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

Stem definitionDrug idCAS RN
5034 9009-65-8

Description:

MoleculeDescription

Synonyms:

  • protamine sulfate
  • protamine
  • protamine sulfates
  • protamine hydrochloride
A group of simple proteins that yield basic amino acids on hydrolysis and that occur combined with nucleic acid in the sperm of fish. Protamines contain very few kinds of amino acids. Protamine sulfate combines with heparin to form a stable inactive complex; it is used to neutralize the anticoagulant action of heparin in the treatment of heparin overdose. (From Merck Index, 11th ed; Martindale, The Extra Pharmacopoeia, 30th ed, p692)
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Aug. 13, 1969 FDA LILLY

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Renal injury 510.13 75.52 111 2376 8500 50594137
Fear 503.55 75.52 121 2366 14428 50588209
Injury 439.42 75.52 141 2346 48784 50553853
Unevaluable event 426.93 75.52 136 2351 45930 50556707
Anhedonia 396.02 75.52 92 2395 9432 50593205
Renal failure 362.68 75.52 150 2337 106483 50496154
Emotional distress 342.60 75.52 103 2384 28560 50574077
Anxiety 241.16 75.52 133 2354 177473 50425164
Stress 228.13 75.52 89 2398 53704 50548933
Renal impairment 208.49 75.52 92 2395 75569 50527068
Multiple organ dysfunction syndrome 180.99 75.52 74 2413 50263 50552374
Pain 132.59 75.52 151 2336 578752 50023885

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Fear 806.70 51.26 197 3681 9307 29561342
Injury 742.33 51.26 213 3665 18833 29551816
Renal injury 702.93 51.26 179 3699 10023 29560626
Unevaluable event 627.75 51.26 208 3670 29643 29541006
Anhedonia 614.07 51.26 150 3728 7050 29563599
Emotional distress 583.80 51.26 165 3713 13730 29556919
Anxiety 413.13 51.26 207 3671 85158 29485491
Renal failure 408.47 51.26 229 3649 118370 29452279
Stress 404.20 51.26 138 3740 21352 29549297
Pain 328.28 51.26 228 3650 171204 29399445
Renal impairment 249.09 51.26 146 3732 81187 29489462
Multiple organ dysfunction syndrome 200.05 51.26 116 3762 63000 29507649
Depression 87.34 51.26 79 3799 85068 29485581
Anaphylactic reaction 82.61 51.26 49 3829 27524 29543125
Hypotension 77.28 51.26 110 3768 194244 29376405
Fear of death 76.25 51.26 17 3861 524 29570125
Procedural hypotension 53.16 51.26 14 3864 876 29569773

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Fear 1138.63 49.50 282 5748 19889 64472813
Renal injury 1097.59 49.50 260 5770 15169 64477533
Injury 1001.44 49.50 318 5712 55674 64437028
Unevaluable event 982.93 49.50 306 5724 50183 64442519
Anhedonia 891.50 49.50 215 5815 13491 64479211
Emotional distress 809.17 49.50 244 5786 35794 64456908
Renal failure 698.55 49.50 338 5692 181350 64311352
Anxiety 559.91 49.50 302 5728 202347 64290355
Stress 543.51 49.50 206 5824 60328 64432374
Renal impairment 416.37 49.50 217 5813 134800 64357902
Pain 353.10 49.50 337 5693 553174 63939528
Multiple organ dysfunction syndrome 326.53 49.50 168 5862 101245 64391457
Depression 118.05 49.50 113 5917 183178 64309524
Fear of death 107.82 49.50 25 6005 1302 64491400
Hypotension 106.79 49.50 153 5877 380821 64111881
Death 75.01 49.50 149 5881 482556 64010146
Anaphylactic reaction 74.11 49.50 57 5973 68607 64424095
Procedural hypotension 70.12 49.50 19 6011 1867 64490835
Vasoplegia syndrome 58.65 49.50 18 6012 2749 64489953
Cerebrovascular accident 58.35 49.50 68 5962 137515 64355187
Diarrhoea 52.60 49.50 4 6026 722700 63770002
Fatigue 52.16 49.50 5 6025 748725 63743977
Organ failure 49.89 49.50 17 6013 3616 64489086

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V03AB14 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Antidotes
MeSH PA D003029 Coagulants
MeSH PA D006401 Hematologic Agents
MeSH PA D006494 Heparin Antagonists
FDA MoA N0000175981 Heparin Binding Activity
FDA PE N0000175982 Reversed Anticoagulation Activity
FDA EPC N0000175983 Heparin Reversal Agent

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

DiseaseRelationSNOMED_IDDOID
Heparin overdose indication 296926001
Neuropathic pain off-label use 247398009




🐶 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:

None

External reference:

IDSource
0DE9724IHC UNII
D02224 KEGG_DRUG
4017458 VUID
N0000178966 NUI
9012-00-4 SECONDARY_CAS_RN
4017458 VANDF
4019917 VANDF
C0033602 UMLSCUI
CHEMBL1201651 ChEMBL_ID
DB09141 DRUGBANK_ID
CHEMBL2108125 ChEMBL_ID
D011479 MESH_DESCRIPTOR_UI
717 INN_ID
DB13700 DRUGBANK_ID
236471 RXNORM
2311 MMSL
5377 MMSL
d00362 MMSL
350083007 SNOMEDCT_US
372630008 SNOMEDCT_US
64520006 SNOMEDCT_US
002093 NDDF
006047 NDDF
006048 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PROTAMINE SULFATE HUMAN PRESCRIPTION DRUG LABEL 1 51662-1414 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections
Protamine Sulfate Human Prescription Drug Label 1 63323-229 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections
Protamine Sulfate Human Prescription Drug Label 1 63323-229 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections
Protamine Sulfate Human Prescription Drug Label 1 63323-229 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections