Stem definition | Drug id | CAS RN |
---|---|---|
gabamimetic agents | 2819 | 68506-86-5 |
Dose | Unit | Route |
---|---|---|
2 | g | O |
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
EoM (Fraction excreted unchanged in urine) | 60 % | Benet LZ, Broccatelli F, Oprea TI |
MRTD (Maximum Recommended Therapeutic Daily Dose) | 442.42 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
BA (Bioavailability) | 99 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Date | Agency | Company | Orphan |
---|---|---|---|
Aug. 21, 2009 | FDA | LUNDBECK LLC |
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 |
---|---|---|---|---|---|---|
Seizure | 1559.26 | 32.46 | 576 | 5209 | 122478 | 46557799 |
Drug withdrawal convulsions | 605.69 | 32.46 | 110 | 5675 | 1231 | 46679046 |
Infantile spasms | 391.43 | 32.46 | 60 | 5725 | 203 | 46680074 |
Product dose omission issue | 273.29 | 32.46 | 199 | 5586 | 168321 | 46511956 |
Retinogram abnormal | 209.21 | 32.46 | 32 | 5753 | 106 | 46680171 |
Drug ineffective | 195.60 | 32.46 | 319 | 5466 | 677519 | 46002758 |
Death | 192.61 | 32.46 | 221 | 5564 | 335327 | 46344950 |
Epilepsy | 184.40 | 32.46 | 79 | 5706 | 23659 | 46656618 |
Status epilepticus | 176.35 | 32.46 | 66 | 5719 | 13913 | 46666364 |
Irritability | 138.98 | 32.46 | 69 | 5716 | 28877 | 46651400 |
Visual field defect | 123.74 | 32.46 | 41 | 5744 | 6042 | 46674235 |
Somnolence | 109.88 | 32.46 | 115 | 5670 | 156406 | 46523871 |
Brain operation | 98.10 | 32.46 | 20 | 5765 | 422 | 46679855 |
Aggression | 77.14 | 32.46 | 43 | 5742 | 22701 | 46657576 |
Change in seizure presentation | 70.46 | 32.46 | 14 | 5771 | 258 | 46680019 |
Tonic convulsion | 69.97 | 32.46 | 18 | 5767 | 1088 | 46679189 |
Focal dyscognitive seizures | 69.46 | 32.46 | 22 | 5763 | 2806 | 46677471 |
Partial seizures | 64.38 | 32.46 | 24 | 5761 | 4986 | 46675291 |
Drug resistance | 62.08 | 32.46 | 34 | 5751 | 17334 | 46662943 |
Generalised tonic-clonic seizure | 57.63 | 32.46 | 38 | 5747 | 27084 | 46653193 |
Respiratory distress | 56.63 | 32.46 | 40 | 5745 | 31876 | 46648401 |
Optic atrophy | 55.64 | 32.46 | 15 | 5770 | 1087 | 46679190 |
Abnormal behaviour | 53.42 | 32.46 | 33 | 5752 | 21025 | 46659252 |
Seizure cluster | 51.25 | 32.46 | 10 | 5775 | 167 | 46680110 |
Infantile spitting up | 49.16 | 32.46 | 8 | 5777 | 43 | 46680234 |
Retinal injury | 49.04 | 32.46 | 10 | 5775 | 211 | 46680066 |
Intellectual disability | 47.57 | 32.46 | 12 | 5773 | 670 | 46679607 |
Temporal lobe epilepsy | 43.56 | 32.46 | 10 | 5775 | 373 | 46679904 |
Pneumonia | 43.44 | 32.46 | 123 | 5662 | 376197 | 46304080 |
Epidural lipomatosis | 42.80 | 32.46 | 8 | 5777 | 105 | 46680172 |
Pneumonia aspiration | 41.33 | 32.46 | 33 | 5752 | 31572 | 46648705 |
Coma blister | 40.28 | 32.46 | 8 | 5777 | 147 | 46680130 |
Ophthalmological examination abnormal | 38.85 | 32.46 | 7 | 5778 | 74 | 46680203 |
Nausea | 38.06 | 32.46 | 19 | 5766 | 687435 | 45992842 |
Hypotonia | 37.62 | 32.46 | 19 | 5766 | 8210 | 46672067 |
Bronchiolitis | 37.05 | 32.46 | 13 | 5772 | 2272 | 46678005 |
Blindness | 36.20 | 32.46 | 24 | 5761 | 17245 | 46663032 |
Respiratory failure | 35.75 | 32.46 | 51 | 5734 | 94765 | 46585512 |
