urticaria |
Disease ID | 525 |
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Disease | urticaria |
Manually Symptom | (Waiting for update.) |
Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:7) C0033774 | pruritus | 9 C0221232 | wheals | 5 C0033774 | itching | 3 C0042769 | virus infection | 1 C0016470 | food allergy | 1 C0014457 | eosinophilia | 1 C0016470 | food allergies | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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(Waiting for update.) |
All Snps(Total Genotypes:2) | |||||||||||||
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snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
rs11673309 | 25455139 | 728 | C5AR1 | umls:C0042109 | BeFree | Influence of component 5a receptor 1 (C5AR1) -1330T/G polymorphism on nonsedating H1-antihistamines therapy in Chinese patients with chronic spontaneous urticaria. | 0.000271442 | 2014 | C5AR1 | 19 | 47308566 | T | G |
rs730012 | 19862937 | 4056 | LTC4S | umls:C0042109 | BeFree | The A-444C polymorphism in the leukotriene C4 synthase gene is associated with aspirin-induced urticaria. | 0.002909916 | 2009 | LTC4S | 5 | 179793637 | 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:68) | |||||||||
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CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
C0042109 | acetaminophen | D000082 | 103-90-2 | urticaria | MESH:D014581 | marker/mechanism | 10400483 | ||
C0042109 | allopurinol | D000493 | 315-30-0 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | amcinonide | C012716 | - | urticaria | MESH:D014581 | marker/mechanism | 8449700 | ||
C0042109 | amiloride | D000584 | 2609-46-3 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | aminoglutethimide | D000616 | 125-84-8 | urticaria | MESH:D014581 | marker/mechanism | 7274074 | ||
C0042109 | azithromycin | D017963 | 83905-01-5 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | aztreonam | D001398 | 78110-38-0 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | caffeine | D002110 | 1958/8/2 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | carbamazepine | D002220 | 298-46-4 | urticaria | MESH:D014581 | marker/mechanism | 3824622 | ||
C0042109 | carbenicillin | D002228 | 4697-36-3 | urticaria | MESH:D014581 | marker/mechanism | 6176609 | ||
C0042109 | carbimazole | D002231 | 22232-54-8 | urticaria | MESH:D014581 | marker/mechanism | 15785249 | ||
C0042109 | cefotaxime | D002439 | 63527-52-6 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | ceftazidime | D002442 | 78439-06-2 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | celecoxib | D000068579 | - | urticaria | MESH:D014581 | marker/mechanism | 11476468 | ||
C0042109 | cephalexin | D002506 | 15686-71-2 | urticaria | MESH:D014581 | marker/mechanism | 15365421 | ||
C0042109 | cetirizine | D017332 | 83881-51-0 | urticaria | MESH:D014581 | therapeutic | 11034010 | ||
C0042109 | cimetidine | D002927 | 51481-61-9 | urticaria | MESH:D014581 | marker/mechanism | 6638053 | ||
C0042109 | cimetidine | D002927 | 51481-61-9 | urticaria | MESH:D014581 | therapeutic | 2404434 | ||
C0042109 | ciprofloxacin | D002939 | 85721-33-1 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | clemastine | D002974 | 15686-51-8 | urticaria | MESH:D014581 | therapeutic | 2569997 | ||
C0042109 | dapsone | D003622 | 80-08-0 | urticaria | MESH:D014581 | therapeutic | 2985516 | ||
C0042109 | diatrizoate | D003973 | 117-96-4 | urticaria | MESH:D014581 | marker/mechanism | 2917833 | ||
C0042109 | diclofenac | D004008 | 15307-86-5 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | dicloxacillin | D004009 | 3116-76-5 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | diltiazem | D004110 | 42399-41-7 | urticaria | MESH:D014581 | marker/mechanism | 3120959 | ||
C0042109 | etomidate | D005045 | 33125-97-2 | urticaria | MESH:D014581 | marker/mechanism | 2675669 | ||
C0042109 | fenoprofen | D005279 | 31879-05-7 | urticaria | MESH:D014581 | marker/mechanism | 1115460 | ||
C0042109 | fluoxetine | D005473 | 54910-89-3 | urticaria | MESH:D014581 | marker/mechanism | 2628588 | ||
C0042109 | hydroxocobalamin | D006879 | 13422-51-0 | urticaria | MESH:D014581 | marker/mechanism | 5572387 | ||
C0042109 | hydroxyzine | D006919 | 68-88-2 | urticaria | MESH:D014581 | therapeutic | 1683191 | ||
C0042109 | indomethacin | D007213 | 53-86-1 | urticaria | MESH:D014581 | marker/mechanism | 1115460 | ||
C0042109 | ketorolac | D020910 | 66635-83-4 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | lansoprazole | D064747 | - | urticaria | MESH:D014581 | marker/mechanism | 12464168 | ||
C0042109 | lidocaine | D008012 | 137-58-6 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | loratadine | D017336 | 79794-75-5 | urticaria | MESH:D014581 | therapeutic | 10188144 | ||
C0042109 | lovastatin | D008148 | 75330-75-5 | urticaria | MESH:D014581 | marker/mechanism | 10084510 | ||
C0042109 | mefloquine | D015767 | 53230-10-7 | urticaria | MESH:D014581 | marker/mechanism | 10457122 | ||
C0042109 | meloxicam | C065757 | 71125-38-7 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | meprobamate | D008620 | 57-53-4 | urticaria | MESH:D014581 | marker/mechanism | 5092569 | ||
C0042109 | montelukast | C093875 | 158966-92-8 | urticaria | MESH:D014581 | therapeutic | 10982225 | ||
C0042109 | nevirapine | D019829 | 129618-40-2 | urticaria | MESH:D014581 | marker/mechanism | 12738113 | ||
C0042109 | ofloxacin | D015242 | 82419-36-1 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | omeprazole | D009853 | 73590-58-6 | urticaria | MESH:D014581 | marker/mechanism | 12464168 | ||
C0042109 | pefloxacin | D015366 | 70458-92-3 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | phenindione | D010630 | 1983/12/5 | urticaria | MESH:D014581 | marker/mechanism | 4248923 | ||
C0042109 | phenylpropanolamine | D010665 | 14838-15-4 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | piperacillin | D010878 | 61477-96-1 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | piroxicam | D010894 | 36322-90-4 | urticaria | MESH:D014581 | marker/mechanism | 10982225 | ||
C0042109 | propylthiouracil | D011441 | 51-52-5 | urticaria | MESH:D014581 | marker/mechanism | 14530534 | ||
C0042109 | ramipril | D017257 | 87333-19-5 | urticaria | MESH:D014581 | marker/mechanism | 12780733 | ||
C0042109 | rifampin | D012293 | 13292-46-1 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | rifaximin | C042734 | - | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | succinylcholine | D013390 | 306-40-1 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | sulfadiazine | D013411 | 68-35-9 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | tenoxicam | C032801 | 59804-37-4 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | terfenadine | D016593 | 50679-08-8 | urticaria | MESH:D014581 | therapeutic | 2565098 | ||
C0042109 | thalidomide | D013792 | 50-35-1 | urticaria | MESH:D014581 | marker/mechanism | 2985516 | ||
C0042109 | thiopental | D013874 | 76-75-5 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | ticlopidine | D013988 | 55142-85-3 | urticaria | MESH:D014581 | marker/mechanism | 8855878 | ||
C0042109 | tinidazole | D014011 | 19387-91-8 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | tolmetin | D014046 | 26171-23-3 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | valdecoxib | C406224 | - | urticaria | MESH:D014581 | marker/mechanism | 15702813 | ||
C0042109 | vancomycin | D014640 | 1404-90-6 | urticaria | MESH:D014581 | marker/mechanism | 3747614 | ||
C0042109 | vitamin a | D014801 | 11103-57-4 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | thiamine | D013831 | 59-43-8 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | vitamin e | D014810 | 1406-18-4 | urticaria | MESH:D014581 | marker/mechanism | 11792017 | ||
C0042109 | zafirlukast | C062735 | 107753-78-6 | urticaria | MESH:D014581 | therapeutic | 14512923 | ||
C0042109 | ziprasidone | C092292 | 146939-27-7 | urticaria | MESH:D014581 | marker/mechanism | 17446198 |
FDA approved drug and dosage information(Total Drugs:26) | ||||||||
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DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
MESH:D014581 | claritin | loratadine | 10MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
MESH:D014581 | claritin | loratadine | 1MG/ML | SYRUP;ORAL | Over-the-counter | None | Yes | Yes |
MESH:D014581 | claritin | loratadine | 10MG | CAPSULE;ORAL | Over-the-counter | None | Yes | Yes |
MESH:D014581 | loratadine | loratadine | 10MG | TABLET;ORAL | Discontinued | None | No | No |
MESH:D014581 | loratadine | loratadine | 1MG/ML | SUSPENSION;ORAL | Over-the-counter | None | Yes | Yes |
MESH:D014581 | mevacor | lovastatin | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
MESH:D014581 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
MESH:D014581 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
MESH:D014581 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
MESH:D014581 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
MESH:D014581 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
MESH:D014581 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
MESH:D014581 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
MESH:D014581 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
MESH:D014581 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
MESH:D014581 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
MESH:D014581 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
MESH:D014581 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
MESH:D014581 | mobic | meloxicam | 7.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
MESH:D014581 | mobic | meloxicam | 7.5MG/5ML | SUSPENSION;ORAL | Prescription | None | Yes | Yes |
MESH:D014581 | celebrex | celecoxib | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
MESH:D014581 | celebrex | celecoxib | 100MG | CAPSULE;ORAL | Prescription | None | No | No |
MESH:D014581 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
MESH:D014581 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
MESH:D014581 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
MESH:D014581 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
FDA labeling changes(Total Drugs:26) | |||||||||||||
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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:D014581 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
MESH:D014581 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
MESH:D014581 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
MESH:D014581 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
MESH:D014581 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
MESH:D014581 | 02/14/2002 | mevacor | lovastatin | Heterozygous Familial Hypercholesterolemia | New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age | Labeling | B | - | - | - | Merck | 07/17/2001 | FALSE' |
MESH:D014581 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
MESH:D014581 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
MESH:D014581 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
MESH:D014581 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
MESH:D014581 | 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:D014581 | 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:D014581 | 06/17/2004 | prevacid | lansoprazole | Short-term treatment of symptomatic GERD and erosive Esophagitis | Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
MESH:D014581 | 06/17/2004 | prevacid | lansoprazole | Short-term treatment of symptomatic GERD and erosive Esophagitis | Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
MESH:D014581 | 06/17/2004 | prevacid | lansoprazole | Short-term treatment of symptomatic GERD and erosive Esophagitis | Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
MESH:D014581 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |
MESH:D014581 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |
MESH:D014581 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |
MESH:D014581 | 11/8/2005 | mobic | meloxicam | Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Safety and efficacy established in patients 2 years of age and older Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk Information on dose, PK parameters, AE profile and clinical studies | Labeling | - | - | B, P | - | Boehringer Ingelheim | 04/15/2005 | FALSE' |
MESH:D014581 | 11/8/2005 | mobic | meloxicam | Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Safety and efficacy established in patients 2 years of age and older Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk Information on dose, PK parameters, AE profile and clinical studies | Labeling | - | - | B, P | - | Boehringer Ingelheim | 04/15/2005 | FALSE' |
MESH:D014581 | 12/15/2006 | celebrex | celecoxib | Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) | New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs | Labeling | B | - | - | - | Pfizer | 08/23/2006 | FALSE' |
MESH:D014581 | 12/15/2006 | celebrex | celecoxib | Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) | New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs | Labeling | B | - | - | - | Pfizer | 08/23/2006 | FALSE' |
MESH:D014581 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
MESH:D014581 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |
MESH:D014581 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
MESH:D014581 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |