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

Stem definition	Drug id	CAS RN
	4212	7757-82-6

Description:

Molecule	Description
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

Molecule

Description

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:

Date	Agency	Company	Orphan
April 30, 1986	FDA	HOSPIRA
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
Febrile neutropenia	162.50	23.11	79	2051	118370	63368522
Hepatic function abnormal	79.92	23.11	34	2096	37108	63449784
Myelosuppression	69.13	23.11	27	2103	23676	63463216
Neutrophil count decreased	57.77	23.11	31	2099	56375	63430517
Platelet count decreased	55.03	23.11	39	2091	116083	63370809
Pneumonia	32.29	23.11	56	2074	456711	63030181
Acute myeloid leukaemia	31.31	23.11	14	2116	17133	63469759
Liver disorder	30.03	23.11	20	2110	53667	63433225
Electrocardiogram QT prolonged	25.87	23.11	19	2111	59511	63427381

FDA Adverse Event Reporting System (Male)

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	126.92	29.35	74	1304	136775	34818778
Myelosuppression	104.13	29.35	36	1342	19229	34936324
Hepatic function abnormal	72.03	29.35	35	1343	44328	34911225
Platelet count decreased	48.52	29.35	39	1339	119678	34835875
Acute myeloid leukaemia	40.76	29.35	18	1360	18252	34937301
Pneumonia	39.68	29.35	59	1319	362568	34592985

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
Febrile neutropenia	278.72	22.16	152	3204	230847	79510185
Myelosuppression	167.00	22.16	63	3293	40233	79700799
Hepatic function abnormal	149.34	22.16	69	3287	73038	79667994
Platelet count decreased	99.94	22.16	75	3281	194589	79546443
Pneumonia	68.77	22.16	109	3247	660137	79080895
Acute myeloid leukaemia	68.76	22.16	31	3325	30854	79710178
Neutrophil count decreased	68.64	22.16	45	3311	93914	79647118
Liver disorder	48.79	22.16	33	3323	72384	79668648
Sepsis	38.78	22.16	52	3304	269376	79471656
Electrocardiogram QT prolonged	35.86	22.16	30	3326	90356	79650676
Pyrexia	35.64	22.16	84	3272	678625	79062407
Bone marrow failure	31.36	22.16	22	3334	51085	79689947
Renal disorder	27.89	22.16	19	3337	42086	79698946
Bronchopulmonary aspergillosis	27.55	22.16	15	3341	22279	79718753

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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

🐶 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
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	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
0.225GM;0.188GM;1.479GM	SUTAB	BRAINTREE LABS	N213135	Nov. 10, 2020	RX	TABLET	ORAL	11382864	Aug. 4, 2037	GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY

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
0.225GM;0.188GM;1.479GM	SUTAB	BRAINTREE LABS	N213135	Nov. 10, 2020	RX	TABLET	ORAL	Nov. 10, 2023	NEW PRODUCT
0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT	SUFLAVE	BRAINTREE LABS	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	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
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:

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	27 sections
PEG-3350 and Electrolytes	HUMAN PRESCRIPTION DRUG LABEL	5	10572-100	POWDER, FOR SOLUTION	22.74 g	ORAL	NDA authorized generic	27 sections
PEG-3350 and Electrolytes	HUMAN PRESCRIPTION DRUG LABEL	5	10572-100	POWDER, FOR SOLUTION	22.74 g	ORAL	NDA authorized generic	27 sections
PEG-3350 and Electrolytes	HUMAN PRESCRIPTION DRUG LABEL	5	10572-100	POWDER, FOR SOLUTION	22.74 g	ORAL	NDA authorized generic	27 sections
PEG-3350 and Electrolytes	HUMAN PRESCRIPTION DRUG LABEL	5	10572-101	POWDER, FOR SOLUTION	22.74 g	ORAL	NDA authorized generic	27 sections
PEG-3350 and Electrolytes	HUMAN PRESCRIPTION DRUG LABEL	5	10572-101	POWDER, FOR SOLUTION	22.74 g	ORAL	NDA authorized generic	27 sections
PEG-3350 and Electrolytes	HUMAN PRESCRIPTION DRUG LABEL	5	10572-101	POWDER, FOR SOLUTION	22.74 g	ORAL	NDA authorized generic	27 sections
PEG-3350 and Electrolytes	HUMAN PRESCRIPTION DRUG LABEL	5	10572-101	POWDER, FOR SOLUTION	22.74 g	ORAL	NDA authorized generic	27 sections
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	HUMAN PRESCRIPTION DRUG LABEL	3	10572-112	SOLUTION, CONCENTRATE	13.13 g	ORAL	NDA	28 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
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
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
EBV/CFS Plus	HUMAN OTC DRUG LABEL	20	43742-1184	LIQUID	6 [hp_X]	ORAL	unapproved drug other	9 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
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