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 |
|---|---|
|
Synonyms:
|
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)
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1 | g | O |
| 6 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Hosey CM, Chan R, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 25, 1996 | FDA | RARE DIS THERAP |
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 |
|---|---|---|---|---|---|---|
| Hypermethioninaemia | 90.75 | 32.69 | 9 | 364 | 10 | 50604741 |
| Brain oedema | 41.97 | 32.69 | 11 | 362 | 12359 | 50592392 |
| Intracranial pressure increased | 36.46 | 32.69 | 8 | 365 | 4244 | 50600507 |
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 |
|---|---|---|---|---|---|---|
| Overdose | 80.73 | 45.13 | 27 | 175 | 79792 | 29494533 |
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 |
|---|---|---|---|---|---|---|
| Hypermethioninaemia | 114.32 | 40.60 | 12 | 526 | 27 | 64498167 |
| Overdose | 88.57 | 40.60 | 37 | 501 | 159529 | 64338665 |
| Intracranial pressure increased | 52.12 | 40.60 | 12 | 526 | 6977 | 64491217 |
| Brain oedema | 47.00 | 40.60 | 14 | 524 | 22061 | 64476133 |
| Treatment noncompliance | 45.18 | 40.60 | 16 | 522 | 43466 | 64454728 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| 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 |
| 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 |
| FDA MoA | N0000175804 | Methylating Activity |
| FDA EPC | N0000175805 | Methylating Agent |
| CHEBI has role | CHEBI:78675 | fundamental metabolites |
Drug Use | Suggest Off label Use Form| |View source of the data|
| 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 | ||
| Complicated UTI with Pseudomonas Aeruginosa | indication | ||
| Cerebral edema | contraindication | 2032001 | |
| Achilles tendinitis | contraindication | 11654001 | |
| Lowered convulsive threshold | contraindication | 19260006 | |
| Short bowel syndrome | contraindication | 26629001 | DOID:10605 |
| Torsades de pointes | contraindication | 31722008 | |
| Transplantation of heart | contraindication | 32413006 | |
| Crohn's disease | contraindication | 34000006 | |
| Tendinitis | contraindication | 34840004 | DOID:971 |
| Hypermethioninemia | contraindication | 43123004 | |
| Hypokalemia | contraindication | 43339004 | |
| Transplant of kidney | contraindication | 70536003 | |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Transplant of lung | contraindication | 88039007 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Myasthenia gravis | contraindication | 91637004 | DOID:437 |
| Prolonged QT interval | contraindication | 111975006 | |
| Gastrointestinal obstruction | contraindication | 126765001 | |
| Acute pancreatitis | contraindication | 197456007 | DOID:2913 |
| Meconium ileus | contraindication | 206523001 | |
| Peripheral nerve disease | contraindication | 302226006 | |
| Operation on gastrointestinal tract | contraindication | 386621005 | |
| Pseudomembranous enterocolitis | contraindication | 397683000 | |
| Traumatic rupture of tendon | contraindication | 415749005 | |
| Congenital long QT syndrome | contraindication | 442917000 | |
| Shoulder Tendonitis | contraindication |
🐶 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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1GM/SCOOPFUL | BETAINE | NOVITIUM PHARMA | A214864 | Nov. 23, 2021 | RX | FOR SOLUTION | ORAL | Aug. 2, 2022 | COMPETITIVE GENERIC THERAPY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4019632 | VUID |
| N0000147725 | NUI |
| D03103 | KEGG_DRUG |
| 1512 | RXNORM |
| C0005304 | UMLSCUI |
| CHEBI:17750 | CHEBI |
| BET | PDB_CHEM_ID |
| CHEMBL95889 | ChEMBL_ID |
| 247 | PUBCHEM_CID |
| DB06756 | DRUGBANK_ID |
| CHEMBL1182 | ChEMBL_ID |
| CHEMBL1201130 | ChEMBL_ID |
| D001622 | MESH_DESCRIPTOR_UI |
| 4550 | IUPHAR_LIGAND_ID |
| 3SCV180C9W | UNII |
| 11810 | MMSL |
| 14793 | MMSL |
| 167417 | MMSL |
| 167421 | MMSL |
| 46863 | MMSL |
| d04875 | MMSL |
| 001115 | NDDF |
| 004543 | NDDF |
| 006281 | NDDF |
| 4018110 | VANDF |
| 4019632 | VANDF |
| 391841000 | SNOMEDCT_US |
| 413645006 | SNOMEDCT_US |
| 43356007 | SNOMEDCT_US |
| 107-43-7 | SECONDARY_CAS_RN |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| FACE IT HD PERFECT BB SPF30 PA 01 | HUMAN OTC DRUG LABEL | 5 | 51523-103 | CREAM | 2 mL | TOPICAL | OTC monograph not final | 7 sections |
| FACE IT HD PERFECT BB SPF30 PA 02 | HUMAN OTC DRUG LABEL | 5 | 51523-104 | CREAM | 2 mL | TOPICAL | OTC monograph not final | 7 sections |
| Cystadane | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52276-400 | POWDER, FOR SOLUTION | 1 g | ORAL | NDA | 16 sections |
| Cystadane | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52276-401 | POWDER, FOR SOLUTION | 1 g | ORAL | Unapproved drug for use in drug shortage | 3 sections |
| Betaine Anhydrous For Oral Solution | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55792-002 | POWDER, FOR SOLUTION | 1 g | ORAL | ANDA | 16 sections |
| EnBrace HR | HUMAN PRESCRIPTION DRUG LABEL | 16 | 64661-650 | CAPSULE, DELAYED RELEASE PELLETS | 500 ug | ORAL | UNAPPROVED DRUG OTHER | 11 sections |
| EnLyte | HUMAN PRESCRIPTION DRUG LABEL | 18 | 64661-711 | CAPSULE, DELAYED RELEASE PELLETS | 500 ug | ORAL | unapproved drug other | 12 sections |
| Cystadane | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66621-4000 | POWDER, FOR SOLUTION | 6 g | ORAL | NDA | 16 sections |
| ATONO2 Oxygen Baby | HUMAN OTC DRUG LABEL | 1 | 70993-0005 | LOTION | 0.20 g | TOPICAL | unapproved drug other | 6 sections |
| Wizyoung Vitamin Collagen Essence Mask Pack | HUMAN OTC DRUG LABEL | 2 | 71102-100 | PATCH | 0.75 g | TOPICAL | unapproved drug other | 8 sections |
| Wizyoung Diamond Collagen Essence Mask Pack | HUMAN OTC DRUG LABEL | 2 | 71102-101 | PATCH | 0.75 g | TOPICAL | unapproved drug other | 8 sections |
| Betaine Anhydrous for Oral Solution | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72647-900 | FOR SOLUTION | 1 g | ORAL | ANDA | 24 sections |
| HWASAMONG Dr.All Scalp HealingShampoo | HUMAN OTC DRUG LABEL | 2 | 76678-0001 | SHAMPOO | 0.50 g | TOPICAL | unapproved drug other | 7 sections |