Cefdinir
Cefdinir Prescribing Information
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 for oral suspension 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
Acute Exacerbations of Chronic Bronchitis caused by
Uncomplicated Skin and Skin Structure Infections
caused by
Acute Bacterial Otitis Media caused by
Uncomplicated Skin and Skin Structure Infections caused by
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Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
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):
| ADVERSE EVENTS ASSOCIATED WITH CEFDINIR SUSPENSION U.S. TRIALS IN PEDIATRIC PATIENTS (N = 1783)* | ||
| Incidence ≥ 1% | Diarrhea Rash Vomiting | 8% 3% 1% |
| Incidence < 1% but > 0.1% | Cutaneous moniliasis Abdominal pain Leukopenia† Vaginal moniliasis Vaginitis Abnormal stools Dyspepsia Hyperkinesia Increased AST† Maculopapular rash Nausea | 0.9% 0.8% 0.3% 0.3% of girls 0.3% of girls 0.2% 0.2% 0.2% 0.2% 0.2% 0.2% |
* 977 males, 806 females
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.:
LABORATORY VALUE CHANGES OF POSSIBLE CLINICAL SIGNIFICANCE OBSERVED WITH CEFDINIR SUSPENSION U.S. TRIALS IN PEDIATRIC PATIENTS (N = 1783) | ||
| Incidence ≥1% | ↑Lymphocytes, ↓Lymphocytes ↑Alkaline phosphatase ↓Bicarbonate* ↑Eosinophils ↑Lactate dehydrogenase ↑Platelets ↑PMNs, ↓PMNs ↑Urine protein | 2%, 0.8% 1% 1% 1% 1% 1% 1%, 1% 1% |
| Incidence < 1% but > 0.1% | ↑Phosphorus, ↓Phosphorus ↑Urine pH ↓White blood cells, ↑White blood cells ↓Calcium* ↓Hemoglobin ↑Urine leukocytes ↑Monocytes ↑AST ↑Potassium* ↑Urine specific gravity, ↓Urine specific gravity ↓Hematocrit* | 0.9%, 0.4% 0.8% 0.7%, 0.3% 0.5% 0.5% 0.5% 0.4% 0.3% 0.3% 0.3%, 0.1% 0.2% |
Antacids (aluminum- or magnesium-containing)
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 therapy, cefdinir should be taken at least 2 hours before or after the antacid
Probenecid
As with other β-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir, resulting in an approximate doubling in AUC, a 54% increase in peak cefdinir plasma levels, and a 50% prolongation in the apparent elimination t1/2.
Iron Supplements and Foods Fortified With Iron
Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO4) or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively. If iron supplements are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the supplement.
The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on cefdinir absorption has not been studied.
Concomitantly administered iron-fortified infant formula (2.2 mg elemental iron/6 oz) has no significant effect on cefdinir pharmacokinetics. Therefore, cefdinir for oral suspension can be administered with iron-fortified infant formula.
There have been reports of reddish stools in patients receiving cefdinir. In many cases, patients were also receiving iron-containing products. The reddish color is due to the formation of a nonabsorbable complex between cefdinir or its breakdown products and iron in the gastrointestinal tract.
Cefdinir for Oral Suspension USP contains the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The empirical formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:
Cefdinir for Oral Suspension USP, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir per 5 mL and the following inactive ingredients: sucrose, sodium benzoate, xanthan gum, guar gum, colloidal silicone dioxide, magnesium stearate, sodium citrate anhydrous, citric acid anhydrous and strawberry flavoring.