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

Stem definition	Drug id	CAS RN
sympathomimetic, phenethyl derivatives	1028	51-43-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: epinephrine vasoconstrictine nephridine renoform suprarenin epinephrine bitartrate (-)-adrenaline epinephrine hydrochloride	The active sympathomimetic hormone from the ADRENAL MEDULLA. It stimulates both the alpha- and beta- adrenergic systems, causes systemic VASOCONSTRICTION and gastrointestinal relaxation, stimulates the HEART, and dilates BRONCHI and cerebral vessels. It is used in ASTHMA and CARDIAC FAILURE and to delay absorption of local ANESTHETICS. Molecular weight: 183.21 Formula: C9H13NO3 CLOGP: -0.68 LIPINSKI: 0 HAC: 4 HDO: 4 TPSA: 72.72 ALOGS: -0.99 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

epinephrine
vasoconstrictine
nephridine
renoform
suprarenin
epinephrine bitartrate
(-)-adrenaline
epinephrine hydrochloride

The active sympathomimetic hormone from the ADRENAL MEDULLA. It stimulates both the alpha- and beta- adrenergic systems, causes systemic VASOCONSTRICTION and gastrointestinal relaxation, stimulates the HEART, and dilates BRONCHI and cerebral vessels. It is used in ASTHMA and CARDIAC FAILURE and to delay absorption of local ANESTHETICS.

Molecular weight: 183.21
Formula: C9H13NO3
CLOGP: -0.68
LIPINSKI: 0
HAC: 4
HDO: 4
TPSA: 72.72
ALOGS: -0.99
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.50	mg	P
2.24	mg	Inhal.aerosol
20	mg	Inhal.solution

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
S (Water solubility)	0.18 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.09 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
Nov. 19, 1948	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
Sinusitis	903.90	9.70	1687	134438	224966	63127931
Hereditary angioedema	618.31	9.70	309	135816	7253	63345644
Local anaesthetic systemic toxicity	500.82	9.70	149	135976	750	63352147
Stress cardiomyopathy	491.64	9.70	286	135839	9164	63343733
Anaphylactic reaction	433.16	9.70	617	135508	65483	63287414
Infusion site pain	416.29	9.70	321	135804	16548	63336349
Contraindicated product administered	378.18	9.70	22	136103	217626	63135271
Device failure	372.43	9.70	204	135921	5807	63347090
Infusion site swelling	361.52	9.70	238	135887	9532	63343365
Pemphigus	355.30	9.70	8	136117	183718	63169179

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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
Device failure	372.58	10.53	150	69827	2226	34884728
Drug ineffective	358.82	10.53	1828	68149	454923	34432031
Sinusitis	353.47	10.53	425	69552	40977	34845977
Anaphylactic reaction	353.05	10.53	377	69600	31924	34855030
Anaphylactic shock	268.42	10.53	236	69741	15705	34871249
Anaesthetic complication	244.62	10.53	90	69887	1030	34885924
Cardiac arrest	242.30	10.53	570	69407	95589	34791365
Toxic anterior segment syndrome	194.39	10.53	77	69900	1092	34885862
Methaemoglobinaemia	178.73	10.53	103	69874	3478	34883476
Local anaesthetic systemic toxicity	161.36	10.53	48	69929	262	34886692

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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
Anaphylactic reaction	720.44	9.42	860	157610	82883	79503035
Stress cardiomyopathy	626.92	9.42	346	158124	10820	79575098
Local anaesthetic systemic toxicity	614.95	9.42	178	158292	876	79585042
Toxic anterior segment syndrome	531.79	9.42	202	158268	2562	79583356
Cardiac arrest	526.57	9.42	1098	157372	170998	79414920
Anaesthetic complication	496.74	9.42	194	158276	2665	79583253
Anaphylactic shock	481.20	9.42	467	158003	35529	79550389
Hereditary angioedema	380.63	9.42	194	158276	5141	79580777
Kounis syndrome	365.76	9.42	176	158294	4106	79581812
Device failure	348.68	9.42	193	158277	6068	79579850

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FDA Adverse Event Reporting System (Pediatric)

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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
Methaemoglobinaemia	32.77	29.15	10	151	71	89560
Cardiac arrest neonatal	31.31	29.15	10	151	84	89547

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Pharmacologic Action:

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Source	Code	Description
ATC	A01AD01	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Other agents for local oral treatment
ATC	B02BC09	BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS VITAMIN K AND OTHER HEMOSTATICS Local hemostatics
ATC	C01CA24	CARDIOVASCULAR SYSTEM CARDIAC THERAPY CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES Adrenergic and dopaminergic agents
ATC	R01AA14	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Sympathomimetics, plain
ATC	R03AA01	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Alpha- and beta-adrenoreceptor agonists
ATC	R03AK01	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	S01EA01	SENSORY ORGANS OPHTHALMOLOGICALS ANTIGLAUCOMA PREPARATIONS AND MIOTICS Sympathomimetics in glaucoma therapy
ATC	S01EA51	SENSORY ORGANS OPHTHALMOLOGICALS ANTIGLAUCOMA PREPARATIONS AND MIOTICS Sympathomimetics in glaucoma therapy
CHEBI has role	CHEBI:24621	hormones
CHEBI has role	CHEBI:35522	beta-adrenergic agonists

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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
Bronchiectasis	indication	12295008	DOID:9563
Bronchitis	indication	32398004	DOID:6132
Anaphylaxis	indication	39579001
Local anesthesia, by infiltration	indication	44596000
Low blood pressure	indication	45007003
Wheezing	indication	56018004
Hypotension associated with septic shock	indication	76571007
Open-angle glaucoma	indication	84494001	DOID:1067
Pulmonary emphysema	indication	87433001
Dyspnea	indication	267036007

