protamine sulfate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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
Fear 531.95 63.07 120 2812 16502 90609013
Renal injury 530.96 63.07 110 2822 10133 90615382
Unevaluable event 454.64 63.07 135 2797 54713 90570802
Anhedonia 411.80 63.07 91 2841 11340 90614175
Renal failure 392.90 63.07 150 2782 130857 90494658
Emotional distress 355.28 63.07 102 2830 36560 90588955
Injury 301.77 63.07 140 2792 197209 90428306
Stress 224.69 63.07 88 2844 81307 90544208
Anxiety 223.53 63.07 133 2799 309639 90315876
Renal impairment 219.23 63.07 93 2839 105328 90520187
Multiple organ dysfunction syndrome 188.89 63.07 74 2858 68262 90557253
Pain 116.89 63.07 151 2781 996190 89629325
Hypotension 66.21 63.07 66 2866 325331 90300184

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 828.87 46.53 196 4007 10769 42606363
Injury 768.53 46.53 213 3990 22103 42595029
Renal injury 715.27 46.53 178 4025 12102 42605030
Unevaluable event 653.10 46.53 207 3996 34081 42583051
Anhedonia 642.18 46.53 149 4054 7491 42609641
Emotional distress 606.09 46.53 165 4038 15928 42601204
Renal failure 425.11 46.53 228 3975 143498 42473634
Anxiety 404.20 46.53 207 3996 118353 42498779
Stress 341.79 46.53 137 4066 44075 42573057
Pain 317.72 46.53 230 3973 244618 42372514
Renal impairment 243.70 46.53 145 4058 110083 42507049
Multiple organ dysfunction syndrome 189.42 46.53 118 4085 96917 42520215
Anaphylactic reaction 117.48 46.53 65 4138 42678 42574454
Hypotension 100.77 46.53 125 4078 257506 42359626
Depression 88.42 46.53 79 4124 111284 42505848
Fear of death 78.71 46.53 17 4186 605 42616527
Procedural hypotension 55.46 46.53 14 4189 989 42616143
Vasoplegia syndrome 54.24 46.53 17 4186 2638 42614494
Organ failure 47.26 46.53 15 4188 2425 42614707

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 1205.40 45.20 280 6524 22913 110559582
Renal injury 1144.37 45.20 258 6546 18455 110564040
Unevaluable event 1051.26 45.20 304 6500 58923 110523572
Anhedonia 944.35 45.20 213 6591 15215 110567280
Emotional distress 852.24 45.20 243 6561 44604 110537891
Injury 769.06 45.20 317 6487 176948 110405547
Renal failure 758.20 45.20 337 6467 226237 110356258
Anxiety 526.93 45.20 302 6502 344776 110237719
Stress 509.01 45.20 204 6600 105144 110477351
Renal impairment 433.41 45.20 217 6587 188228 110394267
Multiple organ dysfunction syndrome 331.69 45.20 169 6635 151541 110430954
Pain 319.81 45.20 339 6465 954616 109627879
Hypotension 161.73 45.20 179 6625 523670 110058825
Fear of death 112.55 45.20 25 6779 1642 110580853
Anaphylactic reaction 109.90 45.20 75 6729 114225 110468270
Depression 105.57 45.20 113 6691 317222 110265273
Death 78.76 45.20 148 6656 698721 109883774
Aplastic anaemia 76.93 45.20 35 6769 24273 110558222
Procedural hypotension 72.66 45.20 19 6785 2486 110580009
Cerebrovascular accident 66.32 45.20 68 6736 181216 110401279
Vasoplegia syndrome 66.29 45.20 21 6783 5418 110577077
Cardiac arrest 54.88 45.20 64 6740 196689 110385806
Pulmonary hypertension 54.83 45.20 37 6767 55183 110527312
Organ failure 52.16 45.20 17 6787 4800 110577695
Fatigue 51.57 45.20 7 6797 1215951 109366544
Post procedural haemorrhage 48.02 45.20 22 6782 15490 110567005

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

Related Drugs by ATC class:

V03AB Antidotes 28 drugs
4-dimethylaminophenolacetylcysteineamyl nitriteandexanet alfaatropinecopper sulfatedimercaprolethanolflumazenilfomepizoleglutathionehydroxocobalamin show all 28 →

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
CHEBI:749540 CHEBI
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 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 65219-646 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections