Cefdinir
Cefdinir Prescribing Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP 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 for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
(See
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP 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 for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Caused by
Caused by
Caused by
Caused by
Caused by
Caused by
Caused by
Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day.
At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.
Final Concentration | Final Volume (mL) | Amount of Water | Directions |
125 mg/5 mL | 60 | 50 mL | Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. |
100 | 80 mL | ||
250 mg/5 mL | 60 | 49 mL | Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. |
100 | 80 mL |
After mixing, the suspension can be stored at room temperature (25°C/77°F). The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be used for 10 days, after which any unused portion must be discarded.
Cefdinir for oral suspension is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
In clinical trials, 2289 pediatric patients (1783 U.S. and 506 non-U.S.) were treated with the recommended dose of cefdinir suspension (14 mg/kg/day). Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to cefdinir. Forty of 2289 (2%) patients discontinued medication due to adverse events considered by the investigators to be possibly, probably, or definitely associated with cefdinir therapy. Discontinuations were primarily for gastrointestinal disturbances, usually diarrhea. Five of 2289 (0.2%) 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 suspension in multiple-dose clinical trials (N = 1783 cefdinir-treated patients):
Incidence ≥ 1% | Diarrhea | 8% |
Rash | 3% | |
Vomiting | 1% | |
Incidence < 1% but > 0.1% | Cutaneous moniliasis | 0.9% |
Abdominal pain | 0.8% | |
Leukopenia 2 | 0.3% | |
Vaginal moniliasis | 0.3% of girls | |
Vaginitis | 0.3% of girls | |
Abnormal stools | 0.2% | |
Dyspepsia | 0.2% | |
Hyperkinesia | 0.2% | |
Increased AST 2 | 0.2% | |
Maculopapular rash | 0.2% | |
Nausea | 0.2% | |
| 1. 977 males, 806 females 2. Laboratory changes were occasionally reported as adverse events. | ||
NOTE: In both cefdinir- and control-treated patients, rates of diarrhea and rash were higher in the youngest pediatric patients. The incidence of diarrhea in cefdinir-treated patients ≤ 2 years of age was 17% (95/557) compared with 4% (51/1226) in those > 2 years old. The incidence of rash (primarily diaper rash in the younger patients) was 8% (43/557) in patients ≤ 2 years of age compared with 1% (8/1226) in those > 2 years old.
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.:
Incidence ≥ 1% | ↑Lymphocytes, ↓Lymphocytes | 2%, 0.8% |
↑Alkaline phosphatase | 1% | |
↓Bicarbonate 1 | 1% | |
↑Eosinophils | 1% | |
↑Lactate dehydrogenase | 1% | |
↑Platelets | 1% | |
↑PMNs, ↓PMNs | 1%, 1% | |
↑Urine protein | 1% | |
Incidence < 1% but > 0.1% | ↑Phosphorus, ↓Phosphorus | 0.9%, 0.4% |
↑Urine pH | 0.8% | |
↓White blood cells, ↑White blood cells | 0.7%, 0.3% | |
↓Calcium 1 | 0.5% | |
↓Hemoglobin | 0.5% | |
↑Urine leukocytes | 0.5% | |
↑Monocytes | 0.4% | |
↑AST | 0.3% | |
↑Potassium 1 | 0.3% | |
↑Urine specific gravity, ↓Urine specific gravity | 0.3%, 0.1% | |
↓Hematocrit 1 | 0.2% | |
| 1. N = 1387 for these parameters | ||
Concomitant administration of 300 mg cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. Time to reach Cmax is also prolonged by 1 hour. There are no significant effects on cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after cefdinir. If antacids are required during cefdinir for oral suspension therapy, cefdinir for oral suspension should be taken at least 2 hours before or after the antacid.