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

Stem definition	Drug id	CAS RN
oxytocin derivatives	2042	50-56-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxytocin orasthin oxystin partocon perlacton synthetic oxytocin	A nonapeptide hormone released from the neurohypophysis (PITUITARY GLAND, POSTERIOR). It differs from VASOPRESSIN by two amino acids at residues 3 and 8. Oxytocin acts on SMOOTH MUSCLE CELLS, such as causing UTERINE CONTRACTIONS and MILK EJECTION. Molecular weight: 1007.19 Formula: C43H66N12O12S2 CLOGP: 0.06 LIPINSKI: 3 HAC: 24 HDO: 12 TPSA: 399.53 ALOGS: -4.26 ROTB: 17 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxytocin
orasthin
oxystin
partocon
perlacton
synthetic oxytocin

A nonapeptide hormone released from the neurohypophysis (PITUITARY GLAND, POSTERIOR). It differs from VASOPRESSIN by two amino acids at residues 3 and 8. Oxytocin acts on SMOOTH MUSCLE CELLS, such as causing UTERINE CONTRACTIONS and MILK EJECTION.

Molecular weight: 1007.19
Formula: C43H66N12O12S2
CLOGP: 0.06
LIPINSKI: 3
HAC: 24
HDO: 12
TPSA: 399.53
ALOGS: -4.26
ROTB: 17

Status: OFP

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

Drug dosage:

Dose	Unit	Route
15	U	N
200	U	O
15	U	P

ADMET properties:

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Property	Value	Reference
S (Water solubility)	12 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
April 17, 1980	FDA	NOVARTIS

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
Exposure during pregnancy	873.17	33.28	361	4807	155186	63328668
Maternal exposure during pregnancy	565.52	33.28	298	4870	219764	63264090
Postpartum haemorrhage	386.38	33.28	75	5093	1906	63481948
Maternal exposure during delivery	381.57	33.28	71	5097	1429	63482425
Premature delivery	251.55	33.28	94	5074	30187	63453667
Hypotension	204.62	33.28	172	4996	272432	63211422
Caesarean section	202.44	33.28	69	5099	16963	63466891
Uterine atony	195.08	33.28	30	5138	174	63483680
Normal newborn	165.88	33.28	50	5118	8291	63475563
Uterine rupture	133.39	33.28	28	5140	1058	63482796

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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
Foetal exposure during pregnancy	378.83	106.85	89	384	38012	34918446
Premature baby	204.21	106.85	48	425	19585	34936873
Low birth weight baby	117.66	106.85	26	447	7879	34948579

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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
Exposure during pregnancy	814.80	36.87	275	4063	100857	79639193
Maternal exposure during pregnancy	723.05	36.87	272	4066	136266	79603784
Postpartum haemorrhage	372.45	36.87	66	4272	1529	79738521
Maternal exposure during delivery	363.25	36.87	63	4275	1283	79738767
Premature delivery	282.42	36.87	87	4251	23380	79716670
Uterine atony	202.28	36.87	29	4309	155	79739895
Caesarean section	200.78	36.87	58	4280	12477	79727573
Normal newborn	184.32	36.87	48	4290	7024	79733026
Pre-eclampsia	132.65	36.87	37	4301	7004	79733046
Ventilation perfusion mismatch	126.44	36.87	23	4315	617	79739433

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	G02AC01	GENITO URINARY SYSTEM AND SEX HORMONES OTHER GYNECOLOGICALS UTEROTONICS Ergot alkaloids and oxytocin incl. analogues, in combination
ATC	H01BB02	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES POSTERIOR PITUITARY LOBE HORMONES Oxytocin and analogues
CHEBI has role	CHEBI:35620	vasodilator agents
CHEBI has role	CHEBI:36063	oxytocic agents
FDA CS	M0015703	Oxytocin
FDA EPC	N0000175828	Oxytocic
FDA PE	N0000009705	Increased Uterine Smooth Muscle Contraction or Tone
MeSH PA	D010120	Oxytocics
MeSH PA	D012102	Reproductive Control 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
Postpartum hemorrhage	indication	47821001
Incomplete miscarriage	indication	156072005
Induction of labor	indication	236958009
Pregnancy with abortive outcome	indication	363681007
Placental Reserve Studies	off-label use
Multiple pregnancy	contraindication	16356006
Grand multipara	contraindication	18656007
Placenta previa	contraindication	36813001	DOID:11060
Hypertensive disorder	contraindication	38341003	DOID:10763
Fetal distress	contraindication	130955003