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.97	acidic
pKa2	12.82	acidic
pKa3	13.64	acidic
pKa4	8.71	Basic

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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
0.15MG/0.3ML (0.15MG/0.3ML)	SYMJEPI	ADAMIS PHARMS CORP	N207534	Sept. 27, 2018	RX	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	11141540	Oct. 20, 2036	A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF EPINEPHRINE
0.3MG/0.3ML (0.3MG/0.3ML)	SYMJEPI	ADAMIS PHARMS CORP	N207534	June 15, 2017	RX	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	11141540	Oct. 20, 2036	A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF EPINEPHRINE
10MG/250ML (40MCG/ML)	EPINEPHRINE IN 0.9% SODIUM CHLORIDE	PAR STERILE PRODUCTS	N215875	April 21, 2023	RX	SOLUTION	INTRAVENOUS	11083698	March 21, 2039	TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
1MG/ML (1MG/ML)	EPINEPHRINE	BPI LABS	N205029	July 29, 2014	RX	SOLUTION	INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	10004700	Aug. 14, 2034	EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE 1), INCLUDING ANAPHYLAXIS; A METHOD OF TREATING ALLERGIC REACTION, ANAPHYLAXIS, ANAPHYLACTIC SHOCK, OR COMBINATION THEREOF BY AN INJECTION OF AT LEAST ONE DOSAGE OF THE INJECTABLE LIQUID PHARMACEUTICAL
1MG/ML (1MG/ML)	EPINEPHRINE	BPI LABS	N205029	July 29, 2014	RX	SOLUTION	INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	10039728	Aug. 14, 2034	INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
1MG/ML (1MG/ML)	EPINEPHRINE	BPI LABS	N205029	July 29, 2014	RX	SOLUTION	INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	9283197	Aug. 15, 2034	EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
1MG/ML (1MG/ML)	EPINEPHRINE	BPI LABS	N205029	July 29, 2014	RX	SOLUTION	INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	9283197	Aug. 15, 2034	INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
1MG/ML (1MG/ML)	EPINEPHRINE	BPI LABS	N205029	July 29, 2014	RX	SOLUTION	INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	9283197	Aug. 15, 2034	INDUCTION AND MAINTENANCE OF MYDRIASIS DURING INTRAOCULAR SURGERY
2MG/250ML (8MCG/ML)	EPINEPHRINE IN 0.9% SODIUM CHLORIDE	PAR STERILE PRODUCTS	N215875	April 21, 2023	RX	SOLUTION	INTRAVENOUS	11083698	March 21, 2039	TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
4MG/250ML (16MCG/ML)	EPINEPHRINE IN 0.9% SODIUM CHLORIDE	PAR STERILE PRODUCTS	N215875	April 21, 2023	RX	SOLUTION	INTRAVENOUS	11083698	March 21, 2039	TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN	AGONIST	Ki	6.66	CHEMBL	CHEMBL
Alpha-1B adrenergic receptor	GPCR	P35368	ADA1B_HUMAN	AGONIST	Ki	6.50	IUPHAR	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	AGONIST	Ki	6.56	DRUG MATRIX	CHEMBL
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	AGONIST	Kd	6.20	CHEMBL	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN	AGONIST	Ki	5.70	CHEMBL	CHEMBL
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN	AGONIST	Ki	6.40	DRUG MATRIX	CHEMBL
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN	AGONIST	Ki	6.45	DRUG MATRIX	CHEMBL
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN		Ki	5.40	PDSP
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN		Kd	4.26	CHEMBL
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	6.04	CHEMBL

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External reference:

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ID	Source
001774	NDDF
001776	NDDF
006223	NDDF
126134000	SNOMEDCT_US
203180	RXNORM
2142	INN_ID
3451	MMSL
3500	MMSL
387362001	SNOMEDCT_US
4018032	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Epinephrine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5985	INJECTION	0.15 mg	INTRAMUSCULAR	ANDA	24 sections
Epinephrine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5986	INJECTION	0.30 mg	INTRAMUSCULAR	ANDA	24 sections
epinephrine	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1694	INJECTION	0.30 mg	SUBCUTANEOUS	NDA AUTHORIZED GENERIC	25 sections
epinephrine	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1694	INJECTION	0.30 mg	SUBCUTANEOUS	NDA AUTHORIZED GENERIC	25 sections
epinephrine	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1695	INJECTION	0.15 mg	SUBCUTANEOUS	NDA AUTHORIZED GENERIC	25 sections
epinephrine	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1695	INJECTION	0.15 mg	SUBCUTANEOUS	NDA AUTHORIZED GENERIC	25 sections
Lidocaine	HUMAN PRESCRIPTION DRUG LABEL	2	0362-0262	INJECTION, SOLUTION	0.02 mg	SUBCUTANEOUS	ANDA	23 sections
Lidocaine	HUMAN PRESCRIPTION DRUG LABEL	2	0362-0262	INJECTION, SOLUTION	0.02 mg	SUBCUTANEOUS	ANDA	23 sections
Lidocaine	HUMAN PRESCRIPTION DRUG LABEL	2	0362-0898	INJECTION, SOLUTION	0.01 mg	SUBCUTANEOUS	ANDA	23 sections
Lidocaine	HUMAN PRESCRIPTION DRUG LABEL	2	0362-0898	INJECTION, SOLUTION	0.01 mg	SUBCUTANEOUS	ANDA	23 sections

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