SummaryCefdinir, marketed under the brand name Omnicef, is a small molecule drug that acts as a penicillin-binding protein (PBP) inhibitor and a cell wall inhibitor. It is indicated for the treatment and prevention of infections caused by susceptible bacteria. Cefdinir works by inhibiting the growth and multiplication of bacteria that cause infections, including streptococcus, staphylococcus, and Haemophilus influenzae. It is approved in several countries, including the US, China, Japan, and South Korea. Omnicef is available as capsules or an oral suspension and is typically administered once or twice daily depending on the severity of the infection. It is important to use this medication only for the treatment or prevention of bacterial infections, as overuse or misuse can lead to the development of drug-resistant bacteria. |
Drug Type Small molecule drug |
Synonyms Cefdinir (JP17/USP/INN), Cefzon Capsule, CFDN + [19] |
Target |
Action inhibitors |
Mechanism PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), Cell wall inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date |
RegulationPriority Review (China) |
Molecular FormulaC14H13N5O5S2 |
InChIKeyRTXOFQZKPXMALH-GHXIOONMSA-N |
CAS Registry91832-40-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Bronchitis | Japan | 27 Apr 2017 | |
Cystitis | Japan | 27 Apr 2017 | |
Otitis Media | Japan | 27 Apr 2017 | |
Pneumonia, Bacterial | Japan | 27 Apr 2017 | |
Sinusitis | Japan | 27 Apr 2017 | |
Skin Diseases, Bacterial | Japan | 27 Apr 2017 | |
Acute maxillary sinusitis | United States | 04 Dec 1997 | |
Bacterial otitis media | United States | 04 Dec 1997 | |
Bronchitis, Chronic | United States | 04 Dec 1997 | |
Community Acquired Pneumonia | United States | 04 Dec 1997 | |
Non-complicated skin and skin structure infection | United States | 04 Dec 1997 | |
Pharyngitis | United States | 04 Dec 1997 | |
Tonsillitis | United States | 04 Dec 1997 | |
Bacterial Infections | Japan | 04 Oct 1991 | |
Gram-Negative Bacterial Infections | - | - | 01 Jan 1991 |
Gram-Positive Bacterial Infections | - | - | 01 Jan 1991 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Acute otitis media | Phase 3 | United States | 01 Jul 2002 | |
Acute otitis media | Phase 3 | Chile | 01 Jul 2002 | |
Acute otitis media | Phase 3 | Costa Rica | 01 Jul 2002 | |
Acute otitis media | Phase 3 | Dominican Republic | 01 Jul 2002 | |
Acute otitis media | Phase 3 | Guatemala | 01 Jul 2002 | |
Acute otitis media | Phase 3 | Israel | 01 Jul 2002 | |
Acute otitis media | Phase 3 | Panama | 01 Jul 2002 | |
Acute Bronchitis | Phase 1 | China | 24 Mar 2013 | |
Adnexitis | Phase 1 | China | 24 Mar 2013 | |
Blepharitis | Phase 1 | China | 24 Mar 2013 |
Phase 4 | 385 | (Short Course) | eaghvgirvv: Pr (Higher DOOR in Short-Course) = 0.69 (95% CI, 0.63 - 0.75), P-Value = <0.001 View more | - | 03 Feb 2021 | ||
(Standard Course) | |||||||
Phase 1 | - | 32 | (Cefdinir (Test)) | jzonwrftxq(eyxkwunvsu) = ejwbpfrbci iiukonqiqt (cwnndsyfik, 573.068) View more | - | 21 Jul 2009 | |
(Omnicef® (Reference)) | jzonwrftxq(eyxkwunvsu) = ggcoixlsdl iiukonqiqt (cwnndsyfik, 531.404) View more | ||||||
Phase 1 | - | 32 | (Cefdinir (Test)) | nbmeinsjyu(egqyunfthq) = lazamdyvzg vsyufcuuxi (svbuudapuj, 537.12) View more | - | 21 Jul 2009 | |
(Omnicef® (Reference)) | nbmeinsjyu(egqyunfthq) = unzvcxwreb vsyufcuuxi (svbuudapuj, 481.25) View more | ||||||
Phase 1 | - | 32 | (Cefdinir (Test)) | ixavrunkyj(bjxupvnior) = fwjtbvttuo iruljknpkb (anljadgjsn, 775.044) View more | - | 21 Jul 2009 | |
(Omnicef® (Reference)) | ixavrunkyj(bjxupvnior) = mimqitzawm iruljknpkb (anljadgjsn, 732.845) View more | ||||||
Phase 1 | - | 32 | (Cefdinir (Test)) | aqhvnemjtc(jubsfjqwah) = xphyvbccsy gvajoozjkz (fmciyguubf, 882.84) View more | - | 21 Jul 2009 | |
(Omnicef® (Reference)) | aqhvnemjtc(jubsfjqwah) = outcvrgmne gvajoozjkz (fmciyguubf, 823.85) View more |