PedAM
Pediatric Disease Annotations & Medicines
| disseminated intravascular coagulation | ||||
| Disease ID | 1130 |
|---|---|
| Disease | disseminated intravascular coagulation |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:17) C0036690 | sepsis | 29 C0019080 | hemorrhage | 10 C0009450 | infection | 6 C0003486 | aortic aneurysm | 4 C0796095 | c syndrome | 3 C0005779 | coagulopathy | 3 C0948600 | organ failure | 3 C0040053 | thrombosis | 3 C0085650 | purpura fulminans | 2 C0040034 | thrombocytopenia | 2 C0019087 | hemorrhagic diathesis | 1 C0037285 | skin manifestation | 1 C0023467 | acute myeloid leukemia | 1 C0022660 | acute renal failure | 1 C0041296 | tuberculosis | 1 C0087086 | thrombi | 1 C0162739 | hellp syndrome | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
GWASdb Annotation(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
Mapped by lexical matching(Total Items:0) |
|---|
| (Waiting for update.) |
Mapped by homologous gene(Total Items:0) |
|---|
| (Waiting for update.) |
Chemical(Total Drugs:36) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0012739 | acetylcysteine | D000111 | 616-91-1 | disseminated intravascular coagulation | MESH:D004211 | therapeutic | 8104747 | ||
| C0012739 | alprazolam | D000525 | 28981-97-7 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 10464538 | ||
| C0012739 | aminocaproic acid | D015119 | 60-32-2 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 3158905 | ||
| C0012739 | amphetamine | D000661 | 300-62-9 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 16161930 | ||
| C0012739 | ampicillin | D000667 | 69-53-4 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 712173 | ||
| C0012739 | argatroban | C031942 | 74863-84-6 | disseminated intravascular coagulation | MESH:D004211 | therapeutic | 12361208 | ||
| C0012739 | carbamazepine | D002220 | 298-46-4 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 10464538 | ||
| C0012739 | carmustine | D002330 | 154-93-8 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 6845142 | ||
| C0012739 | cefotaxime | D002439 | 63527-52-6 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 9915680 | ||
| C0012739 | cladribine | D017338 | 4291-63-8 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 10792402 | ||
| C0012739 | colchicine | D003078 | 64-86-8 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 4562795 | ||
| C0012739 | dronabinol | D013759 | - | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 16161930 | ||
| C0012739 | cisplatin | D002945 | 15663-27-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 1729088 | ||
| C0012739 | diethylstilbestrol | D004054 | 56-53-1 | disseminated intravascular coagulation | MESH:D004211 | therapeutic | 65916 | ||
| C0012739 | disopyramide | D004206 | 3737/9/5 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 7071649 | ||
| C0012739 | griseofulvin | D006118 | 126-07-8 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 2084866 | ||
| C0012739 | haloperidol | D006220 | 52-86-8 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 6732389 | ||
| C0012739 | indomethacin | D007213 | 53-86-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 8163032 | ||
| C0012739 | lamotrigine | C047781 | 84057-84-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 9371937 | ||
| C0012739 | lepirudin | C083544 | - | disseminated intravascular coagulation | MESH:D004211 | therapeutic | 12361208 | ||
| C0012739 | olanzapine | C076029 | 132539-06-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 10464538 | ||
| C0012739 | phenytoin | D010672 | 57-41-0 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 1147459 | ||
| C0012739 | piperacillin | D010878 | 61477-96-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 10830188 | ||
| C0012739 | progesterone | D011374 | 57-83-0 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 65916 | ||
| C0012739 | propylthiouracil | D011441 | 51-52-5 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 10684339 | ||
| C0012739 | pyrimethamine | D011739 | 58-14-0 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 1124444 | ||
| C0012739 | quinine | D011803 | 130-95-0 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 10474732 | ||
| C0012739 | rifampin | D012293 | 13292-46-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 1811361 | ||
| C0012739 | succinylcholine | D013390 | 306-40-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 2917103 | ||
| C0012739 | thalidomide | D013792 | 50-35-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 19112952 | ||
| C0012739 | thiopental | D013874 | 76-75-5 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 2917103 | ||
| C0012739 | ticlopidine | D013988 | 55142-85-3 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 19309387 | ||
| C0012739 | tranexamic acid | D014148 | 1197-18-8 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 2670794 | ||
| C0012739 | tranexamic acid | D014148 | 1197-18-8 | disseminated intravascular coagulation | MESH:D004211 | therapeutic | 1961348 | ||
| C0012739 | valproic acid | D014635 | 99-66-1 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 1534246 | ||
| C0012739 | vindesine | D014751 | 53643-48-4 | disseminated intravascular coagulation | MESH:D004211 | marker/mechanism | 1729088 | ||
FDA approved drug and dosage information(Total Drugs:16) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D004211 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004211 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004211 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004211 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004211 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004211 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004211 | argatroban | argatroban | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MESH:D004211 | argatroban | argatroban | 250MG/250ML | INJECTABLE; INJECTION | None (Tentative Approval) | None | No | No |
| MESH:D004211 | argatroban | argatroban | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MESH:D004211 | argatroban | argatroban | 250MG/250ML | INJECTABLE; INJECTION | None (Tentative Approval) | None | No | No |
| MESH:D004211 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004211 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D004211 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004211 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D004211 | lysteda | tranexamic acid | 650MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004211 | lysteda | tranexamic acid | 650MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
FDA labeling changes(Total Drugs:16) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D004211 | 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:D004211 | 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:D004211 | 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:D004211 | 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:D004211 | 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:D004211 | 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:D004211 | 5/5/2008 | argatroban | argatroban | Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis | Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages | Labeling | - | - | B, P | - | Encysive | - | FALSE' |
| MESH:D004211 | 5/5/2008 | argatroban | argatroban | Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis | Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages | Labeling | - | - | B, P | - | Encysive | - | FALSE' |
| MESH:D004211 | 5/5/2008 | argatroban | argatroban | Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis | Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages | Labeling | - | - | B, P | - | Encysive | - | FALSE' |
| MESH:D004211 | 5/5/2008 | argatroban | argatroban | Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis | Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages | Labeling | - | - | B, P | - | Encysive | - | FALSE' |
| MESH:D004211 | 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:D004211 | 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:D004211 | 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:D004211 | 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:D004211 | 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' | - |
| MESH:D004211 | 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' | - |