Cefdinir
Generic: CEFDINIR
Basic Information
Manufacturer
Sandoz Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
38f6adf7-e26c-4764-8ec9-360813874dd4
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents Community-Acquired Pneumonia Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ).
Acute Exacerbations of Chronic Bronchitis Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).
Acute Maxillary Sinusitis Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).
NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION .
Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes (see CLINICAL STUDIES ).
NOTE: Cefdinir is effective in the eradication of S.
pyogenes from the oropharynx.
Cefdinir has not, however, been studied for the prevention of rheumatic fever following S.
pyogenes pharyngitis/tonsillitis.
Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes .
Pediatric Patients Acute Bacterial Otitis Media Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).
Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes (see CLINICAL STUDIES ).
NOTE: Cefdinir is effective in the eradication of S.
pyogenes from the oropharynx.
Cefdinir has not, however, been studied for the prevention of rheumatic fever following S.
pyogenes pharyngitis/tonsillitis.
Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes .
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents Community-Acquired Pneumonia Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ).
Acute Exacerbations of Chronic Bronchitis Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).
Acute Maxillary Sinusitis Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).
NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION .
Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes (see CLINICAL STUDIES ).
NOTE: Cefdinir is effective in the eradication of S.
pyogenes from the oropharynx.
Cefdinir has not, however, been studied for the prevention of rheumatic fever following S.
pyogenes pharyngitis/tonsillitis.
Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes .
Pediatric Patients Acute Bacterial Otitis Media Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).
Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes (see CLINICAL STUDIES ).
NOTE: Cefdinir is effective in the eradication of S.
pyogenes from the oropharynx.
Cefdinir has not, however, been studied for the prevention of rheumatic fever following S.
pyogenes pharyngitis/tonsillitis.
Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes .
Warnings
WARNINGS BEFORE THERAPY WITH CEFDINIR IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDINIR, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS.
IF CEFDINIR IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.
IF AN ALLERGIC REACTION TO CEFDINIR OCCURS, THE DRUG SHOULD BE DISCONTINUED.
SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefdinir, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
difficile .
C.
difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C.
difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibacterial use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C.
difficile , and surgical evaluation should be instituted as clinically indicated.
IF CEFDINIR IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.
IF AN ALLERGIC REACTION TO CEFDINIR OCCURS, THE DRUG SHOULD BE DISCONTINUED.
SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefdinir, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
difficile .
C.
difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C.
difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibacterial use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C.
difficile , and surgical evaluation should be instituted as clinically indicated.
Adverse Reactions
ADVERSE EVENTS Clinical Trials Cefdinir Capsules (Adult and Adolescent Patients) In clinical trials, 5093 adult and adolescent patients (3841 U.S.
and 1252 non-U.S.) were treated with the recommended dose of cefdinir capsules (600 mg/day).
Most adverse events were mild and self-limiting.
No deaths or permanent disabilities were attributed to cefdinir.
One hundred forty-seven of 5093 (3%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with cefdinir therapy.
The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea.
Nineteen of 5093 (0.4%) patients were discontinued due to rash thought related to cefdinir administration.
In the U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir capsules in multiple-dose clinical trials (N=3841 cefdinir-treated patients): Adverse Events Associated with Cefdinir Capsules U.S.
Trials in Adult and Adolescent Patients (N=3841) 1733 males, 2108 females Incidence ≥ 1% Diarrhea 15% Vaginal moniliasis 4% of women Nausea 3% Headache 2% Abdominal pain 1% Vaginitis 1% of women Incidence < 1% but > 0.1% Rash 0.9% Dyspepsia 0.7% Flatulence 0.7% Vomiting 0.7% Abnormal stools 0.3% Anorexia 0.3% Constipation 0.3% Dizziness 0.3% Dry mouth 0.3% Asthenia 0.2% Insomnia 0.2% Leukorrhea 0.2% of women Moniliasis 0.2% Pruritus 0.2% Somnolence 0.2% The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the U.S.: Laboratory Value Changes Observed with Cefdinir Capsules U.S.
