PedAM
Pediatric Disease Annotations & Medicines
| meningoencephalitis | ||||
| Disease ID | 1116 |
|---|---|
| Disease | meningoencephalitis |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:3) |
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:7) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0025309 | chlorambucil | D002699 | 305-03-3 | meningoencephalitis | MESH:D008590 | therapeutic | 9173749 | ||
| C0025309 | erythromycin | D004917 | 114-07-8 | meningoencephalitis | MESH:D008590 | marker/mechanism | 8614533 | ||
| C0025309 | linezolid | D000069349 | - | meningoencephalitis | MESH:D008590 | therapeutic | 18651266 | ||
| C0025309 | nevirapine | D019829 | 129618-40-2 | meningoencephalitis | MESH:D008590 | marker/mechanism | 11450872 | ||
| C0025309 | sulfisoxazole | D013444 | 127-69-5 | meningoencephalitis | MESH:D008590 | marker/mechanism | 8614533 | ||
| C0025309 | vancomycin | D014640 | 1404-90-6 | meningoencephalitis | MESH:D008590 | therapeutic | 12621510 | ||
| C0025309 | vincristine | D014750 | - | meningoencephalitis | MESH:D008590 | marker/mechanism | 6573227 | ||
FDA approved drug and dosage information(Total Drugs:6) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D008590 | zyvox | linezolid | 400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
| MESH:D008590 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D008590 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D008590 | zyvox | linezolid | 400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
| MESH:D008590 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D008590 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
FDA labeling changes(Total Drugs:6) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D008590 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D008590 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D008590 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D008590 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D008590 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D008590 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |