PedAM
Pediatric Disease Annotations & Medicines
| hypoglycemia | ||||
| Disease ID | 526 |
|---|---|
| Disease | hypoglycemia |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:18) C0036572 | seizures | 17 C0021670 | insulinoma | 14 C0426768 | o sign | 7 C0262405 | brain dysfunction | 5 C0021308 | infarction | 5 C0036690 | sepsis | 5 C1266119 | solitary fibrous tumor | 3 C0442874 | neuropathy | 3 C0039070 | syncope | 2 C0020672 | hypothermia | 2 C0242363 | islet cell tumors | 1 C0018922 | hemangiopericytoma | 1 C0020649 | hypotension | 1 C0796095 | c syndrome | 1 C0022116 | ischemia | 1 C0234533 | generalized seizure | 1 C0022638 | ketosis | 1 C0039981 | thoracic tumor | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:11) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs137852671 | 20042013 | 6833 | ABCC8 | umls:C0020615 | BeFree | Here, we report a family carrying the dominant heterozygous germ line E1506K mutation in ABCC8 associated with persistent hypoglycemia in the newborn period and diabetes in adulthood. | 0.094797276 | 2010 | ABCC8 | 11 | 17394295 | C | T |
| rs146962483 | 15690314 | 8086 | AAAS | umls:C0020615 | BeFree | We conclude that a novel R155P mutation in the ALADIN gene is associated with Allgrove syndrome and that insulin-induced hypoglycemia, rather than ACTH stimulation tests, should be used for accurate diagnosis of adrenal insufficiency in this disorder. | 0.000271442 | 2005 | IGF2;INS-IGF2 | 11 | 2133069 | C | G,T |
| rs386597997 | 22591706 | 1559 | CYP2C9 | umls:C0020615 | BeFree | In logistic regression analysis before and after adjustment for other factors known to affect this condition (age, body mass index, sulfonylurea mean daily dose, duration of T2DM, renal function and CYP2C9 genotype) KCNJ11 E23K polymorphism did not affect hypoglycemia risk. | 0.009001189 | 2012 | NA | NA | NA | NA | NA |
| rs386597997 | 19214942 | 3767 | KCNJ11 | umls:C0020615 | BeFree | The E23K variant of KCNJ11 and the risk for severe sulfonylurea-induced hypoglycemia in patients with type 2 diabetes. | 0.008620127 | 2009 | NA | NA | NA | NA | NA |
| rs386597997 | 22591706 | 3767 | KCNJ11 | umls:C0020615 | BeFree | Association of KCNJ11 E23K gene polymorphism with hypoglycemia in sulfonylurea-treated type 2 diabetic patients. | 0.008620127 | 2012 | NA | NA | NA | NA | NA |
| rs386597997 | 16142506 | 3767 | KCNJ11 | umls:C0020615 | BeFree | The Glu23Lys polymorphism in KCNJ11 and impaired hypoglycaemia awareness in patients with type 1 diabetes. | 0.008620127 | 2005 | NA | NA | NA | NA | NA |
| rs5219 | 22591706 | 3767 | KCNJ11 | umls:C0020615 | BeFree | Association of KCNJ11 E23K gene polymorphism with hypoglycemia in sulfonylurea-treated type 2 diabetic patients. | 0.008620127 | 2012 | KCNJ11 | 11 | 17388025 | T | C |
| rs5219 | 16142506 | 3767 | KCNJ11 | umls:C0020615 | BeFree | The Glu23Lys polymorphism in KCNJ11 and impaired hypoglycaemia awareness in patients with type 1 diabetes. | 0.008620127 | 2005 | KCNJ11 | 11 | 17388025 | T | C |
| rs5219 | 19214942 | 3767 | KCNJ11 | umls:C0020615 | BeFree | The E23K variant of KCNJ11 and the risk for severe sulfonylurea-induced hypoglycemia in patients with type 2 diabetes. | 0.008620127 | 2009 | KCNJ11 | 11 | 17388025 | T | C |
| rs5219 | 22591706 | 1559 | CYP2C9 | umls:C0020615 | BeFree | In logistic regression analysis before and after adjustment for other factors known to affect this condition (age, body mass index, sulfonylurea mean daily dose, duration of T2DM, renal function and CYP2C9 genotype) KCNJ11 E23K polymorphism did not affect hypoglycemia risk. | 0.009001189 | 2012 | KCNJ11 | 11 | 17388025 | T | C |
| rs757110 | 21142918 | 6833 | ABCC8 | umls:C0020615 | BeFree | ABCC8 polymorphism (Ser1369Ala): influence on severe hypoglycemia due to sulfonylureas. | 0.094797276 | 2010 | ABCC8 | 11 | 17396930 | C | T,A |
GWASdb Annotation(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:0) | |
|---|---|
| (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:16) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0020615 | acetaminophen | D000082 | 103-90-2 | hypoglycemia | MESH:D007003 | marker/mechanism | 10447915 | ||
| C0020615 | acetohexamide | D000092 | 968-81-0 | hypoglycemia | MESH:D007003 | marker/mechanism | 5935425 | ||
| C0020615 | chloroquine | D002738 | 1954/5/7 | hypoglycemia | MESH:D007003 | marker/mechanism | 8162653 | ||
| C0020615 | cimetidine | D002927 | 51481-61-9 | hypoglycemia | MESH:D007003 | therapeutic | 2414028 | ||
| C0020615 | clonidine | D003000 | 4205-90-7 | hypoglycemia | MESH:D007003 | marker/mechanism | 11487765 | ||
| C0020615 | disopyramide | D004206 | 3737/9/5 | hypoglycemia | MESH:D007003 | marker/mechanism | 6413187 | ||
| C0020615 | enalapril | D004656 | 75847-73-3 | hypoglycemia | MESH:D007003 | marker/mechanism | 7951836 | ||
| C0020615 | leucovorin | D002955 | 1958/5/9 | hypoglycemia | MESH:D007003 | therapeutic | 18173932 | ||
| C0020615 | labetalol | D007741 | 36894-69-6 | hypoglycemia | MESH:D007003 | marker/mechanism | 8198664 | ||
| C0020615 | lansoprazole | D064747 | - | hypoglycemia | MESH:D007003 | marker/mechanism | 12507665 | ||
| C0020615 | methotrexate | D008727 | 1959/5/2 | hypoglycemia | MESH:D007003 | marker/mechanism | 18173932 | ||
| C0020615 | octreotide | D015282 | 83150-76-9 | hypoglycemia | MESH:D007003 | therapeutic | 8422773 | ||
| C0020615 | ofloxacin | D015242 | 82419-36-1 | hypoglycemia | MESH:D007003 | marker/mechanism | 17026994 | ||
| C0020615 | propranolol | D011433 | 525-66-6 | hypoglycemia | MESH:D007003 | marker/mechanism | 3019152 | ||
| C0020615 | streptozocin | D013311 | 18883-66-4 | hypoglycemia | MESH:D007003 | marker/mechanism | 22940631 | ||
| C0020615 | valproic acid | D014635 | 99-66-1 | hypoglycemia | MESH:D007003 | marker/mechanism | 8215567 | ||
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:D007003 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| MESH:D007003 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MESH:D007003 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
| MESH:D007003 | prevacid | lansoprazole | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| MESH:D007003 | prevacid | lansoprazole | 15MG/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| MESH:D007003 | prevacid | lansoprazole | 15MG | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
| MESH:D007003 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D007003 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D007003 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D007003 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
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:D007003 | 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:D007003 | 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:D007003 | 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:D007003 | 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:D007003 | 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:D007003 | 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:D007003 | 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:D007003 | 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:D007003 | 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:D007003 | 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 |