PedAM
Pediatric Disease Annotations & Medicines
| status epilepticus | ||||
| Disease ID | 371 |
|---|---|
| Disease | status epilepticus |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:20) C2707258 | infections C1963101 | encephalopathy C1962972 | proteinuria C1868998 | cytotoxic edema C1739395 | takotsubo cardiomyopathy C0740265 | acid-base disorders C0426980 | motor symptom C0235169 | excitability C0233763 | visual hallucinations C0162557 | fulminant hepatic failure C0036572 | seizures C0035204 | respiratory disorders C0032285 | pneumoniae C0027927 | neurosyphilis C0027765 | neurologic disorders C0022660 | acute renal failure C0018989 | hemiparesis C0015695 | fatty liver C0012739 | disseminated intravascular coagulation C0001125 | lactic acidosis |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:6) C0085584 | encephalopathy | 32 C0036572 | seizures | 25 C0235169 | excitability | 1 C0027927 | neurosyphilis | 1 C0032285 | pneumoniae | 1 C0233763 | visual hallucinations | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:1) | |||||||||||||
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| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs113994097 | 18294203 | 5428 | POLG | umls:C0038220 | BeFree | Homozygous W748S mutation in the POLG1 gene in patients with juvenile-onset Alpers syndrome and status epilepticus. | 0.081628651 | 2008 | POLG | 15 | 89323426 | C | G |
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:66) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0038220 | acetaminophen | D000082 | 103-90-2 | status epilepticus | MESH:D013226 | marker/mechanism | 8960081 | ||
| C0038220 | acetylcysteine | D000111 | 616-91-1 | status epilepticus | MESH:D013226 | marker/mechanism | 8960081 | ||
| C0038220 | adenosine triphosphate | D000255 | 56-65-5 | status epilepticus | MESH:D013226 | marker/mechanism | 10344793 | ||
| C0038220 | albendazole | D015766 | 54965-21-8 | status epilepticus | MESH:D013226 | marker/mechanism | 9724010 | ||
| C0038220 | alprazolam | D000525 | 28981-97-7 | status epilepticus | MESH:D013226 | marker/mechanism | 14644903 | ||
| C0038220 | amiloride | D000584 | 2609-46-3 | status epilepticus | MESH:D013226 | marker/mechanism | 18572151 | ||
| C0038220 | amitriptyline | D000639 | 50-48-6 | status epilepticus | MESH:D013226 | marker/mechanism | 7001962 | ||
| C0038220 | amlodipine | D017311 | 88150-42-9 | status epilepticus | MESH:D013226 | therapeutic | 11218825 | ||
| C0038220 | amoxapine | D000657 | 14028-44-5 | status epilepticus | MESH:D013226 | marker/mechanism | 7621219 | ||
| C0038220 | amphetamine | D000661 | 300-62-9 | status epilepticus | MESH:D013226 | marker/mechanism | 2788249 | ||
| C0038220 | atropine | D001285 | 51-55-8 | status epilepticus | MESH:D013226 | therapeutic | 19111886 | ||
| C0038220 | baclofen | D001418 | 1134-47-0 | status epilepticus | MESH:D013226 | marker/mechanism | 1346454 | ||
| C0038220 | baclofen | D001418 | 1134-47-0 | status epilepticus | MESH:D013226 | therapeutic | 8817469 | ||
| C0038220 | busulfan | D002066 | 55-98-1 | status epilepticus | MESH:D013226 | marker/mechanism | 14631624 | ||
| C0038220 | carbamazepine | D002220 | 298-46-4 | status epilepticus | MESH:D013226 | marker/mechanism | 10897162 | ||
| C0038220 | carbamazepine | D002220 | 298-46-4 | status epilepticus | MESH:D013226 | therapeutic | 11240605 | ||
| C0038220 | cefotaxime | D002439 | 63527-52-6 | status epilepticus | MESH:D013226 | marker/mechanism | 3110537 | ||
| C0038220 | ceftazidime | D002442 | 78439-06-2 | status epilepticus | MESH:D013226 | marker/mechanism | 11498064 | ||
| C0038220 | chloroquine | D002738 | 1954/5/7 | status epilepticus | MESH:D013226 | marker/mechanism | 7762925 | ||
| C0038220 | chlorpromazine | D002746 | 50-53-3 | status epilepticus | MESH:D013226 | marker/mechanism | 4605009 | ||
| C0038220 | choline | D002794 | 62-49-7 | status epilepticus | MESH:D013226 | marker/mechanism | 1815138 | ||
| C0038220 | cimetidine | D002927 | 51481-61-9 | status epilepticus | MESH:D013226 | marker/mechanism | 552491 | ||
| C0038220 | ciprofloxacin | D002939 | 85721-33-1 | status epilepticus | MESH:D013226 | marker/mechanism | 10084426 | ||
| C0038220 | citalopram | D015283 | 59729-33-8 | status epilepticus | MESH:D013226 | marker/mechanism | 11985646 | ||
| C0038220 | clonidine | D003000 | 4205-90-7 | status epilepticus | MESH:D013226 | marker/mechanism | 18206800 | ||
| C0038220 | cyclophosphamide | D003520 | 50-18-0 | status epilepticus | MESH:D013226 | marker/mechanism | 14631624 | ||
| C0038220 | cyclosporine | D016572 | 59865-13-3 | status epilepticus | MESH:D013226 | marker/mechanism | 11605780 | ||
| C0038220 | cyclosporine | D016572 | 59865-13-3 | status epilepticus | MESH:D013226 | therapeutic | 17095192 | ||
| C0038220 | ethambutol | D004977 | 74-55-5 | status epilepticus | MESH:D013226 | marker/mechanism | 1152365 | ||
| C0038220 | etomidate | D005045 | 33125-97-2 | status epilepticus | MESH:D013226 | therapeutic | 2745868 | ||
| C0038220 | felbamate | C047360 | 25451-15-4 | status epilepticus | MESH:D013226 | therapeutic | 10691107 | ||
| C0038220 | fenfluramine | D005277 | 458-24-2 | status epilepticus | MESH:D013226 | marker/mechanism | 7667346 | ||
| C0038220 | fluoxetine | D005473 | 54910-89-3 | status epilepticus | MESH:D013226 | marker/mechanism | 8016019 | ||
| C0038220 | fosphenytoin | C043114 | 93390-81-9 | status epilepticus | MESH:D013226 | therapeutic | 16434340 | ||
| C0038220 | glutathione | D005978 | 70-18-8 | status epilepticus | MESH:D013226 | marker/mechanism | 15752349 | ||
| C0038220 | haloperidol | D006220 | 52-86-8 | status epilepticus | MESH:D013226 | marker/mechanism | 9413831 | ||
| C0038220 | ifosfamide | D007069 | 3778-73-2 | status epilepticus | MESH:D013226 | marker/mechanism | 12035842 | ||
| C0038220 | indomethacin | D007213 | 53-86-1 | status epilepticus | MESH:D013226 | marker/mechanism | 1979027 | ||
| C0038220 | lamotrigine | C047781 | 84057-84-1 | status epilepticus | MESH:D013226 | marker/mechanism | 17846277 | ||
| C0038220 | lidocaine | D008012 | 137-58-6 | status epilepticus | MESH:D013226 | marker/mechanism | 16040365 | ||
| C0038220 | lidocaine | D008012 | 137-58-6 | status epilepticus | MESH:D013226 | therapeutic | 10025129 | ||
| C0038220 | lorazepam | D008140 | 846-49-1 | status epilepticus | MESH:D013226 | therapeutic | 11240605 | ||
| C0038220 | mebendazole | D008463 | 31431-39-7 | status epilepticus | MESH:D013226 | marker/mechanism | 10727200 | ||
| C0038220 | methohexital | D008723 | 18652-93-2 | status epilepticus | MESH:D013226 | marker/mechanism | 900462 | ||
| C0038220 | methohexital | D008723 | 18652-93-2 | status epilepticus | MESH:D013226 | therapeutic | 5690286 | ||
| C0038220 | methotrexate | D008727 | 1959/5/2 | status epilepticus | MESH:D013226 | marker/mechanism | 16138356 | ||
| C0038220 | morphine | D009020 | 57-27-2 | status epilepticus | MESH:D013226 | marker/mechanism | 10812579 | ||
| C0038220 | nitric oxide | D009569 | 10102-43-9 | status epilepticus | MESH:D013226 | marker/mechanism | 20149694 | ||
| C0038220 | norepinephrine | D009638 | 51-41-2 | status epilepticus | MESH:D013226 | marker/mechanism | 15488322 | ||
| C0038220 | ofloxacin | D015242 | 82419-36-1 | status epilepticus | MESH:D013226 | marker/mechanism | 8059139 | ||
| C0038220 | olanzapine | C076029 | 132539-06-1 | status epilepticus | MESH:D013226 | therapeutic | 15965316 | ||
| C0038220 | pentobarbital | D010424 | 76-74-4 | status epilepticus | MESH:D013226 | therapeutic | 11587876 | ||
| C0038220 | phenytoin | D010672 | 57-41-0 | status epilepticus | MESH:D013226 | marker/mechanism | 10084426 | ||
| C0038220 | phenytoin | D010672 | 57-41-0 | status epilepticus | MESH:D013226 | therapeutic | 10691107 | ||
| C0038220 | picrotoxin | D010852 | 124-87-8 | status epilepticus | MESH:D013226 | marker/mechanism | 9255601 | ||
| C0038220 | pilocarpine | D010862 | 92-13-7 | status epilepticus | MESH:D013226 | marker/mechanism | 10027775 | ||
| C0038220 | progesterone | D011374 | 57-83-0 | status epilepticus | MESH:D013226 | therapeutic | 16084511 | ||
| C0038220 | pyridoxine | D011736 | - | status epilepticus | MESH:D013226 | therapeutic | 18610679 | ||
| C0038220 | ritonavir | D019438 | - | status epilepticus | MESH:D013226 | marker/mechanism | 20851280 | ||
| C0038220 | tacrolimus | D016559 | 109581-93-3 | status epilepticus | MESH:D013226 | marker/mechanism | 10528682 | ||
| C0038220 | tacrolimus | D016559 | 109581-93-3 | status epilepticus | MESH:D013226 | therapeutic | 17095192 | ||
| C0038220 | theophylline | D013806 | 58-55-9 | status epilepticus | MESH:D013226 | marker/mechanism | 108053 | ||
| C0038220 | thiopental | D013874 | 76-75-5 | status epilepticus | MESH:D013226 | therapeutic | 16116121 | ||
| C0038220 | tranexamic acid | D014148 | 1197-18-8 | status epilepticus | MESH:D013226 | marker/mechanism | 10525986 | ||
