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ipratropium 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
atropine derivatives	1475	60205-81-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ipratropium ipratropium bromide ipratropium bromide hydrate ipratropium bromide monohydrate	A muscarinic antagonist structurally related to ATROPINE but often considered safer and more effective for inhalation use. It is used for various bronchial disorders, in rhinitis, and as an antiarrhythmic. Molecular weight: 332.46 Formula: C20H30NO3 CLOGP: -2.19 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 46.53 ALOGS: -5.48 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ipratropium
ipratropium bromide
ipratropium bromide hydrate
ipratropium bromide monohydrate

A muscarinic antagonist structurally related to ATROPINE but often considered safer and more effective for inhalation use. It is used for various bronchial disorders, in rhinitis, and as an antiarrhythmic.

Molecular weight: 332.46
Formula: C20H30NO3
CLOGP: -2.19
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 46.53
ALOGS: -5.48
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.24	mg	N
0.12	mg	Inhal.aerosol
0.12	mg	Inhal.powder
0.30	mg	Inhal.solution

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	50 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	5.10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	31.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	3 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	1.64 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.95 %	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
Dec. 29, 1986	FDA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	1287.45	10.87	1005	56755	126556	63304706
Wheezing	829.22	10.87	690	57070	94905	63336357
Obstructive airways disorder	580.70	10.87	311	57449	20388	63410874
Chronic obstructive pulmonary disease	494.91	10.87	429	57331	62257	63369005
Dyspnoea	480.94	10.87	1502	56258	659811	62771451
Sleep disorder due to a general medical condition	341.40	10.87	183	57577	12005	63419257
Pneumonia	254.40	10.87	951	56809	455816	62975446
Cough	254.23	10.87	710	57050	292033	63139229
Productive cough	245.35	10.87	295	57465	62913	63368349
Chest discomfort	222.52	10.87	376	57384	109593	63321669

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	699.67	11.82	511	43180	42145	34871095
Wheezing	548.83	11.82	437	43254	40965	34872275
Chronic obstructive pulmonary disease	467.56	11.82	428	43263	48490	34864750
Obstructive airways disorder	453.62	11.82	267	43424	15227	34898013
Dyspnoea	330.60	11.82	1125	42566	375657	34537583
Asthma-chronic obstructive pulmonary disease overlap syndrome	269.88	11.82	89	43602	1198	34912042
Appendicolith	240.62	11.82	144	43547	8457	34904783
Full blood count abnormal	193.19	11.82	171	43520	18497	34894743
Appendicitis	182.58	11.82	150	43541	14657	34898583
Stress	174.09	11.82	202	43489	30145	34883095

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	1620.56	10.55	1263	84523	133832	79524770
Wheezing	1072.03	10.55	935	84851	115729	79542873
Obstructive airways disorder	870.78	10.55	496	85290	30963	79627639
Chronic obstructive pulmonary disease	846.12	10.55	715	85071	84704	79573898
Dyspnoea	599.62	10.55	2148	83638	854877	78803725
Full blood count abnormal	376.33	10.55	327	85459	40147	79618455
Asthma-chronic obstructive pulmonary disease overlap syndrome	352.05	10.55	132	85654	3089	79655513
Productive cough	348.69	10.55	452	85334	87879	79570723
Cough	336.09	10.55	1010	84776	365779	79292823
Pneumonia	322.54	10.55	1483	84303	658763	78999839

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	R01AX03	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Other nasal preparations
ATC	R03AL01	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL02	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03BB01	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Anticholinergics
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:48876	muscarinic antagonists
CHEBI has role	CHEBI:53784	antispasmodics
FDA EPC	N0000175574	Anticholinergic
FDA MoA	N0000175370	Cholinergic Antagonists
MeSH PA	D018927	Anti-Asthmatic Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Bronchospasm	indication	4386001
Chronic obstructive lung disease	indication	13645005	DOID:3083
Bronchitis	indication	32398004	DOID:6132
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Pulmonary emphysema	indication	87433001
Chronic Obstructive Pulmonary Disease with Bronchospasms	indication
Asthma	off-label use	195967001	DOID:2841
Asthma-chronic obstructive pulmonary disease overlap syndrome	off-label use	10692761000119107
Ocular hypertension	contraindication	4210003	DOID:9282

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.24	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	9.29	WOMBAT-PK	CHEMBL
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	8.82	WOMBAT-PK
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	9.18	WOMBAT-PK
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	8.77	WOMBAT-PK
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	9.31	WOMBAT-PK
Solute carrier family 22 member 2	Transporter	O15244	S22A2_HUMAN		IC50	4.82	WOMBAT-PK
Muscarinic acetylcholine receptor M2	GPCR		ACM2_RAT		Ki	9.11	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR		ACM1_RAT		Ki	9.54	CHEMBL
Muscarinic acetylcholine receptor M3	GPCR		ACM3_RAT		Ki	9.74	CHEMBL

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External reference:

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ID	Source
X8M	PDB_CHEM_ID
001750	NDDF
004943	NDDF
108624006	SNOMEDCT_US
1309404	RXNORM
325	IUPHAR_LIGAND_ID
372518007	SNOMEDCT_US
3746	PUBCHEM_CID
386881005	SNOMEDCT_US
4019341	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Atrovent HFA	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0087	AEROSOL, METERED	17 ug	RESPIRATORY (INHALATION)	NDA	29 sections
Atrovent HFA	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0087	AEROSOL, METERED	17 ug	RESPIRATORY (INHALATION)	NDA	29 sections
AtroventHFA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0961	AEROSOL, METERED	17 ug	RESPIRATORY (INHALATION)	NDA	25 sections
Combivent Respimat	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0024	SPRAY, METERED	20 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Combivent Respimat	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0024	SPRAY, METERED	20 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Ipratropium Bromide	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0045	SPRAY	21 ug	NASAL	ANDA	3 sections
Ipratropium Bromide	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0045	SPRAY	21 ug	NASAL	ANDA	3 sections
Ipratropium Bromide	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0046	SPRAY	42 ug	NASAL	ANDA	16 sections
Ipratropium Bromide	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0046	SPRAY	42 ug	NASAL	ANDA	16 sections
Ipratropium Bromide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7970	SOLUTION	0.50 mg	RESPIRATORY (INHALATION)	ANDA	22 sections

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