Usual Adult Dose for Nosocomial Pneumonia

750 mg orally or IV every 24 hours for 7 to 14 days

Comments:

• Adjunctive therapy recommended as clinically indicated.
• Coadministration with an antipseudomonal beta-lactam recommended if Pseudomonas aeruginosa is a documented/possible pathogen.
• Current guidelines should be consulted for additional information.

Use: For the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, P aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae

Usual Adult Dose for Pneumonia

For 7 to 14 day regimen: 500 mg orally or IV every 24 hours for 7 to 14 days
For 5-day regimen: 750 mg orally or IV every 24 hours for 5 days

Comments:

• Multi-drug resistant S pneumoniae (MDRSP) isolates are isolates resistant to at least 2 of the following antibacterials: penicillin (MIC at least 2 mcg/mL), second-generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and sulfamethoxazole-trimethoprim.

Use: For the treatment of community-acquired pneumonia:

• For 7 to 14 day regimen: Due to methicillin-susceptible S aureus, S pneumoniae (including MDRSP), H influenzae, H parainfluenzae, K pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae
• For 5-day regimen: Due to S pneumoniae (excluding MDRSP), H influenzae, H parainfluenzae, M pneumoniae, or C pneumoniae

Usual Adult Dose for Skin and Structure Infection

Complicated infection: 750 mg orally or IV every 24 hours for 7 to 14 days
Uncomplicated infection: 500 mg orally or IV every 24 hours for 7 to 10 days

Uses: For the treatment of complicated skin and skin structure infections due to methicillin-susceptible S aureus, Enterococcus faecalis, S pyogenes, or Proteus mirabilis; for the treatment of mild to moderate uncomplicated skin and skin structure infections (including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections) due to methicillin-susceptible S aureus or S pyogenes

Usual Adult Dose for Prostatitis

500 mg orally or IV every 24 hours for 28 days

Use: For the treatment of chronic bacterial prostatitis due to E coli, E faecalis, or methicillin-susceptible S epidermidis

Usual Adult Dose for Inhalation Bacillus anthracis

500 mg orally or IV every 24 hours for 60 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to aerosolized Bacillus anthracis.
• Efficacy based on plasma levels reached in humans, a surrogate endpoint reasonably likely to predict clinical benefit; this drug has not been tested in humans for postexposure prevention of inhalation anthrax.
• Safety of this drug has not been established for therapy durations exceeding 28 days; prolonged therapy recommended only when the benefit outweighs the risk.

Use: For inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized B anthracis

US CDC Recommendations: 750 mg orally or IV every 24 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days

Systemic anthrax:

• With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
• When meningitis has been excluded: 2 weeks or until patient is clinically stable (whichever is longer)
• Patients exposed to aerosolized spores will require prophylaxis to complete an antimicrobial regimen of 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:

• Bioterrorism-related cases: 60 days
• Naturally-acquired cases: 7 to 10 days

Comments:

• Ciprofloxacin is preferred for pregnant women.
• Recommended as an alternative oral drug for postexposure prophylaxis and as an alternative IV drug for the treatment of systemic anthrax
• Recommended as a preferred oral drug for the treatment of cutaneous anthrax without systemic involvement
• Recommended for all strains (regardless of penicillin susceptibility or if susceptibility is unknown) when used for postexposure prophylaxis, systemic anthrax when meningitis has been excluded, or cutaneous anthrax without systemic involvement
• Recommended for use with a protein synthesis inhibitor when used for systemic anthrax; the addition of a bactericidal beta-lactam is recommended with possible/confirmed meningitis.
• Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Cutaneous Bacillus anthracis

500 mg orally or IV every 24 hours for 60 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to aerosolized Bacillus anthracis.
• Efficacy based on plasma levels reached in humans, a surrogate endpoint reasonably likely to predict clinical benefit; this drug has not been tested in humans for postexposure prevention of inhalation anthrax.
• Safety of this drug has not been established for therapy durations exceeding 28 days; prolonged therapy recommended only when the benefit outweighs the risk.

