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 |
|---|---|
|
Synonyms:
|
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.
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)
| 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 |
| Product administration error | 424.36 | 68.67 | 143 | 7746 | 22254 | 63458879 |
| Injection site erythema | 387.36 | 68.67 | 194 | 7695 | 82980 | 63398153 |
| Injection site nodule | 361.76 | 68.67 | 86 | 7803 | 3749 | 63477384 |
| Cervical incompetence | 333.40 | 68.67 | 59 | 7830 | 558 | 63480575 |
| Breech presentation | 311.55 | 68.67 | 62 | 7827 | 1152 | 63479981 |
| Shortened cervix | 256.49 | 68.67 | 40 | 7849 | 155 | 63480978 |
| Amniotic cavity infection | 238.51 | 68.67 | 50 | 7839 | 1213 | 63479920 |
| Induced labour | 234.59 | 68.67 | 47 | 7842 | 904 | 63480229 |
| Injection site rash | 230.47 | 68.67 | 87 | 7802 | 18722 | 63462411 |
| Premature separation of placenta | 182.04 | 68.67 | 43 | 7846 | 1818 | 63479315 |
| Pre-eclampsia | 163.66 | 68.67 | 56 | 7833 | 9077 | 63472056 |
| Premature rupture of membranes | 161.49 | 68.67 | 48 | 7841 | 4945 | 63476188 |
| Injection site warmth | 160.10 | 68.67 | 63 | 7826 | 15132 | 63466001 |
| Injection site urticaria | 154.09 | 68.67 | 60 | 7829 | 14013 | 63467120 |
| Stillbirth | 147.24 | 68.67 | 48 | 7841 | 6702 | 63474431 |
| Abortion spontaneous | 135.27 | 68.67 | 80 | 7809 | 47115 | 63434018 |
| Injection site bruising | 130.57 | 68.67 | 75 | 7814 | 41835 | 63439298 |
| Cervical dilatation | 127.91 | 68.67 | 16 | 7873 | 0 | 63481133 |
| Premature delivery | 127.07 | 68.67 | 66 | 7823 | 30215 | 63450918 |
| Product prescribing error | 121.03 | 68.67 | 61 | 7828 | 26228 | 63454905 |
| Drug ineffective | 116.55 | 68.67 | 3 | 7886 | 1044762 | 62436371 |
| Gestational diabetes | 110.66 | 68.67 | 41 | 7848 | 8355 | 63472778 |
| Product administered at inappropriate site | 109.38 | 68.67 | 32 | 7857 | 3117 | 63478016 |
| Therapy cessation | 107.03 | 68.67 | 59 | 7830 | 30398 | 63450735 |
| Maternal drugs affecting foetus | 105.17 | 68.67 | 35 | 7854 | 5207 | 63475926 |
| Injection site reaction | 102.92 | 68.67 | 73 | 7816 | 58451 | 63422682 |
| Maternal exposure timing unspecified | 102.27 | 68.67 | 37 | 7852 | 7050 | 63474083 |
| Nonreassuring foetal heart rate pattern | 98.16 | 68.67 | 15 | 7874 | 49 | 63481084 |
| Limb discomfort | 97.42 | 68.67 | 55 | 7834 | 29661 | 63451472 |
| Pruritus | 86.47 | 68.67 | 158 | 7731 | 361295 | 63119838 |
| Gestational hypertension | 85.88 | 68.67 | 25 | 7864 | 2392 | 63478741 |
| Exposure during pregnancy | 82.46 | 68.67 | 99 | 7790 | 155448 | 63325685 |
| Placenta praevia | 76.27 | 68.67 | 19 | 7870 | 1005 | 63480128 |
| Vaginal haemorrhage | 69.43 | 68.67 | 43 | 7846 | 27444 | 63453689 |
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 |
|---|---|---|---|---|---|---|
| Premature baby | 2480.75 | 1066.51 | 371 | 137 | 19262 | 34937161 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Breech presentation | 365.77 | 86 | 61 | 6318 | 641 | 79737368 |
| Injection site nodule | 355.90 | 86 | 78 | 6301 | 3702 | 79734307 |
| Product administration error | 349.80 | 86 | 121 | 6258 | 31725 | 79706284 |
| Cervical incompetence | 347.03 | 86 | 56 | 6323 | 471 | 79737538 |
| Amniotic cavity infection | 268.42 | 86 | 48 | 6331 | 779 | 79737230 |
| Shortened cervix | 264.58 | 86 | 38 | 6341 | 128 | 79737881 |
| Induced labour | 246.35 | 86 | 45 | 6334 | 827 | 79737182 |
| Injection site rash | 215.62 | 86 | 73 | 6306 | 17881 | 79720128 |
| Premature separation of placenta | 212.07 | 86 | 42 | 6337 | 1204 | 79736805 |
| Pre-eclampsia | 197.77 | 86 | 55 | 6324 | 6986 | 79731023 |
| Premature rupture of membranes | 157.73 | 86 | 41 | 6338 | 4028 | 79733981 |
| Injection site warmth | 157.51 | 86 | 55 | 6324 | 14752 | 79723257 |
| Injection site urticaria | 149.44 | 86 | 51 | 6328 | 12775 | 79725234 |
| Injection site bruising | 138.73 | 86 | 67 | 6312 | 40935 | 79697074 |
| Gestational diabetes | 131.27 | 86 | 39 | 6340 | 6254 | 79731755 |
| Premature delivery | 129.49 | 86 | 54 | 6325 | 23413 | 79714596 |
| Abortion spontaneous | 127.10 | 86 | 57 | 6322 | 29450 | 79708559 |
| Cervical dilatation | 126.52 | 86 | 15 | 6364 | 0 | 79738009 |
| Product prescribing error | 110.08 | 86 | 59 | 6320 | 44754 | 79693255 |
| Exposure during pregnancy | 107.23 | 86 | 78 | 6301 | 101054 | 79636955 |
| Limb discomfort | 106.05 | 86 | 52 | 6327 | 32798 | 79705211 |
| Gestational hypertension | 103.05 | 86 | 25 | 6354 | 1854 | 79736155 |
| Maternal exposure timing unspecified | 95.65 | 86 | 30 | 6349 | 5762 | 79732247 |
| Vaginal haemorrhage | 93.47 | 86 | 42 | 6337 | 21775 | 79716234 |
| Therapy cessation | 90.96 | 86 | 49 | 6330 | 37513 | 79700496 |
| Injection site reaction | 86.19 | 86 | 54 | 6325 | 54731 | 79683278 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| 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 |