Visual impairment | 34.65 | 32.46 | 42 | 5743 | 66647 | 46613630 |
Rhinovirus infection | 34.58 | 32.46 | 14 | 5771 | 3622 | 46676655 |
Respiratory syncytial virus bronchiolitis | 34.38 | 32.46 | 8 | 5777 | 317 | 46679960 |
Pain | 33.38 | 32.46 | 9 | 5776 | 476939 | 46203338 |
Therapeutic product effective for unapproved indication | 32.60 | 32.46 | 6 | 5779 | 72 | 46680205 |
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 |
---|---|---|---|---|---|---|
Seizure | 1539.48 | 40.74 | 597 | 4912 | 97878 | 29849091 |
Drug withdrawal convulsions | 547.18 | 40.74 | 105 | 5404 | 1054 | 29945915 |
Infantile spasms | 503.24 | 40.74 | 80 | 5429 | 219 | 29946750 |
Product dose omission issue | 340.03 | 40.74 | 210 | 5299 | 91421 | 29855548 |
Drug ineffective | 226.74 | 40.74 | 293 | 5216 | 340094 | 29606875 |
Visual field defect | 203.32 | 40.74 | 61 | 5448 | 4375 | 29942594 |
Retinogram abnormal | 175.38 | 40.74 | 28 | 5481 | 79 | 29946890 |
Status epilepticus | 162.51 | 40.74 | 65 | 5444 | 11007 | 29935962 |
Brain operation | 109.99 | 40.74 | 22 | 5487 | 276 | 29946693 |
Death | 98.08 | 40.74 | 207 | 5302 | 357076 | 29589893 |
Infantile spitting up | 96.91 | 40.74 | 15 | 5494 | 32 | 29946937 |
Somnolence | 91.03 | 40.74 | 100 | 5409 | 96663 | 29850306 |
Visual impairment | 83.45 | 40.74 | 58 | 5451 | 30380 | 29916589 |
Epilepsy | 78.78 | 40.74 | 48 | 5461 | 20121 | 29926848 |
Ophthalmological examination abnormal | 68.38 | 40.74 | 11 | 5498 | 33 | 29946936 |
Sudden unexplained death in epilepsy | 68.34 | 40.74 | 16 | 5493 | 434 | 29946535 |
Irritability | 63.33 | 40.74 | 44 | 5465 | 23006 | 29923963 |
Aggression | 60.85 | 40.74 | 52 | 5457 | 36855 | 29910114 |
Optic atrophy | 59.68 | 40.74 | 16 | 5493 | 760 | 29946209 |
Postictal paralysis | 55.36 | 40.74 | 11 | 5498 | 133 | 29946836 |
Respiratory distress | 53.42 | 40.74 | 46 | 5463 | 32926 | 29914043 |
Partial seizures | 51.37 | 40.74 | 21 | 5488 | 3746 | 29943223 |
Respiratory syncytial virus infection | 46.69 | 40.74 | 19 | 5490 | 3349 | 29943620 |
Crying | 46.39 | 40.74 | 22 | 5487 | 5587 | 29941382 |
Abnormal behaviour | 46.13 | 40.74 | 38 | 5471 | 25585 | 29921384 |
Seizure cluster | 44.62 | 40.74 | 9 | 5500 | 118 | 29946851 |
Source | Code | Description |
---|---|---|
ATC | N03AG04 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Fatty acid derivatives |
FDA EPC | N0000175753 | Anti-epileptic Agent |
MeSH PA | D000927 | Anticonvulsants |
MeSH PA | D002491 | Central Nervous System Agents |
MeSH PA | D004791 | Enzyme Inhibitors |
MeSH PA | D018682 | GABA Agents |
MeSH PA | D018377 | Neurotransmitter Agents |
CHEBI has role | CHEBI:35623 | antiepileptic |
CHEBI has role | CHEBI:63674 | 4-aminobutyrate transaminase inhibitors |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
West syndrome | indication | 28055006 | |
Epilepsy characterized by intractable complex partial seizures | indication | 442481002 | |
Suicidal thoughts | contraindication | 6471006 | |
Weight gain finding | contraindication | 8943002 | |
Visual field defect | contraindication | 12184005 | |
Reduced visual acuity | contraindication | 13164000 | |
Mood swings | contraindication | 18963009 | |
