Cefdinir (Page 5 of 8)

Labor and Delivery

Cefdinir has not been studied for use during labor and delivery.

Nursing Mothers

Following administration of single 600 mg doses, cefdinir was not detected in human breast milk.

Pediatric Use

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.

Geriatric Use

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).

ADVERSE REACTIONS

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) a
a 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)
a N <3841 for these parameters
Incidence ≥1% ↑Urine leukocytes 2%
↑Urine protein 2%
↑Gamma-glutamyltransferase a 1%
↓Lymphocytes, ↑Lymphocytes 1%, 0.2%
↑Microhematuria 1%
Incidence <1% but >0.1% ↑Glucose a 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 a 0.6%, 0.2%
↓Bicarbonate a 0.6%
↑Phosphorus, ↓Phosphorus a 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 a 0.2%
↑Platelets 0.2%
↑Potassium a 0.2%
↑Urine pH a 0.2%

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