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Omnicef Indications, Dosage, Storage, Stability - Cefdinir

Omnicef Indications, Dosage, Storage, Stability - Cefdinir

INDICATIONS

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 micro-organisms in the conditions listed below.

Adults and Adolescents

Community-Acquired Pneumonia caused by Haemophilus influenzae (including b-lactamase producing strains), Haemophilus parainfluenzae (including b-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including b-lactamase producing strains) (see CLINICAL PHARMACOLOGY - CLINICAL STUDIES).

Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including b-lactamase producing strains), Haemophilus parainfluenzae (including b-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), Moraxella catarrhalis (including b-lactamase producing strains).

Acute Maxillary Sinusitis caused by Haemophilus influenzae (including b-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including b-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 PHARMACOLOGY - 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 b-lactamase producing strains) and Streptococcus pyogenes.

Pediatric Patients

Acute Bacterial Otitis Media caused by Haemophilus influenzae (including b-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including b-lactamase producing strains).

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL PHARMACOLOGY - 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 b-lactamase producing strains) and Streptococcus pyogenes.

DOSAGE AND ADMINISTRATION

(See INDICATIONS)

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)
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	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

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

Pediatric Patients (Age 6 Months Through 12 Years)
Type of Infection	Dosage	Duration
Acute Bacterial Otitis Media	7 mg/kg q12h or14 mg/kg q24h	5 to 10 days 10 days
Acute Maxillary Sinusitis	7 mg/kg q12h or 14 mg/kg q24h	10 days 10 days
Pharyngitis/ Tonsillitis	7 mg/kg q12h or 14 mg/kg q24h	5 to 10 days 10 days
Uncomplicated Skin and Skin Structure Infections	7 mg/kg q12h	10 days

OMNICEF FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART
Weight	125 mg/ 5 mL
9 kg/ 20 lbs	2.5 mL (½ tsp) q12h or 5 mL (1 tsp) q24h
18 kg/ 40 lbs	5 mL (1 tsp) q12h or 10 mL (2 tsp) q24h
27 kg/ 60 lbs	7.5 mL (1½ tsp) q12h or 15 mL (3 tsp) q24h
36 kg/ 80 lbs	10 mL (2 tsp) q12h or 20 mL (4 tsp) q24h
³43 kg a /95 lbs	12 mL (2½ tsp) q12h or 24 mL (5 tsp) q24h

^a Pediatric patients who weigh ³43 kg should receive the maximum daily dose of
600 mg.

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:	CLcr =	(weight) (140 - age) (72)(serum creatinine)
Females:	CLcr =	0.85 ´ 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:

CLcr

= K-

height or length body serum creatinine

1

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
Final Concentration	Final Volume (mL)	Amount of Water	Directions
125 mg/5 mL	60	38 mL	Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot.
	100	63 mL

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.

HOW SUPPLIED

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

60 Capsules/Bottle NDC 0071-0067-20
OMNI-PAC™ 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. The reconstituted suspension has a cream color and strawberry flavor. The powder is available as follows:

60-mL bottles NDC 0071-2006-16

100-mL bottles NDC 0071-2006-18

Store the capsules and unsuspended powder at 25°C (77°F); excursions permitted to 15 to 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

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 4th ed. Approved Standard, NCCLS Document M7-A4, Vol 17(2). NCCLS, Villanova, PA, Jan 1997.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests, 6th ed. Approved Standard, NCCLS Document M2-A6, Vol 17(1). NCCLS, Villanova, PA, Jan 1997.
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.

Rx only

Manufactured by: CEPH International Corporation
Carolina, Puerto Rico 00986

Under License of:
Fujisawa Pharmaceutical Co, Ltd
Osaka, Japan

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