PedAM
Pediatric Disease Annotations & Medicines
| optic neuritis | ||||
| Disease ID | 375 |
|---|---|
| Disease | optic neuritis |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:18) C2598155 | pain C1868685 | disseminated sclerosis C1417325 | multiple sclerosis C1290884 | inflammatory disease C0948402 | hypertrophic pachymeningitis C0858618 | dyschromatopsia C0852416 | pupillary signs C0520998 | phosphenes C0456909 | blindness C0235272 | retinal damage C0234131 | motor dysfunction C0162293 | papillitis C0155288 | papilledema C0036454 | visual field defects C0036454 | scotomas C0029440 | osteoma C0026896 | myasthenia gravis C0007682 | disease of the central nervous system |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:10) C0026769 | multiple sclerosis | 36 C0456909 | blindness | 5 C1290884 | inflammatory disease | 3 C0234131 | motor dysfunction | 1 C0948402 | hypertrophic pachymeningitis | 1 C0030193 | pain | 1 C0026896 | myasthenia gravis | 1 C0036454 | visual field defects | 1 C0029440 | osteoma | 1 C0007682 | disease of the central nervous system | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:0) | |
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| (Waiting for update.) | |
GWASdb Annotation(Total Genotypes:0) | |
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| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:0) | |
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| (Waiting for update.) | |
Mapped by lexical matching(Total Items:0) |
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| (Waiting for update.) |
Mapped by homologous gene(Total Items:0) |
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| (Waiting for update.) |
Chemical(Total Drugs:10) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0029134 | albendazole | D015766 | 54965-21-8 | optic neuritis | MESH:D009902 | marker/mechanism | 9843265 | ||
| C0029134 | carmustine | D002330 | 154-93-8 | optic neuritis | MESH:D009902 | marker/mechanism | 625262 | ||
| C0029134 | chloramphenicol | D002701 | 56-75-7 | optic neuritis | MESH:D009902 | marker/mechanism | 3380586 | ||
| C0029134 | cisplatin | D002945 | 15663-27-1 | optic neuritis | MESH:D009902 | marker/mechanism | 9325480 | ||
| C0029134 | ethambutol | D004977 | 74-55-5 | optic neuritis | MESH:D009902 | marker/mechanism | 1030352 | ||
| C0029134 | ethchlorvynol | D004984 | 113-18-8 | optic neuritis | MESH:D009902 | marker/mechanism | 6226702 | ||
| C0029134 | hydroxocobalamin | D006879 | 13422-51-0 | optic neuritis | MESH:D009902 | therapeutic | 4175520 | ||
| C0029134 | minoxidil | D008914 | 38304-91-5 | optic neuritis | MESH:D009902 | marker/mechanism | 6342503 | ||
| C0029134 | pamidronate | C019248 | 40391-99-9 | optic neuritis | MESH:D009902 | marker/mechanism | 9132334 | ||
| C0029134 | vigabatrin | D020888 | 60643-86-9 | optic neuritis | MESH:D009902 | marker/mechanism | 8164764 | ||
FDA approved drug and dosage information(Total Drugs:2) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D009902 | sabril | vigabatrin | 500MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| MESH:D009902 | sabril | vigabatrin | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | AA | Yes | Yes |
FDA labeling changes(Total Drugs:2) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DiseaseID | Pediatric_Labeling_Date | Trade_Name | Generic_Name_or_Proper_Name | Indications Studied | Label Changes Summary | Product Labeling | BPCA(B) | PREA(P) | BPCA(B) and PREA(P) | Pediatric Rule (R) | Sponsor | Pediatric Exclusivity Granted Date | NNPS |
| MESH:D009902 | 10/26/2013 | sabril | vigabatrin | Refractory complex partial seizures (rCPS) | Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials | Labeling | - | - | B,P | - | Lundbeck LLC | 3/10/2013 | FALSE' |
| MESH:D009902 | 10/26/2013 | sabril | vigabatrin | Refractory complex partial seizures (rCPS) | Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials | Labeling | - | - | B,P | - | Lundbeck LLC | 3/10/2013 | FALSE' |