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

Indication: Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1. 1 Acute Maxillary Sinusitis ( 1. 2 Community-Acquired Pneumonia ( 1. 3 Pharyngitis/Tonsillitis ( 1. 4 Uncomplicated Skin and Skin Structure Infections ( 1. 5 Acute Otitis Media in Pediatric Patients ( 1. 6 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1. 7 Helicobacter pylori 1. 8 Limitations of Use 1. 9 Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Streptococcus pneumoniae [see Indications and Usage (1. 9) Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Moraxella catarrhalis Streptococcus pneumoniae [see Indications and Usage (1. 9) Clarithromycin tablets are indicated [see Indications and Usage (1. 9) Haemophilus influenzae Mycoplasma pneumoniae Streptococcus pneumoniae Chlamydophila pneumoniae Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus Streptococcus pyogenes Clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Moraxella catarrhalis Streptococcus pneumoniae [see Clinical Studies (14. 2) Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium Mycobacterium intracellulare [see Clinical Studies (14. 1) Clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate H. pylori [see Clinical Studies (14. 3) Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae Staphylococcus aureus To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin 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.

Indication: Cefpodoxime proxetil 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. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media Streptococcus pneumoniae Streptococcus pyogenes, Haemophilusinfluenzae or Moraxella (Branhamella) catarrhalis Pharyngitis and/or tonsillitis Streptococcus pyogenes NOTE: Community-acquired pneumonia S. pneumoniae or H. Influenzae Acute bacterial exacerbation of chronic bronchitis S. pneumoniae, H. influenzae M. catarrhalis. H. influenzae. Acute, uncomplicated urethral and cervical gonorrhea Neisseria gonorrhoeae Acute, uncomplicated ano-rectal infections in women Neisseria gonorrhoeae NOTE: N. gonorrhoeae N. gonorrhoeae Uncomplicated skin and skin structure infections Staphylococcus aureus Streptococcus pyogenes NOTE: DOSAGE AND ADMINISTRATION Acute maxillary sinusitis Haemophilusinfluenzae Streptococcus pneumoniae Moraxella catarrhalis. Uncomplicated urinary tract infections (cystitis) Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis Staphylococcus saprophyticus NOTE: CLINICAL STUDIES

Indication: INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Community-Acquired Pneumonia Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES Acute Exacerbations of Chronic Bronchitis Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis Acute Maxillary Sinusitis Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE: Pediatric Use DOSAGE AND ADMINISTRATION Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes Staphylococcus aureus Streptococcus pyogenes Acute Bacterial Otitis Media Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Streptococcus pyogenes CLINICAL STUDIES S. pyogenes 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 posttherapy, 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%) 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 BID Amoxicillin/Clavulanate 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 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

Indication: Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1. 1) Acute Maxillary Sinusitis (1. 2) Community-Acquired Pneumonia (1. 3) Pharyngitis/Tonsillitis (1. 4) Uncomplicated Skin and Skin Structure Infections (1. 5) Acute Otitis Media in Pediatric Patients (1. 6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1. 7) Helicobacter pylori Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clarithromycin and other antibacterial drugs, Clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 9) Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae [see Indications and Usage (1. Clarithromycin tablets (in adults) are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae [see Indications and Usage (1. Clarithromycin tablets are indicated [see Indications and Usage (1. 9)] Haemophilus influenzae Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, Streptococcus pyogenes Clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae [see Clinical Studies (14. Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium Mycobacterium intracellulare [see Clinical Studies (14. Clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate H. pylori [see Clinical Studies (14. Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae Staphylococcus aureus To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin 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: INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Community-Acquired Pneumonia Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES Acute Exacerbations of Chronic Bronchitis Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis Acute Maxillary Sinusitis Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE: Pediatric Use DOSAGE AND ADMINISTRATION Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes Staphylococcus aureus Streptococcus pyogenes Acute Bacterial Otitis Media Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Streptococcus pyogenes CLINICAL STUDIES S. pyogenes 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 posttherapy, 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%) 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 BID Amoxicillin/Clavulanate 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 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

Indication: 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. Adults and Adolescents 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 Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes S. pyogenes Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus Streptococcus pyogenes Pediatric Patients Acute Bacterial Otitis Media Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes S. pyogenes Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus Streptococcus pyogenes

Indication: Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1. 1 Acute Maxillary Sinusitis ( 1. 2 Community-Acquired Pneumonia ( 1. 3 Pharyngitis/Tonsillitis ( 1. 4 Uncomplicated Skin and Skin Structure Infections ( 1. 5 Acute Otitis Media in Pediatric Patients ( 1. 6 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1. 7 Helicobacter pylori 1. 8 Limitations of Use 1. 9 Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Streptococcus pneumoniae [see Indications and Usage (1. 9) Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Moraxella catarrhalis Streptococcus pneumoniae [see Indications and Usage (1. 9) Clarithromycin tablets are indicated [see Indications and Usage (1. 9) Haemophilus influenzae Mycoplasma pneumoniae Streptococcus pneumoniae Chlamydophila pneumoniae Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus Streptococcus pyogenes Clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Moraxella catarrhalis Streptococcus pneumoniae [see Clinical Studies (14. 2) Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium Mycobacterium intracellulare [see Clinical Studies (14. 1) Clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate H. pylori [see Clinical Studies (14. 3) Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae Staphylococcus aureus To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin 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.

Indication: Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1. 1 Acute Maxillary Sinusitis ( 1. 2 Community-Acquired Pneumonia ( 1. 3 Pharyngitis/Tonsillitis ( 1. 4 Uncomplicated Skin and Skin Structure Infections ( 1. 5 Acute Otitis Media in Pediatric Patients ( 1. 6 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1. 7 Helicobacter pylori 1. 8 Limitations of Use 1. 9 Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Streptococcus pneumoniae [see Indications and Usage (1. 9) Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Moraxella catarrhalis Streptococcus pneumoniae [see Indications and Usage (1. 9) Clarithromycin tablets are indicated [see Indications and Usage (1. 9) Haemophilus influenzae Mycoplasma pneumoniae Streptococcus pneumoniae Chlamydophila pneumoniae Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus Streptococcus pyogenes Clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae Moraxella catarrhalis Streptococcus pneumoniae [see Clinical Studies (14. 2) Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium Mycobacterium intracellulare [see Clinical Studies (14. 1) Clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate H. pylori [see Clinical Studies (14. 3) Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae Staphylococcus aureus To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin 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.

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