PedAM
Pediatric Disease Annotations & Medicines
| gastritis | ||||
| Disease ID | 906 |
|---|---|
| Disease | gastritis |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:10) C0850666 | helicobacter pylori infection | 37 C0002871 | anemia | 10 C0038358 | gastric ulcer | 5 C0030193 | pain | 3 C0024623 | stomach cancer | 3 C0019080 | hemorrhage | 2 C0024299 | lymphomas | 2 C0267373 | intestinal bleeding | 1 C0349530 | early gastric cancer | 1 C0030920 | gastroduodenal ulcer | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:28) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs1045642 | 18644389 | 5243 | ABCB1 | umls:C0017152 | BeFree | We assessed the MDR1 C3435T polymorphism in H. pylori-positive gastritis alone patients (n=150), gastric cancer (n=292), gastric ulcer (n=215), and duodenal ulcer (n=163) and H. pylori-negative subjects (n=168) as control by a PCR-based method. | 0.005276948 | 2008 | ABCB1 | 7 | 87509329 | A | T,G |
| rs11614913 | 21073609 | 406938 | MIR146A | umls:C0017152 | BeFree | We evaluated the associations of three SNPs (rs11614913, rs2910164, and rs3746444) in pre-miRNAs (miR-196a2, miR-146a, and miR-499) with the risk of gastric cancer (GC) and peptic ulcer diseases, and with the severity of Helicobacter pylori-induced gastritis in Japanese population. | 0.000542884 | 2010 | MIR196A2 | 12 | 53991815 | C | T |
| rs11614913 | 21073609 | 574501 | MIR499A | umls:C0017152 | BeFree | We evaluated the associations of three SNPs (rs11614913, rs2910164, and rs3746444) in pre-miRNAs (miR-196a2, miR-146a, and miR-499) with the risk of gastric cancer (GC) and peptic ulcer diseases, and with the severity of Helicobacter pylori-induced gastritis in Japanese population. | 0.000271442 | 2010 | MIR196A2 | 12 | 53991815 | C | T |
| rs2066844 | 20332463 | 64127 | NOD2 | umls:C0017152 | BeFree | We investigated the allelic frequencies of TLR4 (D299G and T399I) and NOD2/CARD15 (R702W, G908R, and L1007finsC) SNPs in 87 asymptomatic serologically H. pylori-positive individuals (Group I), in 63 patients with antrum-predominant gastritis (Group II) and in 60 patients with corpus-predominant gastritis or pangastritis (Group III). | 0.005005506 | 2010 | NOD2 | 16 | 50712015 | C | T |
| rs2066844 | 20332463 | 7099 | TLR4 | umls:C0017152 | BeFree | We investigated the allelic frequencies of TLR4 (D299G and T399I) and NOD2/CARD15 (R702W, G908R, and L1007finsC) SNPs in 87 asymptomatic serologically H. pylori-positive individuals (Group I), in 63 patients with antrum-predominant gastritis (Group II) and in 60 patients with corpus-predominant gastritis or pangastritis (Group III). | 0.013821129 | 2010 | NOD2 | 16 | 50712015 | C | T |
| rs2066845 | 20332463 | 64127 | NOD2 | umls:C0017152 | BeFree | We investigated the allelic frequencies of TLR4 (D299G and T399I) and NOD2/CARD15 (R702W, G908R, and L1007finsC) SNPs in 87 asymptomatic serologically H. pylori-positive individuals (Group I), in 63 patients with antrum-predominant gastritis (Group II) and in 60 patients with corpus-predominant gastritis or pangastritis (Group III). | 0.005005506 | 2010 | NOD2 | 16 | 50722629 | G | C,T |
| rs2066845 | 20332463 | 7099 | TLR4 | umls:C0017152 | BeFree | We investigated the allelic frequencies of TLR4 (D299G and T399I) and NOD2/CARD15 (R702W, G908R, and L1007finsC) SNPs in 87 asymptomatic serologically H. pylori-positive individuals (Group I), in 63 patients with antrum-predominant gastritis (Group II) and in 60 patients with corpus-predominant gastritis or pangastritis (Group III). | 0.013821129 | 2010 | NOD2 | 16 | 50722629 | G | C,T |
| rs2274223 | 25503145 | 51196 | PLCE1 | umls:C0017152 | BeFree | Herein, we aimed to evaluate associations between PSCA (C>T, rs2294008; G>A, rs2976392), MUC1 (C>T, rs4072037) and PLCE1 (A>G, rs2274223) SNPs and GC or high-risk gastritis (HRAG). | 0.000542884 | 2015 | PLCE1 | 10 | 94306584 | A | G |
| rs2294008 | 25582162 | 8000 | PSCA | umls:C0017152 | BeFree | Frequency of PSCA rs2294008 C/C genotype in duodenal ulcer was 36.1%, which was significantly higher than those with gastric cancer (12.4%), gastric ulcer (19.0%), gastritis (10.7%), and H. pylori-negatives (19.5%) (p < .001). | 0.000542884 | 2015 | PSCA | 8 | 142680513 | C | T |
| rs2294008 | 25503145 | 4582 | MUC1 | umls:C0017152 | BeFree | Polymorphisms of PSCA (rs2976392, rs2294008) and MUC1 (rs4072037) genes are associated with GC and HRAG. | 0.00827274 | 2015 | PSCA | 8 | 142680513 | C | T |
| rs2294008 | 25503145 | 51196 | PLCE1 | umls:C0017152 | BeFree | Herein, we aimed to evaluate associations between PSCA (C>T, rs2294008; G>A, rs2976392), MUC1 (C>T, rs4072037) and PLCE1 (A>G, rs2274223) SNPs and GC or high-risk gastritis (HRAG). | 0.000542884 | 2015 | PSCA | 8 | 142680513 | C | T |
| rs2294008 | 25503145 | 8000 | PSCA | umls:C0017152 | BeFree | Polymorphisms of PSCA (rs2976392, rs2294008) and MUC1 (rs4072037) genes are associated with GC and HRAG. | 0.000542884 | 2015 | PSCA | 8 | 142680513 | C | T |
| rs2910164 | 21073609 | 574501 | MIR499A | umls:C0017152 | BeFree | We evaluated the associations of three SNPs (rs11614913, rs2910164, and rs3746444) in pre-miRNAs (miR-196a2, miR-146a, and miR-499) with the risk of gastric cancer (GC) and peptic ulcer diseases, and with the severity of Helicobacter pylori-induced gastritis in Japanese population. | 0.000271442 | 2010 | LOC285628;MIR146A | 5 | 160485411 | C | G |
| rs2910164 | 21073609 | 406938 | MIR146A | umls:C0017152 | BeFree | We evaluated the associations of three SNPs (rs11614913, rs2910164, and rs3746444) in pre-miRNAs (miR-196a2, miR-146a, and miR-499) with the risk of gastric cancer (GC) and peptic ulcer diseases, and with the severity of Helicobacter pylori-induced gastritis in Japanese population. | 0.000542884 | 2010 | LOC285628;MIR146A | 5 | 160485411 | C | G |
| rs2976392 | 25503145 | 8000 | PSCA | umls:C0017152 | BeFree | Polymorphisms of PSCA (rs2976392, rs2294008) and MUC1 (rs4072037) genes are associated with GC and HRAG. | 0.000542884 | 2015 | PSCA | 8 | 142681514 | G | A |
| rs2976392 | 25503145 | 4582 | MUC1 | umls:C0017152 | BeFree | Polymorphisms of PSCA (rs2976392, rs2294008) and MUC1 (rs4072037) genes are associated with GC and HRAG. | 0.00827274 | 2015 | PSCA | 8 | 142681514 | G | A |
| rs2976392 | 25503145 | 51196 | PLCE1 | umls:C0017152 | BeFree | Herein, we aimed to evaluate associations between PSCA (C>T, rs2294008; G>A, rs2976392), MUC1 (C>T, rs4072037) and PLCE1 (A>G, rs2274223) SNPs and GC or high-risk gastritis (HRAG). | 0.000542884 | 2015 | PSCA | 8 | 142681514 | G | A |
| rs3746444 | 21073609 | 574501 | MIR499A | umls:C0017152 | BeFree | We evaluated the associations of three SNPs (rs11614913, rs2910164, and rs3746444) in pre-miRNAs (miR-196a2, miR-146a, and miR-499) with the risk of gastric cancer (GC) and peptic ulcer diseases, and with the severity of Helicobacter pylori-induced gastritis in Japanese population. | 0.000271442 | 2010 | MYH7B;MIR499A;MIR499B | 20 | 34990448 | A | G |
| rs3746444 | 21073609 | 406938 | MIR146A | umls:C0017152 | BeFree | We evaluated the associations of three SNPs (rs11614913, rs2910164, and rs3746444) in pre-miRNAs (miR-196a2, miR-146a, and miR-499) with the risk of gastric cancer (GC) and peptic ulcer diseases, and with the severity of Helicobacter pylori-induced gastritis in Japanese population. | 0.000542884 | 2010 | MYH7B;MIR499A;MIR499B | 20 | 34990448 | A | G |
| rs4072037 | 25503145 | 4582 | MUC1 | umls:C0017152 | BeFree | Polymorphisms of PSCA (rs2976392, rs2294008) and MUC1 (rs4072037) genes are associated with GC and HRAG. | 0.00827274 | 2015 | MUC1 | 1 | 155192276 | C | T |
| rs4072037 | 25503145 | 8000 | PSCA | umls:C0017152 | BeFree | Polymorphisms of PSCA (rs2976392, rs2294008) and MUC1 (rs4072037) genes are associated with GC and HRAG. | 0.000542884 | 2015 | MUC1 | 1 | 155192276 | C | T |
| rs4072037 | 25503145 | 51196 | PLCE1 | umls:C0017152 | BeFree | Herein, we aimed to evaluate associations between PSCA (C>T, rs2294008; G>A, rs2976392), MUC1 (C>T, rs4072037) and PLCE1 (A>G, rs2274223) SNPs and GC or high-risk gastritis (HRAG). | 0.000542884 | 2015 | MUC1 | 1 | 155192276 | C | T |
| rs4986790 | 18082569 | 7099 | TLR4 | umls:C0017152 | BeFree | Association of Toll-like receptor-4 (Asp299Gly and Thr399Ileu) gene polymorphisms with gastritis and precancerous lesions. | 0.013821129 | 2007 | TLR4 | 9 | 117713024 | A | G |
| rs4986790 | 20332463 | 7099 | TLR4 | umls:C0017152 | BeFree | We investigated the allelic frequencies of TLR4 (D299G and T399I) and NOD2/CARD15 (R702W, G908R, and L1007finsC) SNPs in 87 asymptomatic serologically H. pylori-positive individuals (Group I), in 63 patients with antrum-predominant gastritis (Group II) and in 60 patients with corpus-predominant gastritis or pangastritis (Group III). | 0.013821129 | 2010 | TLR4 | 9 | 117713024 | A | G |
