PedAM
Pediatric Disease Annotations & Medicines
| pneumonia | ||||
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:30) | |||||||||||||
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| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs12252 | 23997235 | 10410 | IFITM3 | umls:C0032285 | BeFree | We have genotyped a possible splice-site altering single-nucleotide polymorphism (rs12252) in the IFITM3 gene in 34 patients with H1N1 influenza and severe pneumonia, and >5000 individuals comprising patients with community-acquired mild lower respiratory tract infection and matched controls of Caucasian ancestry. | 0.000271442 | 2014 | IFITM3 | 11 | 320772 | A | G |
| rs1799983 | 20811626 | 4846 | NOS3 | umls:C0032285 | BeFree | In contrast, NOS3:rs1799983 displayed a protective effect with a 45% reduction in pneumonitis risk (HR:0.55, 95% CI:0.31-0.96). | 0.000271442 | 2010 | NOS3 | 7 | 150999023 | T | G |
| rs1799983 | 20811626 | 342977 | NANOS3 | umls:C0032285 | BeFree | In contrast, NOS3:rs1799983 displayed a protective effect with a 45% reduction in pneumonitis risk (HR:0.55, 95% CI:0.31-0.96). | 0.000271442 | 2010 | NOS3 | 7 | 150999023 | T | G |
| rs1799983 | 20811626 | 342977 | NANOS3 | umls:C3714636 | BeFree | In contrast, NOS3:rs1799983 displayed a protective effect with a 45% reduction in pneumonitis risk (HR:0.55, 95% CI:0.31-0.96). | 0.000271442 | 2010 | NOS3 | 7 | 150999023 | T | G |
| rs1799983 | 20811626 | 4846 | NOS3 | umls:C3714636 | BeFree | In contrast, NOS3:rs1799983 displayed a protective effect with a 45% reduction in pneumonitis risk (HR:0.55, 95% CI:0.31-0.96). | 0.000271442 | 2010 | NOS3 | 7 | 150999023 | T | G |
| rs1801274 | 21737555 | 708 | C1QBP | umls:C0032285 | BeFree | Four risk single-nucleotide polymorphisms were significantly (p<0.0001) associated with severe pneumonia: rs1801274 (Fc fragment of immunoglobulin G, low-affinity IIA, receptor (FCGR2A) gene, chromosome 1; OR 2.68, 95% CI 1.69-4.25); rs9856661 (gene unknown, chromosome 3; OR 2.62, 95% CI 1.64-4.18); rs8070740 (RPA interacting protein (RPAIN) gene, chromosome 17; OR 2.67, 95% CI 1.63-4.39); and rs3786054 (complement component 1, q subcomponent binding protein (C1QBP) gene, chromosome 17; OR 3.13, 95% CI 1.89-5.17). | 0.000271442 | 2012 | FCGR2A | 1 | 161509955 | A | G |
| rs1801274 | 21737555 | 84268 | RPAIN | umls:C0032285 | BeFree | Four risk single-nucleotide polymorphisms were significantly (p<0.0001) associated with severe pneumonia: rs1801274 (Fc fragment of immunoglobulin G, low-affinity IIA, receptor (FCGR2A) gene, chromosome 1; OR 2.68, 95% CI 1.69-4.25); rs9856661 (gene unknown, chromosome 3; OR 2.62, 95% CI 1.64-4.18); rs8070740 (RPA interacting protein (RPAIN) gene, chromosome 17; OR 2.67, 95% CI 1.63-4.39); and rs3786054 (complement component 1, q subcomponent binding protein (C1QBP) gene, chromosome 17; OR 3.13, 95% CI 1.89-5.17). | 0.000271442 | 2012 | FCGR2A | 1 | 161509955 | A | G |
| rs1982073 | 19380441 | 7040 | TGFB1 | umls:C0032285 | BeFree | Single nucleotide polymorphism at rs1982073:T869C of the TGFbeta 1 gene is associated with the risk of radiation pneumonitis in patients with non-small-cell lung cancer treated with definitive radiotherapy. | 0.121628651 | 2009 | NA | NA | NA | NA | NA |
| rs1982073 | 19380441 | 7040 | TGFB1 | umls:C3714636 | BeFree | Single nucleotide polymorphism at rs1982073:T869C of the TGFbeta 1 gene is associated with the risk of radiation pneumonitis in patients with non-small-cell lung cancer treated with definitive radiotherapy. | 0.000814326 | 2009 | NA | NA | NA | NA | NA |
| rs2868371 | 23374503 | 3315 | HSPB1 | umls:C0032285 | BeFree | Functional promoter variant rs2868371 of HSPB1 is associated with risk of radiation pneumonitis after chemoradiation for non-small cell lung cancer. | 0.000542884 | 2013 | HSPB1 | 7 | 76301442 | C | G |
| rs2868371 | 23374503 | 3315 | HSPB1 | umls:C3714636 | BeFree | Functional promoter variant rs2868371 of HSPB1 is associated with risk of radiation pneumonitis after chemoradiation for non-small cell lung cancer. | 0.000542884 | 2013 | HSPB1 | 7 | 76301442 | C | G |
| rs3786054 | 21737555 | 708 | C1QBP | umls:C0032285 | BeFree | Four risk single-nucleotide polymorphisms were significantly (p<0.0001) associated with severe pneumonia: rs1801274 (Fc fragment of immunoglobulin G, low-affinity IIA, receptor (FCGR2A) gene, chromosome 1; OR 2.68, 95% CI 1.69-4.25); rs9856661 (gene unknown, chromosome 3; OR 2.62, 95% CI 1.64-4.18); rs8070740 (RPA interacting protein (RPAIN) gene, chromosome 17; OR 2.67, 95% CI 1.63-4.39); and rs3786054 (complement component 1, q subcomponent binding protein (C1QBP) gene, chromosome 17; OR 3.13, 95% CI 1.89-5.17). | 0.000271442 | 2012 | C1QBP | 17 | 5435739 | G | A |
| rs3786054 | 21737555 | 84268 | RPAIN | umls:C0032285 | BeFree | Four risk single-nucleotide polymorphisms were significantly (p<0.0001) associated with severe pneumonia: rs1801274 (Fc fragment of immunoglobulin G, low-affinity IIA, receptor (FCGR2A) gene, chromosome 1; OR 2.68, 95% CI 1.69-4.25); rs9856661 (gene unknown, chromosome 3; OR 2.62, 95% CI 1.64-4.18); rs8070740 (RPA interacting protein (RPAIN) gene, chromosome 17; OR 2.67, 95% CI 1.63-4.39); and rs3786054 (complement component 1, q subcomponent binding protein (C1QBP) gene, chromosome 17; OR 3.13, 95% CI 1.89-5.17). | 0.000271442 | 2012 | C1QBP | 17 | 5435739 | G | A |
| rs4340 | 26222869 | 3827 | KNG1 | umls:C3714636 | BeFree | rs4340 polymorphism at intron 16 of the angiotensin-converting enzyme (CD143) gene was reported to repress cough reflex by reducing bradykinin and substance P levels, thus increasing the likelihood to develop pneumonia. | 0.000271442 | 2015 | NA | NA | NA | NA | NA |
| rs4340 | 26222869 | 1636 | ACE | umls:C3714636 | BeFree | Genetic Association Between CD143 rs4340 Polymorphism and Pneumonia risk: A Meta Analysis. | 0.000542884 | 2015 | NA | NA | NA | NA | NA |
| rs4340 | 26222869 | 3827 | KNG1 | umls:C0032285 | BeFree | rs4340 polymorphism at intron 16 of the angiotensin-converting enzyme (CD143) gene was reported to repress cough reflex by reducing bradykinin and substance P levels, thus increasing the likelihood to develop pneumonia. | 0.000271442 | 2015 | NA | NA | NA | NA | NA |
| rs4340 | 26222869 | 6863 | TAC1 | umls:C0032285 | BeFree | rs4340 polymorphism at intron 16 of the angiotensin-converting enzyme (CD143) gene was reported to repress cough reflex by reducing bradykinin and substance P levels, thus increasing the likelihood to develop pneumonia. | 0.000271442 | 2015 | NA | NA | NA | NA | NA |
| rs4340 | 26222869 | 1636 | ACE | umls:C0032285 | BeFree | Genetic Association Between CD143 rs4340 Polymorphism and Pneumonia risk: A Meta Analysis. | 0.009544073 | 2015 | NA | NA | NA | NA | NA |
| rs4340 | 26222869 | 6863 | TAC1 | umls:C3714636 | BeFree | rs4340 polymorphism at intron 16 of the angiotensin-converting enzyme (CD143) gene was reported to repress cough reflex by reducing bradykinin and substance P levels, thus increasing the likelihood to develop pneumonia. | 0.000271442 | 2015 | NA | NA | NA | NA | NA |
| rs4986790 | 25427560 | 7099 | TLR4 | umls:C0032285 | BeFree | Furthermore, the cosegregating TLR4 polymorphisms Asp299Gly and Thr399Ile were independent risk factors for the development of both sepsis and pneumonia (OR: 3.55; 95% CI: 1.21-10.4, P=0.021 and OR: 3.57, 95% CI: 1.3-9.86, P=0.014, respectively). | 0.003528744 | 2014 | TLR4 | 9 | 117713024 | A | G |
| rs4986790 | 25427560 | 7099 | TLR4 | umls:C3714636 | BeFree | Furthermore, the cosegregating TLR4 polymorphisms Asp299Gly and Thr399Ile were independent risk factors for the development of both sepsis and pneumonia (OR: 3.55; 95% CI: 1.21-10.4, P=0.021 and OR: 3.57, 95% CI: 1.3-9.86, P=0.014, respectively). | 0.000542884 | 2014 | TLR4 | 9 | 117713024 | A | G |
| rs4986791 | 25427560 | 7099 | TLR4 | umls:C3714636 | BeFree | Furthermore, the cosegregating TLR4 polymorphisms Asp299Gly and Thr399Ile were independent risk factors for the development of both sepsis and pneumonia (OR: 3.55; 95% CI: 1.21-10.4, P=0.021 and OR: 3.57, 95% CI: 1.3-9.86, P=0.014, respectively). | 0.000542884 | 2014 | TLR4 | 9 | 117713324 | C | T |
| rs4986791 | 25427560 | 7099 | TLR4 | umls:C0032285 | BeFree | Furthermore, the cosegregating TLR4 polymorphisms Asp299Gly and Thr399Ile were independent risk factors for the development of both sepsis and pneumonia (OR: 3.55; 95% CI: 1.21-10.4, P=0.021 and OR: 3.57, 95% CI: 1.3-9.86, P=0.014, respectively). | 0.003528744 | 2014 | TLR4 | 9 | 117713324 | C | T |
| rs5743313 | 23151015 | 7098 | TLR3 | umls:C0032285 | BeFree | The TLR3 rs5743313/CT polymorphism was found in all of the children with pneumonia and influenza infection, but in a significantly smaller number of those with A/H1N1/2009 influenza without pneumonia (<0.0001). | 0.000542884 | 2012 | TLR3 | 4 | 186079213 | C | T |
| rs5743708 | 25427560 | 7097 | TLR2 | umls:C0032285 | BeFree | The presence of the TLR2 Arg753Gln polymorphism was significantly associated with pneumonia in AML patients (odds ratio (OR): 10.78; 95% confidence interval (CI): 2.0-58.23; P=0.006). | 0.001357209 | 2014 | TLR2 | 4 | 153705165 | G | A |
| rs5743708 | 25427560 | 7097 | TLR2 | umls:C3714636 | BeFree | The presence of the TLR2 Arg753Gln polymorphism was significantly associated with pneumonia in AML patients (odds ratio (OR): 10.78; 95% confidence interval (CI): 2.0-58.23; P=0.006). | 0.000271442 | 2014 | TLR2 | 4 | 153705165 | G | A |
| rs8070740 | 21737555 | 84268 | RPAIN | umls:C0032285 | BeFree | Four risk single-nucleotide polymorphisms were significantly (p<0.0001) associated with severe pneumonia: rs1801274 (Fc fragment of immunoglobulin G, low-affinity IIA, receptor (FCGR2A) gene, chromosome 1; OR 2.68, 95% CI 1.69-4.25); rs9856661 (gene unknown, chromosome 3; OR 2.62, 95% CI 1.64-4.18); rs8070740 (RPA interacting protein (RPAIN) gene, chromosome 17; OR 2.67, 95% CI 1.63-4.39); and rs3786054 (complement component 1, q subcomponent binding protein (C1QBP) gene, chromosome 17; OR 3.13, 95% CI 1.89-5.17). | 0.000271442 | 2012 | RPAIN | 17 | 5428576 | A | G |
| rs8070740 | 21737555 | 708 | C1QBP | umls:C0032285 | BeFree | Four risk single-nucleotide polymorphisms were significantly (p<0.0001) associated with severe pneumonia: rs1801274 (Fc fragment of immunoglobulin G, low-affinity IIA, receptor (FCGR2A) gene, chromosome 1; OR 2.68, 95% CI 1.69-4.25); rs9856661 (gene unknown, chromosome 3; OR 2.62, 95% CI 1.64-4.18); rs8070740 (RPA interacting protein (RPAIN) gene, chromosome 17; OR 2.67, 95% CI 1.63-4.39); and rs3786054 (complement component 1, q subcomponent binding protein (C1QBP) gene, chromosome 17; OR 3.13, 95% CI 1.89-5.17). | 0.000271442 | 2012 | RPAIN | 17 | 5428576 | A | G |
| rs9856661 | 21737555 | 84268 | RPAIN | umls:C0032285 | BeFree | Four risk single-nucleotide polymorphisms were significantly (p<0.0001) associated with severe pneumonia: rs1801274 (Fc fragment of immunoglobulin G, low-affinity IIA, receptor (FCGR2A) gene, chromosome 1; OR 2.68, 95% CI 1.69-4.25); rs9856661 (gene unknown, chromosome 3; OR 2.62, 95% CI 1.64-4.18); rs8070740 (RPA interacting protein (RPAIN) gene, chromosome 17; OR 2.67, 95% CI 1.63-4.39); and rs3786054 (complement component 1, q subcomponent binding protein (C1QBP) gene, chromosome 17; OR 3.13, 95% CI 1.89-5.17). | 0.000271442 | 2012 | NA | 3 | 54043229 | A | C |
| rs9856661 | 21737555 | 708 | C1QBP | umls:C0032285 | BeFree | Four risk single-nucleotide polymorphisms were significantly (p<0.0001) associated with severe pneumonia: rs1801274 (Fc fragment of immunoglobulin G, low-affinity IIA, receptor (FCGR2A) gene, chromosome 1; OR 2.68, 95% CI 1.69-4.25); rs9856661 (gene unknown, chromosome 3; OR 2.62, 95% CI 1.64-4.18); rs8070740 (RPA interacting protein (RPAIN) gene, chromosome 17; OR 2.67, 95% CI 1.63-4.39); and rs3786054 (complement component 1, q subcomponent binding protein (C1QBP) gene, chromosome 17; OR 3.13, 95% CI 1.89-5.17). | 0.000271442 | 2012 | NA | 3 | 54043229 | A | C |
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:41) | |||||||||
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| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0032285 | amikacin | D000583 | 37517-28-5 | pneumonia | MESH:D011014 | therapeutic | 1108649 | ||
| C0032285 | ampicillin | D000667 | 69-53-4 | pneumonia | MESH:D011014 | therapeutic | 6637917 | ||
| C0032285 | azithromycin | D017963 | 83905-01-5 | pneumonia | MESH:D011014 | therapeutic | 10858333 | ||
| C0032285 | bleomycin | D001761 | 11056-06-7 | pneumonia | MESH:D011014 | marker/mechanism | 16317386 | ||
| C0032285 | capsaicin | D002211 | 404-86-4 | pneumonia | MESH:D011014 | marker/mechanism | 22575871 | ||
| C0032285 | carbenicillin | D002228 | 4697-36-3 | pneumonia | MESH:D011014 | therapeutic | 256433 | ||
| C0032285 | carmustine | D002330 | 154-93-8 | pneumonia | MESH:D011014 | marker/mechanism | 6354414 | ||
| C0032285 | cefotaxime | D002439 | 63527-52-6 | pneumonia | MESH:D011014 | therapeutic | 1583528 | ||
| C0032285 | ceftazidime | D002442 | 78439-06-2 | pneumonia | MESH:D011014 | therapeutic | 21227004 | ||
| C0032285 | chloramphenicol | D002701 | 56-75-7 | pneumonia | MESH:D011014 | marker/mechanism | 4023934 | ||
| C0032285 | chloramphenicol | D002701 | 56-75-7 | pneumonia | MESH:D011014 | therapeutic | 2041948 | ||
| C0032285 | ciprofloxacin | D002939 | 85721-33-1 | pneumonia | MESH:D011014 | therapeutic | 1541177 | ||
| C0032285 | crizotinib | C551994 | - | pneumonia | MESH:D011014 | marker/mechanism | 23686600 | ||
| C0032285 | cyclophosphamide | D003520 | 50-18-0 | pneumonia | MESH:D011014 | marker/mechanism | 2705179 | ||
| C0032285 | dapsone | D003622 | 80-08-0 | pneumonia | MESH:D011014 | marker/mechanism | 19583683 | ||
| C0032285 | cisplatin | D002945 | 15663-27-1 | pneumonia | MESH:D011014 | marker/mechanism | 21415776 | ||
| C0032285 | doxycycline | D004318 | 564-25-0 | pneumonia | MESH:D011014 | therapeutic | 9145823 | ||
| C0032285 | enoxacin | D015365 | 74011-58-8 | pneumonia | MESH:D011014 | therapeutic | 3258863 | ||
| C0032285 | erythromycin | D004917 | 114-07-8 | pneumonia | MESH:D011014 | therapeutic | 10858333 | ||
| C0032285 | everolimus | D000068338 | - | pneumonia | MESH:D011014 | marker/mechanism | 17346627 | ||
| C0032285 | fluoxetine | D005473 | 54910-89-3 | pneumonia | MESH:D011014 | therapeutic | 17477857 | ||
| C0032285 | gefitinib | C419708 | 184475-35-2 | pneumonia | MESH:D011014 | marker/mechanism | 20646869 | ||
| C0032285 | gemcitabine | C056507 | 103882-84-4 | pneumonia | MESH:D011014 | marker/mechanism | 12365019 | ||
| C0032285 | indomethacin | D007213 | 53-86-1 | pneumonia | MESH:D011014 | therapeutic | 21983654 | ||
| C0032285 | lamotrigine | C047781 | 84057-84-1 | pneumonia | MESH:D011014 | marker/mechanism | 16442685 | ||
| C0032285 | linezolid | D000069349 | - | pneumonia | MESH:D011014 | therapeutic | 14520146 | ||
| C0032285 | liposomal amphotericin b | C068538 | - | pneumonia | MESH:D011014 | therapeutic | 8901182 | ||
| C0032285 | methotrexate | D008727 | 1959/5/2 | pneumonia | MESH:D011014 | marker/mechanism | 10846532 | ||
| C0032285 | moxifloxacin | C104727 | - | pneumonia | MESH:D011014 | therapeutic | 19680025 | ||