Use: For inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized B anthracis

US CDC Recommendations: 750 mg orally or IV every 24 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days

Systemic anthrax:

• With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
• When meningitis has been excluded: 2 weeks or until patient is clinically stable (whichever is longer)
• Patients exposed to aerosolized spores will require prophylaxis to complete an antimicrobial regimen of 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:

• Bioterrorism-related cases: 60 days
• Naturally-acquired cases: 7 to 10 days

Comments:

• Ciprofloxacin is preferred for pregnant women.
• Recommended as an alternative oral drug for postexposure prophylaxis and as an alternative IV drug for the treatment of systemic anthrax
• Recommended as a preferred oral drug for the treatment of cutaneous anthrax without systemic involvement
• Recommended for all strains (regardless of penicillin susceptibility or if susceptibility is unknown) when used for postexposure prophylaxis, systemic anthrax when meningitis has been excluded, or cutaneous anthrax without systemic involvement
• Recommended for use with a protein synthesis inhibitor when used for systemic anthrax; the addition of a bactericidal beta-lactam is recommended with possible/confirmed meningitis.
• Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Anthrax Prophylaxis

500 mg orally or IV every 24 hours for 60 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to aerosolized Bacillus anthracis.
• Efficacy based on plasma levels reached in humans, a surrogate endpoint reasonably likely to predict clinical benefit; this drug has not been tested in humans for postexposure prevention of inhalation anthrax.
• Safety of this drug has not been established for therapy durations exceeding 28 days; prolonged therapy recommended only when the benefit outweighs the risk.

Use: For inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized B anthracis

US CDC Recommendations: 750 mg orally or IV every 24 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days

Systemic anthrax:

• With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
• When meningitis has been excluded: 2 weeks or until patient is clinically stable (whichever is longer)
• Patients exposed to aerosolized spores will require prophylaxis to complete an antimicrobial regimen of 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:

• Bioterrorism-related cases: 60 days
• Naturally-acquired cases: 7 to 10 days

Comments:

• Ciprofloxacin is preferred for pregnant women.
• Recommended as an alternative oral drug for postexposure prophylaxis and as an alternative IV drug for the treatment of systemic anthrax
• Recommended as a preferred oral drug for the treatment of cutaneous anthrax without systemic involvement
• Recommended for all strains (regardless of penicillin susceptibility or if susceptibility is unknown) when used for postexposure prophylaxis, systemic anthrax when meningitis has been excluded, or cutaneous anthrax without systemic involvement
• Recommended for use with a protein synthesis inhibitor when used for systemic anthrax; the addition of a bactericidal beta-lactam is recommended with possible/confirmed meningitis.
• Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Plague

500 mg orally or IV every 24 hours for 10 to 14 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to Yersinia pestis.
• Higher doses (750 mg orally or IV every 24 hours) can be used for treatment of plague if clinically indicated.
• Efficacy studies not conducted in humans with plague for ethical and feasibility reasons; approval based on efficacy study in animals.

Uses: For treatment of plague (including pneumonic and septicemic plague) due to Y pestis and prophylaxis for plague

Usual Adult Dose for Plague Prophylaxis

500 mg orally or IV every 24 hours for 10 to 14 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to Yersinia pestis.
• Higher doses (750 mg orally or IV every 24 hours) can be used for treatment of plague if clinically indicated.
• Efficacy studies not conducted in humans with plague for ethical and feasibility reasons; approval based on efficacy study in animals.

Uses: For treatment of plague (including pneumonic and septicemic plague) due to Y pestis and prophylaxis for plague

Usual Adult Dose for Urinary Tract Infection

Complicated infection:

• For 10-day regimen: 250 mg orally or IV every 24 hours for 10 days
• For 5-day regimen: 750 mg orally or IV every 24 hours for 5 days

Uncomplicated infection: 250 mg orally or IV every 24 hours for 3 days

Comments:

• Since fluoroquinolones (including this drug) have been associated with serious side effects and uncomplicated urinary tract infection (UTI) is self-limiting for some patients, this drug should be saved for treatment of uncomplicated UTIs in patients with no alternative treatment options.

