Product Description.:
Suspension , off-white , strawberry
contains white to off-white powder for reconstitution
OMNICEF?
(cefdinir) for Oral Suspension
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 bacteria.
Proprietary name: OMNICEF
Established name: cefdinir
Route of administration: ORAL (C38288)
Active ingredients (moiety): cefdinir (cefdinir)
# Strength Form Inactive ingredients
1 300 MILLIGRAM CAPSULE (C25158) carboxymethylcellulose calcium, NF, polyoxyl 40 stearate, NF, magnesium stearate, NF, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, NF, gelatin, NF, silicon dioxide, NF, sodium lauryl sulfate, NF
2 125 MILLIGRAM POWDER, FOR SUSPENSION (C42975) sucrose, NF, citric acid, USP, sodium citrate, USP, sodium benzoate, NF, xanthan gum, NF, guar gum, NF, artificial strawberry and cream flavors, silicon dioxide, NF, magnesium stearate, NF
3 250 MILLIGRAM POWDER, FOR SUSPENSION (C42975) sucrose, NF, citric acid, USP, sodium citrate, USP, sodium benzoate, NF, xanthan gum, NF, guar gum, NF, artificial strawberry and cream flavors, silicon dioxide, NF, magnesium stearate, NF
OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension contain 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.
OMNICEF Capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, NF polyoxyl 40 stearate, NF and magnesium stearate, NF. The capsule shells contain FD&C Blue #1 FD&C Red #40 D&C Red #28 titanium dioxide, NF gelatin, NF silicon dioxide, NF and sodium lauryl sulfate, NF.
OMNICEF for Oral Suspension, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir per 5 mL and the following inactive ingredients: sucrose, NF citric acid, USP sodium citrate, USP sodium benzoate, NF xanthan gum, NF guar gum, NF artificial strawberry and cream flavors silicon dioxide, NF and magnesium stearate, NF.
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 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 (incl
