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

Stem definitionDrug idCAS RN
4212 7757-82-6

Description:

MoleculeDescription

Synonyms:

  • sodium sulfate
  • sodium sulfate anhydrous
  • sulfuric acid disodium salt
  • disodium sulfate
Sodium sulfate, potassium sulfate, and magnesium sulfate combination is used to cleanse the colon (bowel) before colonoscopy.
  • Molecular weight: 142.04
  • Formula: Na2O4S
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 80.26
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
April 30, 1986 FDA HOSPIRA
Jan. 22, 2021 PMDA NIHON PHARMACEUTICAL CO., LTD.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 167.47 23.41 79 1852 97588 50505605
Myelosuppression 80.56 23.41 27 1904 13490 50589703
Hepatic function abnormal 79.92 23.41 34 1897 32647 50570546
Neutrophil count decreased 59.97 23.41 31 1900 45995 50557198
Platelet count decreased 55.54 23.41 39 1892 100687 50502506
Liver disorder 34.41 23.41 20 1911 37202 50565991
Pneumonia 33.43 23.41 55 1876 378346 50224847
Acute myeloid leukaemia 31.31 23.41 14 1917 15060 50588133
Electrocardiogram QT prolonged 23.78 23.41 18 1913 51868 50551325

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 133.81 29.06 74 1215 112166 29461072
Myelosuppression 116.69 29.06 36 1253 12191 29561047
Hepatic function abnormal 72.78 29.06 35 1254 39224 29534014
Platelet count decreased 49.71 29.06 39 1250 104633 29468605
Pneumonia 40.82 29.06 59 1230 320113 29253125
Acute myeloid leukaemia 40.78 29.06 18 1271 16495 29556743

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 291.18 24.03 152 2917 187505 64308158
Myelosuppression 191.86 24.03 63 3006 23767 64471896
Hepatic function abnormal 149.75 24.03 69 3000 64244 64431419
Platelet count decreased 101.76 24.03 75 2994 167636 64328027
Pneumonia 72.38 24.03 109 2960 559467 63936196
Neutrophil count decreased 71.71 24.03 45 3024 77151 64418512
Acute myeloid leukaemia 68.61 24.03 31 3038 27432 64468231
Liver disorder 54.33 24.03 33 3036 53318 64442345
Sepsis 35.58 24.03 49 3020 230292 64265371
Electrocardiogram QT prolonged 33.97 24.03 29 3040 79419 64416244
Pyrexia 31.90 24.03 77 2992 558567 63937096
Bone marrow failure 30.20 24.03 22 3047 47930 64447733
Renal disorder 28.79 24.03 19 3050 35346 64460317
Bronchopulmonary aspergillosis 28.01 24.03 15 3054 19070 64476593

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
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




🐶 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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
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 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 9326969 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
0.225GM;0.188GM;1.479GM SUTAB BRAINTREE LABS N213135 Nov. 10, 2020 RX TABLET ORAL 11033498 Aug. 4, 2037 GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.225GM;0.188GM;1.479GM SUTAB BRAINTREE LABS N213135 Nov. 10, 2020 RX TABLET ORAL Nov. 10, 2023 NEW PRODUCT
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:

IDSource
4019142 VUID
N0000179247 NUI
D05877 KEGG_DRUG
4019142 VANDF
C0074769 UMLSCUI
CHEBI:32149 CHEBI
CHEMBL233406 ChEMBL_ID
CHEMBL3989856 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
7727-73-3 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PEG-3350 and Electrolytes HUMAN PRESCRIPTION DRUG LABEL 5 10572-100 POWDER, FOR SOLUTION 22.74 g ORAL NDA authorized generic 26 sections
PEG-3350 and Electrolytes HUMAN PRESCRIPTION DRUG LABEL 5 10572-100 POWDER, FOR SOLUTION 22.74 g ORAL NDA authorized generic 26 sections
PEG-3350 and Electrolytes HUMAN PRESCRIPTION DRUG LABEL 5 10572-101 POWDER, FOR SOLUTION 22.74 g ORAL NDA authorized generic 26 sections
PEG-3350 and Electrolytes HUMAN PRESCRIPTION DRUG LABEL 5 10572-101 POWDER, FOR SOLUTION 22.74 g ORAL NDA authorized generic 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 24 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
EBV/CFS Plus HUMAN OTC DRUG LABEL 20 43742-1184 LIQUID 6 [hp_X] ORAL unapproved drug other 9 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
SUTAB HUMAN PRESCRIPTION DRUG LABEL 3 52268-201 TABLET 17.75 g ORAL NDA 19 sections
GoLYTELY HUMAN PRESCRIPTION DRUG LABEL 5 52268-700 POWDER, FOR SOLUTION 21.50 g ORAL NDA 25 sections
GoLYTELY HUMAN PRESCRIPTION DRUG LABEL 5 52268-700 POWDER, FOR SOLUTION 21.50 g ORAL NDA 25 sections
GoLYTELY HUMAN PRESCRIPTION DRUG LABEL 5 54868-0054 POWDER, FOR SOLUTION 22.74 g ORAL NDA 17 sections
PEG-3350 and Electrolytes HUMAN PRESCRIPTION DRUG LABEL 5 54868-6138 POWDER, FOR SOLUTION 22.74 g ORAL NDA authorized generic 17 sections
Throat Care HUMAN OTC DRUG LABEL 27 55714-4794 LIQUID 15 [hp_X] ORAL unapproved medical gas 10 sections
BronCare HUMAN OTC DRUG LABEL 29 55714-4840 PELLET 15 [hp_X] ORAL unapproved homeopathic 10 sections
Inflammation II HUMAN OTC DRUG LABEL 14 57520-0123 LIQUID 30 [hp_X] ORAL unapproved homeopathic 9 sections
LGBHP HUMAN OTC DRUG LABEL 9 57520-0136 LIQUID 30 [hp_X] ORAL unapproved homeopathic 9 sections
Systemic Detox HUMAN OTC DRUG LABEL 19 57520-0227 LIQUID 30 [hp_X] ORAL unapproved homeopathic 9 sections
Polyethylene Glycol 3350 and electrolytes - Unflavored HUMAN PRESCRIPTION DRUG LABEL 5 64380-765 POWDER, FOR SOLUTION 22.74 g ORAL ANDA 23 sections
Polyethylene Glycol 3350 and electrolytes with Lemon Flavor HUMAN PRESCRIPTION DRUG LABEL 5 64380-766 POWDER, FOR SOLUTION 22.74 g ORAL ANDA 23 sections
Polyethylene Glycol 3350 and electrolyteswith Orange Flavor HUMAN PRESCRIPTION DRUG LABEL 5 64380-767 POWDER, FOR SOLUTION 22.74 g ORAL ANDA 23 sections