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

Stem definition	Drug id	CAS RN
steroids, progestogens	4189	630-56-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxyprogesterone caproate 17-alpha-hydroxy-progesterone caproate delalutin 17alpha-hydroxyprogesterone makena 17alpha-Hydroxyprogesterone hexanoate hydroxyprogesterone hexanoate progesterone caproate gestageno hydroxyprogesterone caproate	Hydroxyprogesterone derivative that acts as a PROGESTIN and is used to reduce the risk of recurrent MISCARRIAGE and of PREMATURE BIRTH. It is also used in combination with ESTROGEN in the management of MENSTRUATION DISORDERS. Molecular weight: 428.61 Formula: C27H40O4 CLOGP: 5.99 LIPINSKI: 1 HAC: 4 HDO: 0 TPSA: 60.44 ALOGS: -5.69 ROTB: 7 Status: OFM Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxyprogesterone caproate
17-alpha-hydroxy-progesterone caproate
delalutin
17alpha-hydroxyprogesterone
makena
17alpha-Hydroxyprogesterone hexanoate
hydroxyprogesterone hexanoate
progesterone caproate
gestageno
hydroxyprogesterone caproate

Hydroxyprogesterone derivative that acts as a PROGESTIN and is used to reduce the risk of recurrent MISCARRIAGE and of PREMATURE BIRTH. It is also used in combination with ESTROGEN in the management of MENSTRUATION DISORDERS.

Molecular weight: 428.61
Formula: C27H40O4
CLOGP: 5.99
LIPINSKI: 1
HAC: 4
HDO: 0
TPSA: 60.44
ALOGS: -5.69
ROTB: 7

Status: OFM

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

Drug dosage:

Dose	Unit	Route
10	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Oct. 3, 1975	FDA	ACTAVIS LABS UT 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
Preterm premature rupture of membranes	1599.39	68.67	254	7635	1155	63479978
Premature baby	1320.11	68.67	338	7551	20397	63460736
Injection site pruritus	1185.87	68.67	368	7521	44748	63436385
Injection site pain	1154.68	68.67	473	7416	129327	63351806
Premature labour	679.00	68.67	180	7709	12324	63468809
Injection site swelling	548.33	68.67	210	7679	47362	63433771
Injection site mass	547.05	68.67	166	7723	18490	63462643
Uterine contractions during pregnancy	526.82	68.67	86	7803	474	63480659
Inappropriate schedule of product administration	504.23	68.67	249	7640	103716	63377417
Product dose omission issue	491.39	68.67	324	7565	233989	63247144

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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
Premature baby	2480.75	1066.51	371	137	19262	34937161

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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
Preterm premature rupture of membranes	1714.39	86	251	6128	1022	79736987
Injection site pain	1105.28	86	406	5973	129432	79608577
Injection site pruritus	1069.57	86	303	6076	41980	79696029
Premature labour	773.82	86	170	6209	8220	79729789
Uterine contractions during pregnancy	529.34	86	79	6300	371	79737638
Product dose omission issue	522.22	86	293	6086	247244	79490765
Inappropriate schedule of product administration	521.60	86	240	6139	133388	79604621
Injection site swelling	502.68	86	175	6204	46957	79691052
Injection site mass	470.01	86	136	6243	20048	79717961
Injection site erythema	379.92	86	164	6215	78033	79659976

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	G03DA03	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS Pregnen (4) derivatives
ATC	G03FA02	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS AND ESTROGENS IN COMBINATION Progestogens and estrogens, fixed combinations
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:59826	progestins
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
FDA CS	M0447349	Progesterone Congeners
FDA EPC	N0000175602	Progestin
MeSH PA	D004965	Estrogen Antagonists
MeSH PA	D006727	Hormone Antagonists

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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
Prevention of Premature Labor	indication
Endometrial carcinoma	off-label use	254878006	DOID:2871
Impaired glucose tolerance	contraindication	9414007
Jaundice	contraindication	18165001
Depressive disorder	contraindication	35489007
Migraine	contraindication	37796009	DOID:6364
Hypertensive disorder	contraindication	38341003	DOID:10763
Mild pre-eclampsia	contraindication	41114007
Body fluid retention	contraindication	43498006
Chronic heart failure	contraindication	48447003

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN	AGONIST	IC50	7.66	SCIENTIFIC LITERATURE	DRUG LABEL
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	5.26	DRUG MATRIX
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN		Ki	5.57	DRUG MATRIX
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	7.74	CHEMBL
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN		Ki	7.64	DRUG MATRIX
Mitogen-activated protein kinase 3	Kinase	P27361	MK03_HUMAN		IC50	5.50	DRUG MATRIX
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	7	CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		Ki	6.31	DRUG MATRIX
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	8.81	DRUG MATRIX

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External reference:

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ID	Source
001291	NDDF
001293	NDDF
1087965	RXNORM
126110005	SNOMEDCT_US
126111009	SNOMEDCT_US
169870	PUBCHEM_CID
179630	MMSL
21807M87J2	UNII
276F2O42F5	UNII
3385	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Hydroxyprogesterone Caproate	HUMAN PRESCRIPTION DRUG LABEL	1	0517-1767	INJECTION	250 mg	INTRAMUSCULAR	ANDA	24 sections
Hydroxyprogesterone Caproate	HUMAN PRESCRIPTION DRUG LABEL	1	0517-1791	INJECTION	250 mg	INTRAMUSCULAR	ANDA	24 sections
HYDROXYPROGESTERONE CAPROATE	Human Prescription Drug Label	1	47335-037	INJECTION	250 mg	INTRAMUSCULAR	ANDA	26 sections
HYDROXYPROGESTERONE CAPROATE	Human Prescription Drug Label	1	55150-309	INJECTION	250 mg	INTRAMUSCULAR	ANDA	26 sections
HYDROXYPROGESTERONE CAPROATE	Human Prescription Drug Label	1	55150-310	INJECTION	1250 mg	INTRAMUSCULAR	ANDA	26 sections
Hydroxyprogesterone Caproate	Human Prescription Drug Label	1	55150-311	INJECTION	1250 mg	INTRAMUSCULAR	ANDA	12 sections
Hydroxyprogesterone Caproate	Human Prescription Drug Label	1	55150-311	INJECTION	1250 mg	INTRAMUSCULAR	ANDA	12 sections
Hydroxyprogesterone Caproate	Human Prescription Drug Label	1	55150-311	INJECTION	1250 mg	INTRAMUSCULAR	ANDA	12 sections
Hydroxyprogesterone Caproate	HUMAN PRESCRIPTION DRUG LABEL	1	66993-038	INJECTION	250 mg	INTRAMUSCULAR	NDA authorized generic	28 sections
Hydroxyprogesterone Caproate	HUMAN PRESCRIPTION DRUG LABEL	1	66993-039	INJECTION	250 mg	INTRAMUSCULAR	NDA authorized generic	28 sections

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