Cefdinir
CEFDINIR CAPSULES, USP 300 mg Rx only 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 bacteria.
05424558-6c83-63c5-e063-6294a90a9424
HUMAN PRESCRIPTION DRUG LABEL
Sep 13, 2023
Pharmasource Meds, LLC
DUNS: 118772692
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefdinir
PRODUCT DETAILS
INGREDIENTS (11)
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
DOSAGE & ADMINISTRATION
(seeINDICATIONS 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 b.i.d.
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 |
300 mg q12h |
5 to 10 days |
Acute Maxillary Sinusitis |
300 mg q12h |
10 days |
Pharyngitis/Tonsillitis |
300 mg q12h |
5 to 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 .8 5 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. 1 |
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 2and 0.45 for infants (up to 1 year). 3 |
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.