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 518.91 65.38 111 2515 9328 63477068
Fear 514.48 65.38 121 2505 15645 63470751
Unevaluable event 435.18 65.38 136 2490 51250 63435146
Injury 407.21 65.38 141 2485 73106 63413290
Anhedonia 398.74 65.38 92 2534 10882 63475514
Renal failure 373.21 65.38 150 2476 117502 63368894
Emotional distress 347.09 65.38 103 2523 32446 63453950
Anxiety 239.95 65.38 134 2492 217407 63268989
Stress 223.76 65.38 89 2537 67078 63419318
Renal impairment 209.94 65.38 92 2534 88263 63398133
Multiple organ dysfunction syndrome 188.18 65.38 75 2551 56677 63429719
Pain 124.99 65.38 152 2474 740476 62745920

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 816.43 45.63 197 3758 10279 34942697
Injury 755.88 45.63 213 3742 20474 34932502
Renal injury 712.56 45.63 179 3776 11016 34941960
Unevaluable event 639.86 45.63 208 3747 32382 34920594
Anhedonia 628.25 45.63 150 3805 7435 34945541
Emotional distress 595.05 45.63 165 3790 14861 34938115
Renal failure 419.40 45.63 229 3726 130328 34822648
Anxiety 412.06 45.63 207 3748 99221 34853755
Stress 377.48 45.63 138 3817 30209 34922767
Pain 322.04 45.63 228 3727 204447 34748529
Renal impairment 248.69 45.63 146 3809 94367 34858609
Multiple organ dysfunction syndrome 195.11 45.63 116 3839 76450 34876526
Depression 88.43 45.63 79 3876 97019 34855957
Hypotension 86.26 45.63 115 3840 221534 34731442
Anaphylactic reaction 84.73 45.63 50 3905 32251 34920725
Fear of death 77.17 45.63 17 3938 577 34952399
Procedural hypotension 54.51 45.63 14 3941 922 34952054
Vasoplegia syndrome 53.57 45.63 16 3939 1840 34951136
Organ failure 47.51 45.63 15 3940 2076 34950900

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 1163.90 52.18 282 5963 21704 79716439
Renal injury 1119.25 52.18 260 5985 16667 79721476
Unevaluable event 1007.10 52.18 306 5939 55279 79682864
Injury 954.92 52.18 318 5927 77178 79660965
Anhedonia 911.41 52.18 215 6030 14683 79723460
Emotional distress 826.73 52.18 244 6001 39725 79698418
Renal failure 722.85 52.18 338 5907 200630 79537513
Anxiety 554.84 52.18 303 5942 248209 79489934
Stress 524.01 52.18 206 6039 79406 79658737
Renal impairment 420.62 52.18 217 6028 157566 79580577
Pain 336.68 52.18 338 5907 703464 79034679
Multiple organ dysfunction syndrome 330.45 52.18 169 6076 120077 79618066
Depression 118.91 52.18 113 6132 216677 79521466
Hypotension 118.22 52.18 158 6087 440159 79297984
Fear of death 108.91 52.18 25 6220 1491 79736652
Death 76.77 52.18 149 6096 566365 79171778
Anaphylactic reaction 75.20 52.18 58 6187 83685 79654458
Procedural hypotension 72.14 52.18 19 6226 2004 79736139
Vasoplegia syndrome 65.39 52.18 20 6225 3610 79734533
Cerebrovascular accident 61.46 52.18 68 6177 155224 79582919
Fatigue 54.79 52.18 5 6240 929722 78808421
Diarrhoea 53.91 52.18 4 6241 880485 78857658

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
002093 NDDF
006047 NDDF
006048 NDDF
350083007 SNOMEDCT_US
372630008 SNOMEDCT_US
64520006 SNOMEDCT_US

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 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
Protamine Sulfate Human Prescription Drug Label 1 63323-229 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections