Cefdinir Information
Cefdinir ()
Cefdinir () Description
Cefdinir () capsules contain 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 phosphate buffer. The molecular formula is CHNOS and the molecular weight is 395.42. Cefdinir () has the structural formula shown below:
Cefdinir () capsules contain 300 mg Cefdinir () and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac.
Cefdinir () Clinical Pharmacology
As with other cephalosporins, bactericidal activity of Cefdinir () results from inhibition of cell wall synthesis. Cefdinir () is stable in the presence of some, but not all, β-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to Cefdinir () .
Cefdinir () has been shown to be active against most strains of the following microorganisms, both
Cefdinir () 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.
Cefdinir () Contraindications
Cefdinir () capsules are contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
Cefdinir () Warnings
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Cefdinir () Precautions
Prescribing Cefdinir () in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered.
Cefdinir () , as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis.
In patients with transient or persistent renal insufficiency (creatinine clearance
Patients should be counseled that antibacterial drugs including Cefdinir () should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefdinir () is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefdinir () or other antibacterial drugs in the future.
Antacids containing magnesium or aluminum interfere with the absorption of Cefdinir () . If this type of antacid is required during Cefdinir () therapy, Cefdinir () should be taken at least 2 hours before or after the antacid.
Iron supplements, including multivitamins that contain iron, interfere with the absorption of Cefdinir () . If iron supplements are required during Cefdinir () therapy, Cefdinir () should be taken at least 2 hours before or after the supplement.
Iron-fortified infant formula does not significantly interfere with the absorption of Cefdinir () .
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Cefdinir () Adverse Reactions
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):
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.:
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):
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 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.:
The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:
Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment (see ).
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see and ). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Cefdinir () Overdosage
Information on Cefdinir () overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600 mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other β-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes Cefdinir () from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.
Cefdinir () Dosage And Administration
(see for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, Cefdinir () capsules should be administered twice daily in these infections. Cefdinir () capsules may be taken without regard to meals.
Cefdinir () How Supplied
Bottles of 20 NDC 21695-620-20
20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Cefdinir () Clinical Studies
In a controlled, double-blind study in adults and adolescents conducted in the U.S., Cefdinir () BID was compared with cefaclor 500 mg TID. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:
In a second controlled, investigator-blind study in adults and adolescents conducted primarily in Europe, Cefdinir () BID was compared with amoxicillin/clavulanate 500/125 mg TID. Using strict evaluability and clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:
In four controlled studies conducted in the United States, Cefdinir () was compared with 10 days of penicillin in adult, adolescent, and pediatric patients. Two studies (one in adults and adolescents, the other in pediatric patients) compared 10 days of Cefdinir () QD or BID to penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 5 to 10 days posttherapy, the following clinical cure rtes, microbiologic eradication rates, and statistical outcomes were obtained:
Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of Cefdinir () BID to 10 days of penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 4 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:
Cefdinir () References
Manufactured for: 2400 Route 130 North Dayton, NJ 08810
Manufactured by:
Chitkul (V)-502 307, A.P., India
Revised: 12/2008
Repackaged by:
Thousand Oaks, CA 91320
Cefdinir () Principal Display Panel
