Indication: Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 12. 15 Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Streptococcus pneumoniae. Pseudomonas aeruginosa [see Clinical Studies ( 14. 1) Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae [see Dosage and Administration ( 2. nd Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydophila pneumoniae [see Dosage and Administration ( 2. Levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis [see Clinical Studies ( 14. Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes. Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis [see Clinical Studies ( 14. 6 Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis [see Dosage and Administration ( 2. [see Clinical Studies ( 14. 9 Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis Y. pestis [see Dosage and Administration ( 2. 2 [see Clinical Studies ( 14. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis [see Clinical Studies ( 14. 7 Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa [see Clinical Studies (14. Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, [see Clinical Studies (14. 8 Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, Staphylococcus saprophyticus. [see Warnings and Precautions ( 5. 15 Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis. 15 Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis [see Clinical Studies ( 14. 15 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets 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. Culture and susceptibility testing [see Microbiology ( 12. Pseudomonas aeruginosa.

Indication: Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1. 2 Enterococcus faecium 1. 3 To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 4 Linezolid tablet is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablet is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [ see Warnings and Precautions ( 5. 4 Nosocomial pneumonia Staphylococcus aureus Streptococcus pneumoniae see Clinical Studies ( 14 Community-acquired pneumonia Streptococcus pneumoniae Staphylococcus aureus see Clinical Studies ( 14 Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis Staphylococcus aureus Streptococcus pyogenes Streptococcus agalactiae see Clinical Studies ( 14 Uncomplicated skin and skin structure infections Staphylococcus aureus Streptococcus pyogenes see Clinical Studies ( 14 Vancomycin-resistant Enterococcus faecium see Clinical Studies ( 14 To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid tablets and other antibacterial drugs, linezolid tablets should be used only to treat 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. The safety and efficacy of linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

Indication: INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP 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. Cefdinir for oral suspension, USP 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. Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE Pediatric Use DOSAGE AND ADMINISTRATION Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE S. pyogenes Caused by Staphylococcus aureus Streptococcus pyogenes Acute Bacterial Otitis Media Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE S. pyogenes Caused by Staphylococcus aureus Streptococcus pyogenes.
Community-Acquired Pneumonia
Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES
Acute Exacerbations of Chronic Bronchitis
Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis
Acute Maxillary Sinusitis
Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE Pediatric Use DOSAGE AND ADMINISTRATION
Uncomplicated Skin and Skin Structure Infections
Caused by Staphylococcus aureus Streptococcus pyogenes
Community-Acquired Bacterial Pneumonia
In a controlled, double-blind study in adults and adolescents conducted in the U.S., cefdinir BID was compared with cefaclor 500 mg TID. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days post therapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained: U.S. Community-Acquired Pneumonia Study Cefdinir vs Cefaclor Cefdinir BID Cefaclor TID Outcome Clinical Cure Rates 150/187 (80%) 147/186 (79%) Cefdinir equivalent to control Eradication Rates Overall 177/195 (91%) 184/200 (92%) Cefdinir equivalent to control S. pneumoniae 31/31 (100%) 35/35 (100%) H. influenzae 55/65 (85%) 60/72 (83%) M. catarrhalis 10/10 (100%) 11/11 (100%) H. parainfluenzae 81/89 (91%) 78/82 (95%) European Community-Acquired Pneumonia Study Cefdinir vs Amoxicillin/Clavulanate Cefdinir BID Amoxicillin/ Clavulanate TID Outcome Clinical Cure Rates 83/104 (80%) 86/97 (89%) Cefdinir not equivalent to control Eradication Rates Overall 85/96 (89%) 84/90 (93%) Cefdinir equivalent to control S. pneumoniae 42/44 (95%) 43/44 (98%) H. influenzae 26/35 (74%) 21/26 (81%) M. catarrhalis 6/6 (100%) 8/8 (100%) H. parainfluenzae 11/11 (100%) 12/12 (100%)
Streptococcal Pharyngitis/Tonsillitis
In four controlled studies conducted in the United States, cefdinir was compared with 10 days of penicillin in adult, adolescent, and pediatric patients. Two studies (one in adults and adolescents, the other in pediatric patients) compared 10 days of cefdinir QD or BID to penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 5 to 10 days post therapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained: Pharyngitis/Tonsillitis Studies Cefdinir (10 days) vs Penicillin (10 days) Study Efficacy Parameter Cefdinir QD Cefdinir BID Penicillin QID Outcome Adults/ Adolescents Eradication of S. pyogenes 192/210 (91%) 199/217 (92%) 181/217 (83%) Cefdinir superior to control Clinical Cure Rates 199/210 (95%) 209/217 (96%) 193/217 (89%) Cefdinir superior to control Pediatric Patients Eradication of S. pyogenes 215/228 (94%) 214/227 (94%) 159/227 (70%) Cefdinir superior to control Clinical Cure Rates 222/228 (97%) 218/227 (96%) 196/227 (86%) Cefdinir superior to control Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of cefdinir BID to 10 days of penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 4 to 10 days post therapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained: Pharyngitis/Tonsillitis Studies Cefdinir (5 days) vs Penicillin (10 days) Study Efficacy Parameter Cefdinir BID Penicillin QID Outcome Adults/ Adolescents Eradication of S. pyogenes 193/218 (89%) 176/214 (82%) Cefdinir equivalent to control Clinical Cure Rates 194/218 (89%) 181/214 (85%) Cefdinir equivalent to control Pediatric Patients Eradication of S. pyogenes 176/196 (90%) 135/193 (70%) Cefdinir superior to control Clinical Cure Rates 179/196 (91%) 173/193 (90%) Cefdinir equivalent to control

