Cefdinir has not been studied for use during labor and delivery.
Following administration of single 600 mg doses, cefdinir was not detected in human breast milk.
Safety and efficacy in neonates and infants less than 6 months of age have not been established. Use of cefdinir for the treatment of acute maxillary sinusitis in pediatric patients (age 6 months through 12 years) is supported by evidence from adequate and well-controlled studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adult and pediatric patients, and comparative pharmacokinetic data in the pediatric population.
Efficacy is comparable in geriatric patients and younger adults. While cefdinir has been well-tolerated in all age groups, in clinical trials geriatric patients experienced a lower rate of adverse events, including diarrhea, than younger adults. Dose adjustment in elderly patients is not necessary unless renal function is markedly compromised (see DOSAGE AND ADMINISTRATION).
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):
|a 1733 males, 2108 females|
|Vaginal moniliasis||4% of Women|
|Vaginitis||1% of Women|
|Incidence <1% but >0.1%||Rash||0.9%|
|Leukorrhea||0.2% of Women|
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.:
|a N <3841 for these parameters|
|Incidence ≥1%||↑Urine leukocytes||2%|
|↓Lymphocytes, ↑Lymphocytes||1%, 0.2%|
|Incidence <1% but >0.1%||↑Glucose a||0.9%|
|↑White blood cells, ↓White blood cells||0.9%, 0.7%|
|↑Alanine aminotransferase (ALT)||0.7%|
|↑Urine specific gravity, ↓Urine specific gravity a||0.6%, 0.2%|
|↑Phosphorus, ↓Phosphorus a||0.6%, 0.3%|
|↑Aspartate aminotransferase (AST)||0.4%|
|↑Blood urea nitrogen (BUN)||0.3%|
|↑Polymorphonuclear neutrophils (PMNs), ↓PMNs||0.3%, 0.2%|
|↑Lactate dehydrogenase a||0.2%|
|↑Urine pH a||0.2%|
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