Usual Adult Dose for Pneumonia

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

Comments:

• Multi-drug resistant Streptococcus 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 due to susceptible isolates of S pneumoniae (including MDRSP), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae

Usual Adult Dose for Skin or Soft Tissue Infection

400 mg orally or IV every 24 hours

Duration of therapy:

• Complicated infections: 7 to 21 days
• Uncomplicated infections: 7 days

Uses: For the treatment of complicated skin and skin structure infections due to susceptible isolates of methicillin-susceptible S aureus, Escherichia coli, K pneumoniae, or Enterobacter cloacae; for the treatment of uncomplicated skin and skin structure infections due to susceptible isolates of methicillin-susceptible S aureus or S pyogenes

Usual Adult Dose for Skin and Structure Infection

400 mg orally or IV every 24 hours

Duration of therapy:

• Complicated infections: 7 to 21 days
• Uncomplicated infections: 7 days

Uses: For the treatment of complicated skin and skin structure infections due to susceptible isolates of methicillin-susceptible S aureus, Escherichia coli, K pneumoniae, or Enterobacter cloacae; for the treatment of uncomplicated skin and skin structure infections due to susceptible isolates of methicillin-susceptible S aureus or S pyogenes

Usual Adult Dose for Intraabdominal Infection

400 mg orally or IV every 24 hours for 5 to 14 days

Use: For the treatment of complicated intraabdominal infections including polymicrobial infections (such as abscess) due to susceptible isolates of E coli, Bacteroides fragilis, S anginosus, S constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, B thetaiotaomicron, or Peptostreptococcus species

Usual Adult Dose for Plague

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

Comments:

• Therapy should be started as soon as possible after suspected/confirmed exposure to Yersinia pestis.
• Efficacy studies not conducted in humans with plague for ethical and feasibility reasons; indication based on efficacy study in animals only.

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

Usual Adult Dose for Plague Prophylaxis

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

Comments:

• Therapy should be started as soon as possible after suspected/confirmed exposure to Yersinia pestis.
• Efficacy studies not conducted in humans with plague for ethical and feasibility reasons; indication based on efficacy study in animals only.

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

Usual Adult Dose for Sinusitis

400 mg orally or IV every 24 hours for 10 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 susceptible isolates of S pneumoniae, H influenzae, or M catarrhalis

Usual Adult Dose for Bronchitis

400 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 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 susceptible isolates of S pneumoniae, H influenzae, H parainfluenzae, K pneumoniae, methicillin-susceptible S aureus, or M catarrhalis

Usual Adult Dose for Inhalation Bacillus anthracis

US CDC recommendations: 400 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: At least 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, injection, and 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

US CDC recommendations: 400 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: At least 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, injection, and 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

US CDC recommendations: 400 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: At least 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, injection, and 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 Tuberculosis - Active

US CDC, Infectious Diseases Society of America (IDSA), and American Thoracic Society recommendations: 400 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 Surgical Prophylaxis

American Society of Health-System Pharmacists (ASHP), IDSA, Surgical Infection Society (SIS), and Society for Healthcare Epidemiology of America (SHEA) recommendations:

• Preoperative dose: 400 mg orally or IV once, starting within 120 minutes before surgical incision

Comments:

• Recommended as part of an alternative regimen for surgical prophylaxis for hysterectomy (vaginal or abdominal); coadministration with other agents is recommended.
• A single prophylactic dose is usually sufficient; if prophylaxis is continued postoperatively, duration should be less than 24 hours.
• Before use, local susceptibility should be reviewed due to increasing resistance of E coli to fluoroquinolones.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Inhalation Bacillus anthracis

American Academy of Pediatrics recommendations:
Up to 4 weeks of age:

• Gestational age 32 to 37 weeks: 5 mg/kg IV every 24 hours
• Term neonate: 10 mg/kg IV every 24 hours

3 months to 11 years:

• For 3 months to less than 2 years: 6 mg/kg IV every 12 hours
• For 2 to 5 years: 5 mg/kg IV every 12 hours
• For 6 to 11 years: 4 mg/kg IV every 12 hours

Maximum dose: 200 mg/dose

12 years or older:
Less than 45 kg: 4 mg/kg IV every 12 hours

• Maximum dose: 200 mg/dose

At least 45 kg: 400 mg IV once a day

Duration of Therapy: At least 2 to 3 weeks, continuing until patient is clinically stable

• Patients will require prophylaxis with a different agent to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:

• Dosing for neonates provided only as guidance during emergency biological weapon event (based on available text or pharmacokinetic data extrapolated from older children).
• Recommended as an alternative IV drug for the treatment of systemic/severe anthrax (anthrax meningitis or disseminated infection and meningitis cannot be excluded)
• Recommended for use with a protein synthesis inhibitor plus (a bactericidal beta-lactam [all applicable patients] or a bactericidal glycopeptide [patients 3 months or older])
• Systemic/severe anthrax includes anthrax meningitis; inhalation anthrax; or injection, gastrointestinal, 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

American Academy of Pediatrics recommendations:
Up to 4 weeks of age:

• Gestational age 32 to 37 weeks: 5 mg/kg IV every 24 hours
• Term neonate: 10 mg/kg IV every 24 hours

3 months to 11 years:

• For 3 months to less than 2 years: 6 mg/kg IV every 12 hours
• For 2 to 5 years: 5 mg/kg IV every 12 hours
• For 6 to 11 years: 4 mg/kg IV every 12 hours

Maximum dose: 200 mg/dose

12 years or older:
Less than 45 kg: 4 mg/kg IV every 12 hours

• Maximum dose: 200 mg/dose

At least 45 kg: 400 mg IV once a day

Duration of Therapy: At least 2 to 3 weeks, continuing until patient is clinically stable

• Patients will require prophylaxis with a different agent to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:

• Dosing for neonates provided only as guidance during emergency biological weapon event (based on available text or pharmacokinetic data extrapolated from older children).
• Recommended as an alternative IV drug for the treatment of systemic/severe anthrax (anthrax meningitis or disseminated infection and meningitis cannot be excluded)
• Recommended for use with a protein synthesis inhibitor plus (a bactericidal beta-lactam [all applicable patients] or a bactericidal glycopeptide [patients 3 months or older])
• Systemic/severe anthrax includes anthrax meningitis; inhalation anthrax; or injection, gastrointestinal, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended; caution recommended.

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 acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis.

CONTRAINDICATIONS:
History of hypersensitivity to the active component or any quinolone class antibacterial agent

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis and CAPD: No adjustment recommended.

Other Comments

Administration advice:

• Administer via IV infusion only; do not administer via IM, intraarterial, intrathecal, intraperitoneal, or subcutaneous injection.
• Administer IV doses over at least 60 minutes by direct infusion or through Y-type IV infusion set; avoid rapid or bolus IV infusion.
• Do not administer IV solution if particulate matter and/or discoloration observed.
• May administer oral doses without regard to meals
• May switch from IV to oral therapy when clinically indicated at the physician's discretion; no dose adjustment needed.
• If same IV line or Y-type line used for sequential infusion of other drugs, or if "piggyback" method is used, flush the line before and after infusion of this drug with an infusion solution compatible to all drugs administered via the common line.
• Administer oral doses at least 4 hours before or 8 hours after iron-, zinc-, aluminum-, or magnesium-containing products (e.g., antacids, sucralfate, mineral supplements/multivitamins, buffered didanosine).

Storage requirements:

• Store at 20C to 25C (68C to 77F), excursions permitted to 15C to 30C (59F to 86F).
• IV solution: Do not refrigerate (product will precipitate).
• Oral tablets: Avoid high humidity.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

IV compatibility:

• Compatible IV solutions (at ratios from 1:10 to 10:1): Sterile Water for Injection, USP; 0.9% Sodium Chloride Injection, USP; 1 Molar Sodium Chloride Injection; 10% Dextrose for Injection, USP; 5% Dextrose Injection, USP; Lactated Ringers for Injection
• 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:

• 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.
• IV solution recommended when route is beneficial to patient (e.g., oral dosing is not tolerated).
• The Avelox(R) Injection and Moxifloxacin Injection contain about 34.2 and 52.5 mEq (787 and 1207 mg) of sodium in 250 mL, respectively.

Monitoring:

• Cardiovascular: ECG in patients with liver cirrhosis
• Metabolic: Blood glucose in diabetic patients

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 medical attention immediately in an emergency room or call 911 if sudden, severe, constant pain in the stomach, chest, or back occurs.
• 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.
• 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 during therapy; use sun protection (e.g., protective clothing, sunscreen) if sun exposure cannot be avoided. Contact physician if sunburn-like reaction or skin eruption develops.