Cefixime
Cefixime, Suprax (cefixime) is a small molecule pharmaceutical. Cefixime was first approved as Suprax on 1989-04-28. It is used to treat bacterial infections, bacterial pneumonia, bacterial skin diseases, bronchitis, and escherichia coli infections amongst others in the USA.
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Commercial
Trade Name
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Cefixime, Suprax (discontinued: Cefixime, Suprax)
Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cefixime
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUPRAX | Lupin Research | N-202091 RX | 2013-02-20 | 1 products, RLD, RS |
| SUPRAX | Lupin Research | N-203195 RX | 2012-06-01 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cefixime | NDA authorized generic | 2024-09-26 |
| cefixime 400 mg ud | ANDA | 2023-01-13 |
| suprax | ANDA, New Drug Application | 2023-12-15 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cefixime, Suprax, Lupin Ltd | |||
| 9233112 | 2028-12-14 | DP | U-1676 |
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01D: Other beta-lactam antibacterials in atc
— J01DD: Third-generation cephalosporins
— J01DD08: Cefixime
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA15: Cefixime and ornidazole
— J01RA16: Cefixime and azithromycin
HCPCS
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Clinical
Clinical Trials
48 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gonorrhea | D006069 | DOID_7551 | A54 | 3 | 2 | — | 3 | 1 | 9 |
| Infections | D007239 | EFO_0000544 | — | 1 | 3 | — | 2 | 2 | 8 |
| Communicable diseases | D003141 | — | — | 1 | 2 | — | 2 | 2 | 7 |
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | 1 | — | 2 | 1 | 4 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 1 | — | 2 | 1 | 4 |
| Syphilis | D013587 | EFO_0007504 | A53.9 | 1 | 2 | 1 | 1 | — | 4 |
| Fever | D005334 | HP_0001945 | R50.9 | — | — | — | 2 | 1 | 3 |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | — | — | 3 | — | 3 |
| Typhoid fever | D014435 | EFO_0006789 | A01.0 | — | — | — | 2 | — | 2 |
| Necrosis | D009336 | — | — | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uterine cervicitis | D002575 | HP_0030160 | N72 | — | — | 1 | — | — | 1 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | — | 1 | — | — | 1 |
| Vaginitis | D014627 | EFO_0005757 | N76 | — | — | 1 | — | — | 1 |
| Abscess | D000038 | EFO_0003030 | — | — | — | 1 | — | — | 1 |
| Liver abscess | D008100 | HP_0100523 | K75.0 | — | — | 1 | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | 1 | — | — | 1 |
| Vesico-ureteral reflux | D014718 | EFO_0007536 | N13.7 | — | — | 1 | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 3 | 1 | — | — | — | 4 |
| Coinfection | D060085 | — | — | — | 1 | — | — | 1 | 2 |
| Anaphylaxis | D000707 | — | T88.6 | — | 1 | — | — | — | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | 1 | — | — | — | 1 |
| Drug hypersensitivity | D004342 | EFO_0009482 | T88.7 | — | 1 | — | — | — | 1 |
| Cephalosporin resistance | D018550 | — | Z16.19 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 5 | — | — | — | — | 5 |
| Bacterial infections | D001424 | — | A49 | 2 | — | — | — | 1 | 3 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 1 | — | — | — | — | 1 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | 1 | — | — | — | — | 1 |
| Rhabdomyosarcoma | D012208 | — | — | 1 | — | — | — | — | 1 |
| Hepatoblastoma | D018197 | — | C22.2 | 1 | — | — | — | — | 1 |
| Wilms tumor | D009396 | EFO_0000212 | — | 1 | — | — | — | — | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | — | — | 2 | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Papilloma | D010212 | — | — | — | — | — | — | 1 | 1 |
| Neutropenia | D009503 | — | D70 | — | — | — | — | 1 | 1 |
| Chemotherapy-induced febrile neutropenia | D064146 | — | — | — | — | — | — | 1 | 1 |
| Febrile neutropenia | D064147 | — | — | — | — | — | — | 1 | 1 |
| Hyperthermia | D000084462 | — | — | — | — | — | — | 1 | 1 |
| Recreational drug use | D000084783 | — | — | — | — | — | — | 1 | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
| Laboratory infection | D007757 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cefixime |
| INN | cefixime |
| Description | Cefixime is a third-generation cephalosporin antibiotic bearing vinyl and (2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. It is used in the treatment of gonorrhoea, tonsilitis, pharyngitis, bronchitis, and urinary tract infections. It has a role as an antibacterial drug and a drug allergen. |
| Classification | Small molecule |
| Drug class | cephalosporins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=CC1=C(C(=O)O)N2C(=O)[C@@H](NC(=O)/C(=N\OCC(=O)O)c3csc(N)n3)[C@H]2SC1 |
Identifiers
| PDB | — |
| CAS-ID | 79350-37-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1541 |
| ChEBI ID | 472657 |
| PubChem CID | 5362065 |
| DrugBank | DB00671 |
| UNII ID | XZ7BG04GJX (ChemIDplus, GSRS) |
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Cefixime
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Safety
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Adverse Events
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1,428 adverse events reported
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