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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.

Approved
Approval ID

05424558-6c83-63c5-e063-6294a90a9424

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 13, 2023

Manufacturers
FDA

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

NDC Product Code82982-071
Application NumberANDA210220
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2023
Generic NameCefdinir

INGREDIENTS (11)

POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CEFDINIRActive
Quantity: 300 mg in 1 1
Code: CI0FAO63WC
Classification: ACTIB

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/28/2022

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
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 .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.

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