| C0032285 | nitric oxide | D009569 | 10102-43-9 | pneumonia | MESH:D011014 | marker/mechanism | 17450216 | ||
| C0032285 | ofloxacin | D015242 | 82419-36-1 | pneumonia | MESH:D011014 | therapeutic | 15708235 | ||
| C0032285 | paclitaxel | D017239 | - | pneumonia | MESH:D011014 | marker/mechanism | 12367796 | ||
| C0032285 | piperacillin | D010878 | 61477-96-1 | pneumonia | MESH:D011014 | therapeutic | 6391888 | ||
| C0032285 | piroxicam | D010894 | 36322-90-4 | pneumonia | MESH:D011014 | therapeutic | 21414392 | ||
| C0032285 | rosiglitazone | C089730 | - | pneumonia | MESH:D011014 | therapeutic | 24612634 | ||
| C0032285 | sirolimus | D020123 | 53123-88-9 | pneumonia | MESH:D011014 | marker/mechanism | 15219060 | ||
| C0032285 | theophylline | D013806 | 58-55-9 | pneumonia | MESH:D011014 | therapeutic | 1541177 | ||
| C0032285 | vancomycin | D014640 | 1404-90-6 | pneumonia | MESH:D011014 | therapeutic | 15221158 | ||
| C0032285 | vinblastine | D014747 | 865-21-4 | pneumonia | MESH:D011014 | marker/mechanism | 54212 | ||
| C0032285 | voriconazole | D065819 | - | pneumonia | MESH:D011014 | therapeutic | 19148589 | ||
| C0032285 | vorinostat | C111237 | - | pneumonia | MESH:D011014 | marker/mechanism | 18854394 | ||
FDA approved drug and dosage information(Total Drugs:18) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D011014 | 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:D011014 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D011014 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D011014 | 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:D011014 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D011014 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D011014 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D011014 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D011014 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D011014 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D011014 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D011014 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D011014 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MESH:D011014 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| MESH:D011014 | rapamune | sirolimus | 1MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
| MESH:D011014 | rapamune | sirolimus | 1MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D011014 | afinitor | everolimus | 5MG | TABLET;ORAL | Prescription | None | Yes | No |
| MESH:D011014 | inomax | nitric oxide | 100PPM Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | GAS;INHALATION | Discontinued | None | Yes | No |
FDA labeling changes(Total Drugs:18) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D011014 | 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:D011014 | 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:D011014 | 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:D011014 | 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:D011014 | 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:D011014 | 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:D011014 | 01/17/2003 | lamictal | lamotrigine | Adjunctive therapy for partial seizures | Extended indication from adults to pediatric patients e 2 years Patients aged 2 - 18 years had clearance influenced predominantly by total body weight and concurrent antiepileptic drug (AED) therapy. The oral clearance was higher, on a body weight basis, in pediatric patients than in adults Because of increased clearance in pediatrics, maintenance doses in patients weighing < 30 kg may need an increase of as much as 50% based upon clinical response Evidence shows that the inclusion of VPA in a multi-drug regimen increases the risk of serious, potentially life-threatening rash in pediatric patients Approximately 11.5% of the 1,081 pediatric patients who received the drug as adjunctive therapy in clinical trials discontinued treatment because of an AE | Labeling | B | - | - | - | GlaxoSmithKline | 02/14/2007 | FALSE' |