Indication: Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1. 3 Enterococcus faecium 1. 4 Limitations of Use: 1. 5 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezolid injection formulations and other antibacterial drugs, Linezolid injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 6 Linezolid injection is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus Streptococcus pneumoniae see Clinical Studies (14) Linezolid injection is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae Staphylococcus aureus see Clinical Studies (14) Linezolid injection is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus Streptococcus pyogenes Streptococcus agalactiae see Clinical Studies (14) Linezolid injection is indicated for the treatment of vancomycin-resistant Enterococcus faecium see Clinical Studies (14) see Warnings and Precautions (5. 4) see Clinical Studies (14) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezolid injection and other antibacterial drugs, Linezolid injection 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.

Indication: Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1. 1 Acute bacterial sinusitis in adults ( 1. 1 Uncomplicated skin and skin structure infections in adults ( 1. 1 Urethritis and cervicitis in adults ( 1. 1 Genital ulcer disease in men ( 1. 1 Acute otitis media in pediatric patients (6 months of age and older) ( 1. 2 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1. 2 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1. 2 Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. 3 To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. 4 Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Acute bacterial sinusitis due to Haemophilus influenzae Moraxella catarrhalis. Streptococcus pneumoniae Community-acquired pneumonia due to Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumoniae, Streptococcus pneumoniae Pharyngitis/tonsillitis caused by Streptococcus pyogenes Uncomplicated skin and skin structure infections due to Staphylococcus aureus Streptococcus pyogenes Streptococcus agalactiae Urethritis and cervicitis due to Chlamydia trachomatis Neisseria gonorrhoeae Genital ulcer disease in men due to Haemophilus ducreyi [see Use in Specific Populations (8. 4) Clinical Studies (14. 2) Acute otitis media ( > 6 months of age Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Community-acquired pneumonia ( > 6 months of age Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumonia Streptococcus pneumoniae Pharyngitis/tonsillitis ( > 2 years of age Streptococcus pyogenes Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomial infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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.

Indication: Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 12. 15 Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Streptococcus pneumoniae. Pseudomonas aeruginosa [see Clinical Studies ( 14. 1) Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae [see Dosage and Administration ( 2. nd Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydophila pneumoniae [see Dosage and Administration ( 2. Levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis [see Clinical Studies ( 14. Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes. Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis [see Clinical Studies ( 14. 6 Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis [see Dosage and Administration ( 2. [see Clinical Studies ( 14. 9 Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis Y. pestis [see Dosage and Administration ( 2. 2 [see Clinical Studies ( 14. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis [see Clinical Studies ( 14. 7 Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa [see Clinical Studies (14. Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, [see Clinical Studies (14. 8 Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, Staphylococcus saprophyticus. [see Warnings and Precautions ( 5. 15 Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis. 15 Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis [see Clinical Studies ( 14. 15 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets 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. Culture and susceptibility testing [see Microbiology ( 12. Pseudomonas aeruginosa.

Indication: To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tabletsand other antibacterial drugs, levofloxacin tablets 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. Levofloxacin tablets are indicated for the treatment of adults (>=18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and Susceptibility Testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see MICROBIOLOGY( 12. 4 As with other drugs in this class, some isolates of Pseudomonas aeruginosa Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (>=18 years of age) with infections caused by designated, susceptible bacteria ( 1 , 12. 12 1. 11 1. 13 1. 14 Levofloxacin tablets are indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus Pseudomonas aeruginosa Serratiamarcescens Escherichia coli, Klebsiellapneumoniae, Haemophilusinfluenzae, Streptococcus pneumoniae Pseudomonas eruginosa CLINICAL STUDIES( 14. 1 Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae Streptococcus pneumoniae Haemophilusinfluenzae Haemophilusparainfluenzae Klebsiellapneumoniae Moraxella catarrhalis Chlamydophilapneumoniae Legionella pneumophila Mycoplasma pneumoniae DOSAGE AND ADMINISTRATION ( 2. 1 CLINICAL STUDIES( 14. 2 MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC >=2 mcg/mL), 2 nd Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae ( Haemophilusinfluenzae, Haemophilusparainfluenzae, Mycoplasma pneumoniae, or Chlamydophilapneumoniae DOSAGE AND ADMINISTRATION ( 2. 3 Levofloxacin tablets are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae Haemophilusinfluenzae Moraxella catarrhalis CLINICAL STUDIES( 14. 4 Levofloxacin tablets are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae Haemophilusinfluenzae Haemophilusparainfluenzae Moraxella catarrhalis Levofloxacin tablets are indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus Enterococcus faecalis Streptococcus pyogenes Proteus mirabilis CLINICAL STUDIES( 14. 5 Levofloxacin tablets are indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes. Levofloxacin tablets are indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli Enterococcus faecalis Staphylococcus epidermidis CLINICAL STUDIES( 14. 6 Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections due to Escherichia coli Klebsiellapneumoniae Proteus mirabilis CLINICAL STUDIES( 14. 7 Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis Enterobacter cloacae Escherichia coli Klebsiellapneumoniae Proteus mirabilis Pseudomonas aeruginosa CLINICAL STUDIES( 14. 8 Levofloxacin tablets are indicated for the treatment of acute pyelonephritis caused by Escherichia coli CLINICAL STUDIES ( 14. 8 Levofloxacin tablets are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiellapneumoniae, Staphylococcus saprophyticus. Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. DOSAGE AND ADMINISTRATION ( 2. 2 CLINICAL STUDIES ( 14. 9) Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) DOSAGE AND ADMINISTRATION 2. 2 CLINICAL STUDIES 14.

Indication: INDICATIONS AND USAGE
Azithromycin tablets, USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Acute bacterial exacerbations of chronic obstructive pulmonary disease Haemophilus influenzae, Moraxella catarrhalis Streptococcus pneumoniae. Acute bacterial sinusitis Haemophilus influenzae, Moraxella catarrhalis Streptococcus pneumoniae. Community-acquired pneumonia Chlamydophilapneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae Streptococcus pneumoniae NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). Pharyngitis/tonsillitis Streptococcus pyogenes Streptococcus pyogenes Streptococcus pyogenes Uncomplicated skin and skin structure infections Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae. Urethritis and cervicitis Chlamydia trachomatis Neisseria gonorrhoeae. Genital ulcer disease Haemophilus ducreyi Azithromycin, at the recommended dose, should not be relied upon to treat syphilis. Antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin 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. (See PRECAUTIONS: Pediatric Use CLINICAL STUDIES IN PEDIATRIC PATIENTS Acute otitis media Haemophilus influenzae, Moraxella catarrhalis Streptococcus pneumoniae. DOSAGE AND ADMINISTRATION Community-acquired pneumonia Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae Streptococcus pneumoniae DOSAGE AND ADMINISTRATION NOTE: Azithromycin should not be used in pediatric patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). Pharyngitis/tonsillitis Streptococcus pyogenes DOSAGE AND ADMINISTRATION Streptococcus pyogenes Streptococcus pyogenes Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin.
Treatment of pneumonia
In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae Streptococcus pneumoniae
Genitourinary
Monilia, vaginitis and nephritis.
Nervous System
Dizziness, headache, vertigo and somnolence.
Community-Acquired Pneumonia
For the recommended dosage regimen of 10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5, the most frequent side effects attributed to treatment were diarrhea/loose stools, abdominal pain, vomiting, nausea and rash. The incidence is described in the table below: Dosage Regimen Diarrhea/ Loose stools, % Abdominal Pain, % Vomiting, % Nausea, % Rash, % 5-day 5.8% 1.9% 1.9% 1.9% 1.6%
Nervous System
Headache (otitis media dosage), hyperkinesia, dizziness, agitation, nervousness and insomnia.

Indication: Levofloxacin is a fluoroquinolone antibacterial indicated in adults (>=18 years of age) with infections caused by designated, susceptible bacteria ( 1 12. 4 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1. Levofloxacin are indicated for the treatment of adults (>=18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin susceptible Staphylococcus aureus Pseudomonas aeruginosa Serratia marcescens Escherichia coli Klebsiella pneumoniae Haemophilus influenzae Streptococcus pneumoniae Pseudomonas aeruginosa [see Clinical Studies ( 14. 1 Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae Streptococcus pneumoniae Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Chlamydophila pneumoniae Legionella pneumophila Mycoplasma pneumoniae [see Dosage and Administration ( 2. 1 and Clinical Studies ( 14. 2 MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC >=2 mcg/mL), 2nd generation cephalosporins, e. , cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae Chlamydophila pneumoniae see Dosage and Administration ( 2. 3 Levofloxacin s indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus Enterococcus faecalis Streptococcus pyogenes Proteus mirabilis [see Clinical Studies ( 14. 5 ) Levofloxacin is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus Streptococcus pyogenes Levofloxacin is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli Enterococcus faecalis Staphylococcus epidermidis [see Clinical Studies ( 14. 6 Levofloxacin is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. [see Dosage and Administration ( 2. 2 and Clinical Studies ( 14. 9 Levofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) [see Dosage and Administration ( 2. 10 Levofloxacin is indicated for the treatment of complicated urinary tract infections due to Escherichia coli Klebsiella pneumoniae Proteus mirabilis [see Clinical Studies ( 14. 7 Levofloxacin is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa [see Clinical Studies ( 14. 8 Levofloxacin s indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [ see Clinical Studies ( 14. 8 Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5. 15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. Levofloxacin is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis [see Clinical Studies (14. 4) Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ see Warnings and Precautions (5. 15) Levofloxacin is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis [see Clinical Studies ( 14. 4 Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ see Warnings and Precautions (5. 14) To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin 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. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [ see Microbiology (12. 4) As with other drugs in this class, some isolates of Pseudomonas aeruginosa.

Indication: INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. Cefdinir capsules 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. Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE Pediatric Use DOSAGE AND ADMINISTRATION Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE S. pyogenes Caused by Staphylococcus aureus Streptococcus pyogenes Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE S. pyogenes Caused by Staphylococcus aureus Streptococcus pyogenes.
Community-Acquired Pneumonia:
Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES
Acute Exacerbations of Chronic Bronchitis:
Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis
Acute Maxillary Sinusitis:
Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE Pediatric Use DOSAGE AND ADMINISTRATION
Uncomplicated Skin and Skin Structure Infections:
Caused by Staphylococcus aureus Streptococcus pyogenes
Acute Bacterial Otitis Media:
Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis
Community-Acquired Bacterial Pneumonia:
In a controlled, double-blind study in adults and adolescents conducted in the US, cefdinir BID was compared with cefaclor 500 mg TID. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained: US Community-Acquired Pneumonia Study Cefdinir vs Cefaclor Cefdinir BID Cefaclor TID Outcome Clinical Cure Rates Eradication Rates 150/187 (80%) 147/186 (79%) Cefdinir equivalent to control Overall 177/195 (91%) 184/200 (92%) Cefdinir equivalent to control S . pneumoniae 31/31 (100%) 35/35 (100%) H . influenzae 55/65 (85%) 60/72 (83%) M . catarrhalis 10/10 (100%) 11/11 (100%) H . parainfluenzae 81/89 (91%) 78/82 (95%) In a second controlled, investigator-blind study in adults and adolescents conducted primarily in Europe, cefdinir BID was compared with amoxicillin/clavulanate 500/125 mg TID. Using strict evaluability and clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained: European Community-Acquired Pneumonia Study Cefdinir vs Amoxicillin/Clavulanate Cefdinir vs Cefaclor Cefdinir BID Amoxicillin / Clavulanate TID Outcome Clinical Cure Rates Eradication Rates 83/104 (80%) 86/97 (89%) Cefdinir not equivalent to control Overall 85/96 (89%) 84/90 (93%) Cefdinir equivalent to control S . pneumoniae 42/44 (95%) 43/44 (98%) H . influenzae 26/35 (74%) 21/26 (81%) M . catarrhalis 6/6 (100%) 8/8 (100%) H . parainfluenzae 11/11 (100%) 12/12 (100%)
Streptococcal Pharyngitis/Tonsillitis:
In four controlled studies conducted in the United States, cefdinir was compared with 10 days of penicillin in adult, adolescent, and pediatric patients. Two studies (one in adults and adolescents, the other in pediatric patients) compared 10 days of cefdinir QD or BID to penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 5 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained: Pharyngitis/Tonsillitis Studies Cefdinir (10 days) vs Penicillin (10 days) Study Efficacy Parameter Cefdinir QD Cefdinir BID Penicillin QID Outcome Adults/ Adolescents Eradication of S . pyogenes 192/210 (91%) 199/217 (92%) 181/217 (83%) Cefdinir superior to control Clinical Cure Rates 199/210 (95%) 209/217 (96%) 193/217 (89%) Cefdinir superior to control Pediatric Patients Eradication of S . pyogenes 215/228 (94%) 214/227 (94%) 159/227 (70%) Cefdinir superior to control Clinical Cure Rates 222/228 (97%) 218/227 (96%) 196/227 (86%) Cefdinir superior to control Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of cefdinir BID to 10 days of penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/ clinical response criteria 4 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained: Pharyngitis/Tonsillitis Studies Cefdinir (5 days) vs Penicillin (10 days) Study Efficacy Parameter Cefdinir BID Penicillin QID Outcome Adults/ Adolescents Eradication of S . pyogenes 193/218 (89%) 176/214 (82%) Cefdinir equivalent to control Clinical Cure Rates 194/218 (89%) 181/214 (85%) Cefdinir equivalent to control Pediatric Patients Eradication of S . pyogenes 176/196 (90%) 135/193 (70%) Cefdinir superior to control Clinical Cure Rates 179/196 (91%) 173/193 (90%) Cefdinir equivalent to control