Uses:

• For 10-day regimen: For the treatment of mild to moderate complicated UTIs due to E faecalis, Enterobacter cloacae, E coli, K pneumoniae, P mirabilis, or P aeruginosa
• For 5-day regimen: For the treatment of complicated UTIs due to E coli, K pneumoniae, or P mirabilis
• For the treatment of mild to moderate uncomplicated UTIs due to E coli, K pneumoniae, or S saprophyticus

Usual Adult Dose for Pyelonephritis

250 mg orally or IV every 24 hours for 10 days

• Including cases with concurrent bacteremia: 750 mg orally or IV every 24 hours for 5 days

Use: For the treatment of acute pyelonephritis due to E coli (including cases with concurrent bacteremia)

Usual Adult Dose for Cystitis

250 mg orally or IV every 24 hours for 3 days

Comments:

• Since fluoroquinolones (including this drug) have been associated with serious side effects and uncomplicated UTI is self-limiting for some patients, this drug should be saved for treatment of uncomplicated UTIs in patients with no alternative treatment options.

Use: For the treatment of mild to moderate uncomplicated UTIs due to E coli, K pneumoniae, or S saprophyticus

Usual Adult Dose for Bronchitis

500 mg orally or IV every 24 hours for 7 days

Comments:

• Since fluoroquinolones (including this drug) have been associated with serious side effects and acute bacterial exacerbation of chronic bronchitis (ABECB) is self-limiting for some patients, this drug should be saved for treatment of ABECB in patients with no alternative treatment options.

Use: For the treatment of ABECB due to methicillin-susceptible S aureus, S pneumoniae, H influenzae, H parainfluenzae, or M catarrhalis

Usual Adult Dose for Sinusitis

500 mg orally or IV every 24 hours for 10 to 14 days or 750 mg orally or IV every 24 hours for 5 days

Comments:

• Since fluoroquinolones (including this drug) have been associated with serious side effects and acute bacterial sinusitis (ABS) is self-limiting for some patients, this drug should be saved for treatment of ABS in patients with no alternative treatment options.

Use: For the treatment of ABS due to S pneumoniae, H influenzae, or M catarrhalis

Usual Adult Dose for Tuberculosis - Active

US CDC, Infectious Diseases Society of America (IDSA), and American Thoracic Society (ATS) Recommendations: 500 to 1000 mg orally or IV once a day

Comments:

• Recommended as a second-line drug
• Optimal duration of therapy has not been established.
• The WHO recommends susceptibility testing and a tailored regimen using second-line drugs based on test results, if testing and second-line drugs are available.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Nongonococcal Urethritis

US CDC Recommendations: 500 mg orally once a day for 7 days

Comments:

• Recommended as an alternative regimen
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Chlamydia Infection

US CDC Recommendations: 500 mg orally once a day for 7 days

Comments:

• Recommended as an alternative regimen
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Pelvic Inflammatory Disease

US CDC Recommendations: 500 mg orally once a day for 14 days

Comments:

• Recommended as an alternative agent for mild to moderately severe acute pelvic inflammatory disease (PID)
• Due to high rates of resistance, fluoroquinolones are not recommended for treatment of gonococcal infections in the US; as a result, regimens that include a quinolone are not recommended for the treatment of PID.
• If parenteral cephalosporin therapy is not possible, use of this drug (with oral metronidazole) can be considered if community prevalence and individual risk for gonorrhea are low.
• Prior to therapy, diagnostic tests for gonorrhea must be performed; if test results are positive for quinolone-resistant Neisseria gonorrhoeae and cephalosporin therapy is not possible, an infectious-disease specialist should be consulted.
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Epididymitis - Sexually Transmitted

US CDC recommendations: 500 mg orally once a day for 10 days

Comments:

• A recommended regimen for acute epididymitis most likely due to enteric organisms
• With ceftriaxone, a recommended regimen for acute epididymitis most likely due to sexually-transmitted chlamydia and gonorrhea and enteric organisms (men practicing insertive anal sex)
• Due to high rates of resistance, fluoroquinolones are not recommended for treatment of gonococcal infections in the US; use of this drug should be considered if infection is most likely due to enteric organisms and tests have ruled out gonorrhea.
• All patients should be tested for other sexually-transmitted infections (including HIV).
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Inhalation Bacillus anthracis

6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours

• Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of therapy: 60 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to aerosolized B anthracis.
• Efficacy based on plasma levels reached in humans, a surrogate endpoint reasonably likely to predict clinical benefit; this drug has not been tested in humans for postexposure prevention of inhalation anthrax.
• Safety of this drug has not been established for therapy durations exceeding 14 days; increased rate of musculoskeletal side effects compared to controls; prolonged therapy recommended only when the benefit outweighs the risk.
• The tablet formulation is recommended for patients weighing at least 30 kg; alternative formulations may be considered for patients weighing less than 30 kg.

