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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4212 | 7757-82-6 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Sodium sulfate, potassium sulfate, and magnesium sulfate combination is used to cleanse the colon (bowel) before colonoscopy.
|
None
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 22, 2021 | PMDA | NIHON PHARMACEUTICAL CO., LTD. | |
| April 30, 1986 | FDA | HOSPIRA |
| 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 145.11 | 20.17 | 76 | 2472 | 158273 | 90467626 |
| Hepatic function abnormal | 78.45 | 20.17 | 34 | 2514 | 46254 | 90579645 |
| Neutrophil count decreased | 58.73 | 20.17 | 32 | 2516 | 71500 | 90554399 |
| Myelosuppression | 52.55 | 20.17 | 27 | 2521 | 53564 | 90572335 |
| Platelet count decreased | 50.79 | 20.17 | 37 | 2511 | 136932 | 90488967 |
| Pneumonia | 30.73 | 20.17 | 60 | 2488 | 637999 | 89987900 |
| Acute myeloid leukaemia | 28.03 | 20.17 | 13 | 2535 | 20627 | 90605272 |
| Electrocardiogram QT prolonged | 25.52 | 20.17 | 19 | 2529 | 72437 | 90553462 |
| Laryngeal inflammation | 23.67 | 20.17 | 4 | 2544 | 137 | 90625762 |
| Anaemia | 21.77 | 20.17 | 37 | 2511 | 352765 | 90273134 |
| 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 105.26 | 24.69 | 76 | 1737 | 185627 | 42433895 |
| Myelosuppression | 69.45 | 24.69 | 34 | 1779 | 40427 | 42579095 |
| Hepatic function abnormal | 64.44 | 24.69 | 35 | 1778 | 51532 | 42567990 |
| Pneumonia | 43.96 | 24.69 | 70 | 1743 | 422079 | 42197443 |
| Platelet count decreased | 37.13 | 24.69 | 37 | 1776 | 138544 | 42480978 |
| Acute myeloid leukaemia | 36.04 | 24.69 | 18 | 1795 | 22238 | 42597284 |
| 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 247.34 | 19.28 | 151 | 3991 | 316616 | 110268541 |
| Hepatic function abnormal | 143.72 | 19.28 | 69 | 4073 | 89226 | 110495931 |
| Myelosuppression | 116.70 | 19.28 | 61 | 4081 | 94279 | 110490878 |
| Platelet count decreased | 87.72 | 19.28 | 71 | 4071 | 230372 | 110354785 |
| Pneumonia | 70.60 | 19.28 | 121 | 4021 | 876593 | 109708564 |
| Neutrophil count decreased | 65.37 | 19.28 | 46 | 4096 | 120895 | 110464262 |
| Acute myeloid leukaemia | 62.89 | 19.28 | 30 | 4112 | 38080 | 110547077 |
| Sepsis | 37.05 | 19.28 | 53 | 4089 | 327293 | 110257864 |
| Liver disorder | 34.45 | 19.28 | 34 | 4108 | 142209 | 110442948 |
| Electrocardiogram QT prolonged | 34.01 | 19.28 | 30 | 4112 | 108930 | 110476227 |
| Pyrexia | 29.65 | 19.28 | 87 | 4055 | 898178 | 109686979 |
| Bone marrow failure | 28.91 | 19.28 | 21 | 4121 | 57827 | 110527330 |
| Bronchopulmonary aspergillosis | 27.72 | 19.28 | 16 | 4126 | 29847 | 110555310 |
| Renal disorder | 27.11 | 19.28 | 19 | 4123 | 49460 | 110535697 |
| Blast cell count increased | 21.57 | 19.28 | 6 | 4136 | 1631 | 110583526 |
| Aspartate aminotransferase increased | 21.23 | 19.28 | 28 | 4114 | 159908 | 110425249 |
| Anaemia | 20.95 | 19.28 | 56 | 4086 | 547030 | 110038127 |
| Blood lactate dehydrogenase increased | 19.70 | 19.28 | 15 | 4127 | 44319 | 110540838 |
| Pneumonia fungal | 19.52 | 19.28 | 10 | 4132 | 14744 | 110570413 |
None
| Source | Code | Description |
|---|---|---|
| ATC | A06AD13 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Osmotically acting laxatives |
| ATC | A12CA02 | ALIMENTARY TRACT AND METABOLISM MINERAL SUPPLEMENTS OTHER MINERAL SUPPLEMENTS Sodium |
| MeSH PA | D002400 | Cathartics |
| MeSH PA | D005765 | Gastrointestinal Agents |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Incomplete passage of stool | indication | 249515001 | |
| Anuria | contraindication | 2472002 | DOID:2983 |
| Hypocalcemia | contraindication | 5291005 | |
| Hyperkalemia | contraindication | 14140009 | |
| Severe chronic ulcerative colitis | contraindication | 14311001 | |
| Primary hyperoxaluria | contraindication | 17901006 | DOID:2977 |
| Acute vomiting | contraindication | 23971007 | |
| Complete atrioventricular block | contraindication | 27885002 | |
| Toxic megacolon | contraindication | 28536002 | DOID:1770 |
| Dehydration | contraindication | 34095006 | |
| Gastrointestinal ulcer | contraindication | 40845000 | |
| Toxic colitis | contraindication | 42359007 | |
| Hypokalemia | contraindication | 43339004 | |
| Gastrointestinal perforation | contraindication | 51875005 | |
| Paralytic ileus | contraindication | 55525008 | DOID:8442 |
