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

Stem definition	Drug id	CAS RN
bronchodilators, phenethylamine derivatives	1575	34391-04-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: xopenex levalbuterol HCl levosalbutamol (-)-Salbutamol (R)-Salbutamol levalbuterol levalbuterol hydrochloride levalbuterol tartrate	The R-isomer of albuterol. 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:

xopenex
levalbuterol HCl
levosalbutamol
(-)-Salbutamol
(R)-Salbutamol
levalbuterol
levalbuterol hydrochloride
levalbuterol tartrate

The R-isomer of albuterol.

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:

None

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	46 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.23 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	180 mg/mL	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
March 25, 1999	FDA	OAK PHARMS INC

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	222.92	13.04	221	17138	127340	63344323
Infective pulmonary exacerbation of cystic fibrosis	141.84	13.04	62	17297	8755	63462908
Chronic obstructive pulmonary disease	121.32	13.04	115	17244	62571	63409092
Pneumonia	94.98	13.04	307	17052	456460	63015203
Bronchitis	89.15	13.04	138	17221	124797	63346866
Dyspnoea	78.99	13.04	373	16986	660940	62810723
Sinusitis	78.64	13.04	184	17175	226469	63245194
Infusion site erythema	54.43	13.04	36	17323	11643	63460020
Product quality issue	51.44	13.04	56	17303	35809	63435854
Cystic fibrosis	49.21	13.04	22	17337	3274	63468389

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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
Infective pulmonary exacerbation of cystic fibrosis	114.53	17.06	44	6314	6757	34943816
Asthma	89.84	17.06	69	6289	42587	34907986
Dyspnoea	56.61	17.06	173	6185	376609	34573964
Chronic obstructive pulmonary disease	50.63	17.06	53	6305	48865	34901708
Pneumonia	46.66	17.06	158	6200	362469	34588104
Cough	37.95	17.06	84	6274	150056	34800517
Sinusitis	37.81	17.06	42	6316	41360	34909213
Respiratory distress	35.74	17.06	38	6320	35627	34914946
Upper respiratory tract infection	32.73	17.06	35	6323	33024	34917549
Toxic optic neuropathy	31.86	17.06	10	6348	840	34949733

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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
Infective pulmonary exacerbation of cystic fibrosis	185.99	13.96	78	16951	12773	79714586
Asthma	169.95	13.96	175	16854	134920	79592439
Chronic obstructive pulmonary disease	128.40	13.96	122	16907	85297	79642062
Dyspnoea	97.18	13.96	400	16629	856625	78870734
Pneumonia	83.39	13.96	319	16710	659927	79067432
Bronchitis	70.39	13.96	111	16918	130533	79596826
Cystic fibrosis	67.91	13.96	27	17002	3853	79723506
Product quality issue	63.78	13.96	55	16974	33885	79693474
Cough	63.44	13.96	197	16832	366592	79360767
Respiratory distress	46.84	13.96	60	16969	58279	79669080

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
FDA EPC	N0000175779	beta2-Adrenergic Agonist
FDA MoA	N0000009922	Adrenergic beta2-Agonists

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

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Disease	Relation	SNOMED_ID	DOID
Bronchospasm	indication	4386001
Acute exacerbation of asthma	indication	708038006
Bronchospasm Prevention	indication
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Hypokalemia	contraindication	43339004
Conduction disorder of the heart	contraindication	44808001
Ketoacidosis	contraindication	56051008
Diabetes mellitus	contraindication	73211009	DOID:9351
Prolonged QT interval	contraindication	111975006

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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	10.07	acidic
pKa2	9.46	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 0.045MG BASE/INH	XOPENEX HFA	LUPIN	N021730	March 11, 2005	RX	AEROSOL, METERED	INHALATION	7256310	Oct. 8, 2024	TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	AGONIST	Ki	5.42		CHEMBL	CHEMBL

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External reference:

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ID	Source
007763	NDDF
007764	NDDF
010710	NDDF
116090007	SNOMEDCT_US
123600	PUBCHEM_CID
14178	MMSL
167701	MMSL
20402	MMSL
237159	RXNORM
398965008	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-4145	SOLUTION	0.31 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-4146	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-4147	SOLUTION, CONCENTRATE	1.25 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-4147	SOLUTION, CONCENTRATE	1.25 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-4148	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9930	SOLUTION	0.31 mg	RESPIRATORY (INHALATION)	ANDA	31 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9930	SOLUTION	0.31 mg	RESPIRATORY (INHALATION)	ANDA	31 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9931	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	ANDA	31 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9931	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	ANDA	31 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9932	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	ANDA	31 sections

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