Use: For inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized B anthracis

American Academy of Pediatrics Recommendations for Children 1 Month or Older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours

• Systemic anthrax when meningitis has been excluded: 10 mg/kg IV every 12 hours

Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days after exposure

Systemic anthrax:

• With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
• When meningitis has been excluded: At least 14 days or until patient is clinically stable (whichever is longer)
• Patients will require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:

• Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
• Naturally-acquired cases: 7 to 10 days

Follow-up for severe anthrax: To complete a regimen of 14 days or longer

• Patients may require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:

• Recommended as an alternative oral drug for postexposure prophylaxis, for the treatment of cutaneous anthrax without systemic involvement, and follow-up therapy for severe anthrax
• Recommended as an alternative IV drug for the treatment of systemic anthrax
• Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic anthrax when meningitis has been excluded, follow-up therapy for severe anthrax, or cutaneous anthrax without systemic involvement
• Recommended for use with a protein synthesis inhibitor when used for systemic anthrax (including follow-up); the addition of a bactericidal antimicrobial (beta-lactam or glycopeptide) is recommended with possible/confirmed meningitis.
• Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Cutaneous Bacillus anthracis

6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours

• Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of therapy: 60 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to aerosolized B anthracis.
• Efficacy based on plasma levels reached in humans, a surrogate endpoint reasonably likely to predict clinical benefit; this drug has not been tested in humans for postexposure prevention of inhalation anthrax.
• Safety of this drug has not been established for therapy durations exceeding 14 days; increased rate of musculoskeletal side effects compared to controls; prolonged therapy recommended only when the benefit outweighs the risk.
• The tablet formulation is recommended for patients weighing at least 30 kg; alternative formulations may be considered for patients weighing less than 30 kg.

Use: For inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized B anthracis

American Academy of Pediatrics Recommendations for Children 1 Month or Older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours

• Systemic anthrax when meningitis has been excluded: 10 mg/kg IV every 12 hours

Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days after exposure

Systemic anthrax:

• With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
• When meningitis has been excluded: At least 14 days or until patient is clinically stable (whichever is longer)
• Patients will require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:

• Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
• Naturally-acquired cases: 7 to 10 days

Follow-up for severe anthrax: To complete a regimen of 14 days or longer

• Patients may require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:

• Recommended as an alternative oral drug for postexposure prophylaxis, for the treatment of cutaneous anthrax without systemic involvement, and follow-up therapy for severe anthrax
• Recommended as an alternative IV drug for the treatment of systemic anthrax
• Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic anthrax when meningitis has been excluded, follow-up therapy for severe anthrax, or cutaneous anthrax without systemic involvement
• Recommended for use with a protein synthesis inhibitor when used for systemic anthrax (including follow-up); the addition of a bactericidal antimicrobial (beta-lactam or glycopeptide) is recommended with possible/confirmed meningitis.
• Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Anthrax Prophylaxis

6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours

• Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of therapy: 60 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to aerosolized B anthracis.
• Efficacy based on plasma levels reached in humans, a surrogate endpoint reasonably likely to predict clinical benefit; this drug has not been tested in humans for postexposure prevention of inhalation anthrax.
• Safety of this drug has not been established for therapy durations exceeding 14 days; increased rate of musculoskeletal side effects compared to controls; prolonged therapy recommended only when the benefit outweighs the risk.
• The tablet formulation is recommended for patients weighing at least 30 kg; alternative formulations may be considered for patients weighing less than 30 kg.

Use: For inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized B anthracis

American Academy of Pediatrics Recommendations for Children 1 Month or Older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours

• Systemic anthrax when meningitis has been excluded: 10 mg/kg IV every 12 hours

Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days after exposure

Systemic anthrax:

• With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
• When meningitis has been excluded: At least 14 days or until patient is clinically stable (whichever is longer)
• Patients will require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:

• Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
• Naturally-acquired cases: 7 to 10 days

Follow-up for severe anthrax: To complete a regimen of 14 days or longer

• Patients may require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:

• Recommended as an alternative oral drug for postexposure prophylaxis, for the treatment of cutaneous anthrax without systemic involvement, and follow-up therapy for severe anthrax
• Recommended as an alternative IV drug for the treatment of systemic anthrax
• Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic anthrax when meningitis has been excluded, follow-up therapy for severe anthrax, or cutaneous anthrax without systemic involvement
• Recommended for use with a protein synthesis inhibitor when used for systemic anthrax (including follow-up); the addition of a bactericidal antimicrobial (beta-lactam or glycopeptide) is recommended with possible/confirmed meningitis.
• Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Plague

6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours

• Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of therapy: 10 to 14 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to Y pestis.
• Efficacy studies not conducted in humans with plague for ethical and feasibility reasons; approval based on efficacy study in animals.
• The tablet formulation is recommended for patients weighing at least 30 kg; alternative formulations may be considered for patients weighing less than 30 kg.

Uses: For treatment of plague (including pneumonic and septicemic plague) due to Y pestis and prophylaxis for plague

Usual Pediatric Dose for Plague Prophylaxis

6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours

• Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of therapy: 10 to 14 days

Comments:

• Drug administration should begin as soon as possible after suspected/confirmed exposure to Y pestis.
• Efficacy studies not conducted in humans with plague for ethical and feasibility reasons; approval based on efficacy study in animals.
• The tablet formulation is recommended for patients weighing at least 30 kg; alternative formulations may be considered for patients weighing less than 30 kg.

Uses: For treatment of plague (including pneumonic and septicemic plague) due to Y pestis and prophylaxis for plague

Renal Dose Adjustments

Adult Patients:
When dosage in patients with CrCl at least 50 mL/min is 750 mg every 24 hours:

• CrCl 20 to 49 mL/min: 750 mg orally or IV every 48 hours
• CrCl 10 to 19 mL/min: 750 mg orally or IV once, followed by 500 mg orally or IV every 48 hours

When dosage in patients with CrCl at least 50 mL/min is 500 mg every 24 hours:

• CrCl 20 to 49 mL/min: 500 mg orally or IV once, followed by 250 mg orally or IV every 24 hours
• CrCl 10 to 19 mL/min: 500 mg orally or IV once, followed by 250 mg orally or IV every 48 hours

When dosage in patients with CrCl at least 50 mL/min is 250 mg every 24 hours:

• CrCl 20 to 49 mL/min: No adjustment recommended.
• CrCl 10 to 19 mL/min: 250 mg orally or IV every 48 hours; no adjustment recommended if treating uncomplicated UTI

US CDC, IDSA, and ATS Recommendations for Tuberculosis:

• CrCl less than 30 mL/min: 750 to 1000 mg orally or IV 3 times a week

Pediatric Patients: Data not available

Comments:

• This drug should be used with caution in patients with renal dysfunction; careful clinical observation and appropriate laboratory tests recommended before and during therapy.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:
SERIOUS SIDE EFFECTS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CNS EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS:

• Fluoroquinolones (including this drug) have been associated with disabling and potentially irreversible serious side effects that have occurred together (including tendinitis and tendon rupture, peripheral neuropathy, CNS effects). This drug should be discontinued immediately and use of fluoroquinolones (including this drug) should be avoided in patients with any of these serious side effects.
• Fluoroquinolones (including this drug) may exacerbate muscle weakness in patients with myasthenia gravis. This drug should be avoided in patients with known history of myasthenia gravis.
• Since fluoroquinolones (including this drug) have been associated with serious side effects, this drug should be reserved for use in patients with no alternative treatment options for uncomplicated urinary tract infection, acute bacterial exacerbation of chronic bronchitis, or acute bacterial sinusitis.

CONTRAINDICATIONS:
Known hypersensitivity to the active component, other quinolones, or any of the ingredients

Safety and efficacy have not been established in patients younger than 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Adult Patients:
Hemodialysis or CAPD:

• When dosage in patients with CrCl at least 50 mL/min is 750 mg every 24 hours: 750 mg orally or IV once, followed by 500 mg orally or IV every 48 hours
• When dosage in patients with CrCl at least 50 mL/min is 500 mg every 24 hours: 500 mg orally or IV once, followed by 250 mg orally or IV every 48 hours
• When dosage in patients with CrCl at least 50 mL/min is 250 mg every 24 hours: Data not available

US CDC, IDSA, and ATS Recommendations for Tuberculosis:

• Hemodialysis: 750 to 1000 mg orally or IV 3 times a week
• Peritoneal dialysis: Data not available

For continuous renal replacement therapy (CRRT), some experts recommend: 250 mg every 24 hours

Pediatric Patients: Data not available

Comments:

• This drug should be used with caution in patients with renal dysfunction; careful clinical observation and appropriate laboratory tests recommended before and during therapy.
• Supplemental doses are not required after hemodialysis or CAPD.
• Some experts recommend administering this drug after hemodialysis on hemodialysis days.
• Clearance may be significantly increased with CRRT; to ensure doses are adequate, close monitoring recommended.

Other Comments

Administration advice:

• Administer the injection only by IV infusion; not for IM, intrathecal, intraperitoneal, or subcutaneous administration.
• Infuse 250 and 500 mg IV doses over at least 60 minutes and 750 mg doses over at least 90 minutes; avoid rapid or bolus IV infusion (associated with hypotension).
• Do not use injection in flexible containers in series connections.
• If the same IV line is used for sequential infusion of several drugs, flush the line before and after infusion of this drug with an infusion solution compatible to all drugs.
• May switch from IV to oral therapy when clinically indicated at the physician's discretion; no dose adjustment needed.
• May administer the tablets without regard to meals; administer the oral solution 1 hour before or 2 hours after eating.
• Administer the tablets and the oral solution at the same time each day.
• Maintain adequate hydration of patients to prevent formation of highly concentrated urine.
• Administer oral doses at least 2 hours before or 2 hours after iron-, zinc-, aluminum-, or magnesium-containing products (e.g., antacids, sucralfate, mineral supplements/multivitamins, buffered didanosine).
• Consult the manufacturer product information regarding missed doses.

Storage requirements:

• IV Injection (premixed solution in flexible container): Store at or below 25C (77F); brief exposure up to 40C (104F) does not harm product; avoid excessive heat; protect from freezing and light.
• IV Injection (vials): Store at controlled room temperature; protect from light.
• Oral Solution: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
• Tablets: Store at 15C to 30C (59F to 86F); close bottle well.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

IV compatibility:

• Limited data regarding compatibility with other IV products; additives or other drugs should not be added to this drug or infused concurrently through the same IV line.

General:

• This drug is indicated for the treatment of adults with mild, moderate, and severe infections due to susceptible isolates of the designated bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
• Appropriate culture and susceptibility testing recommended before therapy to isolate and identify infecting organisms and to establish susceptibility to this drug. Therapy may be started before test results are known; appropriate therapy should be continued when results are available.
• Some isolates of P aeruginosa may develop resistance relatively quickly during therapy.
• IV injection recommended when route is beneficial to patient (e.g., oral dosing is not tolerated).

Monitoring:

• Infections/Infestations: Culture and susceptibility (periodically during therapy)
• Metabolic: Blood glucose in diabetics

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Drink plenty of fluids.
• Avoid missing doses and complete the entire course of therapy.
• Stop this drug immediately and contact healthcare provider if a serious side effect occurs.
• Seek emergency medical care if you have sudden pain in the stomach, chest, or back.
• Stop this drug and contact healthcare provider if tendon pain, swelling, or inflammation develops or you have weakness or are unable to use 1 of your joints; rest and do not exercise. If your child has any joint-related problems during or after therapy, contact your child's physician.
• Stop this drug at once and contact physician if symptoms of peripheral neuropathy develop.
• Contact physician if persistent headache (with or without blurred vision), any symptoms of muscle weakness (including respiratory problems) or QT interval prolongation (including prolonged heart palpitations, loss of consciousness), signs/symptoms of liver injury, or watery and bloody stools occur.
• Stop this drug at first sign of skin rash, hives or other skin reactions, rapid heartbeat, problems swallowing or breathing, swelling suggestive of angioedema, or other symptoms of allergic reaction.
• Do not drive, operate machinery, or engage in other tasks that require mental alertness or coordination until you know how the drug affects you.
• Avoid or minimize exposure to natural or artificial sunlight; use sun protection (e.g., protective clothing, sunscreen) if sun exposure cannot be avoided. Contact physician if sunburn-like reaction or skin eruption develops.
• For lactating women: You may pump and discard breast milk during therapy and for 2 days after the last dose; do not breastfeed during therapy and for 2 days after the last dose.

Frequently asked questions

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