clidinium Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
muscarinic receptors agonists/antagonists 676 7020-55-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • clidinium
  • clidinium bromide
  • quarzan
a synthetic anticholinergic agent that has antispasmodic and antisecretory effect on the gastrointestinal tract
  • Molecular weight: 352.45
  • Formula: C22H26NO3
  • CLOGP: -0.05
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -6.01
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
None FDA ROCHE

FDA Adverse Event Reporting System (Female)

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
Apraxia 49.26 20.86 12 2036 1663 46682351
Perseveration 44.36 20.86 8 2040 255 46683759
Hyperreflexia 35.69 20.86 12 2036 5242 46678772
Cognitive disorder 34.54 20.86 21 2027 36862 46647152
Disorientation 34.52 20.86 21 2027 36897 46647117
Myoclonus 27.03 20.86 13 2035 14339 46669675
Gait disturbance 24.56 20.86 31 2017 145232 46538782
Dementia 23.58 20.86 12 2036 14918 46669096
Cholecystitis chronic 21.26 20.86 10 2038 10489 46673525

FDA Adverse Event Reporting System (Male)

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

Pharmacologic Action:

SourceCodeDescription
ATC A03CA02 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
ANTISPASMODICS IN COMBINATION WITH PSYCHOLEPTICS
Synthetic anticholinergic agents in combination with psycholeptics
FDA PE N0000008779 Decreased Parasympathetic Acetylcholine Activity
FDA PE N0000009022 Digestive/GI System Activity Alteration
FDA PE N0000009048 GI Motility Alteration
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:50370 parasympatholytics
CHEBI has role CHEBI:53784 antispasmodics
MeSH PA D010276 Parasympatholytics
MeSH PA D018373 Peripheral Nervous System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Irritable bowel syndrome indication 10743008 DOID:9778
Enterocolitis indication 43752006
Brain damage contraindication 2470005
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Urinary tract obstruction contraindication 7163005 DOID:5200
Severe chronic ulcerative colitis contraindication 14311001
Disorder of lung contraindication 19829001 DOID:850
Glaucoma contraindication 23986001 DOID:1686
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Hyperactive behavior contraindication 44548000
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Paralytic ileus contraindication 55525008 DOID:8442
Peptic reflux disease contraindication 57643001
Ulcerative colitis contraindication 64766004 DOID:8577
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Sleep apnea contraindication 73430006 DOID:0050847
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Hiatal hernia contraindication 84089009 DOID:12642
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Hypoalbuminemia contraindication 119247004
Gastrointestinal obstruction contraindication 126765001
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Myocardial dysfunction contraindication 233928007
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Drowsy contraindication 271782001
Pregnancy, function contraindication 289908002
Severe chronic obstructive pulmonary disease contraindication 313299006
Angle-closure glaucoma contraindication 392291006 DOID:13550
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Disorder of coronary artery contraindication 414024009
Porphyria contraindication 418470004

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.67 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
5MG;2.5MG CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE ECI PHARMS LLC A213530 Oct. 20, 2020 RX CAPSULE ORAL April 24, 2021 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 9.60 IUPHAR CHEMBL
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST CHEMBL CHEMBL

External reference:

IDSource
4019682 VUID
N0000179084 NUI
D00716 KEGG_DRUG
3485-62-9 SECONDARY_CAS_RN
4018831 VANDF
4019682 VANDF
C0055877 UMLSCUI
CHEBI:3743 CHEBI
CHEMBL620 ChEMBL_ID
CHEMBL1200950 ChEMBL_ID
DB00771 DRUGBANK_ID
C054940 MESH_SUPPLEMENTAL_RECORD_UI
2784 PUBCHEM_CID
366 IUPHAR_LIGAND_ID
463 INN_ID
BO76JF850N UNII
21232 RXNORM
3953 MMSL
4465 MMSL
d00991 MMSL
001747 NDDF
004702 NDDF
387323005 SNOMEDCT_US
57853003 SNOMEDCT_US
87283008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Librax HUMAN PRESCRIPTION DRUG LABEL 2 0187-4100 CAPSULE 2.50 mg ORAL NDA 18 sections
Not applicable HUMAN PRESCRIPTION DRUG LABEL 2 0276-0500 CAPSULE 2.50 1 ORAL ANDA 19 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 10135-622 CAPSULE 2.50 mg ORAL UNULLPPROVED DRUG OTHER 17 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 11534-197 CAPSULE 2.50 mg ORAL ANDA 19 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 42494-409 CAPSULE 2.50 mg ORAL NDA authorized generic 20 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 42582-300 CAPSULE 2.50 mg ORAL UNULLPPROVED DRUG OTHER 18 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 42582-301 CAPSULE 2.50 mg ORAL UNULLPPROVED DRUG OTHER 18 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 43598-706 CAPSULE 2.50 mg ORAL ANDA 15 sections
Chlordiazepoxide Hydrochloride/Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 50090-0131 CAPSULE 2.50 mg ORAL Unapproved drug other 19 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 50090-1528 CAPSULE 2.50 mg ORAL NDA authorized generic 18 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 51293-607 CAPSULE 2.50 mg ORAL UNULLPPROVED DRUG OTHER 18 sections
Chlordiazepoxide Hydrochloride/Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 51293-696 CAPSULE 2.50 mg ORAL ANDA 20 sections
Chlordiazepoxide Hydrochloride/Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 63629-2021 CAPSULE 2.50 mg ORAL ANDA 19 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 63629-2146 CAPSULE 2.50 mg ORAL NDA authorized generic 20 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 63629-2373 CAPSULE 2.50 mg ORAL ANDA 19 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide Human Prescription Drug Label 2 67877-731 CAPSULE 2.50 mg ORAL ANDA 18 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 68151-2500 CAPSULE 2.50 mg ORAL NDA authorized generic 18 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 69189-0489 CAPSULE 2.50 mg ORAL NDA authorized generic 18 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 70700-185 CAPSULE 2.50 1 ORAL ANDA 18 sections
Chlordiazepoxide Hydrochloride and Clidinium Bromide HUMAN PRESCRIPTION DRUG LABEL 2 71186-006 CAPSULE, GELATIN COATED 2.50 mg ORAL UNULLPPROVED DRUG OTHER 19 sections