aclidinium bromide indications/contra

Stem definitionDrug idCAS RN
4484 320345-99-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • aclidinium bromide
  • Tudorza Pressair
  • aclidinium
  • LAS 34273
  • LAS W-330
a long-acting, inhaled antimuscarinic; in phase I trial 8/2008
  • Molecular weight: 484.65
  • Formula: C26H30NO4S2
  • CLOGP: 2.34
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 55.76
  • ALOGS: -5.53
  • ROTB: 10

Drug dosage:

DoseUnitRoute
0.64 mg Inhal.powder

Approvals:

DateAgencyCompanyOrphan
July 20, 2012 EMA
July 23, 2012 FDA ASTRAZENECA PHARMS

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
Dyspnoea 259.40 45.73 91 391 102843 3282534
Device malfunction 253.31 45.73 48 434 4436 3380941
Product quality issue 224.10 45.73 60 422 26675 3358702
Drug dose omission 220.41 45.73 64 418 38368 3347009
Chronic obstructive pulmonary disease 88.01 45.73 24 458 10985 3374392
Intentional product misuse 71.20 45.73 21 461 12680 3372697
Device failure 69.96 45.73 15 467 2486 3382891
Intentional device misuse 60.83 45.73 10 472 390 3384987
Circumstance or information capable of leading to medication error 55.11 45.73 12 470 2130 3383247
Urinary retention 53.44 45.73 15 467 7557 3377820

Pharmacologic Action:

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SourceCodeDescription
ATC R03AL05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids
ATC R03BB05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Anticholinergics
FDA EPC N0000175574 Anticholinergic
FDA MoA N0000175370 Cholinergic Antagonists
CHEBI has role CHEBI:48876 muscarinic antagonist
CHEBI has role CHEBI:35523 bronchodilator agent

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Chronic obstructive lung disease indication 13645005 DOID:3083

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.97 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.4MG/INH TUDORZA PRESSAIR ASTRAZENECA PHARMS N202450 July 23, 2012 RX POWDER, METERED INHALATION 9056100 July 7, 2020 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS
0.4MG/INH TUDORZA PRESSAIR ASTRAZENECA PHARMS N202450 July 23, 2012 RX POWDER, METERED INHALATION 9333195 July 7, 2020 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS
0.4MG/INH TUDORZA PRESSAIR ASTRAZENECA PHARMS N202450 July 23, 2012 RX POWDER, METERED INHALATION 7078412 July 16, 2020 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS
0.4MG/INH TUDORZA PRESSAIR ASTRAZENECA PHARMS N202450 July 23, 2012 RX POWDER, METERED INHALATION RE46417 Sept. 5, 2020 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 10.15 CHEMBL CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 10.10 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 10.10 CHEMBL
Muscarinic acetylcholine receptor M4 GPCR IC50 9.70 CHEMBL
Muscarinic acetylcholine receptor M5 GPCR IC50 9.80 CHEMBL

External reference:

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IDSource
7449 IUPHAR_LIGAND_ID
D08837 KEGG_DRUG
4031720 VUID
N0000185730 NUI
C2699758 UMLSCUI
CHEMBL551466 ChEMBL_ID
CHEMBL1194325 ChEMBL_ID
C542859 MESH_SUPPLEMENTAL_RECORD_UI
DB08897 DRUGBANK_ID
UQW7UF9N91 UNII
8544 INN_ID
1303097 RXNORM
014614 NDDF
28687 MMSL
4031720 VANDF
N0000185730 NDFRT
703922001 SNOMEDCT_US
11519741 PUBCHEM_CID
CHEBI:65344 CHEBI

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Tudorza Pressair HUMAN PRESCRIPTION DRUG LABEL 1 0310-0800 INHALANT 400 ug RESPIRATORY (INHALATION) NDA 17 sections