions and plasma albumin concentrations" (Breitkreutz & al, 2000). Albumin concentration are inversely correlated with muscle wasting ([[cachexia]]), a condition associated with AIDS.
* An animal study indicates that acetylcysteine may decrease mortality associated with [[influenza]] (Ungheri ''et al.'', 2000)
* Animal studies suggest that NAC may help prevent noise-induced hearing loss (Kopke ''et al.'', 2005).    A clinical trial to determine efficacy in preventing noise-induced sensorineural hearing loss in humans is currently (2006) being jointly conducted by the US Army and US Navy.
* It has been suggested that NAC may help sufferers of [[Samter's triad]] by increasing levels of glutathione allowing faster breakdown of [[salicylate]]s, though there is no evidence that it is of benefit (Bachert ''et al.'', 2003).
* There are claims that acetylcysteine taken together with vitamin C and B1 can be used to prevent and relieve symptoms of [[veisalgia]] (hangover following [[ethanol]] (alcohol) consumption). The claimed mechanism is through scavenging of [[acetaldehyde]], a toxic intermediate in the metabolism of ethanol.
* It has been shown to help women with PCOS (polycystic ovary syndrome) to reduce insulin problems and possibly improve fertility. (Fulghesu, ''et al'', 2002)


==Chemistry==
<!--Patient Counseling Information-->
Acetylcysteine is the ''N''-[[acetyl]] derivative of the amino acid <small>L</small>-[[cysteine]], and is a precursor in the formation of the antioxidant [[glutathione]] in the body. The [[thiol]] (sulfhydryl) group confers antioxidant effects and is able to [[Redox|reduce]] [[free radical]]s.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


==Possible toxicity==
<!--Precautions with Alcohol-->
Researchers at the [[University of Virginia]] recently reported that acetylcysteine, which is found in many [[bodybuilding supplements]], could potentially cause damage to the [[heart]] and [[lungs]] (Palmer et al., 2007). They found that acetylcysteine was [[drug metabolism|metabolized]] to ''S''-nitroso-''N''-acetylcysteine (SNOAC), which increased [[blood pressure]] in the lungs and [[right ventricle]] of the heart ([[pulmonary artery hypertension]]) in [[mice]] treated with acetylcysteine. The effect was similar to that observed following a 3-week exposure to an oxygen-deprived environment (chronic [[hypoxia (medical)|hypoxia]]). The authors also found that SNOAC induced a hypoxia-like response in the [[gene expression|expression]] of several important [[gene]]s both ''[[in vitro]]'' and ''[[in vivo]]''.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


The implications of these findings for long-term treatment with acetylcysteine have not yet been investigated. The dose used by Palmer and colleagues (2007) was dramatically higher than that used in humans; nonetheless, the drug's effects on the [[control of respiration|hypoxic ventilatory response]] have been observed previously in human subjects at more moderate doses (Hildebrandt et al., 2002).
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>


==References==
<!--Look-Alike Drug Names-->
|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>


<references/>
<!--Drug Shortage Status-->
|drugShortage=
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{{PillImage
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<!--Pill Image-->


==Additional Resources==
<small> <div style="-moz-column-count:2; column-count:2;">
* Bachert C, Hormann K, Mosges R, ''et al.'' "An update on the diagnosis and treatment of sinusitis and nasal polyposis." ''Allergy'' 2003;58(3):176-91. PMID 12653791
* Bailey B, McGuigan MA. Management of anaphylactoid reactions to intravenous N-acetylcysteine. Ann Emerg Med. 1998 Jun;31(6):710–5. PMID 9624310
* Breitkreutz R, Pittack N, Nebe CT, Schuster D, Brust J, Beichert M, Hack V, Daniel V, Edler L, Droge W. "Improvement of immune functions in HIV infection by sulfur supplementation: two randomized trials." ''J Mol Med'' 2000;78(1):55-62. PMID 10759030
* Dawson AH, Henry DA, McEwen J. Adverse reactions to N-acetylcysteine during treatment for paracetamol poisoning. Med J Aust. 1989 Mar 20;150(6):329–31. PMID 2716644
* Fulghesu AM, Ciampelli M, Muzj G, Belosi C, Selvaggi L, Ayala GF, Lanzone A. "N-acetyl-cysteine treatment improves insulin sensitivity in women with polycystic ovary syndrome." ''Fertility and Sterility'' 2002 Jun;77(6):1128-35. PMID 12057717
* Hildebrandt W, Alexander S, Bärtsch P, Dröge W. "[http://bloodjournal.hematologylibrary.org/cgi/content/full/99/5/1552 Effect of N-acetyl-cysteine on the hypoxic ventilatory response and erythropoietin production: linkage between plasma thiol redox state and O(2) chemosensitivity.]" ''Blood'' 2002 Mar 1;99(5):1552-5. Accessed [[November 12]], [[2007]]. PMID 11861267
* Hoffmann U, Fischereder M, Kruger B, Drobnik W, Kramer BK. "The value of N-acetylcysteine in the prevention of radiocontrast agent-induced nephropathy seems questionable." ''J Am Soc Nephrol'' 2004;15:407-10. [http://www.jasn.org/cgi/content/full/15/2/407 Fulltext]. PMID 14747387.
* Kanter MZ. "[http://www.ajhp.org/cgi/content/full/63/19/1821 Comparison of oral and i.v. acetylcysteine in the treatment of acetaminophen poisoning.]" ''Am J Health Syst Pharm'' 2006;63(19):1821–7. PMID 16990628. {{DOI|10.2146/ajhp060050}}
* Kay J, Chow WH, Chan TM, Lo SK, Kwok OH, Yip A, Fan K, Lee CH, Lam WF. "[http://jama.ama-assn.org/cgi/content/full/289/5/553 Acetylcysteine for prevention of acute deterioration of renal function following elective coronary angiography and intervention: a randomized controlled trial.]" ''Journal of the American Medical Association'' 2003 Feb 5;289(5):553-8. Accessed [[December 12]], [[2007]]. PMID 12578487
* Kopke R, Bielefeld E, Liu J, ''et al.'' "Prevention of impulse noise-induced hearing loss with antioxidants." ''Acta Otolaryngol'' 2005;125(3):235-43. PMID 15966690
* LaRowe SD, Myrick H, Hedden S, Mardikian P, Saladin M, McRae A, Brady K, Kalivas PW, Malcolm R. "Is cocaine desire reduced by N-acetylcysteine?" ''Am J Psychiatry''. 2007 Jul;164(7):1115-7. PMID 17606664
* Lynch RM, Robertson R. Anaphylactoid reactions to intravenous N-acetylcysteine: a prospective case controlled study. Accid Emerg Nurs. 2004 Jan;12(1):10–5. PMID 14700565
* Mardikian PN, LaRowe SD, Hedden S, Kalivas PW, Malcolm RJ. "An open-label trial of N-acetylcysteine for the treatment of cocaine dependence: a pilot study." Prog Neuropsychopharmacol Biol Psychiatry. 2007 Mar 30;31(2):389-94. PMID 17113207
* Marenzi G, Assanelli E, Marana I, Lauri G, Campodonico J, Grazi M, De Metrio M, Galli S, Fabbiocchi F, Montorsi P, Veglia F, Bartorelli AL. "N-acetylcysteine and contrast-induced nephropathy in primary angioplasty." ''N Engl J Med.'' 2006 Jun 29;354(26):2773-82. PMID 16807414
* Miner SE, Dzavik V, Nguyen-Ho P, Richardson R, Mitchell J, Atchison D, Seidelin P, Daly P, Ross J, McLaughlin PR, Ing D, Lewycky P, Barolet A, Schwartz L. "N-acetylcysteine reduces contrast-associated nephropathy but not clinical events during long-term follow-up." ''Am Heart J'' 2004;148:690-5. PMID 15459602.
* Palmer LA, Doctor A, Chhabra P, Sheram ML, Laubach VE, Karlinsey MZ, Forbes MS, Macdonald T, Gaston B. "[http://www.jci.org/cgi/content/full/117/9/2592 S-nitrosothiols signal hypoxia-mimetic vascular pathology.]" ''Journal of Clinical Investigation'' 2007 Sep;117(9): 2592-601. Accessed [[December 12]], [[2007]]. PMID 17786245
* Pela R, Calcagni AM, Subiaco S, ''et al.'' "N-acetylcysteine reduces the exacerbation rate in patients with moderate to severe COPD." ''Respiration'' 1999;66(6):495-500. PMID 10575333
* Rossi S, editor. [[Australian Medicines Handbook]] 2006. Adelaide: Australian Medicines Handbook; 2006.
* Schmidt LE, Dalhoff K. Risk factors in the development of adverse reactions to N-acetylcysteine in patients with paracetamol poisoning. Br J Clin Pharmacol. 2001 Jan;51(1):87–91. PMID 11167669
* Tepel M, van der Giet M, Schwarzfeld C, Laufer U, Liermann D, Zidek W. "Prevention of radiographic-contrast-agent-induced reductions in renal function by acetylcysteine." ''[[N Engl J Med]]'' 2000;343:180-4. PMID 10900277.
* Tirouvanziam R, Conrad CK, Bottiglieri T, Herzenberg LA, Moss RB, Herzenberg LA. "[http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=16537378 High-dose oral N-acetylcysteine, a glutathione prodrug, modulates inflammation in cystic fibrosis.]" Proc Natl Acad Sci USA. 2006 Mar 21;103(12):4628-33. PMID 16537378
* Ungheri D, Pisani C, Sanson G, ''et al.'' "Protective effect of n-acetylcysteine in a model of influenza infection in mice." ''Int J Immunopathol Pharmacol'' 2000;13(3):123-128. PMID 12657201
</div> </small>


==See also==
*[[Glutathione]]
*[[Cysteine]]


==External links==
<!--Label Display Image-->
*[http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/500403.html MedlinePlus drug information: Acetylcysteine (inhalation)] – information from USP DI Advice for the Patient


{{Cough and cold preparations}}


{{Antidotes}}


[[Category:Antioxidants]]
[[Category:Antidotes]]


[[ar:أستيل سستين]]
[[da:Acetylcystein]]
[[de:Acetylcystein]]
[[fr:Acétylcystéine]]
[[pl:Acetylocysteina]]
[[pt:Acetilcisteína]]
[[sv:Acetylcystein]]


<!--Category-->


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Revision as of 18:22, 12 December 2014

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];

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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)

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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  • 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)

Condition1
  • Dosing Information
  • Dosage
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There is limited information regarding FDA-Labeled Use of Acetylcysteine (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
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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

  • Condition1

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 Clinical Trial Experience of Acetylcysteine (injection) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Acetylcysteine (injection) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Acetylcysteine (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Acetylcysteine (injection) with respect to geriatric patients.

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

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Acetylcysteine (injection) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Acetylcysteine (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Acetylcysteine (injection) in the drug label.

Pharmacology

There is limited information regarding Acetylcysteine (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Acetylcysteine (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Acetylcysteine (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Acetylcysteine (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Acetylcysteine (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Acetylcysteine (injection) in the drug label.

How Supplied

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 Patient Counseling Information of Acetylcysteine (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Acetylcysteine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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