Cefdinir (Omnicef®)

Cefdinir (Omnicef?)

Classification

Third generation cephalosporin antibiotic

Pharmacology

OMNICEF? (cefdinir) capsules for oral administration contain the active ingredient, cefdinir, an extended-spectrum, semisynthetic cephalosporin. As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all, -lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir; it has enhanced activity against aerobic gram-negative bacteria including E. coli, Klebsiella sp. and P. mirabilis, as well as some anaerobic bacteria. It is also inactive against most strains of Enterobacter spp., Pseudomonas spp., Enterococcus spp., penicillin-resistant streptococci, and methicillin-resistant staphylococci [1].

Indication -FDA & literature supported non-FDA

Cefdinir is FDA approved for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated bacteria in the following conditions:

Adults and Adolescents Community-Acquired Pneumonia & Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae, Haemophilus parainfluenzae, and Moraxella catarrhalis (all including -lactamase producing strains), and Streptococcus pneumoniae (penicillin-susceptible strains only).

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

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.

Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.

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

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes [1].

Off label alternative use in the management of acute uncomplicated cystitis [2]

Pharmacokinetics [1]

Pharmacokinetic Parameter

Absorption

Details

Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule administration. Suspension bioavailability is 120% relative to the capsule formulation. Absorption not significantly impacted by food.

Distribution

The mean volume of distribution (Vdarea) of cefdinir in adult subjects is 0.35 L/kg (? 0.29); in pediatric subjects (age 6 months-12 years), cefdinir Vdarea is 0.67 L/kg (? 0.38). 60-70% bound to plasma proteins.

Metabolism

Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug.

Excretion

Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t?) of 1.7 (? 0.6) hours. Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis

Dosage/Administration

The total daily dose for all adult and adolescent (13 years of age and older) 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.

The recommended dosage and duration of treatment of infections in pediatric patients (6 months through 12 years of age) is a total daily dose of 14 mg/kg, up to

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a maximum of 600 mg per day. Pediatric patients 43 kg or more should receive the maximum dose of 600 mg per day.

See product labeling for additional specific dosage information based on age group and type of infection treated.

Use in Special Population

Patients with renal insufficiency: Dosage adjustment is recommended in patients with markedly compromised renal function (creatinine clearance < 30 mL/min) as AUC is increased approximately 6-fold.

Hemodialysis: Dialysis (4 hours duration) removed 63% of cefdinir from the body and reduced apparent elimination t? from 16 (? 3.5) to 3.2 (? 1.2) hours. Dosage adjustment is recommended

Hepatic Disease: Because cefdinir is predominantly renally eliminated and not appreciably metabolized, studies in patients with hepatic impairment were not conducted. It is not expected that dosage adjustment will be required in this population.

Contraindication [1]

Cefdinir capsules are contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

Precautions

Careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, or other drugs. Cross hypersensitivity among -lactam antibiotics can occur in up to 10% of patients so caution should be exercised if given to penicillin-sensitive patient.

Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including cefdinir, and may range in severity from mild- to life-threatening. Consider this diagnosis in patients who present with diarrhea after the administration of cefdinir.

Prescribing cefdinir capsules in the absence of a proven or strongly suspected bacterial infection or indication is unlikely to benefit the patient and increases the risk of development of drug-resistant bacteria.

Prolonged treatment may result in the possible emergence and overgrowth of resistant organisms.

Caution should be used when prescribing in patients with history of colitis. In patients with transient or persistent renal insufficiency (creatinine

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