Primaxin, Recarbrio(imipenem)
Primaxin, Recarbrio (imipenem) is a small molecule pharmaceutical. Imipenem was first approved as Primaxin on 1985-11-26. It is used to treat bacterial endocarditis, bacterial infections, enterobacteriaceae infections, infectious bone diseases, and intraabdominal infections amongst others in the USA. It has been approved in Europe to treat gram-negative bacterial infections.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| musculoskeletal diseases | D009140 |
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Combinations
Primaxin, Recarbrio (generic drugs available since 2011-12-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| imipenem and cilastatin imipenem and cilastatin | ANDA | 2022-10-11 |
| primaxin | ANDA, New Drug Application | 2020-12-21 |
| recarbrio | New Drug Application | 2021-04-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial endocarditis | EFO_1000830 | D004697 | — |
| bacterial infections | — | D001424 | A49 |
| enterobacteriaceae infections | EFO_1001313 | D004756 | — |
| infectious bone diseases | — | D001850 | — |
| intraabdominal infections | — | D059413 | — |
| pelvic infection | — | D034161 | — |
| pseudomonas infections | EFO_0001076 | D011552 | — |
| respiratory tract infections | — | D012141 | J06.9 |
| staphylococcal infections | — | D013203 | A49.01 |
| streptococcal infections | EFO_1001476 | D013290 | — |
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CILASTATIN SODIUM / IMIPENEM / RELEBACTAM, RECARBRIO, MSD MERCK CO | |||
| 2029-07-16 | GAIN | ||
| 2024-07-16 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cilastatin Sodium / Imipenem / Relebactam, Recarbrio, Msd Merck Co | |||
| 8487093 | 2029-11-19 | DS, DP | U-2586, U-2587, U-2840 |
Clinical
Clinical Trials
62 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 5 | 3 | 1 | — | 9 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 1 | 3 | 4 | 1 | 9 |
| Sepsis | D018805 | A41.9 | 3 | 1 | — | 1 | 1 | 5 | |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 2 | 2 | 1 | — | 5 |
| Infections | D007239 | EFO_0000544 | 1 | — | — | 3 | — | 4 | |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 1 | — | 1 | 1 | 4 |
| Critical illness | D016638 | — | — | — | 2 | 1 | 3 | ||
| Intraabdominal infections | D059413 | — | 1 | 1 | 1 | — | 3 | ||
| Hematologic neoplasms | D019337 | — | 1 | 1 | 1 | — | 2 | ||
| Febrile neutropenia | D064147 | — | — | — | 2 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | A49 | 4 | 2 | 1 | — | 1 | 7 | |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | 1 | — | — | 1 |
| Iatrogenic disease | D007049 | — | — | 1 | — | — | 1 | ||
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | — | 1 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 1 | — | — | 1 |
| Abscess | D000038 | EFO_0003030 | — | — | 1 | — | — | 1 | |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | — | 1 | — | — | 1 |
| Healthcare-associated pneumonia | D000077299 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 2 | — | — | — | 2 |
| Abdominal abscess | D018784 | EFO_1001753 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Communicable diseases | D003141 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | IMIPENEM |
| INN | imipenem |
| Description | Imipenem is a broad-spectrum, intravenous beta-lactam antibiotic of the carbapenem subgroup. It has a role as an antibacterial drug. It is a beta-lactam antibiotic allergen and a member of carbapenems. It is a tautomer of an imipenem zwitterion. |
| Classification | Small molecule |
| Drug class | antibacterial antibiotics, carbapenem derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H](O)[C@H]1C(=O)N2C(C(=O)O)=C(SCCNC=N)C[C@H]12 |
Identifiers
| PDB | — |
| CAS-ID | 64221-86-9 |
| RxCUI | 1545986 |
| ChEMBL ID | CHEMBL148 |
| ChEBI ID | 471744 |
| PubChem CID | 104838 |
| DrugBank | DB01598 |
| UNII ID | Q20IM7HE75 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Primaxin - Merck Sharp & Dohme
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 32,061 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,643 adverse events reported
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