Overview
Cefdinir, also known as Omnicef, is a semi-synthetic, broad-spectrum antibiotic belonging to the third generation of the cephalosporin class. It has been proven to be effective for the treatment of common bacterial infections in the ear, sinus, throat, lungs, and skin. Cefdinir was approved by the FDA in 1997 to treat a variety of mild to moderate infections and was initially marketed by Abbvie. Because of its chemical structure, it is effective against organisms that are resistant to first-line cephalosporin therapy due to the production of beta-lactamase enzymes.
Indication
Cefdinir is indicated to treat acute bacterial otitis media, acute maxillary sinusitis, community-acquired (CA) pneumonia, acute bacterial exacerbations of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections in children and adults. The organisms susceptible to cefdinir have been listed below in addition to their associated clinical condition that may be treated with cefdinir. Various beta-lactamase producing organisms may be treated, as indicated in certain sections below. Respiratory Acute bacterial exacerbations of chronic bronchitis caused by Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis Community-acquired pneumonia caused by Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis Ear, nose, and throat Acute bacterial otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae (penicillin-susceptible only) Tonsillitis caused by Streptococcus pyogenes Pharyngitis caused by Streptococcus pyogenes Acute maxillary sinusitis caused by Haemophilus pneumoniae and Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis Skin and skin structure infections Uncomplicated skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
Associated Conditions
- Acute Exacerbation of Chronic Bronchitis (AECB)
- Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae
- Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenza
- Acute Exacerbations of Chronic Bronchitis caused by Moraxella catarrhalis
- Acute exacerbation of chronic bronchitis caused by Haemophilus parainfluenzae
- Acute maxillary sinusitis
- Acute maxillary sinusitis caused by H. influenzae
- Acute maxillary sinusitis caused by M. catarrhalis
- Acute maxillary sinusitis caused by Susceptible strains of Streptococcus pneumoniae
- Community Acquired Pneumonia (CAP)
- Community acquired pneumonia caused by Susceptible strains of Streptococcus pneumoniae
- Pneumonia due to Haemophilus influenzae (H. influenzae)
- Streptococcal Pharyngitis
- Tonsillitis
- Tonsillitis streptococcal
- Uncomplicated Skin and Skin Structure Infections
- Uncomplicated skin and skin structure infections caused by streptococcus pyogenes, staphylococcus aureus
- Acute otitis media caused by M. catarrhalis
- Acute otitis media caused by S.pneumoniae
- Bacterial otitis media caused by Haemophilus influenzae
- Community aquired pneumonia caused by H. parainfluenzae
- Community aquired pneumonia caused by M.catarrhalis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/11/28 | Phase 2 | UNKNOWN | Beijing University of Chinese Medicine | ||
2018/01/17 | Phase 4 | UNKNOWN | Neutec Ar-Ge San ve Tic A.Ş | ||
2016/09/08 | Phase 4 | Completed | |||
2009/10/23 | Not Applicable | Completed | |||
2009/04/20 | Phase 1 | Completed | |||
2009/04/16 | Phase 1 | Completed | |||
2009/04/16 | Phase 1 | Completed | |||
2009/04/16 | Phase 1 | Completed | |||
2009/02/03 | Phase 1 | Completed | |||
2009/02/03 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 71205-576 | ORAL | 300 mg in 1 1 | 5/1/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-5106 | ORAL | 250 mg in 5 mL | 2/22/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-4419 | ORAL | 250 mg in 5 mL | 2/16/2021 | |
| A-S Medication Solutions | 50090-6171 | ORAL | 250 mg in 5 mL | 5/22/2020 | |
| Ascend Laboratories, LLC | 67877-543 | ORAL | 300 mg in 1 1 | 2/23/2021 | |
| Aurobindo Pharma Limited | 65862-218 | ORAL | 125 mg in 5 mL | 2/14/2024 | |
| RPK Pharmaceuticals, Inc. | 53002-2654 | ORAL | 125 mg in 5 mL | 11/15/2021 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-054 | ORAL | 300 mg in 1 1 | 3/28/2024 | |
| Pharmasource Meds, LLC | 82982-071 | ORAL | 300 mg in 1 1 | 9/13/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-4007 | ORAL | 300 mg in 1 1 | 3/20/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefdinir Tablets | 国药准字H20223316 | 化学药品 | 片剂 | 5/18/2022 | |
| Cefdinir Tablets | 国药准字H20223315 | 化学药品 | 片剂 | 5/18/2022 | |
| Cefdinir Tablets | 国药准字H20140072 | 化学药品 | 片剂 | 5/17/2019 | |
| Cefdinir Tablets | 国药准字H20173222 | 化学药品 | 片剂 | 5/17/2019 | |
| Cefdinir Granules | 国药准字H20253255 | 化学药品 | 颗粒剂 | 1/24/2025 | |
| Cefdinir Granules | 国药准字H20243151 | 化学药品 | 颗粒剂 | 2/6/2024 | |
| Cefdinir Granules | 国药准字H20253773 | 化学药品 | 颗粒剂 | 4/1/2025 | |
| Cefdinir Granules | 国药准字H20253170 | 化学药品 | 颗粒剂 | 1/14/2025 | |
| Cefdinir Granules | 国药准字H20203615 | 化学药品 | 颗粒剂 | 11/24/2020 | |
| Cefdinir Granules | 国药准字H20244249 | 化学药品 | 颗粒剂 | 6/28/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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