PedAM
Pediatric Disease Annotations & Medicines
| amenorrhea | ||||
| Disease ID | 894 |
|---|---|
| Disease | amenorrhea |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:5) C0020514 | hyperprolactinemia | 6 C0235660 | galactorrhea | 4 C0021359 | infertility | 4 C0030794 | pelvic pain | 1 C0022735 | hypogonadotropic hypogonadism | 1 |
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:12) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0002453 | chlorambucil | D002699 | 305-03-3 | amenorrhea | MESH:D000568 | marker/mechanism | 4700007 | ||
| C0002453 | cyclophosphamide | D003520 | 50-18-0 | amenorrhea | MESH:D000568 | marker/mechanism | 16207182 | ||
| C0002453 | desogestrel | D017135 | 54024-22-5 | amenorrhea | MESH:D000568 | marker/mechanism | 2576255 | ||
| C0002453 | etonogestrel | C044815 | - | amenorrhea | MESH:D000568 | marker/mechanism | 20970261 | ||
| C0002453 | medroxyprogesterone acetate | D017258 | 71-58-9 | amenorrhea | MESH:D000568 | marker/mechanism | 3159786 | ||
| C0002453 | mitoxantrone | D008942 | 65271-80-9 | amenorrhea | MESH:D000568 | marker/mechanism | 15623667 | ||
| C0002453 | levonorgestrel | D016912 | 797-63-7 | amenorrhea | MESH:D000568 | marker/mechanism | 12554277 | ||
| C0002453 | olanzapine | C076029 | 132539-06-1 | amenorrhea | MESH:D000568 | marker/mechanism | 10847307 | ||
| C0002453 | sulpiride | D013469 | 15676-16-1 | amenorrhea | MESH:D000568 | marker/mechanism | 20305607 | ||
| C0002453 | tacrolimus | D016559 | 109581-93-3 | amenorrhea | MESH:D000568 | marker/mechanism | 12709079 | ||
| C0002453 | thalidomide | D013792 | 50-35-1 | amenorrhea | MESH:D000568 | marker/mechanism | 15745722 | ||
| C0002453 | ziprasidone | C092292 | 146939-27-7 | amenorrhea | MESH:D000568 | marker/mechanism | 15465997 | ||
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:D000568 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D000568 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D000568 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D000568 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D000568 | mirena | levonorgestrel | 52MG | INTRAUTERINE DEVICE;INTRAUTERINE | Prescription | None | Yes | Yes |
| MESH:D000568 | levonorgestrel | levonorgestrel | 75MG/IMPLANT | IMPLANT;IMPLANTATION | Discontinued | None | No | No |
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:D000568 | 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:D000568 | 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:D000568 | 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:D000568 | 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:D000568 | 1/10/2009 | mirena | levonorgestrel-releasing intrauterine system | Treatment of heavy menstrual bleeding for women using intrauterine contraception | New indication for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception Use before menarche is not indicated | Labeling | - | P | - | - | Berlex | - | TRUE' |
| MESH:D000568 | 10/7/2009 | plan b one step | levonorgestrel | Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years | New single dose 1.5 mg tablet New dosage regimen | Labeling | - | P | - | - | Duramed | - | FALSE' |