Indication: Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamaseen dashnegative) isolates of Streptococcus Streptococcus pneumoniae Staphylococcus spp. Haemophilus influenzae. Infections of the Genitourinary Tract Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamaseen dashnegative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. Infections of the Skin and Skin Structure Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamaseen dashnegative) isolates of Streptococcus spp. Staphylococcus spp. Infections of the Lower Respiratory Tract Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamaseen dashnegative) isolates of Streptococcus spp. pneumoniae, Staphylococcus spp. Adult Patients Only Helicobacter pylori Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori Dual therapy for H. pylori with lansoprazole Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 Adults and Pediatric Patients ( 1 ) Upper Respiratory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adult Patients Only ( 1 ) Helicobacter pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Indication: INDICATIONS AND USAGE
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase-negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, nose, and throat Streptococcus S. pneumoniae Staphylococcus H. influenzae Infections of the genitourinary tract E. mirabilis, E. faecalis Infections of the skin and skin structure Streptococcus Staphylococcus E. coli Infections of the lower respiratory tract Streptococcus S. pneumoniae, Staphylococcus H. influenzae Gonorrhea, acute uncomplicated (ano-genital and urethral infections) N. gonorrhoeae H. pylori Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected MICROBIOLOGY H. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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. Indicated surgical procedures should be performed.
Triple Therapy
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori H. pylori H. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION
Amoxicillin/Clarithromycin/Lansoprazole
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori H. pylori H. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION
Dual Therapy
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected MICROBIOLOGY H. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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. Indicated surgical procedures should be performed.
Triple Therapy
The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.
Amoxicillin/Clarithromycin/Lansoprazole
The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.
Dual Therapy
The most frequently reported adverse events for patients who received amoxicillin three times daily plus lansoprazole three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with amoxicillin three times daily plus lansoprazole three times daily dual therapy than with lansoprazole alone. For more information on adverse reactions with clarithromycin or lansoprazole, refer to their package inserts, ADVERSE REACTIONS
Triple Therapy
The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE
Amoxicillin/Clarithromycin/Lansoprazole
The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE
Dual Therapy
The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS WARNINGS
Amoxicillin/Lansoprazole
The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS WARNINGS
Triple Therapy
Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily.
Dual Therapy
Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily. All treatments were for 14 days. H. pylori Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori H. pylori Eradication Rates en dash Triple Therapy (amoxicillin/clarithromycin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients) Study Triple Therapy Triple Therapy Evaluable Analysis This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H.pylori registered Intent-to-Treat Analysis Patients were included in the analysis if they had documented H. pylori Study 1 92 (p < 0.5) versus lansoprazole/amoxicillin and lansoprazole/clarithromycin dual therapy. 86 Study 2 86 (p < 0.05) versus clarithromycin/amoxicillin dual therapy. 83 H.pylori Eradication Rates en dash Dual Therapy (amoxicillin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients) Study Dual Therapy Dual Therapy Evaluable Analysis This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H.pylori registered Intent-to-Treat Analysis Patients were included in the analysis if they had documented H. pylori Study 1 77 (p < 0.05) versus lansoprazole alone. 70 Study 2 66 (p < 0.05) versus lansoprazole alone or amoxicillin alone. 61

Indication: Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: · Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1. 1 · Maintenance of Healing of Erosive or Ulcerative GERD ( 1. 2 · Treatment of Symptomatic GERD ( 1. 3 · Healing of Duodenal Ulcers ( 1. 4 · Helicobacter pylori 1. 5 · Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1. 6 In adolescent patients 12 years of age and older for: · Short-term Treatment of Symptomatic GERD ( 1. 7 Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered. Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months. Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks. Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks. Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [ see Clinical Pharmacology (12. 2) Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

Indication: Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Streptococcus Streptococcus pneumoniae Staphylococcus Haemophilus influenzae Infections of the Genitourinary Tract: Escherichia coli Proteus mirabilis Enterococcus faecalis Infections of the Skin and Skin Structure: Streptococcus Staphylococcus E. coli Infections of the Lower Respiratory Tract: Streptococcus S. pneumoniae Staphylococcus H. influenzae Adult Patients only Helicobacter pylori Helicobacter pylori (H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 Adults and Pediatric Patients ( 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adult Patients only ( 1 Helicobacter pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules and other antibacterial drugs, amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Indication: Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Streptococcus Streptococcus pneumoniae Staphylococcus Haemophilus influenzae Infections of the Genitourinary Tract: Escherichia coli, Proteus mirabilis Enterococcus faecalis Infections of the Skin and Skin Structure: Streptococcus Staphylococcus E. coli Infections of the Lower Respiratory Tract: Streptococcus S. pneumoniae, Staphylococcus H. influenzae Adult Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori) Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori Dual therapy for H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected H. pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 Adults and Pediatric Patients ( 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adult Patients only ( 1 Helicobacter pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Indication: The components of HELIDAC Therapy (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H 2 H. pylori H. pylori H. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION To reduce the development of drug-resistant bacteria and maintain the effectiveness HELIDAC Therapy and other antibacterial drugs, HELIDAC Therapy 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: Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Streptococcus Streptococcus pneumoniae Staphylococcus Haemophilus influenzae Infections of the Genitourinary Tract: Escherichia coli, Proteus mirabilis Enterococcus faecalis Infections of the Skin and Skin Structure: Streptococcus Staphylococcus E. coli Infections of the Lower Respiratory Tract: Streptococcus S. pneumoniae, Staphylococcus H. influenzae Adult Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori) Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori Dual therapy for H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected H. pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 Adults and Pediatric Patients ( 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adult Patients only ( 1 Helicobacter pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.