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:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	180 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	46 %	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

Approvals:

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

FDA Adverse Event Reporting System (Female)

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
Cough	48.68	13.04	183	17176	292560	63179103
Wheezing	45.08	13.04	88	17271	95507	63376156
Drug intolerance	43.62	13.04	15	17344	308646	63163017
Chest discomfort	43.33	13.04	94	17265	109875	63361788
Drug ineffective	42.92	13.04	145	17214	1044620	62427043
Maternal exposure during pregnancy	42.82	13.04	5	17354	220057	63251606
Upper respiratory tract infection	41.72	13.04	78	17281	81969	63389694
Treatment failure	37.56	13.04	5	17354	199038	63272625
Infusion site swelling	35.85	13.04	26	17333	9744	63461919
Ear infection	35.68	13.04	48	17311	38165	63433498
Systemic lupus erythematosus	35.50	13.04	7	17352	208911	63262752
Rheumatoid arthritis	34.72	13.04	13	17346	253806	63217857
Joint swelling	34.10	13.04	24	17335	327642	63144021
Wound	33.59	13.04	3	17356	163260	63308403
Product dose omission issue	32.89	13.04	139	17220	234174	63237489
Infusion site pain	32.70	13.04	31	17328	16838	63454825
Anaphylactic reaction	32.56	13.04	62	17297	66038	63405625
Productive cough	32.02	13.04	60	17299	63148	63408515
Respiratory tract infection	31.20	13.04	47	17312	41436	63430227
Pulmonary function test decreased	30.96	13.04	17	17342	3930	63467733
Respiratory failure	29.23	13.04	77	17282	101781	63369882
Cardiac failure congestive	28.72	13.04	72	17287	92361	63379302
Alopecia	28.69	13.04	30	17329	337506	63134157
Hepatic enzyme increased	26.61	13.04	11	17348	202317	63269346
Pericarditis	25.56	13.04	3	17356	131576	63340087
Chest pain	24.97	13.04	121	17238	215838	63255825
Pseudomonas infection	24.43	13.04	22	17337	11191	63460472
Acute respiratory failure	24.42	13.04	38	17321	34447	63437216
Discomfort	23.85	13.04	8	17351	167366	63304297
Infusion site extravasation	23.80	13.04	21	17338	10405	63461258
Haemoptysis	23.70	13.04	34	17325	28692	63442971
Nasal congestion	23.46	13.04	54	17305	65606	63406057
Anxiety	23.11	13.04	119	17240	217422	63254241
Headache	22.49	13.04	268	17091	632973	62838690
Respiratory distress	22.10	13.04	36	17323	33915	63437748
Bronchospasm paradoxical	21.17	13.04	5	17354	93	63471570
Off label use	21.03	13.04	104	17255	674358	62797305
Viral infection	20.79	13.04	36	17323	35627	63436036
Impaired quality of life	20.59	13.04	22	17337	13761	63457902
Administration site swelling	20.40	13.04	9	17350	1298	63470365
Bronchospasm	19.74	13.04	24	17335	17256	63454407
Therapeutic product effect incomplete	19.60	13.04	5	17354	125051	63346612
Infusion related reaction	19.55	13.04	23	17336	245498	63226165
Poor quality device used	19.28	13.04	10	17349	2061	63469602
Migraine	19.15	13.04	67	17292	103279	63368384
Therapeutic product effect decreased	18.98	13.04	15	17344	193172	63278491
Arthropathy	18.69	13.04	22	17337	234770	63236893
Tracheitis	17.42	13.04	7	17352	800	63470863
Heart rate increased	17.37	13.04	61	17298	94177	63377486
Pulmonary embolism	16.95	13.04	70	17289	116614	63355049
Dysphonia	15.74	13.04	38	17321	47576	63424087
Musculoskeletal stiffness	15.01	13.04	17	17342	184601	63287062
Supraventricular tachycardia	14.99	13.04	19	17340	14252	63457411
Hospitalisation	14.77	13.04	54	17305	85027	63386636
Febrile neutropenia	14.68	13.04	7	17352	118442	63353221
Bronchitis chronic	14.66	13.04	11	17348	4342	63467321
Neutropenia	14.35	13.04	16	17343	174989	63296674
Infusion site rash	14.04	13.04	8	17351	1986	63469677
Pharyngeal oedema	13.99	13.04	18	17341	13703	63457960
General physical health deterioration	13.86	13.04	21	17338	201381	63270282
Hyperacusis	13.60	13.04	8	17351	2105	63469558
COVID-19	13.51	13.04	64	17295	113039	63358624
Infusion site pruritus	13.46	13.04	12	17347	6023	63465640
Status asthmaticus	13.39	13.04	6	17353	898	63470765
Candida infection	13.23	13.04	26	17333	28325	63443338

FDA Adverse Event Reporting System (Male)

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
Status asthmaticus	26.27	17.06	7	6351	328	34950245
Cystic fibrosis	21.87	17.06	9	6349	1649	34948924
Product quality issue	20.42	17.06	20	6338	17015	34933558
Respiratory failure	20.16	17.06	54	6304	108518	34842055
Pulmonary function test decreased	19.93	17.06	12	6346	4963	34945610
Toxicity to various agents	19.69	17.06	6	6352	200356	34750217
Bronchospasm paradoxical	19.50	17.06	4	6354	58	34950515
Ear infection	18.18	17.06	15	6343	10216	34940357

FDA Adverse Event Reporting System (Geriatric)

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
Acute respiratory failure	39.80	13.96	56	16973	59485	79667874
Wheezing	38.33	13.96	80	16949	116584	79610775
Product dose omission issue	38.23	13.96	128	16901	247409	79479950
Sinusitis	37.49	13.96	109	16920	195392	79531967
Infusion site erythema	37.43	13.96	24	17005	9436	79717923
Pulmonary function test decreased	36.89	13.96	22	17007	7615	79719744
Upper respiratory tract infection	32.89	13.96	65	16964	91103	79636256
Chest discomfort	31.45	13.96	82	16947	137962	79589397
Toxic optic neuropathy	31.04	13.96	11	17018	1142	79726217
Respiratory failure	30.11	13.96	96	16933	180815	79546544
Bronchospasm paradoxical	29.87	13.96	7	17022	163	79727196
Infusion site swelling	28.87	13.96	19	17010	7807	79719552
Status asthmaticus	28.35	13.96	10	17019	1024	79726335
Respiratory syncytial virus infection	27.99	13.96	20	17009	9382	79717977
Bronchospasm	27.28	13.96	30	16999	24829	79702530
Treatment failure	25.95	13.96	3	17026	170483	79556876
Tracheitis	25.92	13.96	10	17019	1318	79726041
Toxicity to various agents	25.02	13.96	32	16997	421508	79305851
Impaired quality of life	24.39	13.96	22	17007	14364	79712995
Headache	24.17	13.96	229	16800	653543	79073816
Viral infection	23.76	13.96	37	16992	42979	79684380
Off label use	23.43	13.96	107	16922	907108	78820251
Nasal congestion	23.41	13.96	51	16978	76501	79650858
Infusion site pain	22.71	13.96	21	17008	14155	79713204
Synovitis	22.10	13.96	3	17026	150731	79576628
Drug intolerance	21.59	13.96	15	17014	264104	79463255
Pseudomonas infection	20.85	13.96	24	17005	20879	79706480
Poor quality device used	20.69	13.96	10	17019	2275	79725084
Chest pain	20.30	13.96	116	16913	282188	79445171
Drug abuse	20.08	13.96	5	17024	162686	79564673
Hospitalisation	19.46	13.96	54	16975	94182	79633177
Pulmonary hypertension	19.45	13.96	36	16993	48044	79679315
Hypoxia	19.23	13.96	57	16972	103186	79624173
Respiratory tract infection	19.13	13.96	36	16993	48653	79678706
Drug interaction	18.54	13.96	38	16991	415145	79312214
Rheumatoid arthritis	18.17	13.96	11	17018	208459	79518900
Joint swelling	18.08	13.96	21	17008	288625	79438734
Haemoptysis	17.91	13.96	38	16991	55961	79671398
Heart rate increased	17.35	13.96	61	16968	120663	79606696
Hepatic enzyme increased	16.83	13.96	9	17020	182601	79544758
Ear infection	16.81	13.96	28	17001	34404	79692955
Anhedonia	16.38	13.96	18	17011	14880	79712479
Anaphylactic reaction	16.32	13.96	47	16982	83696	79643663
Enterovirus infection	16.07	13.96	8	17021	1939	79725420
Drug ineffective	15.93	13.96	151	16878	1080762	78646597
Anxiety	15.86	13.96	99	16930	248413	79478946
Supraventricular tachycardia	15.70	13.96	21	17008	21249	79706110
Pancytopenia	15.52	13.96	8	17021	165737	79561622
Chronic respiratory failure	15.36	13.96	9	17020	3013	79724346
Carbon dioxide increased	15.02	13.96	8	17021	2232	79725127
Neutropenia	14.92	13.96	24	17005	287686	79439673
Productive cough	14.80	13.96	47	16982	88284	79639075
Intentional product use issue	14.76	13.96	7	17022	152105	79575254
Therapeutic product effect incomplete	14.56	13.96	6	17023	141639	79585720
Migraine	14.15	13.96	46	16983	87447	79639912
Cardiac failure congestive	14.07	13.96	64	16965	142338	79585021

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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
Seizure disorder	contraindication	128613002
Chronic myocardial ischemia	contraindication	413844008	DOID:3393

🐶 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)

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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

ID	Source
D02281	KEGG_DRUG
50293-90-8	SECONDARY_CAS_RN
661464-94-4	SECONDARY_CAS_RN
4021157	VANDF
C0772501	UMLSCUI
CHEBI:8746	CHEBI
68H	PDB_CHEM_ID
CHEMBL1002	ChEMBL_ID
DB13139	DRUGBANK_ID
CHEMBL1201061	ChEMBL_ID
CHEMBL3989693	ChEMBL_ID
123600	PUBCHEM_CID
9816	IUPHAR_LIGAND_ID
237159	RXNORM
14178	MMSL
167701	MMSL
20402	MMSL
8043	MMSL
d04427	MMSL
007763	NDDF
007764	NDDF
010710	NDDF
116090007	SNOMEDCT_US
398965008	SNOMEDCT_US
412236007	SNOMEDCT_US
426604008	SNOMEDCT_US
D064412	MESH_DESCRIPTOR_UI
7681	INN_ID
EDN2NBH5SS	UNII

Pharmaceutical products:

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
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9932	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	ANDA	31 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6993	SOLUTION, CONCENTRATE	1.25 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-9690	SOLUTION	0.31 mg	RESPIRATORY (INHALATION)	ANDA	28 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-9691	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	ANDA	28 sections
Levalbuterol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-9692	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	ANDA	28 sections
Levalbuterol tartrate HFA inhalation	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2927	AEROSOL, METERED	45 ug	ORAL	NDA AUTHORIZED GENERIC	27 sections
Levalbuterol tartrate HFA inhalation	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2927	AEROSOL, METERED	45 ug	ORAL	NDA AUTHORIZED GENERIC	27 sections
Levalbuterol Inhalation Solution	Human Prescription Drug Label	1	16714-094	SOLUTION	0.31 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol Inhalation Solution	Human Prescription Drug Label	1	16714-094	SOLUTION	0.31 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol Inhalation Solution	Human Prescription Drug Label	1	16714-095	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol Inhalation Solution	Human Prescription Drug Label	1	16714-095	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol Inhalation Solution	Human Prescription Drug Label	1	16714-096	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Levalbuterol Inhalation Solution	Human Prescription Drug Label	1	16714-096	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Xopenex	HUMAN PRESCRIPTION DRUG LABEL	1	17478-171	SOLUTION, CONCENTRATE	1.25 mg	RESPIRATORY (INHALATION)	NDA	27 sections
Xopenex	HUMAN PRESCRIPTION DRUG LABEL	1	17478-171	SOLUTION, CONCENTRATE	1.25 mg	RESPIRATORY (INHALATION)	NDA	27 sections
Xopenex	HUMAN PRESCRIPTION DRUG LABEL	1	17478-172	SOLUTION	0.31 mg	RESPIRATORY (INHALATION)	NDA	27 sections
Xopenex	HUMAN PRESCRIPTION DRUG LABEL	1	17478-172	SOLUTION	0.31 mg	RESPIRATORY (INHALATION)	NDA	27 sections
Xopenex	HUMAN PRESCRIPTION DRUG LABEL	1	17478-173	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	NDA	27 sections
Xopenex	HUMAN PRESCRIPTION DRUG LABEL	1	17478-173	SOLUTION	0.63 mg	RESPIRATORY (INHALATION)	NDA	27 sections
Xopenex	HUMAN PRESCRIPTION DRUG LABEL	1	17478-174	SOLUTION	1.25 mg	RESPIRATORY (INHALATION)	NDA	27 sections