| FDA CS | M0447349 | Progesterone Congeners |
| MeSH PA | D004965 | Estrogen Antagonists |
| MeSH PA | D006727 | Hormone Antagonists |
| MeSH PA | D006728 | Hormones |
| MeSH PA | D011372 | Progestins |
| FDA EPC | N0000175602 | Progestin |
| 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 |
Drug Use | Suggest Off label Use Form| |View source of the data|
| 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 | |
| Intermenstrual bleeding - irregular | contraindication | 64996003 | |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Hyperglycemia | contraindication | 80394007 | DOID:4195 |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Neoplasm of liver | contraindication | 126851005 | DOID:3571 |
| Deep venous thrombosis | contraindication | 128053003 | |
| Seizure disorder | contraindication | 128613002 | |
| Asthma | contraindication | 195967001 | DOID:2841 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Thromboembolic disorder | contraindication | 371039008 | |
| Carcinoma of female breast | contraindication | 447782002 | |
| Predisposition to Thrombosis | contraindication |
🐶 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Progesterone receptor | Nuclear hormone receptor | AGONIST | IC50 | 7.66 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Sodium-dependent dopamine transporter | Transporter | Ki | 5.26 | DRUG MATRIX | |||||
| Adenosine receptor A3 | GPCR | Ki | 5.57 | DRUG MATRIX | |||||
| Corticosteroid-binding globulin | Secreted | Ki | 7.74 | CHEMBL | |||||
| Glucocorticoid receptor | Nuclear hormone receptor | Ki | 7.64 | DRUG MATRIX | |||||
| Mitogen-activated protein kinase 3 | Kinase | IC50 | 5.50 | DRUG MATRIX | |||||
| Sex hormone-binding globulin | Secreted | Kd | 7 | CHEMBL | |||||
| Androgen receptor | Transcription factor | Ki | 6.31 | DRUG MATRIX | |||||
| Progesterone receptor | Transcription factor | Ki | 8.81 | DRUG MATRIX |
External reference:
| ID | Source |
|---|---|
| 4017613 | VUID |
| N0000179012 | NUI |
| D00949 | KEGG_DRUG |
| 4017613 | VANDF |
| 4019781 | VANDF |
| CHEBI:5812 | CHEBI |
| CHEBI:17252 | CHEBI |
| CHEMBL1200848 | ChEMBL_ID |
| DB06789 | DRUGBANK_ID |
| DB14570 | DRUGBANK_ID |
| 1087965 | RXNORM |
| 179630 | MMSL |
| 3385 | MMSL |
| 4853 | MMSL |
| 7924 | MMSL |
| d00554 | MMSL |
| 001291 | NDDF |
| 001293 | NDDF |
| 126110005 | SNOMEDCT_US |
| 126111009 | SNOMEDCT_US |
| 56014002 | SNOMEDCT_US |
| D000077713 | MESH_DESCRIPTOR_UI |
| D019326 | MESH_DESCRIPTOR_UI |
| C0044971 | UMLSCUI |
| C0045010 | UMLSCUI |
| 633 | INN_ID |
| 169870 | PUBCHEM_CID |
| 716 | INN_ID |
| 68-96-2 | SECONDARY_CAS_RN |
| 6238 | PUBCHEM_CID |
| 276F2O42F5 | UNII |
| 21807M87J2 | UNII |
Pharmaceutical products:
| 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 |
| Makena | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64011-243 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 26 sections |
| Makena | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64011-243 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 26 sections |
| Makena | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64011-247 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 26 sections |
| Makena | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64011-247 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 26 sections |
| Makena | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64011-301 | INJECTION | 250 mg | SUBCUTANEOUS | NDA | 26 sections |
| Makena | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64011-301 | INJECTION | 250 mg | SUBCUTANEOUS | NDA | 26 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 |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-886 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 11 sections |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-886 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 11 sections |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-886 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 11 sections |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-967 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-967 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-967 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69238-1797 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 24 sections |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69238-1797 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 24 sections |
| HYDROXYPROGESTERONE CAPROATE | Human Prescription Drug Label | 1 | 71225-104 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 24 sections |
| Hydroxyprogesterone caproate | Human Prescription Drug Label | 1 | 71225-105 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 24 sections |
| Hydroxyprogesterone Caproate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73301-001 | LIQUID | 250 mg | INTRAMUSCULAR | ANDA | 24 sections |