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Global Guidelines

Treatment Guidelines for Bacterial Respiratory Tract Infections

Find a comprehensive view of practice guidelines on the treatment of bacterial RTIs. Guidelines may not account for individual variations among patients or present complete information for drug products; and are not intended to replace good clinical judgment.

For complete dosing information, please consult the full Prescribing Information for each product.

Acute Bacterial Sinusitis (ABS): American Academy of Otolaryngology
Acute Exacerbation of Chronic Bronchitis (AECB): Canadian Thoracic Society and Canadian Infectious Disease Society
Exacerbation of Chronic Obstructive Pulmonary Disease (COPD): Global Initiative for Chronic Obstructive Lung Disease
Community-acquired Pneumonia (CAP): Infectious Diseases Society of America/American Thoracic Society

Acute Bacterial Sinusitis (ABS) From The American Academy of Otolaryngology 2007 1

American Academy of Otolaryngology (2007)
Patient type Initial Recommendation
First-line therapy
  • Amoxicillin
Patient with penicillin allergy
  • Macrolide
  • Trimethoprim-sulfamethoxazole
Used antibiotics in last 4 to 6 weeks
  • Fluoroquinolone
  • High-dose amoxicillin/clavulanate
Treatment fails – patient may be carrying
antibacterial-resistant bacteria
  • High-dose amoxicillin/clavulanate
  • Respiratory fluoroquinolone
    (gemifloxacin, levofloxacin, moxifloxacin)

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Acute Exacerbation of Chronic Bronchitis (AECB) From The Canadian Thoracic Society and Canadian Infectious Disease Society (2003) 2

Canadian Thoracic Society and Canadian Infectious Disease Society (2003)
Basic clinical state First choice Alternative for treatment failure
Acute tracheobronchitis
  • No antibacterial unless symptoms
    persist for >10 to 14 days
  • Macrolide
  • Tetracycline
Chronic bronchitis without
risk factors (mild)
  • 2nd-generation macrolide
  • 2nd- or 3rd generation cephalosporin
  • Amoxicillin
  • Doxycycline
  • Trimethoprim-sulfamethoxazole
  • Fluoroquinolone
  • β-lactams/ β-lactamase inhibitor
Chronic bronchitis with risk factors (severe)
  • Fluoroquinolone
  • β-lactams/ β-lactamase inhibitor
  • May require perenteral therapy
  • Consider referral to a specialist or hospital
Chronic suppurative bronchitis
    Ambulatory Patients:
  • Tailor the treatment to the airway pathogen
  • P aeruginosa common (ciprofloxacin)
    Hospitalized patients:
  • Parenteral therapy usually required

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Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) From The Global Initiative for Chronic Obstructive Lung Disease [GOLD](2008)*†3

Global Initiative for Chronic Obstructive Lung Disease [GOLD]
Basic clinical state Oral treatment Alternative oral treatment
    Group A:
  • Mild exacerbation
  • No risk factors for poor outcome ‡
  • Β-lactam (penicillin/ampicillin/amoxicillin) §
  • Tetracycline
  • Trimethoprim-sulfamethoxazole(Patients with only one cardinal symptom Ⅱ should not receive antibacterials)
  • β-lactams/
    β-lactamase inhibitor (co-amoxiclav)
  • Macrolide
    (azithromycin, clarithromycin,
    roxithromycin)
  • 2nd- or 3rd- generation
    cephalosporins
  • Ketolides (telithromycin)
    Group B:
  • Moderate exacerbation with
    risk factors for poor outcome ‡
  • β-lactams/ β-lactamase inhibitor
    (co-amoxiclav)

  • Fluoroquinolones
    (gemifloxacin,levofloxacin,
    moxifloxacin)
  • Adapted from Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2008 Update).
  • * All patients with symptoms of a COPD exacerbation should be treated with additional brochodilators ± glucocorticosteroids.
  • † In countries with high incidence of S pneumoniae resistant to penicillin, high dosages of amoxicillin or co-amoxiclav are recommended.
  • ‡ Risk factors for poor outcome in patients with COPD exacerbation: presence of comorbid diseases, severe COPD, frequent exacerbations (>3/yr) and antimicrobial use within last 3 months.
  • § Not appropriate in areas with increased prevalence of ß-lactamase producing H influenzae/ M catarrhalis and/or penicillin-resistant S pneumoniae.
  • ll Cardinal symptoms are increased dyspnea, sputum volume, and sputum purulence.

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Community-acquired Pneumonia (CAP) From Infectious Diseases Society of America/American Thoracic Society [IDSA/ATS](2007) 4

Infectious Diseases Society of America/American Thoracic Society (2007)
Condition Recommendation
Outpatient, previously healthy,
no risk factors for drug-resistant
S. pneumoniae		 A macrolide (strong recommendation)
OR Doxycycline (weak recommendation)
Presence of comorbidities* or exposure to
antimicrobials within 3 months		 A respiratory fluoroquinolone† (strong recommendation)
OR A β-lactam (amoxicillin or amoxicillin/clavulanate preferred) plus a macrolide (strong recommendation)
Regions with high rate of infection (>25%) with
high-level (MIC ≥16 µg/mL) macrolide-resistant
S.pneumonae 		Consider use of alternative agents listed above
for any patient, including those without
comorbidities (moderate recommendation)
Inpatient, non-ICU treatment A respiratory fluoroquinolone† (strong recommendation)
OR A β-lactam‡ plus a macrolide (strong recommendation)

* Such as chronic heart, lung, liver, or renal disease; diabetes mellitus; alcoholism; malignancies; asplenia; immunosuppressing conditions, or use of immunosuppressing drugs;

† gemifloxacin, Moxifloxacin, levofloxacin 750 mg only
†† Respiratory fluoroquinolone should be used for penicillin-allergic patients.

        IDSA = Infectious Diseases Society of America;
        ATS = American Thoracic Society;
        MIC = minimum inhibitory concentration;
        ICU = intensive care unit

References

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Important Safety Information

THE SAFETY AND EFFECTIVENESS OF FACTIVE IN CHILDREN, ADOLESCENTS (<18 YEARS OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.

FACTIVE is contraindicated in patients with a history of hypersensitivity to gemifloxacin, fluoroquinolone antibiotic agents, or any of the product components. Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including FACTIVE. Hypersensitivity reactions reported in patients receiving fluoroquinolone therapy have occasionally been fatal. These reactions may include serious, sometimes fatal skin reactions such as toxic epidermal necrolysis or Stevens-Johnson Syndrome; effects on the liver, including hepatitis, jaundice, and acute hepatic necrosis or failure; renal toxicities including interstitial nephritis and/or acute renal insufficiency or failure; and hematologic effects, including agranulocytosis, thrombocytopenia, and other hematologic abnormalities. These reactions may occur following the first dose or multiple doses. FACTIVE should be discontinued immediately at the first sign of an immediate type I hypersensitivity skin rash or any other manifestation of hypersensitivity reaction.

Fluoroquinolones, including FACTIVE, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation. You should stop taking FACTIVE until tendinitis or tendon rupture have been ruled out, and avoid exercise and using the affected area.

Fluoroquinolones may prolong the QT interval in some patients. FACTIVE should be avoided in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), and patients receiving Class IA or Class III antiarrhythmic agents.

Rare cases of peripheral neuropathy have been reported in patients receiving quinolones.

In clinical studies with FACTIVE, central nervous system (CNS) effects have been reported infrequently. As with other fluoroquinolones, FACTIVE should be used with caution in patients with known or suspected CNS diseases. If CNS reactions occur, FACTIVE should be discontinued and appropriate measures instituted.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibiotic agents, including FACTIVE. If diarrhea occurs, evaluate for CDAD and treat appropriately.

In clinical trials, rash occurred more often with FACTIVE than therapy with comparator agents (2.8% vs. 0.6%). Increasing incidence of rash was associated with younger age (especially below 40), female gender, use of hormone replacement therapy, and longer duration of therapy.

Moderate to severe photosensitivity/phototoxicity reactions can be associated with the use of quinolones after sun or UV light exposure. Excessive exposure to the sun or UV light should be avoided.

Magnesium- and/or aluminum-containing antacids, products containing ferrous sulfate (iron), multivitamin preparations containing zinc or other cations, or Videx® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 3 hours before or 2 hours after FACTIVE. Sucralfate should not be taken within 2 hours of FACTIVE.

In clinical trials, the most common adverse drug reactions (≥2%) were diarrhea, rash, nausea, headache, abdominal pain, vomiting, and dizziness.

This product is available by prescription only.

* Videx® is a registered trademark of Bristol-Myers Squibb Company.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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You are encouraged to report negative side effects of prescription drugs, please click here or call 82-2-6924-3620.

Please note that the information contained on this site is intended for international health care providers and may not be appropriate for your country of origin. Please see the full FACTIVE prescribing information for your country for approved product indications, dosing, and important safety considerations. Click on the "Global Countries" tab above to learn how to obtain country-specific prescribing information.

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