| C0038220 | valproic acid | D014635 | 99-66-1 | status epilepticus | MESH:D013226 | marker/mechanism | 17661800 | ||
| C0038220 | valproic acid | D014635 | 99-66-1 | status epilepticus | MESH:D013226 | therapeutic | 10614572 | ||
FDA approved drug and dosage information(Total Drugs:23) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D013226 | busulfex | busulfan | 6MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MESH:D013226 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MESH:D013226 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | norvir | ritonavir | 80MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
| MESH:D013226 | norvir | ritonavir | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MESH:D013226 | norvir | ritonavir | 100MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
| MESH:D013226 | norvir | ritonavir | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D013226 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D013226 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D013226 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D013226 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D013226 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D013226 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D013226 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D013226 | 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 |
| MESH:D013226 | lysteda | tranexamic acid | 650MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
FDA labeling changes(Total Drugs:23) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D013226 | 01/13/2003 | busulfex | busulfan | Part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases | The population pharmacokinetic estimates of busulfan for clearance and volume of distribution were determined in an open-label, uncontrolled PK study in 24 pediatric patients 5 months to 16 years who received busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases Suggested dosing regimen | Labeling | B | - | - | - | Orphan Medical | 12/3/2002 | FALSE' |
| MESH:D013226 | 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:D013226 | 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:D013226 | 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:D013226 | 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:D013226 | 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:D013226 | 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:D013226 | 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:D013226 | 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:D013226 | 6/10/2005 | norvir | ritonavir | Treatment of HIV-infection in combination with other antiretroviral agents | Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters | Labeling | B | - | - | - | Abbott | 06/14/2005 | FALSE' |
| MESH:D013226 | 6/10/2005 | norvir | ritonavir | Treatment of HIV-infection in combination with other antiretroviral agents | Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters | Labeling | B | - | - | - | Abbott | 06/14/2005 | FALSE' |
| MESH:D013226 | 6/10/2005 | norvir | ritonavir | Treatment of HIV-infection in combination with other antiretroviral agents | Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters | Labeling | B | - | - | - | Abbott | 06/14/2005 | FALSE' |
| MESH:D013226 | 6/10/2005 | norvir | ritonavir | Treatment of HIV-infection in combination with other antiretroviral agents | Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters | Labeling | B | - | - | - | Abbott | 06/14/2005 | FALSE' |
| MESH:D013226 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D013226 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D013226 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D013226 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D013226 | 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:D013226 | 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:D013226 | 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:D013226 | 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:D013226 | 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' |
| MESH:D013226 | 08/21/2013 | lysteda | tranexamic acid | Treatment of cyclic heavy menstrual bleeding | Indicated for women of reproductive age. It is not intended for use in premenarcheal girls Information on PK studyPostmarketing study | - | P | - | - | Ferring | - | FALSE' | - |