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris	Indication
Cats	Postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood	Indication
Cattle	Uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris	Indication
Cattle	Postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood	Indication
Cattle	Contracts smooth muscle cells of the mammary gland for milk letdown	Indication
Dogs	Uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris	Indication
Dogs	Postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood	Indication
Horses	Uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris	Indication
Horses	Postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood	Indication
Sheep	Uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Oxytocin (Label Under Distributors)	Bimeda Animal Health Limited	1
Oxytocin Injectable	Bimeda Animal Health Limited	1
Oxytocin Injection	Zoetis Inc.	1
Oxytocin Injection	Bimeda Animal Health Limited	1
Oxytocin Injection	Bimeda Animal Health Limited	1
PVL Oxytocin Injectable	Bimeda Animal Health Limited	1

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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	9.65	acidic
pKa2	12.47	acidic
pKa3	12.94	acidic
pKa4	13.18	acidic
pKa5	13.47	acidic
pKa6	13.7	acidic
pKa7	13.89	acidic
pKa8	6.4	Basic

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Orange Book patent data (new drug applications)

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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
Oxytocin receptor	GPCR	P30559	OXYR_HUMAN	AGONIST	Ki	9.10	CHEMBL	CHEMBL
Vasopressin V1b receptor	GPCR	P47901	V1BR_HUMAN		EC50	6.35	WOMBAT-PK
Vasopressin V2 receptor	GPCR	P30518	V2R_HUMAN		EC50	6.10	WOMBAT-PK
Oxytocin-neurophysin 1	Secreted	P01178	NEU1_HUMAN				WOMBAT-PK
Vasopressin V1a receptor	GPCR	P37288	V1AR_HUMAN		EC50	6.91	WOMBAT-PK
Oxytocin receptor	GPCR		OXYR_RAT		Ki	9.05	CHEMBL
Vasopressin V2 receptor	GPCR		V2R_RAT		Ki	7.21	CHEMBL
Vasopressin V1a receptor	GPCR		V1AR_RAT	AGONIST	Ki	6.10	IUPHAR

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External reference:

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ID	Source
001307	NDDF
112115002	SNOMEDCT_US
12369008	SNOMEDCT_US
1480	INN_ID
1JQS135EYN	UNII
2174	IUPHAR_LIGAND_ID
4018039	VUID
4018039	VANDF
439302	PUBCHEM_CID
4537	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9742	INJECTION	10 [USPU]	INTRAMUSCULAR	ANDA	20 sections
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9743	INJECTION	10 [USPU]	INTRAMUSCULAR	ANDA	20 sections
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6114	INJECTION	10 [USPU]	INTRAMUSCULAR	NDA	20 sections
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6115	INJECTION	10 [USPU]	INTRAMUSCULAR	NDA	20 sections
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	52533-048	INJECTION, SOLUTION	10 [USPU]	INTRAVENOUS	unapproved drug other	1 sections
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	52533-051	INJECTION, SOLUTION	2 [USPU]	INTRAVENOUS	unapproved drug other
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	52533-054	INJECTION, SOLUTION	30 [USPU]	INTRAVENOUS	unapproved drug other
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	52533-055	INJECTION, SOLUTION	30 [USPU]	INTRAVENOUS	unapproved drug other
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	52533-056	INJECTION, SOLUTION	15 [USPU]	INTRAVENOUS	unapproved drug other	1 sections
Oxytocin	HUMAN PRESCRIPTION DRUG LABEL	1	52533-056	INJECTION, SOLUTION	30 [USPU]	INTRAVENOUS	unapproved drug other	1 sections

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