| Perforation of intestine | contraindication | 56905009 | DOID:2074 |
| Congenital myotonia, autosomal dominant form | contraindication | 57938005 | |
| Acute nephropathy | contraindication | 58574008 | |
| Hypermagnesemia | contraindication | 66978005 | |
| Appendicitis | contraindication | 74400008 | DOID:8337 |
| Hyperchloremia | contraindication | 74450001 | |
| Third degree burn injury | contraindication | 80247002 | |
| Intestinal obstruction | contraindication | 81060008 | DOID:8437 |
| Hyponatremia | contraindication | 89627008 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Anemia due to enzyme deficiency | contraindication | 111577008 | |
| Gastrointestinal obstruction | contraindication | 126765001 | |
| Hb SS disease | contraindication | 127040003 | DOID:10923 |
| Seizure disorder | contraindication | 128613002 | |
| Gastroparesis | contraindication | 235675006 | |
| Chronic diarrhea | contraindication | 236071009 | |
| Hyporeninemic hypoaldosteronism | contraindication | 236464008 | |
| Pyloric obstruction | contraindication | 244815007 | |
| Familial hyperkalemic periodic paralysis | contraindication | 304737009 | DOID:14451 |
| Gastric retention | contraindication | 307227006 | |
| At risk for aspiration | contraindication | 371736008 | |
| Hemochromatosis | contraindication | 399187006 | DOID:2352 |
| Unconscious | contraindication | 418107008 | |
| Severe dehydration | contraindication | 450316000 | |
| Suppression of the Gag Reflex | contraindication | ||
| Predisposition to Nausea and Vomiting | contraindication |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | PLENVU | SALIX | N209381 | May 4, 2018 | RX | FOR SOLUTION | ORAL | 10792306 | March 9, 2032 | FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS |
| 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | PLENVU | SALIX | N209381 | May 4, 2018 | RX | FOR SOLUTION | ORAL | 11529368 | March 9, 2032 | FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS |
| 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | PLENVU | SALIX | N209381 | May 4, 2018 | RX | FOR SOLUTION | ORAL | 9592252 | Aug. 11, 2032 | FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS |
| 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | PLENVU | SALIX | N209381 | May 4, 2018 | RX | FOR SOLUTION | ORAL | 10918723 | Sept. 10, 2033 | FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS |
| 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | PLENVU | SALIX | N209381 | May 4, 2018 | RX | FOR SOLUTION | ORAL | 12083179 | Sept. 10, 2033 | FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS |
| 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | PLENVU | SALIX | N209381 | May 4, 2018 | RX | FOR SOLUTION | ORAL | 9326969 | Sept. 10, 2033 | FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS |
| 0.225GM;0.188GM;1.479GM | SUTAB | AZURITY | N213135 | Nov. 10, 2020 | RX | TABLET | ORAL | 11033498 | Aug. 4, 2037 | GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY |
| 0.225GM;0.188GM;1.479GM | SUTAB | AZURITY | N213135 | Nov. 10, 2020 | RX | TABLET | ORAL | 11382864 | Aug. 4, 2037 | GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY |
| 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | SUFLAVE | AZURITY | N215344 | June 15, 2023 | RX | FOR SOLUTION | ORAL | 12239659 | June 14, 2044 | GASTROINTESTINAL FLAVORED SOLUTION INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY |
| 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | SUFLAVE | AZURITY | N215344 | June 15, 2023 | RX | FOR SOLUTION | ORAL | 12433914 | June 14, 2044 | GASTROINTESTINAL FLAVORED SOLUTION INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | SUFLAVE | AZURITY | N215344 | June 15, 2023 | RX | FOR SOLUTION | ORAL | June 15, 2026 | NEW PRODUCT |
| 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SUPREP BOWEL PREP KIT | AZURITY | 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 |
None
| ID | Source |
|---|---|
| 4019142 | VUID |
| N0000179247 | NUI |
| D05877 | KEGG_DRUG |
| 7727-73-3 | SECONDARY_CAS_RN |
| 4019142 | VANDF |
| C0074769 | UMLSCUI |
| CHEBI:32149 | CHEBI |
| CHEMBL3989856 | ChEMBL_ID |
| CHEMBL233406 | ChEMBL_ID |
| DB09472 | DRUGBANK_ID |
| C012036 | MESH_SUPPLEMENTAL_RECORD_UI |
| 0YPR65R21J | UNII |
| 24436 | PUBCHEM_CID |
| 1299926 | RXNORM |
| 5496 | MMSL |
| NOCODE | MMSL |
| d06418 | MMSL |
| 001190 | NDDF |
| 006177 | NDDF |
| 69958001 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | Human Prescription Drug Label | 3 | 10572-012 | SOLUTION, CONCENTRATE | 17.50 g | ORAL | NDA | 28 sections |
| PEG-3350 and Electrolytes | HUMAN PRESCRIPTION DRUG LABEL | 5 | 10572-100 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA authorized generic | 25 sections |
| PEG-3350 and Electrolytes | HUMAN PRESCRIPTION DRUG LABEL | 5 | 10572-100 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA authorized generic | 25 sections |
| PEG-3350 and Electrolytes | HUMAN PRESCRIPTION DRUG LABEL | 5 | 10572-101 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA authorized generic | 25 sections |
| PEG-3350 and Electrolytes | HUMAN PRESCRIPTION DRUG LABEL | 5 | 10572-101 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA authorized generic | 25 sections |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | Human Prescription Drug Label | 3 | 10572-112 | SOLUTION, CONCENTRATE | 13.13 g | ORAL | NDA | 28 sections |
| SUPREP Bowel Prep | Human Prescription Drug Label | 3 | 24338-175 | SOLUTION, CONCENTRATE | 17.50 g | ORAL | NDA | 27 sections |
| SUPREP Bowel Prep | Human Prescription Drug Label | 3 | 24338-177 | SOLUTION, CONCENTRATE | 13.13 g | ORAL | NDA | 27 sections |
| SUTAB | Human Prescription Drug Label | 3 | 24338-201 | TABLET | 17.75 g | ORAL | NDA | 19 sections |
| GoLYTELY | Human Prescription Drug Label | 5 | 24338-236 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA | 25 sections |
| GoLYTELY | Human Prescription Drug Label | 5 | 24338-236 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA | 25 sections |
| Sodium sulfate, potassium sulfate and magnesium sulfate | HUMAN PRESCRIPTION DRUG LABEL | 3 | 31722-098 | SOLUTION | 17.50 g | ORAL | ANDA | 26 sections |
| Polyethylene Glycol-3350 and Electrolytes with Flavor Pack | HUMAN PRESCRIPTION DRUG LABEL | 5 | 40032-060 | POWDER, FOR SOLUTION | 22.72 g | ORAL | ANDA | 18 sections |
| POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | HUMAN PRESCRIPTION DRUG LABEL | 5 | 40032-090 | POWDER, FOR SOLUTION | 22.74 g | ORAL | ANDA | 23 sections |
| SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 40032-700 | SOLUTION | 17.50 g | ORAL | ANDA | 25 sections |
| GaviLyte - CTM | HUMAN PRESCRIPTION DRUG LABEL | 5 | 43386-060 | POWDER, FOR SOLUTION | 22.72 g | ORAL | ANDA | 10 sections |
| GaviLyte G TM | HUMAN PRESCRIPTION DRUG LABEL | 5 | 43386-090 | POWDER, FOR SOLUTION | 22.74 g | ORAL | ANDA | 24 sections |
| GaviLyte G TM | HUMAN PRESCRIPTION DRUG LABEL | 5 | 43386-090 | POWDER, FOR SOLUTION | 22.74 g | ORAL | ANDA | 24 sections |
| SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 43386-700 | SOLUTION | 17.50 g | ORAL | ANDA | 17 sections |
| PEG-3350 and Electrolytes | HUMAN PRESCRIPTION DRUG LABEL | 5 | 50090-6521 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA authorized generic | 24 sections |
| PEG-3350 and Electrolytes | HUMAN PRESCRIPTION DRUG LABEL | 5 | 50090-6521 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA authorized generic | 24 sections |
| PEG3350 and Electrolytes | Human Prescription Drug Label | 5 | 50090-8020 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA AUTHORIZED GENERIC | 24 sections |
| PEG3350 and Electrolytes | Human Prescription Drug Label | 5 | 50090-8020 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA AUTHORIZED GENERIC | 24 sections |
| Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit | HUMAN PRESCRIPTION DRUG LABEL | 3 | 51672-4170 | SOLUTION | 17.50 g | ORAL | ANDA | 32 sections |
| SUPREP Bowel Prep | Human Prescription Drug Label | 3 | 52268-012 | SOLUTION, CONCENTRATE | 17.50 g | ORAL | NDA | 28 sections |
| GoLYTELY | HUMAN PRESCRIPTION DRUG LABEL | 5 | 52268-100 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA | 25 sections |
| GoLYTELY | HUMAN PRESCRIPTION DRUG LABEL | 5 | 52268-100 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA | 25 sections |
| GoLYTELY | HUMAN PRESCRIPTION DRUG LABEL | 5 | 52268-101 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA | 25 sections |
| GoLYTELY | HUMAN PRESCRIPTION DRUG LABEL | 5 | 52268-101 | POWDER, FOR SOLUTION | 22.74 g | ORAL | NDA | 25 sections |
| SUPREP Bowel Prep | Human Prescription Drug Label | 3 | 52268-112 | SOLUTION, CONCENTRATE | 13.13 g | ORAL | NDA | 28 sections |