Cefdinir

Check Drug InteractionsCheck known drug interactions.

Cefdinir Prescribing Information

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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.

(see

INDICATIONS AND USAGE

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.

Adults and Adolescents:

Community-Acquired Pneumonia:

Caused by

Haemophilus influenzae

(including β-lactamase producing strains),

Haemophilus parainfluenzae

(including β-lactamase producing strains),

Streptococcus pneumoniae

(penicillinsusceptible strains only), and

Moraxella catarrhalis

(including β-lactamase producing strains) (see

CLINICAL STUDIES

Acute Exacerbations of Chronic Bronchitis:

Caused by

Haemophilus influenzae

(including β-lactamase producing strains),

Haemophilus parainfluenzae

(including β-lactamase producing strains),

Streptococcus pneumoniae

(penicillin-susceptible strains only), and

Moraxella catarrhalis

(including β-lactamase producing strains).

Acute Maxillary Sinusitis:

Caused by

Haemophilus influenzae

(including β-lactamase producing strains),

Streptococcus pneumoniae

(penicillin-susceptible strains only), and

Moraxella catarrhalis

(including β-lactamase producing strains).

NOTE

: For information on use in pediatric patients, see

Pediatric Use

and

DOSAGE AND ADMINISTRATION.

Pharyngitis/Tonsillitis:

Caused by

Streptococcus pyogenes

(see

CLINICAL STUDIES

NOTE

: Cefdinir is effective in the eradication of

S. pyogenes

from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following

S. pyogenes

pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin Structure Infections:

Caused by

Staphylococcus aureus

(including β-lactamase producing strains) and

Streptococcus pyogenes

Pediatric Patients:

Acute Bacterial Otitis Media:

Caused by

Haemophilus influenzae

(including β-lactamase producing strains),

Streptococcus pneumoniae

(penicillin-susceptible strains only), and

Moraxella catarrhalis

(including β-lactamase producing strains).

Pharyngitis/Tonsillitis:

Caused by

Streptococcus pyogenes

(see

CLINICAL STUDIES

NOTE

: Cefdinir is effective in the eradication of

S. pyogenes

from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following

S. pyogenes

pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin Structure Infections:

Caused by

Staphylococcus aureus

(including β-lactamase producing strains) and

Streptococcus pyogenes

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.

Header$Type of Infection	Dosage	Duration
Community-Acquired Pneumonia	300 mg q12h	10 days
Acute Exacerbations of Chronic Bronchitis	300 mg q12h	5 to 10 days
	or
Acute Maxillary Sinusitis	600 mg q24h	10 days
	300 mg q12h	10 days
	or
Pharyngitis/Tonsillitis	600 mg q24h	10 days
	300 mg q12h	5 to 10 days
	or
Uncomplicated Skin and Skin Structure Infections	600 mg q24h	10 days
	300 mg q12h	10 days

Concomitant administration of 300 mg cefdinir capsules with 30 mL Maalox^® TC suspension reduces the rate (C_max) and extent (AUC) of absorption by approximately 40%. Time to reach C_max 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 capsules therapy, cefdinir capsules should be taken at least 2 hours before or after the antacid.

Cefdinir capsules 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 molecular formula is C₁₄H₁₃N₅O₅S₂ and the molecular weight is 395.42. Cefdinir has the structural formula shown below:

Cefdinir capsules contain 300 mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate. The capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40; gelatin and titanium dioxide.

Oral Bioavailability:

Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. Plasma cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following administration of suspension to healthy adults, cefdinir bioavailability is 120% relative to capsules. Estimated bioavailability of cefdinir capsules is 21% following administration of a 300 mg capsule dose, and 16% following administration of a 600 mg capsule dose. Estimated absolute bioavailability of cefdinir suspension is 25%.

Effect of Food:

The C_max and AUC of cefdinir from the capsules are reduced by 16% and 10%, respectively, when given with a high-fat meal. The magnitude of these reductions is not likely to be clinically significant. Therefore, cefdinir may be taken without regard to food.

Cefdinir Capsules:

Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 300 and 600 mg oral doses of cefdinir to adult subjects are presented in the following table:

Mean (±SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Capsules to Adult Subjects
Dose	C_m_a_x ( mcg / mL )	t_m_a_x ( hr )	AUC ( mcg . hr / mL )
300 mg	1.60(0.55)	2.9(0.89)	7.05(2.17)
600 mg	2.87(1.01)	3.0(0.66)	11.1(3.87)

Multiple Dosing:

Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function.

Report Adverse Event

Cefdinir

Cefdinir Prescribing Information

Cefdinir PubMed™ News