PedAM
Pediatric Disease Annotations & Medicines
| osteomyelitis | ||||
| Disease ID | 363 |
|---|---|
| Disease | osteomyelitis |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:40) C2707258 | infections C2598155 | pain C2364133 | infection C2240374 | eosinophilia C2074875 | sequestrum C1998328 | abscess of medulla oblongata C1963077 | bone pain C1704275 | pyomyositis C1550639 | fistula C1546533 | abscess C1510420 | cavities C1456822 | lameness C0948162 | bone marrow oedema C0744945 | hip prosthesis infection C0600327 | toxic shock syndrome C0581883 | deafness C0426768 | o sign C0406683 | bullosis diabeticorum C0340708 | deep vein thrombosis C0275901 | nasal tuberculosis C0272412 | splenic abscess C0238790 | bone destruction C0221014 | secondary amyloidosis C0152964 | streptococcal septicaemia C0149871 | deep venous thrombosis C0085652 | pyoderma gangrenosum C0078048 | varicella C0040485 | torticollis C0038160 | staphylococcal infection C0036420 | localized scleroderma C0032541 | polyneuritis C0032308 | staphylococcal pneumonia C0027726 | nephrotic syndrome C0023223 | leg ulcer C0018923 | angiosarcoma C0017661 | iga nephropathy C0012624 | spondylodiscitis C0010356 | cross infections C0007361 | cat-scratch disease C0006105 | brain abscess |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:16) C0000833 | abscess | 36 C0009450 | infection | 31 C0021311 | infections | 20 C0030193 | pain | 6 C0426768 | o sign | 4 C0016169 | fistula | 3 C1704275 | pyomyositis | 3 C0238790 | bone destruction | 2 C0311395 | lameness | 2 C0149871 | deep venous thrombosis | 2 C0333311 | sequestrum | 2 C0012624 | spondylodiscitis | 1 C0006105 | brain abscess | 1 C0042487 | deep vein thrombosis | 1 C0085652 | pyoderma gangrenosum | 1 C0151825 | bone pain | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:4) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs4986790 | 16487238 | 7097 | TLR2 | umls:C0029443 | BeFree | Polymorphisms in TLR2 (Arg753Gln) and TLR4 (Asp299Gly, Thr399Ile) genes are associated with bacterial infections, we therefore studied these polymorphisms in osteomyelitis patients. | 0.000814326 | 2006 | TLR4 | 9 | 117713024 | A | G |
| rs4986790 | 16487238 | 7099 | TLR4 | umls:C0029443 | BeFree | The Toll-like receptor 4 (Asp299Gly) polymorphism is a risk factor for Gram-negative and haematogenous osteomyelitis. | 0.000271442 | 2006 | TLR4 | 9 | 117713024 | A | G |
| rs4986791 | 16487238 | 7097 | TLR2 | umls:C0029443 | BeFree | Polymorphisms in TLR2 (Arg753Gln) and TLR4 (Asp299Gly, Thr399Ile) genes are associated with bacterial infections, we therefore studied these polymorphisms in osteomyelitis patients. | 0.000814326 | 2006 | TLR4 | 9 | 117713324 | C | T |
| rs5743708 | 16487238 | 7097 | TLR2 | umls:C0029443 | BeFree | Polymorphisms in TLR2 (Arg753Gln) and TLR4 (Asp299Gly, Thr399Ile) genes are associated with bacterial infections, we therefore studied these polymorphisms in osteomyelitis patients. | 0.000814326 | 2006 | TLR2 | 4 | 153705165 | G | A |
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:14) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0029443 | ceftazidime | D002442 | 78439-06-2 | osteomyelitis | MESH:D010019 | therapeutic | 1601755 | ||
| C0029443 | chloramphenicol | D002701 | 56-75-7 | osteomyelitis | MESH:D010019 | marker/mechanism | 6071896 | ||
| C0029443 | chloramphenicol | D002701 | 56-75-7 | osteomyelitis | MESH:D010019 | therapeutic | 839647 | ||
| C0029443 | ciprofloxacin | D002939 | 85721-33-1 | osteomyelitis | MESH:D010019 | therapeutic | 1352007 | ||
| C0029443 | daptomycin | D017576 | 103060-53-3 | osteomyelitis | MESH:D010019 | therapeutic | 18606349 | ||
| C0029443 | diclofenac | D004008 | 15307-86-5 | osteomyelitis | MESH:D010019 | marker/mechanism | 15069333 | ||
| C0029443 | linezolid | D000069349 | - | osteomyelitis | MESH:D010019 | therapeutic | 11794421 | ||
| C0029443 | methotrexate | D008727 | 1959/5/2 | osteomyelitis | MESH:D010019 | marker/mechanism | 8779788 | ||
| C0029443 | nafcillin | D009254 | 147-52-4 | osteomyelitis | MESH:D010019 | therapeutic | 6176609 | ||
| C0029443 | ofloxacin | D015242 | 82419-36-1 | osteomyelitis | MESH:D010019 | therapeutic | 1352007 | ||
| C0029443 | pefloxacin | D015366 | 70458-92-3 | osteomyelitis | MESH:D010019 | therapeutic | 1352007 | ||
| C0029443 | rifampin | D012293 | 13292-46-1 | osteomyelitis | MESH:D010019 | therapeutic | 15843291 | ||
| C0029443 | vancomycin | D014640 | 1404-90-6 | osteomyelitis | MESH:D010019 | therapeutic | 18511323 | ||
| C0029443 | zoledronic acid | C088658 | - | osteomyelitis | MESH:D010019 | therapeutic | 18266863 | ||
FDA approved drug and dosage information(Total Drugs:10) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D010019 | 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:D010019 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D010019 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D010019 | 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:D010019 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D010019 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D010019 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MESH:D010019 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| MESH:D010019 | zometa | zoledronic acid | EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | INJECTABLE;IV (INFUSION) | Discontinued | None | Yes | No |
| MESH:D010019 | zometa | zoledronic acid | EQ 4MG BASE/VIAL | INJECTABLE; IV (INFUSION) | Prescription | None | No | No |
FDA labeling changes(Total Drugs:10) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D010019 | 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:D010019 | 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:D010019 | 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:D010019 | 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:D010019 | 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:D010019 | 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:D010019 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D010019 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D010019 | 03/20/2008 | zometa | zoledronic acid | Severe osteogenesis imperfecta | Zoledronic acid is not indicated for use in children Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain Information on PK, clinical study, and AE profile | Labeling | B | - | - | - | Novartis | 12/21/2007 | FALSE' |
| MESH:D010019 | 03/20/2008 | zometa | zoledronic acid | Severe osteogenesis imperfecta | Zoledronic acid is not indicated for use in children Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain Information on PK, clinical study, and AE profile | Labeling | B | - | - | - | Novartis | 12/21/2007 | FALSE' |