potassium sulfate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5485 | 7778-80-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Potassium sulfate is used to cleanse the colon (bowel) before colonoscopy in combination with sodium sulfate and magnesium sulfate.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 22, 2021 | PMDA | NIHON PHARMACEUTICAL CO., LTD. |
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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 21.75 | 20.87 | 33 | 2148 | 234280 | 63252561 |
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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 21.94 | 19.81 | 32 | 2395 | 247505 | 79494456 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
None
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Bowel and colon cleansing preparation for colonoscopy | indication | 225106003 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SUPREP BOWEL PREP KIT | BRAINTREE LABS | N022372 | Aug. 5, 2010 | RX | SOLUTION | ORAL | 6946149 | March 7, 2023 | GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN ADULTS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | NOVEL LABS INC | A202511 | Feb. 23, 2017 | RX | SOLUTION | ORAL | March 6, 2023 | PATENT CHALLENGE |
| 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SUPREP BOWEL PREP KIT | BRAINTREE LABS | N022372 | Aug. 5, 2010 | RX | SOLUTION | ORAL | Aug. 5, 2027 | FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| CHEBI:32036 | CHEBI |
| SO4 | PDB_CHEM_ID |
| SOH | PDB_CHEM_ID |
| SUL | PDB_CHEM_ID |
| CHEMBL2021424 | ChEMBL_ID |
| C031512 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB14499 | DRUGBANK_ID |
| 006117 | NDDF |
| 4017690 | VANDF |
| 4019184 | VANDF |
| C0071780 | UMLSCUI |
| 24507 | PUBCHEM_CID |
| 34323 | RXNORM |
| 27516 | MMSL |
| NOCODE | MMSL |
| d07690 | MMSL |
| 1K573LC5TV | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Kali sulphuricum | HUMAN OTC DRUG LABEL | 1 | 0220-2979 | PELLET | 1 [hp_M] | ORAL | unapproved medical gas | 9 sections |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 10572-012 | SOLUTION, CONCENTRATE | 3.13 g | ORAL | NDA | 28 sections |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 10572-112 | SOLUTION, CONCENTRATE | 2.35 g | ORAL | NDA | 28 sections |
| SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 40032-700 | SOLUTION | 3.13 g | ORAL | ANDA | 25 sections |
| SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 43386-700 | SOLUTION | 3.13 g | ORAL | ANDA | 17 sections |
| SUPREP Bowel Prep | HUMAN PRESCRIPTION DRUG LABEL | 3 | 52268-012 | SOLUTION, CONCENTRATE | 3.13 g | ORAL | NDA | 28 sections |
| SUPREP Bowel Prep | HUMAN PRESCRIPTION DRUG LABEL | 3 | 52268-112 | SOLUTION, CONCENTRATE | 2.35 g | ORAL | NDA | 28 sections |