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)

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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

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FDA Adverse Event Reporting System (Male)

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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

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FDA Adverse Event Reporting System (Geriatric)

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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

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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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

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

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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

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🐶 Veterinary Drug Use

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🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
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
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

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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	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

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Bioactivity Summary:

None

External reference:

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ID	Source
001190	NDDF
006177	NDDF
0YPR65R21J	UNII
1299926	RXNORM
24436	PUBCHEM_CID
4019142	VUID
4019142	VANDF
5496	MMSL
69958001	SNOMEDCT_US
7727-73-3	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
EBV/CFS Plus	HUMAN OTC DRUG LABEL	20	43742-1184	LIQUID	6 [hp_X]	ORAL	unapproved drug other	9 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
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
GoLYTELY	HUMAN PRESCRIPTION DRUG LABEL	5	52268-700	POWDER, FOR SOLUTION	21.50 g	ORAL	NDA	25 sections

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