Cefdinir (Page 7 of 8)

Cephalosporin Class Adverse Events


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 WARNINGS). Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

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.

DOSAGE AND ADMINISTRATION

(see INDICATIONS AND USAGEfor 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.

Adults and Adolescents (Age 13 Years and Older)
Type of Infection Dosage Duration
Community-Acquired Pneumonia 300 mg q12h 10 days
Acute Exacerbations of Chronic Bronchitis 300 mg q12h or 600 mg q24h 5 to 10 days 10 days
Acute Maxillary Sinusitis 300 mg q12h or 600 mg q24h 10 days 10 days
Pharyngitis/Tonsillitis 300 mg q12h or 600 mg q24h 5 to 10 days 10 days
Uncomplicated Skin and Skin Structure Infections 300 mg q12h 10 days

Patients With Renal Insufficiency


For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CL cr ) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males: CL cr = (weight) (140 – age)
(72) (serum creatinine)
Females: CL cr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL (3).
The following formula may be used to estimate creatinine clearance in pediatric patients:
CL cr = K x body length or height
serum creatinine
Where K=0.55 for pediatric patients older than 1 year (4) and 0.45 for infants (up to 1 year) (5).
In the above equation, creatinine clearance is in mL/min/1.73 m 2 , body length or height is in centimeters, and serum creatinine is in mg/dL. For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m 2 , the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.

Patients on Hemodialysis

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.

HOW SUPPLIED

Cefdinir Capsules USP, 300 mg are lavender opaque/turquoise opaque size ‘0’ hard gelatin capsule filled with off-white to yellow powder and imprinted with ‘E99’ on turquoise opaque body with black ink.
Bottles of 30 NDC 65862-177-30
Bottles of 60 NDC 65862-177-60
Bottles of 500 NDC 65862-177-05
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

CLINICAL STUDIES

Community-Acquired Bacterial Pneumonia

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:

U.S. Community-Acquired Pneumonia Study Cefdinir vs Cefaclor
Cefdinir BID Cefaclor TID Outcome
Clinical Cure Rates 150/187 (80%) 147/186 (79%) Cefdinir equivalent to control
Eradication Rates
Overall 177/195 (91%) 184/200 (92%) Cefdinir equivalent to control
S. pneumoniae 31/31 (100%) 35/35 (100%)
H. influenzae 55/65 (85%) 60/72 (83%)
M. catarrhalis 10/10 (100%) 11/11 (100%)
H. parainfluenzae 81/89 (91%) 78/82 (95%)

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:

European Community-Acquired Pneumonia Study Cefdinir vs Amoxicillin/Clavulanate
Cefdinir BID Amoxicillin/Clavulanate TID Outcome
Clinical Cure Rates 83/104 (80%) 86/97(89%) Cefdinir not equivalent to control
Eradication Rates
Overall 85/96 (89%) 84/90 (93%) Cefdinir equivalent to control
S. pneumoniae 42/44 (95%) 43/44 (98%)
H. influenzae 26/35 (74%) 21/26 (81%)
M. catarrhalis 6/6 (100%) 8/8 (100%)
H. parainfluenzae 11/11 (100%) 12/12 (100%)

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