Kidney disease | contraindication | 90708001 | DOID:557 |
Edema | contraindication | 267038008 | |
Anemia | contraindication | 271737000 | DOID:2355 |
Pregnancy, function | contraindication | 289908002 | |
Peripheral nerve disease | contraindication | 302226006 | |
Breastfeeding (mother) | contraindication | 413712001 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 3.94 | acidic |
pKa2 | 10.16 | Basic |
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
500MG | VIGABATRIN | DR REDDYS | A211539 | Jan. 29, 2021 | RX | TABLET | ORAL | July 31, 2021 | COMPETITIVE GENERIC THERAPY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
4-aminobutyrate aminotransferase, mitochondrial | Enzyme | INHIBITOR | CHEMBL | CHEMBL | |||||
Gamma-amino-N-butyrate transaminase | Unclassified | IC50 | 4.38 | CHEMBL |
ID | Source |
---|---|
4025280 | VUID |
N0000171807 | NUI |
D00535 | KEGG_DRUG |
4025280 | VANDF |
C0592085 | UMLSCUI |
CHEBI:63638 | CHEBI |
CHEMBL89598 | ChEMBL_ID |
D020888 | MESH_DESCRIPTOR_UI |
5581 | INN_ID |
GR120KRT6K | UNII |
5665 | PUBCHEM_CID |
4821 | IUPHAR_LIGAND_ID |
DB01080 | DRUGBANK_ID |
14851 | RXNORM |
15507 | MMSL |
36115 | MMSL |
52922 | MMSL |
d04669 | MMSL |
003774 | NDDF |
310283001 | SNOMEDCT_US |
322976008 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Vigabatrin for oral solution USP, 500 mg | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0702 | FOR SOLUTION | 50 mg | ORAL | ANDA | 33 sections |
VIGADRONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0245-0556 | POWDER, FOR SOLUTION | 50 mg | ORAL | ANDA | 35 sections |
Vigabatrin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-3851 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 29 sections |
vigabatrin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-3955 | POWDER, FOR SOLUTION | 50 mg | ORAL | ANDA | 30 sections |
Vigabatrin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-521 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 33 sections |
vigabatrin for oral solution | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-009 | POWDER, FOR SOLUTION | 50 mg | ORAL | ANDA | 36 sections |
Vigabatrin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-651 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 32 sections |
Vigabatrin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-697 | POWDER, FOR SOLUTION | 50 mg | ORAL | ANDA | 31 sections |
VIGABATRIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-358 | POWDER, FOR SOLUTION | 50 mg | ORAL | ANDA | 32 sections |
SABRIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67386-111 | TABLET, FILM COATED | 500 mg | ORAL | NDA | 32 sections |
SABRIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67386-211 | POWDER, FOR SOLUTION | 50 mg | ORAL | NDA | 33 sections |
VIGABATRIN | Human Prescription Drug Label | 1 | 67877-674 | POWDER, FOR SOLUTION | 50 mg | ORAL | ANDA | 31 sections |
VIGABATRIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-964 | POWDER, FOR SOLUTION | 500 mg | ORAL | ANDA | 32 sections |
Vigabatrin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69238-1425 | FOR SOLUTION | 500 mg | ORAL | ANDA | 30 sections |