PedAM
Pediatric Disease Annotations & Medicines
| pancytopenia | ||||
| Disease ID | 364 |
|---|---|
| Disease | pancytopenia |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:33) C2707258 | infections C2364133 | infection C1963279 | viral hepatitis C1963099 | myelodysplasia C1827561 | disseminated mycobacterium kansasii infection C1692886 | septic arthritis C1510471 | vitamin deficiency C1420725 | thymoma C1090821 | sepsis C1027109 | scleroderma C0948600 | organ failure C0743841 | febrile illness C0343387 | neutropenic enterocolitis C0278847 | non-invasive thymoma C0267373 | intestinal bleeding C0242342 | sheehan's syndrome C0240318 | mediastinal mass C0043325 | xanthomatosis C0041321 | miliary tuberculosis C0040188 | tic disorder C0036690 | septicemia C0032285 | pneumonia C0026946 | fungal infection C0024314 | lymphoproliferative disorder C0023462 | malignant megakaryocytosis C0023380 | lethargy C0021345 | infectious mononucleosis C0021051 | immunodeficiency C0020981 | immunoblastic lymphadenopathy C0020550 | hyperthyroidism C0019214 | hepatosplenomegaly C0018213 | graves-basedow disease C0015970 | fever of unknown origin |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:10) C0009450 | infection | 7 C0019214 | hepatosplenomegaly | 5 C0036690 | sepsis | 4 C0020550 | hyperthyroidism | 4 C0242342 | sheehan's syndrome | 2 C0948600 | organ failure | 1 C0032285 | pneumonia | 1 C0041321 | miliary tuberculosis | 1 C0026946 | fungal infection | 1 C0040100 | thymoma | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:3) | |||||||||||||
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| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs28936072 | 12437656 | 147495 | APCDD1 | umls:C0030312 | BeFree | We report a novel missense mutation in DKC1 exon 3 (T113-->C, Ile38Thr) in a Sardinian infant with XL-HHS in whom the disease was characterized by 'T+B-NK-' severe combined immunodeficiency and bone marrow failure. | 0.000271442 | 2002 | DKC1 | X | 154765472 | T | A,C,G |
| rs28936072 | 12437656 | 2591 | GALNT3 | umls:C0030312 | BeFree | We report a novel missense mutation in DKC1 exon 3 (T113-->C, Ile38Thr) in a Sardinian infant with XL-HHS in whom the disease was characterized by 'T+B-NK-' severe combined immunodeficiency and bone marrow failure. | 0.000271442 | 2002 | DKC1 | X | 154765472 | T | A,C,G |
| rs28936072 | 12437656 | 1736 | DKC1 | umls:C0030312 | BeFree | We report a novel missense mutation in DKC1 exon 3 (T113-->C, Ile38Thr) in a Sardinian infant with XL-HHS in whom the disease was characterized by 'T+B-NK-' severe combined immunodeficiency and bone marrow failure. | 0.001085767 | 2002 | DKC1 | X | 154765472 | T | A,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:37) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0030312 | acetaminophen | D000082 | 103-90-2 | pancytopenia | MESH:D010198 | marker/mechanism | 4720777 | ||
| C0030312 | allopurinol | D000493 | 315-30-0 | pancytopenia | MESH:D010198 | marker/mechanism | 957985 | ||
| C0030312 | busulfan | D002066 | 55-98-1 | pancytopenia | MESH:D010198 | marker/mechanism | 20102258 | ||
| C0030312 | carbamazepine | D002220 | 298-46-4 | pancytopenia | MESH:D010198 | marker/mechanism | 12897634 | ||
| C0030312 | carmustine | D002330 | 154-93-8 | pancytopenia | MESH:D010198 | marker/mechanism | 10918425 | ||
| C0030312 | chlorambucil | D002699 | 305-03-3 | pancytopenia | MESH:D010198 | marker/mechanism | 15656036 | ||
| C0030312 | chloramphenicol | D002701 | 56-75-7 | pancytopenia | MESH:D010198 | marker/mechanism | 6071896 | ||
| C0030312 | cladribine | D017338 | 4291-63-8 | pancytopenia | MESH:D010198 | marker/mechanism | 16398735 | ||
| C0030312 | chloroquine | D002738 | 1954/5/7 | pancytopenia | MESH:D010198 | marker/mechanism | 18057166 | ||
| C0030312 | chlorpromazine | D002746 | 50-53-3 | pancytopenia | MESH:D010198 | marker/mechanism | 6016859 | ||
| C0030312 | cimetidine | D002927 | 51481-61-9 | pancytopenia | MESH:D010198 | marker/mechanism | 2079735 | ||
| C0030312 | colchicine | D003078 | 64-86-8 | pancytopenia | MESH:D010198 | marker/mechanism | 15088997 | ||
| C0030312 | cyclophosphamide | D003520 | 50-18-0 | pancytopenia | MESH:D010198 | marker/mechanism | 15656036 | ||
| C0030312 | cisplatin | D002945 | 15663-27-1 | pancytopenia | MESH:D010198 | marker/mechanism | 21544650 | ||
| C0030312 | zalcitabine | D016047 | 7481-89-2 | pancytopenia | MESH:D010198 | marker/mechanism | 12403023 | ||
| C0030312 | fluorouracil | D005472 | 51-21-8 | pancytopenia | MESH:D010198 | marker/mechanism | 6603024 | ||
| C0030312 | leucovorin | D002955 | 1958/5/9 | pancytopenia | MESH:D010198 | marker/mechanism | 7741386 | ||
| C0030312 | leucovorin | D002955 | 1958/5/9 | pancytopenia | MESH:D010198 | therapeutic | 21310276 | ||
| C0030312 | lamotrigine | C047781 | 84057-84-1 | pancytopenia | MESH:D010198 | marker/mechanism | 16442685 | ||
| C0030312 | linezolid | D000069349 | - | pancytopenia | MESH:D010198 | marker/mechanism | 18159560 | ||
| C0030312 | meprobamate | D008620 | 57-53-4 | pancytopenia | MESH:D010198 | marker/mechanism | 5092569 | ||
| C0030312 | methotrexate | D008727 | 1959/5/2 | pancytopenia | MESH:D010198 | marker/mechanism | 10592889 | ||
| C0030312 | nelfinavir | D019888 | 159989-64-7 | pancytopenia | MESH:D010198 | marker/mechanism | 12403023 | ||
| C0030312 | nizatidine | D016567 | 76963-41-2 | pancytopenia | MESH:D010198 | marker/mechanism | 15235935 | ||
| C0030312 | piroxicam | D010894 | 36322-90-4 | pancytopenia | MESH:D010198 | marker/mechanism | 2004031 | ||
| C0030312 | propranolol | D011433 | 525-66-6 | pancytopenia | MESH:D010198 | therapeutic | 11193444 | ||
| C0030312 | propylthiouracil | D011441 | 51-52-5 | pancytopenia | MESH:D010198 | marker/mechanism | 17415292 | ||
| C0030312 | pyrimethamine | D011739 | 58-14-0 | pancytopenia | MESH:D010198 | marker/mechanism | 5106499 | ||
| C0030312 | quinine | D011803 | 130-95-0 | pancytopenia | MESH:D010198 | marker/mechanism | 8323089 | ||
| C0030312 | sulindac | D013467 | 38194-50-2 | pancytopenia | MESH:D010198 | marker/mechanism | 6107481 | ||
| C0030312 | temozolomide | C047246 | 85622-93-1 | pancytopenia | MESH:D010198 | marker/mechanism | 16648049 | ||
| C0030312 | thiotepa | D013852 | 52-24-4 | pancytopenia | MESH:D010198 | marker/mechanism | 10918425 | ||
| C0030312 | tretinoin | D014212 | 302-79-4 | pancytopenia | MESH:D010198 | marker/mechanism | 17136541 | ||
| C0030312 | valproic acid | D014635 | 99-66-1 | pancytopenia | MESH:D010198 | marker/mechanism | 15960580 | ||
| C0030312 | vinorelbine | C030852 | 71486-22-1 | pancytopenia | MESH:D010198 | marker/mechanism | 21544650 | ||
| C0030312 | vitamin a | D014801 | 11103-57-4 | pancytopenia | MESH:D010198 | marker/mechanism | 6701590 | ||
| C0030312 | zidovudine | D015215 | 30516-87-1 | pancytopenia | MESH:D010198 | marker/mechanism | 12403023 | ||
FDA approved drug and dosage information(Total Drugs:27) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D010198 | zyvox | linezolid | 400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
| MESH:D010198 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D010198 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D010198 | zyvox | linezolid | 400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
| MESH:D010198 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D010198 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D010198 | busulfex | busulfan | 6MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MESH:D010198 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D010198 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D010198 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D010198 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D010198 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D010198 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D010198 | temodar | temozolomide | 5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D010198 | temodar | temozolomide | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
| MESH:D010198 | axid | nizatidine | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MESH:D010198 | axid | nizatidine | 15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D010198 | retrovir | zidovudine | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| MESH:D010198 | retrovir | zidovudine | 50MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | Yes |
| MESH:D010198 | retrovir | zidovudine | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MESH:D010198 | retrovir | zidovudine | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D010198 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D010198 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D010198 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D010198 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D010198 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D010198 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
FDA labeling changes(Total Drugs:27) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D010198 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D010198 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D010198 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D010198 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D010198 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D010198 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D010198 | 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:D010198 | 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:D010198 | 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:D010198 | 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:D010198 | 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:D010198 | 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:D010198 | 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:D010198 | 11/3/2003 | temodar | temozolomide | Recurrent CNS tumors | Temozolomide effectiveness in children has not been demonstrated New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. The temozolomide toxicity profile in children is similar to adults | Labeling | B | - | - | - | Schering | 11/20/2002 | FALSE' |
| MESH:D010198 | 11/3/2003 | temodar | temozolomide | Recurrent CNS tumors | Temozolomide effectiveness in children has not been demonstrated New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. The temozolomide toxicity profile in children is similar to adults | Labeling | B | - | - | - | Schering | 11/20/2002 | FALSE' |
| MESH:D010198 | 05/25/2004 | axid | nizatidine | Esophagitis, and heartburn due to GERD | Indicated in pediatric patients 12 years and older Information on dose, PK parameters, and AE profile | Labeling | B | - | - | - | Reliant Pharms | - | FALSE' |
| MESH:D010198 | 05/25/2004 | axid | nizatidine | Esophagitis, and heartburn due to GERD | Indicated in pediatric patients 12 years and older Information on dose, PK parameters, and AE profile | Labeling | B | - | - | - | Reliant Pharms | - | FALSE' |
| MESH:D010198 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D010198 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D010198 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D010198 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D010198 | 09/19/2008 | retrovir syrup, capsules and tablets | zidovudine | Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection | Dosing and administration information provided to children 6 weeks to less than 18 years of age Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies New dosing regimen | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D010198 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D010198 | 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:D010198 | 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:D010198 | 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:D010198 | 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 |