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

Stem definition	Drug id	CAS RN
bronchodilators, phenethylamine derivatives	105	18559-94-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: salbutamol albuterol sabumol dl-Albuterol dl-Salbutamol albuterol sulfate	A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol. Molecular weight: 239.32 Formula: C13H21NO3 CLOGP: 0.06 LIPINSKI: 0 HAC: 4 HDO: 4 TPSA: 72.72 ALOGS: -2.05 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

salbutamol
albuterol
sabumol
dl-Albuterol
dl-Salbutamol
albuterol sulfate

A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.

Molecular weight: 239.32
Formula: C13H21NO3
CLOGP: 0.06
LIPINSKI: 0
HAC: 4
HDO: 4
TPSA: 72.72
ALOGS: -2.05
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.80	mg	Inhal.aerosol
0.80	mg	Inhal.powder
10	mg	Inhal.solution
12	mg	O
12	mg	P

ADMET properties:

Show entries

Search:

Property	Value	Reference
CL (Clearance)	7.80 mL/min/kg	Lombardo F, Berellini G, Obach RS
S (Water solubility)	68 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	50 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	2.40 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.23 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	1.90 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.92 %	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	0.44 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability)	0.02 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Showing 1 to 10 of 10 entries

Previous1Next

Approvals:

Date	Agency	Company	Orphan
May 1, 1981	FDA	SCHERING

FDA Adverse Event Reporting System (Female)

Show entries

Search:

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	5787.47	10.06	5559	414776	122002	62946685
Wheezing	3285.89	10.06	3591	416744	92004	62976683
Dyspnoea	2503.34	10.06	9792	410543	651521	62417166
Obstructive airways disorder	1950.71	10.06	1382	418953	19317	63049370
Cough	1558.08	10.06	4862	415473	287881	62780806
Sleep disorder due to a general medical condition	1464.26	10.06	946	419389	11242	63057445
Full blood count abnormal	1377.37	10.06	1352	418983	30365	63038322
Poor quality device used	1333.81	10.06	506	419829	1565	63067122
Product quality issue	1331.95	10.06	1405	418930	34460	63034227
Productive cough	1120.34	10.06	1712	418623	61496	63007191

Showing 1 to 10 of 921 entries

Previous1 2 3 4 5…93Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

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	3746.51	10.86	2624	207672	40032	34706603
Wheezing	2794.10	10.86	2174	208122	39228	34707407
Dyspnoea	1754.79	10.86	5596	204700	371186	34375449
Obstructive airways disorder	1233.28	10.86	899	209397	14595	34732040
Sleep disorder due to a general medical condition	1062.34	10.86	552	209744	4669	34741966
Cough	1029.41	10.86	2572	207724	147568	34599067
Full blood count abnormal	1022.76	10.86	869	209427	17799	34728836
Product quality issue	953.77	10.86	803	209493	16232	34730403
Chronic obstructive pulmonary disease	916.05	10.86	1292	209004	47626	34699009
Therapeutic product effect incomplete	853.28	10.86	1271	209025	49270	34697365

Showing 1 to 10 of 668 entries

Previous1 2 3 4 5…67Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

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	6988.22	10.04	6250	505795	128845	79103498
Wheezing	4600.04	10.04	4648	507397	112016	79120327
Dyspnoea	3251.24	10.04	12433	499612	844592	78387751
Obstructive airways disorder	2511.88	10.04	1877	510168	29582	79202761
Cough	2097.23	10.04	6124	505921	360665	78871678
Full blood count abnormal	1972.93	10.04	1814	510231	38660	79193683
Productive cough	1679.07	10.04	2432	509613	85899	79146444
Sleep disorder due to a general medical condition	1585.74	10.04	1043	511002	13234	79219109
Chronic obstructive pulmonary disease	1481.51	10.04	2253	509792	83166	79149177
Poor quality device used	1472.65	10.04	554	511491	1731	79230612