Trials in Adult and Adolescent Patients (N=3841) Incidence ≥ 1% ↑Urine leukocytes 2% ↑Urine protein 2% ↑Gamma-glutamyltransferase N < 3841 for these parameters 1% ↓Lymphocytes, ↑Lymphocytes 1%, 0.2% ↑Microhematuria 1% Incidence < 1% but > 0.1% ↑Glucose 0.9% ↑Urine glucose 0.9% ↑White blood cells, ↓White blood cells 0.9%, 0.7% ↑Alanine aminotransferase (ALT) 0.7% ↑Eosinophils 0.7% ↑Urine specific gravity, ↓Urine specific gravity 0.6%, 0.2% ↓Bicarbonate 0.6% ↑Phosphorus, ↓Phosphorus 0.6%, 0.3% ↑Aspartate aminotransferase (AST) 0.4% ↑Alkaline phosphatase 0.3% ↑Blood urea nitrogen (BUN) 0.3% ↓Hemoglobin 0.3% ↑Polymorphonuclear neutrophils (PMNs), ↓PMNs 0.3%, 0.2% ↑Bilirubin 0.2% ↑Lactate dehydrogenase 0.2% ↑Platelets 0.2% ↑Potassium 0.2% ↑Urine pH 0.2%
and 1252 non-U.S.) were treated with the recommended dose of cefdinir capsules (600 mg/day).
Most adverse events were mild and self-limiting.
No deaths or permanent disabilities were attributed to cefdinir.
One hundred forty-seven of 5093 (3%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with cefdinir therapy.
The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea.
Nineteen of 5093 (0.4%) patients were discontinued due to rash thought related to cefdinir administration.
In the U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir capsules in multiple-dose clinical trials (N=3841 cefdinir-treated patients): Adverse Events Associated with Cefdinir Capsules U.S.
Trials in Adult and Adolescent Patients (N=3841) 1733 males, 2108 females Incidence ≥ 1% Diarrhea 15% Vaginal moniliasis 4% of women Nausea 3% Headache 2% Abdominal pain 1% Vaginitis 1% of women Incidence < 1% but > 0.1% Rash 0.9% Dyspepsia 0.7% Flatulence 0.7% Vomiting 0.7% Abnormal stools 0.3% Anorexia 0.3% Constipation 0.3% Dizziness 0.3% Dry mouth 0.3% Asthenia 0.2% Insomnia 0.2% Leukorrhea 0.2% of women Moniliasis 0.2% Pruritus 0.2% Somnolence 0.2% The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the U.S.: Laboratory Value Changes Observed with Cefdinir Capsules U.S.
Trials in Adult and Adolescent Patients (N=3841) Incidence ≥ 1% ↑Urine leukocytes 2% ↑Urine protein 2% ↑Gamma-glutamyltransferase N < 3841 for these parameters 1% ↓Lymphocytes, ↑Lymphocytes 1%, 0.2% ↑Microhematuria 1% Incidence < 1% but > 0.1% ↑Glucose 0.9% ↑Urine glucose 0.9% ↑White blood cells, ↓White blood cells 0.9%, 0.7% ↑Alanine aminotransferase (ALT) 0.7% ↑Eosinophils 0.7% ↑Urine specific gravity, ↓Urine specific gravity 0.6%, 0.2% ↓Bicarbonate 0.6% ↑Phosphorus, ↓Phosphorus 0.6%, 0.3% ↑Aspartate aminotransferase (AST) 0.4% ↑Alkaline phosphatase 0.3% ↑Blood urea nitrogen (BUN) 0.3% ↓Hemoglobin 0.3% ↑Polymorphonuclear neutrophils (PMNs), ↓PMNs 0.3%, 0.2% ↑Bilirubin 0.2% ↑Lactate dehydrogenase 0.2% ↑Platelets 0.2% ↑Potassium 0.2% ↑Urine pH 0.2%