| MESH:D011014 | 8/5/2009 | lamictal | lamotrigine | Adjunctive treatment for partial seizures in pediatric patients 1 24 months | Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%) | Labeling | B | - | - | - | GlaxoSmithKline | 02/14/2007 | FALSE' |
| MESH:D011014 | 05/18/2015 | lamictal | lamotrigine | Maintenance treatment of bipolar disorder | Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 Information on clinical trial and adverse reactions Postmarketing study | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE |
| MESH:D011014 | 05/29/2009 | lamictal xr | lamotrigine | Adjunctive therapy for partial onset seizures in patients e13 years of age | Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established Information on adverse event profile, and clinical studies New dosage form | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D011014 | 01/29/2010 | lamictal xr | lamotrigine | Adjunctive therapy for Primary Generalized Tonic-Clonic seizures | New indication for adjunctive therapy for primary generalized tonic-clonic seizures in patients e 13 years of age Safety and effectiveness for any use in patients < 13 years have not been established Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D011014 | 04/25/2011 | lamictal xr | lamotrigine | Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED) | Approved for conversion to monotherapy in patients e13 years of age with partial seizures receiving treatment with a single antiepileptic drug (AED).Safety and effectiveness have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDsInformation on conversion to monotherapy, adverse reactions, clinical trialNew indication | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D011014 | 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:D011014 | 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:D011014 | 11/3/2005 | rapamune | sirolimus | Prophylaxis of organ rejection in patients undergoing renal transplants | Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk Safety was assessed in a controlled clinical trial in pediatric ( | Labeling | B | - | - | - | Wyeth | 11/17/2004 | FALSE' |
| MESH:D011014 | 11/3/2005 | rapamune | sirolimus | Prophylaxis of organ rejection in patients undergoing renal transplants | Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk Safety was assessed in a controlled clinical trial in pediatric ( | Labeling | B | - | - | - | Wyeth | 11/17/2004 | FALSE' |
| MESH:D011014 | 10/29/2010 | afinitor | everolimus | Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis | Approved for treatment of patients with SEGA associated with TS An open-label, single-arm safety and efficacy trial was conducted in 28 patients 3-34 years with SEGA associated with TS Afinitor has not been studied in patients with SEGA < 3 years of ageMost common adverse reactions (incidence e30%) were stomatitis, upper respiratory tract infection, sinusitis, otitis media, and pyrexiaDose reduction and/or treatment interruption may be needed to manage adverse drug reactions Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions New indication | Labeling | B | - | - | - | Novartis | - | FALSE' |
| MESH:D011014 | 12/21/2010 | inomax | nitric oxide | Prevention of bronchopulmonary dysplasia | INOmax is not indicated for prevention of BPD in preterm neonates d 34 weeks gestational age.Efficacy for the prevention of BPD in preterm infants was not established in three ldouble-blind, placebo-controlled clinical trials in a total of 2,149 preterm infants Information on clinical trials, adverse reaction | Labeling | B | - | - | - | INO Therapeutics | 2/11/2010 | FALSE' |