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

Stem definition	Drug id	CAS RN
	347	590-46-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: betaine oxyneurine betafin glycine betaine betaine anhydrous betaine hydrochloride betaine chloride cystadane betaine HCl	A naturally occurring compound that has been of interest for its role in osmoregulation. As a drug, betaine hydrochloride has been used as a source of hydrochloric acid in the treatment of hypochlorhydria. Betaine has also been used in the treatment of liver disorders, for hyperkalemia, for homocystinuria, and for gastrointestinal disturbances. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1341) Molecular weight: 117.15 Formula: C5H11NO2 CLOGP: -8.17 LIPINSKI: 0 HAC: 3 HDO: 0 TPSA: 40.13 ALOGS: -1.96 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

betaine
oxyneurine
betafin
glycine betaine
betaine anhydrous
betaine hydrochloride
betaine chloride
cystadane
betaine HCl

A naturally occurring compound that has been of interest for its role in osmoregulation. As a drug, betaine hydrochloride has been used as a source of hydrochloric acid in the treatment of hypochlorhydria. Betaine has also been used in the treatment of liver disorders, for hyperkalemia, for homocystinuria, and for gastrointestinal disturbances. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1341)

Molecular weight: 117.15
Formula: C5H11NO2
CLOGP: -8.17
LIPINSKI: 0
HAC: 3
HDO: 0
TPSA: 40.13
ALOGS: -1.96
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
1	g	O
6	g	O

ADMET properties:

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Property	Value	Reference
S (Water solubility)	1570 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Hosey CM, Chan R, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Feb. 14, 2007	EMA	Orphan Europe S.A.R.L.
Oct. 25, 1996	FDA	RARE DIS THERAP

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
Hypermethioninaemia	81.92	28.90	9	386	51	63488576
Brain oedema	42.31	28.90	11	384	14184	63474443
Intracranial pressure increased	36.16	28.90	8	387	5219	63483408

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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
Overdose	78.37	46.55	27	200	91032	34865672

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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
Hypermethioninaemia	105.92	34.50	12	588	75	79743713
Overdose	86.99	34.50	37	563	184169	79559619
Intracranial pressure increased	51.25	34.50	12	588	8310	79735478
Brain oedema	46.54	34.50	14	586	25249	79718539
Treatment noncompliance	43.89	34.50	16	584	52252	79691536

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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Source	Code	Description
ATC	A09AB02	ALIMENTARY TRACT AND METABOLISM DIGESTIVES, INCL. ENZYMES DIGESTIVES, INCL. ENZYMES Acid preparations
ATC	A16AA06	ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Amino acids and derivatives
CHEBI has role	CHEBI:78675	fundamental metabolites
FDA EPC	N0000175805	Methylating Agent
FDA MoA	N0000175804	Methylating Activity
MeSH PA	D000963	Antimetabolites
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D000960	Hypolipidemic Agents
MeSH PA	D057847	Lipid Regulating Agents
MeSH PA	D008082	Lipotropic 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
Homocystinuria	indication	11282001	DOID:9263
Cystitis	indication	38822007	DOID:1679
Klebsiella cystitis	indication	60867007
Infective cystitis	indication	236620008
Escherichia coli urinary tract infection	indication	301011002
Bacterial urinary infection	indication	312124009
Urinary tract infection caused by Klebsiella	indication	369001000119100
E. Coli Pyelonephritis	indication
Enterococcus Complicated UTI	indication
Complicated Proteus UTI	indication

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	1.89	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

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ID	Source
001115	NDDF
004543	NDDF
006281	NDDF
107-43-7	SECONDARY_CAS_RN
11810	MMSL
14793	MMSL
1512	RXNORM
167417	MMSL
167421	MMSL
247	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Anubis Barcelona Total Hydrating	HUMAN OTC DRUG LABEL	10	83021-692	LOTION	5 g	TOPICAL	OTC monograph final	9 sections
Anubis Barcelona Total Hydrating	HUMAN OTC DRUG LABEL	10	83021-692	LOTION	5 g	TOPICAL	OTC monograph final	9 sections
ATONO2 Oxygen Baby	HUMAN OTC DRUG LABEL	1	70993-0005	LOTION	0.20 g	TOPICAL	unapproved drug other	6 sections
Betaine	Human Prescription Drug Label	1	0713-0352	POWDER, FOR SOLUTION	1 g	ORAL	ANDA	23 sections
Betaine Anhydrous	HUMAN PRESCRIPTION DRUG LABEL	1	71863-115	POWDER, FOR SOLUTION	1 g	ORAL	ANDA	15 sections
Betaine Anhydrous For Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	55792-002	POWDER, FOR SOLUTION	1 g	ORAL	ANDA	16 sections
Betaine Anhydrous for Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	72647-900	FOR SOLUTION	1 g	ORAL	ANDA	24 sections
Betaine Anhydrous for Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	72647-900	FOR SOLUTION	1 g	ORAL	ANDA	24 sections
CELRAUM PHEROMONE FRAGRANCE LOVELY PERFUME	HUMAN OTC DRUG LABEL	6	75368-040	SHAMPOO	1.50 g	TOPICAL	unapproved drug other	9 sections
Cystadane	HUMAN PRESCRIPTION DRUG LABEL	1	52276-400	POWDER, FOR SOLUTION	1 g	ORAL	NDA	16 sections

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