Omnicef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Indicated for the treatment of:

For 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).

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).

Pharyngitis/Tonsillitis:

• Caused by Streptococcus pyogenes. 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 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. 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.

Before therapy with cefdinir for oral suspension is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, or other drugs. If Cefdinir is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among β-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cefdinir occurs, the drug should be discontinued. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefdinir, and may range in severity from mild diarrhea to fatal colitis.

Cefdinir, as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis.

Antacids containing magnesium or aluminum interfere with the absorption of cefdinir. If this type of antacid is required during cefdinir for oral suspension therapy, cefdinir for oral suspension should be taken at least 2 hours before or after the antacid.

Iron supplements, including multivitamins that contain iron, interfere with the absorption of cefdinir. If iron supplements are required during cefdinir for oral suspension therapy, cefdinir for oral suspension should be taken at least 2 hours before or after the supplement.

As with other β-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir, resulting in an approximate doubling in AUC, a 54% increase in peak cefdinir plasma levels, and a 50% prolongation in the apparent elimination t½.

A false-positive reaction for ketones in the urine may occur with tests using nitroprusside, but not with those using nitroferricyanide. The administration of cefdinir may result in a false-positive reaction for glucose in urine using Clinitest, Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Tes-Tape) be used. Cephalosporins are known to occasionally induce a positive direct Coombs’ test.

There are no adequate and well-controlled studies in pregnant women. Animal studies: decreased body weight gain.

Following administration of single 600 mg doses, cefdinir was not detected in human breast milk.

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• Adult dosage greater than 600 mg per day or greater than 14 mg/kg per day. GoToSource

• Use in patients under the age of 6 months. GoToSource

• Urinary tract infections. GoToSource

Liver damage. GoToSource

Acute tubulointerstitial nephritis (injury to kidney tubules). GoToSource

Stevens-Johnson syndrome (severe skin reaction). GoToSource

Jaundice, cholestasis (flow of bile from liver is reduced or blocked) and pruritus (severe itching). GoToSource

Pseudomembranous colitis (swelling or inflammation of the large intestine). GoToSource

Seizures. GoToSource

Immune hemolytic anemia (immune system makes antibodies that attack red blood cells).  GoToSource

Hypersensitivity reactions. GoToSource

Clostridium difficile associated diarrhea. GoToSource

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