| rs4986790 | 24508388 | 7099 | TLR4 | umls:C0017152 | BeFree | TLR-4 Asp299Gly G allele substitution may be modified pattern of immune response in the gastric mucosa of H. pylori infected patients and may be H. pylori infected patients with gastritis have increased risk for the development of chronic gastritis. | 0.013821129 | 2013 | TLR4 | 9 | 117713024 | A | G |
| rs4986790 | 20332463 | 64127 | NOD2 | umls:C0017152 | BeFree | We investigated the allelic frequencies of TLR4 (D299G and T399I) and NOD2/CARD15 (R702W, G908R, and L1007finsC) SNPs in 87 asymptomatic serologically H. pylori-positive individuals (Group I), in 63 patients with antrum-predominant gastritis (Group II) and in 60 patients with corpus-predominant gastritis or pangastritis (Group III). | 0.005005506 | 2010 | TLR4 | 9 | 117713024 | A | G |
| rs4986791 | 20332463 | 7099 | TLR4 | umls:C0017152 | BeFree | We investigated the allelic frequencies of TLR4 (D299G and T399I) and NOD2/CARD15 (R702W, G908R, and L1007finsC) SNPs in 87 asymptomatic serologically H. pylori-positive individuals (Group I), in 63 patients with antrum-predominant gastritis (Group II) and in 60 patients with corpus-predominant gastritis or pangastritis (Group III). | 0.013821129 | 2010 | TLR4 | 9 | 117713324 | C | T |
| rs4986791 | 20332463 | 64127 | NOD2 | umls:C0017152 | BeFree | We investigated the allelic frequencies of TLR4 (D299G and T399I) and NOD2/CARD15 (R702W, G908R, and L1007finsC) SNPs in 87 asymptomatic serologically H. pylori-positive individuals (Group I), in 63 patients with antrum-predominant gastritis (Group II) and in 60 patients with corpus-predominant gastritis or pangastritis (Group III). | 0.005005506 | 2010 | TLR4 | 9 | 117713324 | C | T |
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:13) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0017152 | acetaminophen | D000082 | 103-90-2 | gastritis | MESH:D005756 | marker/mechanism | 16983495 | ||
| C0017152 | cimetidine | D002927 | 51481-61-9 | gastritis | MESH:D005756 | therapeutic | 17189874 | ||
| C0017152 | diclofenac | D004008 | 15307-86-5 | gastritis | MESH:D005756 | marker/mechanism | 1439622 | ||
| C0017152 | folic acid | D005492 | 59-30-3 | gastritis | MESH:D005756 | marker/mechanism | 17171786 | ||
| C0017152 | indomethacin | D007213 | 53-86-1 | gastritis | MESH:D005756 | marker/mechanism | 15046732 | ||
| C0017152 | lansoprazole | D064747 | - | gastritis | MESH:D005756 | therapeutic | 9354197 | ||
| C0017152 | octreotide | D015282 | 83150-76-9 | gastritis | MESH:D005756 | marker/mechanism | 2229321 | ||
| C0017152 | octreotide | D015282 | 83150-76-9 | gastritis | MESH:D005756 | therapeutic | 12375148 | ||
| C0017152 | omeprazole | D009853 | 73590-58-6 | gastritis | MESH:D005756 | therapeutic | 10701899 | ||
| C0017152 | pantoprazole | C064276 | 102625-70-7 | gastritis | MESH:D005756 | therapeutic | 16080005 | ||
| C0017152 | piroxicam | D010894 | 36322-90-4 | gastritis | MESH:D005756 | marker/mechanism | 16080005 | ||
| C0017152 | prochlorperazine | D011346 | 58-38-8 | gastritis | MESH:D005756 | therapeutic | 4816841 | ||
| C0017152 | ticlopidine | D013988 | 55142-85-3 | gastritis | MESH:D005756 | marker/mechanism | 11960063 | ||
FDA approved drug and dosage information(Total Drugs:14) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D005756 | 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:D005756 | 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:D005756 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D005756 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D005756 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| MESH:D005756 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MESH:D005756 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
| MESH:D005756 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| MESH:D005756 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MESH:D005756 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
| MESH:D005756 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D005756 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D005756 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D005756 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
FDA labeling changes(Total Drugs:14) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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:D005756 | 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 |