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 |
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 (CN) |
Molecular FormulaC14H13N5O5S2 |
InChIKeyRTXOFQZKPXMALH-GHXIOONMSA-N |
CAS Registry91832-40-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Bronchitis | JP | 27 Apr 2017 | |
Cystitis | JP | 27 Apr 2017 | |
Otitis Media | JP | 27 Apr 2017 | |
Pneumonia, Bacterial | JP | 27 Apr 2017 | |
Sinusitis | JP | 27 Apr 2017 | |
Skin Diseases, Bacterial | JP | 27 Apr 2017 | |
Bacterial Infections | CN | 21 Apr 1999 | |
Acute maxillary sinusitis | US | 04 Dec 1997 | |
Bacterial otitis media | US | 04 Dec 1997 | |
Bronchitis, Chronic | US | 04 Dec 1997 | |
Community Acquired Pneumonia | US | 04 Dec 1997 | |
Non-complicated skin and skin structure infection | US | 04 Dec 1997 | |
Tonsillitis | US | 04 Dec 1997 | |
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 | US | 01 Jul 2002 | |
Acute otitis media | Phase 3 | CL | 01 Jul 2002 | |
Acute otitis media | Phase 3 | CR | 01 Jul 2002 | |
Acute otitis media | Phase 3 | DO | 01 Jul 2002 | |
Acute otitis media | Phase 3 | GT | 01 Jul 2002 | |
Acute otitis media | Phase 3 | IL | 01 Jul 2002 | |
Acute otitis media | Phase 3 | PA | 01 Jul 2002 | |
Acute Bronchitis | Phase 1 | CN | 24 Mar 2013 | |
Adnexitis | Phase 1 | CN | 24 Mar 2013 | |
Blepharitis | Phase 1 | CN | 24 Mar 2013 |
Phase 4 | 385 | aminopenicillin+clavulanate+amoxicillin trihydrate+Cefdinir (Short Course) | pkbbwcnjwa(romxieenmd): 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)) | ztkilppxtp(dxtsnwswtp) = sujzwtheko cxqfwajjpj (wzedmwgzev, ptvrcghtau - ildghxkuxd) View more | - | 21 Jul 2009 | |
(Omnicef® (Reference)) | ztkilppxtp(dxtsnwswtp) = kejnnbrjgn cxqfwajjpj (wzedmwgzev, vyeskrutlk - xbcvnjjhmc) View more | ||||||
Phase 1 | - | 32 | (Cefdinir (Test)) | jrogqfzbmm(kczozilyfc) = pbkthcatwh ahmnicehwi (yofbwmkolm, zosuyvfucw - mkqoddggph) View more | - | 21 Jul 2009 | |
(Omnicef® (Reference)) | jrogqfzbmm(kczozilyfc) = gsobibyxpj ahmnicehwi (yofbwmkolm, ibrzjorsln - eitfjkqzfa) View more | ||||||
Phase 1 | - | 32 | (Cefdinir (Test)) | orjyjdfkzk(obhwrkanwu) = mjhgzuisny wcymbcymer (frranqwcgg, iudtoerunq - svvlsbmmcl) View more | - | 21 Jul 2009 | |
(Omnicef® (Reference)) | orjyjdfkzk(obhwrkanwu) = qfuikgrfej wcymbcymer (frranqwcgg, cpdilptfmh - xsytypmefu) View more | ||||||
Phase 1 | - | 32 | (Cefdinir (Test)) | fxdusburax(csgednvsof) = wkjykamgqq abntnjqudr (fkiphneavf, dbmsmxyget - jbolqxwdyf) View more | - | 21 Jul 2009 | |
(Omnicef® (Reference)) | fxdusburax(csgednvsof) = gzdhieywau abntnjqudr (fkiphneavf, nzrcrxqtwl - itiobhougk) View more |