Showing 1 to 10 of 1,116 entries

Previous1 2 3 4 5…112Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	R03AC02	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Selective beta-2-adrenoreceptor agonists
ATC	R03AK04	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK13	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AL02	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03CC02	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS FOR SYSTEMIC USE Selective beta-2-adrenoreceptor agonists
CHEBI has role	CHEBI:35522	beta-adrenergic agonists
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:78298	environmental contaminants
FDA EPC	N0000175779	beta2-Adrenergic Agonist

Showing 1 to 10 of 22 entries

Previous1 2 3Next

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

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Bronchospasm	indication	4386001
Acute exacerbation of asthma	indication	708038006
Bronchospasm Prevention	indication
Exercise-Induced Bronchospasm Prevention	indication
Chronic Obstructive Pulmonary Disease with Bronchospasms	indication
Chronic obstructive lung disease	off-label use	13645005	DOID:3083
Ocular hypertension	contraindication	4210003	DOID:9282
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Hypokalemia	contraindication	43339004

Showing 1 to 10 of 24 entries

Previous1 2 3Next

🐶 Veterinary Drug Use

Show entries

Search:

Species	Use	Relation
Horses	Immediate relief of bronchospasm and bronchoconstriction associated with reversible airway obstruction	Indication

Showing 1 to 1 of 1 entries

Previous1Next

🐶 Veterinary products

Product	Applicant	Ingredients
Torpex	Boehringer lngelheim Animal Health USA Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.07	acidic
pKa2	9.46	Basic

Orange Book patent data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 90MCG BASE/INH;80MCG/INH	AIRSUPRA	ASTRAZENECA	N214070	Jan. 10, 2023	RX	AEROSOL, METERED	INHALATION	9415009	May 28, 2030	AS-NEEDED TREATMENT OR PREVENTION OF BRONCHOCONSTRICTION AND REDUCTION OF THE RISK OF EXACERBATIONS IN PATIENTS WITH ASTHMA 18 YEARS OF AGE AND OLDER

Showing 1 to 1 of 1 entries

Previous1Next

Orange Book exclusivity data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 90MCG BASE/INH;80MCG/INH	AIRSUPRA	ASTRAZENECA	N214070	Jan. 10, 2023	RX	AEROSOL, METERED	INHALATION	Jan. 10, 2026	NEW PRODUCT

Showing 1 to 1 of 1 entries

Previous1Next

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	AGONIST	Ki	5.95	WOMBAT-PK	CHEMBL
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN		Ki	5.61	PDSP
Beta-2 adrenergic receptor	GPCR		ADRB2_CAVPO		Kd	5.94	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_BOVIN		Kd	6.28	CHEMBL

Showing 1 to 4 of 4 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
68H	PDB_CHEM_ID
001814	NDDF
001815	NDDF
142153	RXNORM
2083	PUBCHEM_CID
2585	INN_ID
3007	MMSL
30960	MMSL
372897005	SNOMEDCT_US
4018796	VUID

Showing 1 to 10 of 30 entries

Previous1 2 3Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Albuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0255	TABLET	2 mg	ORAL	ANDA	23 sections
Albuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0572	TABLET	4 mg	ORAL	ANDA	23 sections
Albuterol Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0742	AEROSOL, METERED	90 ug	RESPIRATORY (INHALATION)	ANDA	14 sections
Albuterol Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0742	AEROSOL, METERED	90 ug	RESPIRATORY (INHALATION)	ANDA	14 sections
Albuterol Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0254-1007	AEROSOL, METERED	108 ug	RESPIRATORY (INHALATION)	NDA authorized generic	24 sections
Albuterol Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6991	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	NDA authorized generic	26 sections
Albuterol Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6991	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	NDA authorized generic	26 sections
Albuterol Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6991	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	NDA authorized generic	26 sections
Albuterol Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6992	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	NDA authorized generic	26 sections
Albuterol Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6992	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	NDA authorized generic	26 sections

Showing 1 to 10 of 30 entries

Previous1 2 3Next