Active ingredients:
Cefdinir 300 mg Hard Gelatin Capsule
250 mg / 5 ml or 125 mg / 5 ml – Powder for Oral Suspension

INDICATIONS AND USAGE

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

TORBENER (cefdinir) is 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).

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.

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

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.

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

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.