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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4518 | 7772-98-7 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
do not confuse synonym sodium hyposulfite with sodium hyposulfite, synonym for di-Na salt of dithionous acid
|
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 14, 1992 | FDA | US ARMY | |
| May 26, 2023 | EMA | Fennec Pharmaceuticals (EU) Limited |
| 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 | 122.83 | 43.08 | 21 | 588 | 3355 | 90624483 |
| Off label use | 102.75 | 43.08 | 72 | 537 | 1102180 | 89525658 |
| 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 | 75.80 | 48.25 | 12 | 284 | 1161 | 42619878 |
| Off label use | 57.03 | 48.25 | 41 | 255 | 638294 | 41982745 |
| 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 | 193.16 | 42.07 | 33 | 905 | 4154 | 110584207 |
| Off label use | 120.99 | 42.07 | 99 | 839 | 1500086 | 109088275 |
| Metabolic acidosis | 57.42 | 42.07 | 24 | 914 | 99720 | 110488641 |
| Spinal cord injury cervical | 42.96 | 42.07 | 6 | 932 | 197 | 110588164 |
None
| Source | Code | Description |
|---|---|---|
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000900 | Anti-Bacterial 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 agent |
| CHEBI has role | CHEBI:86327 | antifungal drug |
| CHEBI has role | CHEBI:90749 | antidote to cyanide poisoning |
| 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 |
None
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| 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 | 11753301 | Feb. 10, 2030 | TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE SERIOUS OR LIFE-THREATENING |
| 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 |
| 12.5GM/50ML (250MG/ML) | SODIUM THIOSULFATE | HOPE PHARMS | N203923 | Feb. 14, 2012 | RX | SOLUTION | INTRAVENOUS | 11753301 | Feb. 10, 2030 | SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE SERIOUS OR LIFE-THREATENING |
| 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 |
| 12.5GM/100ML (125MG/ML) | PEDMARK | FENNEC PHARMS INC | N212937 | Sept. 20, 2022 | RX | SOLUTION | INTRAVENOUS | 11964018 | July 1, 2039 | USE OF A PHARMACEUTICAL COMPOSITION OF ABOUT 0.5M SODIUM THIOSULFATE, ABOUT 0.004M BORIC ACID, AND A PH OF BETWEEN ABOUT 6.5 AND 8.9 FOR REDUCING OTOTOXICITY IN A PEDIATRIC PATIENT RECEIVING CISPLATIN FOR THE TREATMENT OF LOCALIZED CANCER |
| 12.5GM/100ML (125MG/ML) | PEDMARK | FENNEC PHARMS INC | N212937 | Sept. 20, 2022 | RX | SOLUTION | INTRAVENOUS | 11992530 | July 1, 2039 | USE OF A PHARMACEUTICAL COMPOSITION HAVING ABOUT 0.5M AQUEOUS ANHYDROUS SODIUM THIOSULFATE AND A CONCENTRATION OF BORATE IONS OF LESS THAN 0.05% FOR REDUCING OTOTOXICITY IN A PEDIATRIC PATIENT RECEIVING CISPLATIN FOR TREATMENT OF LOCALIZED CANCER |
| 12.5GM/100ML (125MG/ML) | PEDMARK | FENNEC PHARMS INC | N212937 | Sept. 20, 2022 | RX | SOLUTION | INTRAVENOUS | 11998604 | July 1, 2039 | USE OF A PHARMACEUTICAL COMPOSITION HAVING A CONCENTRATION OF ABOUT 0.5M AQUEOUS ANHYDROUS SODIUM THIOSULFATE AND ABOUT 0.004M BORIC ACID FOR REDUCING OTOTOXICITY IN A PEDIATRIC PATIENT RECEIVING CISPLATIN FOR TREATMENT OF LOCALIZED CANCER |
| 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, 2029 | TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS |
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| ID | Source |
|---|---|
| 4017516 | VUID |
| N0000145901 | NUI |
| 10102-17-7 | SECONDARY_CAS_RN |
| 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 |
| HX1032V43M | INXIGHT DRUGS |
| 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 |
| PEDMARK | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73077-010 | INJECTION, SOLUTION | 12.50 g | INTRAVENOUS | NDA | 26 sections |
| PEDMARK | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73077-010 | INJECTION, SOLUTION | 12.50 g | INTRAVENOUS | NDA | 26 sections |