PedAM
Pediatric Disease Annotations & Medicines
| myoglobinuria | ||||
| Disease ID | 699 |
|---|---|
| Disease | myoglobinuria |
| Integrated Phenotype | (Waiting for update.) |
| Text Mined Phenotype | HPO | Name | Sentences' Count(Total Phenotypes:16) HP:0000083 | Renal insufficiency | 11 HP:0003201 | Rhabdomyolysis | 10 HP:0001919 | Acute renal failure | 7 HP:0008682 | Renal tubular necrosis | 3 HP:0003394 | Muscle cramps | 2 HP:0001903 | Anemia | 2 HP:0003326 | Muscle pain | 2 HP:0003198 | Myopathic changes | 2 HP:0001324 | Muscular weakness | 2 HP:0008942 | Rhabdomyolysis, acute | 1 HP:0100806 | Sepsis | 1 HP:0003323 | Muscle weakness, progressive | 1 HP:0003738 | Muscle pain on exercise | 1 HP:0100614 | Muscle inflammation | 1 HP:0003202 | Neurogenic muscle atrophy, especially in the lower limbs | 1 HP:0012378 | Fatigue | 1 |
| Disease ID | 699 |
|---|---|
| Disease | myoglobinuria |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | (Waiting for update.) |
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:0) | |
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| (Waiting for update.) | |
GWASdb Annotation(Total Genotypes:0) | |
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| (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 | ||
| C0027080 | aminocaproic acid | D015119 | 60-32-2 | myoglobinuria | MESH:D009212 | marker/mechanism | 6612533 | ||
| C0027080 | amoxapine | D000657 | 14028-44-5 | myoglobinuria | MESH:D009212 | marker/mechanism | 6870433 | ||
| C0027080 | amphetamine | D000661 | 300-62-9 | myoglobinuria | MESH:D009212 | marker/mechanism | 3057269 | ||
| C0027080 | clozapine | D003024 | 5786-21-0 | myoglobinuria | MESH:D009212 | marker/mechanism | 10085753 | ||
| C0027080 | colchicine | D003078 | 64-86-8 | myoglobinuria | MESH:D009212 | marker/mechanism | 1499522 | ||
| C0027080 | diclofenac | D004008 | 15307-86-5 | myoglobinuria | MESH:D009212 | marker/mechanism | 8701974 | ||
| C0027080 | calcitriol | D002117 | 32222-06-3 | myoglobinuria | MESH:D009212 | marker/mechanism | 10362817 | ||
| C0027080 | enflurane | D004737 | 13838-16-9 | myoglobinuria | MESH:D009212 | marker/mechanism | 731274 | ||
| C0027080 | haloperidol | D006220 | 52-86-8 | myoglobinuria | MESH:D009212 | marker/mechanism | 6121542 | ||
| C0027080 | lovastatin | D008148 | 75330-75-5 | myoglobinuria | MESH:D009212 | marker/mechanism | 3076126 | ||
| C0027080 | loxapine | D008152 | 1977/10/2 | myoglobinuria | MESH:D009212 | marker/mechanism | 7258388 | ||
| C0027080 | methadone | D008691 | 76-99-3 | myoglobinuria | MESH:D009212 | marker/mechanism | 4936579 | ||
| C0027080 | olanzapine | C076029 | 132539-06-1 | myoglobinuria | MESH:D009212 | marker/mechanism | 10085753 | ||
| C0027080 | pyrazinamide | D011718 | 98-96-4 | myoglobinuria | MESH:D009212 | marker/mechanism | 1803050 | ||
| C0027080 | succinylcholine | D013390 | 306-40-1 | myoglobinuria | MESH:D009212 | marker/mechanism | 6744092 | ||
| C0027080 | theophylline | D013806 | 58-55-9 | myoglobinuria | MESH:D009212 | marker/mechanism | 8865732 | ||
FDA approved drug and dosage information(Total Drugs:6) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D009212 | calcijex | calcitriol | 0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MESH:D009212 | 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:D009212 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D009212 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D009212 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D009212 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
FDA labeling changes(Total Drugs:6) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D009212 | 11/16/2001 | calcijex | calcitriol | Management of hypocalcemia in patients undergoing chronic renal dialysis | The safety and effectiveness of calcitriol was examined in a double-blind placebo-controlled trial of 35 pediatric patients (13-18 years of age) with end-stage renal disease and on dialysis. The primary efficacy endpoint favored the calcitriol-treated versus the placebo-treated patients Transient hypercalcemia was seen in 1 of 16 calcitriol-treated patients; 6 of 16 (38%) calcitriol-treated patients and 2 of 19 (11%) placebo-treated patients had Ca x P >75 | Labeling | B | - | - | - | Abbott | 02/16/2001 | FALSE' |
| MESH:D009212 | 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:D009212 | 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:D009212 | 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:D009212 | 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:D009212 | 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' |