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

Stem definition	Drug id	CAS RN
	5034	9009-65-8

Description:

Molecule	Description
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

Molecule

Description

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:

Date	Agency	Company	Orphan
Aug. 13, 1969	FDA	LILLY

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
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 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
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 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
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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