acetylcysteine indications/contra

Stem definitionDrug idCAS RN
mucolytics 66 616-91-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • N-Acetylcysteine
  • acetylcysteine
  • acetadote
  • acetilcysteina
  • L-Acetylcysteine
The N-acetyl derivative of CYSTEINE. It is used as a mucolytic agent to reduce the viscosity of mucous secretions. It has also been shown to have antiviral effects in patients with HIV due to inhibition of viral stimulation by reactive oxygen intermediates.
  • Molecular weight: 163.19
  • Formula: C5H9NO3S
  • CLOGP: -0.62
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 66.40
  • ALOGS: -1.51
  • ROTB: 3

Drug dosage:

DoseUnitRoute
1.60 g Inhal.solution
0.50 g O

Approvals:

DateAgencyCompanyOrphan
Sept. 14, 1963 FDA APOTHECON

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 534.41 53.88 145 546 49538 3335630
Nephropathy toxic 234.32 53.88 45 646 3044 3382124
Medication error 218.93 53.88 54 637 11817 3373351
Stevens-Johnson syndrome 172.14 53.88 40 651 6732 3378436
Toxic epidermal necrolysis 170.97 53.88 37 654 4508 3380660
Overdose 104.70 53.88 39 652 33939 3351229
Anaphylactoid reaction 97.28 53.88 19 672 1377 3383791
Incorrect route of drug administration 83.43 53.88 24 667 9219 3375949
Bronchospasm 56.45 53.88 15 676 4279 3380889

Pharmacologic Action:

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SourceCodeDescription
ATC R05CB01 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
Mucolytics
ATC S01XA08 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
ATC V03AB23 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Antidotes
CHEBI has role CHEBI:74529 antidote to paracetamol poisoning
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:77034 mucolytic
CHEBI has role CHEBI:73336 vulnerary
FDA EPC N0000175429 Antidote
FDA EPC N0000175961 Antidote for Acetaminophen Overdose
FDA PE N0000008867 Decreased Respiratory Secretion Viscosity
FDA PE N0000175960 Increased Glutathione Concentration
FDA MoA N0000175547 Reduction Activity
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000975 Antioxidants
MeSH PA D000998 Antiviral Agents
MeSH PA D005100 Expectorants
MeSH PA D016166 Free Radical Scavengers
MeSH PA D019141 Respiratory System Agents

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Bronchiectasis indication 12295008 DOID:9563
Amyloidosis indication 17602002 DOID:9120
Bronchitis indication 32398004 DOID:6132
General anesthesia indication 50697003
Poisoning by acetaminophen indication 70273001
Cystic fibrosis of the lung indication 86555001
Atelectasis due to Mucous Obstruction indication
Thick Bronchial Secretions indication
Contrast Media-Induced Nephrotoxicity Prevention indication
Bronchospasm contraindication 4386001
Peptic ulcer contraindication 13200003 DOID:750
Esophageal varices contraindication 28670008
Low blood pressure contraindication 45007003
Decreased respiratory function contraindication 80954004
Acute exacerbation of asthma contraindication 708038006
Meconium ileus off-label use 206523001
Bronchial Studies off-label use

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.22 acidic
pKa2 9.96 acidic
pKa3 12.92 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 8399445 Aug. 24, 2025 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 8653061 Aug. 24, 2025 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 9327028 July 21, 2031 COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 8722738 April 6, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
2.5GM CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 RX TABLET, EFFERVESCENT ORAL 8747894 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
2.5GM CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 RX TABLET, EFFERVESCENT ORAL 9561204 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
500MG CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 RX TABLET, EFFERVESCENT ORAL 8747894 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
500MG CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 RX TABLET, EFFERVESCENT ORAL 9561204 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Superoxide dismutase [Mn], mitochondrial Enzyme WOMBAT-PK
Vascular endothelial growth factor A Secreted WOMBAT-PK
Cytochrome c Unclassified WOMBAT-PK

External reference:

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IDSource
CHEBI:28939 CHEBI
4018810 VUID
N0000147113 NUI
C0001047 UMLSCUI
D00221 KEGG_DRUG
CHEMBL600 ChEMBL_ID
4018810 VANDF
N0000147113 NDFRT
N0000006327 NDFRT
000720 NDDF
893 MMSL
197 RXNORM
387440002 SNOMEDCT_US
77731008 SNOMEDCT_US
4127 MMSL
d00762 MMSL
003524 NDDF
DB06151 DRUGBANK_ID
WYQ7N0BPYC UNII
1535 INN_ID
D000111 MESH_DESCRIPTOR_UI
12035 PUBCHEM_CID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3307 SOLUTION 100 mg ORAL ANDA 12 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3308 SOLUTION 200 mg ORAL ANDA 12 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7504 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 13 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7510 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 13 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7604 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 13 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7610 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 13 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7630 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 13 sections
acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0574-0805 INJECTION 200 mg INTRAVENOUS NDA 15 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0574-0815 INJECTION 200 mg INTRAVENOUS NDA 16 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 17478-660 INJECTION 200 mg INTRAVENOUS ANDA 15 sections
Cetylev HUMAN PRESCRIPTION DRUG LABEL 1 24338-700 TABLET, EFFERVESCENT 500 mg ORAL NDA 15 sections
Cetylev HUMAN PRESCRIPTION DRUG LABEL 1 24338-707 TABLET, EFFERVESCENT 2.50 g ORAL NDA 15 sections
Cetylev HUMAN PRESCRIPTION DRUG LABEL 1 24338-725 TABLET, EFFERVESCENT 2.50 g ORAL NDA 15 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 54868-5670 SOLUTION 200 mg ORAL ANDA 5 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55150-259 INJECTION, SOLUTION 6 g INTRAVENOUS ANDA 16 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55154-5730 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 13 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55154-5731 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 13 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-690 SOLUTION 200 mg ORAL ANDA 12 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-691 SOLUTION 100 mg ORAL ANDA 12 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-692 SOLUTION 200 mg ORAL ANDA 12 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-693 SOLUTION 100 mg ORAL ANDA 12 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-694 SOLUTION 200 mg ORAL ANDA 12 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-695 SOLUTION 100 mg ORAL ANDA 12 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-963 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 16 sections
ACETADOTE HUMAN PRESCRIPTION DRUG LABEL 1 66220-207 INJECTION, SOLUTION 200 mg INTRAVENOUS NDA 15 sections
Methazel HUMAN PRESCRIPTION DRUG LABEL 5 69336-350 CAPSULE 50 mg ORAL unapproved drug other 12 sections