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

OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension 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 (penicillin-susceptible 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 Mediacaused 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.

(see INDICATIONS AND USAGE for Indicated Pathogens)

Capsules

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, OMNICEF Capsules should be administered twice daily in these infections. OMNICEF Capsules may be taken without regard to meals.

Adults and Adolescents (Age 13 Years and Older)

Powder for Oral Suspension

The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections; therefore, OMNICEF for Oral Suspension should be administered twice daily in this infection. OMNICEF for Oral Suspension may be administered without regard to meals.

Pediatric Patients (Age 6 Months Through 12 Years)

OMNICEF FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART

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.

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:

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 m², 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 m², 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.

Directions for Mixing Omnicef for Oral Suspension

After mixing, the suspension can be stored at room temperature (25°C/77°F). The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be used for 10 days, after which any unused portion must be discarded.

OMNICEF Capsules, containing 300 mg cefdinir, as lavender and turquoise capsules imprinted with the product name, are available as follows:

60 Capsules/Bottle NDC 0074-3769-60

OMNI-PACTM carton of 3 unit-of-use, 5-day,

10-capsule blister cards NDC 0074-3769-30

OMNICEF for Oral Suspension is a cream-colored powder formulation that, when reconstituted as directed, contains 125 mg cefdinir/5 mL or 250 mg cefdinir/5 mL. The reconstituted suspensions have a cream color and strawberry flavor. The powder is available as follows:

125 mg/5 mL

60-mL bottles NDC 0074-3771-60
100-mL bottles NDC 0074-3771-13

250 mg/5 mL

60-mL bottles NDC 0074-6151-60
100-mL bottles NDC 0074-6151-13

Store the capsules and unsuspended powder at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.

REFERENCES

3. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.

4. Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976;58:259-63.

5. Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984;104:849-54.

Manufactured by: CEPH International Corporation, Carolina, Puerto Rico 00986. For: Abbott Laboratories., North Chicago, IL 60064. Under License of: Astellas Pharma Inc. Tokyo, Japan. FDA Rev date: 9/14/2007

Bookmark this page: