sodium thiosulfate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4518	7772-98-7

Description:

Molecule

Description

Synonyms:

sodium thiosulfate
disodium thiosulphate
sulfothiorine

do not confuse synonym sodium hyposulfite with sodium hyposulfite, synonym for di-Na salt of dithionous acid

Molecular weight: 158.10
Formula: Na2O3S2
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 63.19
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
May 26, 2023	EMA	Fennec Pharmaceuticals (EU) Limited
Feb. 14, 1992	FDA	US ARMY

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
Calciphylaxis	104.88	49.07	18	395	3054	63485555
Off label use	63.81	49.07	44	369	674418	62814191

FDA Adverse Event Reporting System (Male)

None

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
Calciphylaxis	145.52	54.74	25	565	3745	79740053
Off label use	67.28	54.74	54	536	907161	78836637

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000931	Antidotes
MeSH PA	D000975	Antioxidants
MeSH PA	D000995	Antitubercular Agents
MeSH PA	D002614	Chelating Agents
MeSH PA	D020011	Protective Agents
MeSH PA	D064449	Sequestering Agents
CHEBI has role	CHEBI:76595	nephroprotective agents
CHEBI has role	CHEBI:86327	pharmaceutical fungicide

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

Disease	Relation	SNOMED_ID	DOID
Toxic effect of cyanide	indication	66207005
Reduce the risk of ototoxicity associated with cisplatin	indication	292238004
Infection of skin AND/OR subcutaneous tissue	contraindication	19824006
Methemoglobinemia	contraindication	38959009	DOID:10783
Diabetes mellitus	contraindication	73211009	DOID:9351
Condyloma acuminatum	contraindication	240542006	DOID:11168
Skin irritation	contraindication	367466007
Peripheral vascular disease	contraindication	400047006
Blister	contraindication	417237009
Inflammatory dermatosis	contraindication	703938007

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	NITHIODOTE	HOPE PHARMS	N201444	Jan. 14, 2011	RX	SOLUTION, SOLUTION	INTRAVENOUS, INTRAVENOUS	9687506	Feb. 10, 2030	SODIUM NITRITE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION
300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	NITHIODOTE	HOPE PHARMS	N201444	Jan. 14, 2011	RX	SOLUTION, SOLUTION	INTRAVENOUS, INTRAVENOUS	9687506	Feb. 10, 2030	SODIUM NITRITE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM THIOSULFATE FOR THE TREATMENT OF ACUTE CYANIDE POISONING
300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	NITHIODOTE	HOPE PHARMS	N201444	Jan. 14, 2011	RX	SOLUTION, SOLUTION	INTRAVENOUS, INTRAVENOUS	10479686	July 7, 2030	SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION
300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	NITHIODOTE	HOPE PHARMS	N201444	Jan. 14, 2011	RX	SOLUTION, SOLUTION	INTRAVENOUS, INTRAVENOUS	9345724	July 7, 2030	SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING
12.5GM/50ML (250MG/ML)	SODIUM THIOSULFATE	HOPE PHARMS	N203923	Feb. 14, 2012	RX	SOLUTION	INTRAVENOUS	10479686	July 7, 2030	SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION
12.5GM/50ML (250MG/ML)	SODIUM THIOSULFATE	HOPE PHARMS	N203923	Feb. 14, 2012	RX	SOLUTION	INTRAVENOUS	9345724	July 7, 2030	SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING
300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	NITHIODOTE	HOPE PHARMS	N201444	Jan. 14, 2011	RX	SOLUTION, SOLUTION	INTRAVENOUS, INTRAVENOUS	8496973	March 29, 2031	TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
12.5GM/50ML (250MG/ML)	SODIUM THIOSULFATE	HOPE PHARMS	N203923	Feb. 14, 2012	RX	SOLUTION	INTRAVENOUS	8496973	March 29, 2031	TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
12.5GM/100ML (125MG/ML)	PEDMARK	FENNEC PHARMS INC	N212937	Sept. 20, 2022	RX	SOLUTION	INTRAVENOUS	10596190	Jan. 5, 2038	A METHOD OF REDUCING OTOTOXICITY IN A HUMAN PEDIATRIC PATIENT ABOUT 5 YEARS OF AGE OR UNDER WITH LOCALIZED MEDULLOBLASTOMA COMPRISING ADMINISTERING SODIUM THIOSULFATE ABOUT SIX HOURS AFTER ADMINISTRATION OF CISPLATIN

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
12.5GM/100ML (125MG/ML)	PEDMARK	FENNEC PHARMS INC	N212937	Sept. 20, 2022	RX	SOLUTION	INTRAVENOUS	Sept. 20, 2025	NEW PRODUCT
12.5GM/100ML (125MG/ML)	PEDMARK	FENNEC PHARMS INC	N212937	Sept. 20, 2022	RX	SOLUTION	INTRAVENOUS	Sept. 20, 2029	TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OFAGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS

Bioactivity Summary:

None

External reference:

ID	Source
4017516	VUID
N0000145901	NUI
4017516	VANDF
CHEBI:32150	CHEBI
CHEMBL2096650	ChEMBL_ID
C017717	MESH_SUPPLEMENTAL_RECORD_UI
HX1032V43M	UNII
36726	RXNORM
1191	MMSL
5499	MMSL
NOCODE	MMSL
d01404	MMSL
001092	NDDF
002879	NDDF
387209006	SNOMEDCT_US
38828006	SNOMEDCT_US
C0074774	UMLSCUI
24477	PUBCHEM_CID
10102-17-7	SECONDARY_CAS_RN

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Sodium Thiosulfate	HUMAN PRESCRIPTION DRUG LABEL	1	60267-705	INJECTION, SOLUTION	250 mg	INTRAVENOUS	NDA	26 sections
Sodium Thiosulfate	HUMAN PRESCRIPTION DRUG LABEL	1	60267-705	INJECTION, SOLUTION	250 mg	INTRAVENOUS	NDA	26 sections
Sodium Thiosulfate	HUMAN PRESCRIPTION DRUG LABEL	1	60267-705	INJECTION, SOLUTION	250 mg	INTRAVENOUS	NDA	26 sections
PEDMARK	HUMAN PRESCRIPTION DRUG LABEL	1	73077-010	INJECTION, SOLUTION	12.50 g	INTRAVENOUS	NDA	26 sections