PedAM
Pediatric Disease Annotations & Medicines
| hypocalcemia | ||||
| Disease ID | 1357 |
|---|---|
| Disease | hypocalcemia |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:15) C0151723 | hypomagnesemia | 30 C0036572 | seizures | 10 C0039621 | tetany | 8 C0020503 | secondary hyperparathyroidism | 6 C0878544 | cardiomyopathy | 4 C0018801 | heart failure | 3 C0014544 | epilepsy | 2 C0018802 | congestive heart failure | 2 C0018801 | cardiac failure | 2 C0024523 | malabsorption | 1 C0020649 | hypotension | 1 C0262587 | parathyroid adenoma | 1 C0036572 | seizure | 1 C0009951 | convulsions | 1 C0020580 | numbness | 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) | |
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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:18) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0020598 | amifostine | D004999 | 20537-88-6 | hypocalcemia | MESH:D006996 | marker/mechanism | 19813275 | ||
| C0020598 | amikacin | D000583 | 37517-28-5 | hypocalcemia | MESH:D006996 | marker/mechanism | 19884751 | ||
| C0020598 | capreomycin | D002207 | 11003-38-6 | hypocalcemia | MESH:D006996 | marker/mechanism | 6177055 | ||
| C0020598 | carbamazepine | D002220 | 298-46-4 | hypocalcemia | MESH:D006996 | marker/mechanism | 16136018 | ||
| C0020598 | cyclophosphamide | D003520 | 50-18-0 | hypocalcemia | MESH:D006996 | marker/mechanism | 10637075 | ||
| C0020598 | cyclophosphamide | D003520 | 50-18-0 | hypocalcemia | MESH:D006996 | therapeutic | 4833837 | ||
| C0020598 | cisplatin | D002945 | 15663-27-1 | hypocalcemia | MESH:D006996 | marker/mechanism | 8490193 | ||
| C0020598 | calcitriol | D002117 | 32222-06-3 | hypocalcemia | MESH:D006996 | marker/mechanism | 6760236 | ||
| C0020598 | calcitriol | D002117 | 32222-06-3 | hypocalcemia | MESH:D006996 | therapeutic | 80633 | ||
| C0020598 | foscarnet | D017245 | 4428-95-9 | hypocalcemia | MESH:D006996 | marker/mechanism | 8384030 | ||
| C0020598 | imatinib mesylate | D000068877 | - | hypocalcemia | MESH:D006996 | marker/mechanism | 17040091 | ||
| C0020598 | omeprazole | D009853 | 73590-58-6 | hypocalcemia | MESH:D006996 | marker/mechanism | 18221401 | ||
| C0020598 | pamidronate | C019248 | 40391-99-9 | hypocalcemia | MESH:D006996 | marker/mechanism | 16006300 | ||
| C0020598 | phenytoin | D010672 | 57-41-0 | hypocalcemia | MESH:D006996 | marker/mechanism | 849004 | ||
| C0020598 | pyrazinamide | D011718 | 98-96-4 | hypocalcemia | MESH:D006996 | marker/mechanism | 4340029 | ||
| C0020598 | vincristine | D014750 | - | hypocalcemia | MESH:D006996 | marker/mechanism | 4833837 | ||
| C0020598 | cholecalciferol | D002762 | 67-97-0 | hypocalcemia | MESH:D006996 | therapeutic | 80633 | ||
| C0020598 | zoledronic acid | C088658 | - | hypocalcemia | MESH:D006996 | marker/mechanism | 12669777 | ||
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:D006996 | 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:D006996 | 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:D006996 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| MESH:D006996 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| MESH:D006996 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D006996 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D006996 | gleevec | imatinib mesylate | EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE;ORAL | Discontinued | None | Yes | No |
| MESH:D006996 | gleevec | imatinib mesylate | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D006996 | zometa | zoledronic acid | EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | INJECTABLE;IV (INFUSION) | Discontinued | None | Yes | No |
| MESH:D006996 | zometa | zoledronic acid | EQ 4MG BASE/VIAL | INJECTABLE; IV (INFUSION) | Prescription | None | No | No |
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:D006996 | 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:D006996 | 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:D006996 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D006996 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D006996 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D006996 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D006996 | 09/27/2006 | gleevec | imatinib mesylate | Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase | Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients | Labeling | - | - | B, P | - | Novartis | 9/6/2006 | FALSE' |
| MESH:D006996 | 09/27/2006 | gleevec | imatinib mesylate | Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase | Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients | Labeling | - | - | B, P | - | Novartis | 9/6/2006 | FALSE' |
| MESH:D006996 | 03/20/2008 | zometa | zoledronic acid | Severe osteogenesis imperfecta | Zoledronic acid is not indicated for use in children Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain Information on PK, clinical study, and AE profile | Labeling | B | - | - | - | Novartis | 12/21/2007 | FALSE' |
| MESH:D006996 | 03/20/2008 | zometa | zoledronic acid | Severe osteogenesis imperfecta | Zoledronic acid is not indicated for use in children Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain Information on PK, clinical study, and AE profile | Labeling | B | - | - | - | Novartis | 12/21/2007 | FALSE' |