Usual Adult Dose for Bronchitis

400 mg orally every 12 hours for 10 days

Comments:

• Since fluoroquinolones (including this drug) have been associated with serious side effects and acute bacterial exacerbations 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 Haemophilus influenzae or Streptococcus pneumoniae

Usual Adult Dose for Pneumonia

400 mg orally every 12 hours for 10 days

Uses: For the treatment of community-acquired pneumonia due to H influenzae or S pneumoniae; for the treatment of uncomplicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, S pyogenes, or Proteus mirabilis

Usual Adult Dose for Skin and Structure Infection

400 mg orally every 12 hours for 10 days

Uses: For the treatment of community-acquired pneumonia due to H influenzae or S pneumoniae; for the treatment of uncomplicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, S pyogenes, or Proteus mirabilis

Usual Adult Dose for Gonococcal Infection - Uncomplicated

400 mg orally once

Uses: For the treatment of acute, uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae

US CDC recommendations:

• Due to high rates of resistance, fluoroquinolones are not recommended for treatment of gonococcal infections in the US; dual therapy with ceftriaxone and azithromycin is the recommended regimen for treatment of gonorrhea in the US.
• Antimicrobial susceptibility patterns should be monitored.
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Nongonococcal Urethritis

300 mg orally every 12 hours for 7 days

Uses: For the treatment of nongonococcal cervicitis and urethritis due to Chlamydia trachomatis; for the treatment of mixed infection of the cervix and urethra due to C trachomatis and N gonorrhoeae

US CDC recommendations: 300 mg orally twice a day for 7 days

Comments:

• Recommended as an alternative regimen for nongonococcal urethritis and for chlamydial infection
• Due to high rates of resistance, fluoroquinolones are not recommended for treatment of gonococcal infections in the US; dual therapy with ceftriaxone and azithromycin is the recommended regimen for treatment of gonorrhea in the US.
• Antimicrobial susceptibility patterns should be monitored.
• 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

300 mg orally every 12 hours for 7 days

Uses: For the treatment of nongonococcal cervicitis and urethritis due to Chlamydia trachomatis; for the treatment of mixed infection of the cervix and urethra due to C trachomatis and N gonorrhoeae

US CDC recommendations: 300 mg orally twice a day for 7 days

Comments:

• Recommended as an alternative regimen for nongonococcal urethritis and for chlamydial infection
• Due to high rates of resistance, fluoroquinolones are not recommended for treatment of gonococcal infections in the US; dual therapy with ceftriaxone and azithromycin is the recommended regimen for treatment of gonorrhea in the US.
• Antimicrobial susceptibility patterns should be monitored.
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Cervicitis

300 mg orally every 12 hours for 7 days

Uses: For the treatment of nongonococcal cervicitis and urethritis due to Chlamydia trachomatis; for the treatment of mixed infection of the cervix and urethra due to C trachomatis and N gonorrhoeae

US CDC recommendations: 300 mg orally twice a day for 7 days

Comments:

• Recommended as an alternative regimen for nongonococcal urethritis and for chlamydial infection
• Due to high rates of resistance, fluoroquinolones are not recommended for treatment of gonococcal infections in the US; dual therapy with ceftriaxone and azithromycin is the recommended regimen for treatment of gonorrhea in the US.
• Antimicrobial susceptibility patterns should be monitored.
• 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

400 mg orally every 12 hours for 10 to 14 days

Comments:

• If suspect infecting pathogens include anaerobic microorganisms, appropriate treatment for anaerobic pathogens should be used.

Use: For the treatment of acute pelvic inflammatory disease (including severe infection) due to C trachomatis and/or N gonorrhoeae

US CDC recommendations: 400 mg orally twice 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 N 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 Cystitis

200 mg orally every 12 hours

Duration of therapy:

• For infections due to Escherichia coli or Klebsiella pneumoniae: 3 days
• For infections due to other organisms: 7 days

Comments:

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

Use: For the treatment of uncomplicated cystitis due to Citrobacter diversus, Enterobacter aerogenes, E coli, K pneumoniae, P mirabilis, or Pseudomonas aeruginosa

Usual Adult Dose for Urinary Tract Infection

200 mg orally every 12 hours for 10 days

Use: For the treatment of complicated urinary tract infections due to E coli, K pneumoniae, P mirabilis, C diversus, or P aeruginosa

Usual Adult Dose for Prostatitis

300 mg orally every 12 hours for 6 weeks

Use: For the treatment of prostatitis due to E coli

Usual Adult Dose for Epididymitis - Non-Specific

US CDC recommendations: 300 mg orally twice 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 Adult Dose for Epididymitis - Sexually Transmitted

US CDC recommendations: 300 mg orally twice 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 Adult Dose for Pyelonephritis

Some experts recommend: 200 to 400 mg orally every 12 hours for 7 to 14 days

Comments:

• Recommended as empiric therapy in uncomplicated acute pyelonephritis
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Shigellosis

Infectious Diseases Society of America (IDSA) recommendations: 300 mg orally twice a day

Duration of Therapy:

• Immunocompetent patients: 3 days
• Immunocompromised patients: 7 to 10 days (Shigella species); 3 days (other listed pathogens)

Comments:

• Recommended for Shigella species, E coli species (enterotoxigenic, enteropathogenic, enteroinvasive), Aeromonas, Plesiomonas
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Infectious Diarrhea

Infectious Diseases Society of America (IDSA) recommendations: 300 mg orally twice a day

Duration of Therapy:

• Immunocompetent patients: 3 days
• Immunocompromised patients: 7 to 10 days (Shigella species); 3 days (other listed pathogens)

Comments:

• Recommended for Shigella species, E coli species (enterotoxigenic, enteropathogenic, enteroinvasive), Aeromonas, Plesiomonas
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Salmonella Enteric Fever

IDSA recommendations: 300 mg orally twice a day

Duration of Therapy:

• Immunocompetent patients: 5 to 7 days
• Immunocompromised patients: 14 days (or longer if relapsing)

Comments:

• Recommended for non-typhi species of Salmonella if severe, patient is older than 50 years, or patient has prostheses, valvular heart disease, severe atherosclerosis, malignancy, or uremia
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Salmonella Gastroenteritis

IDSA recommendations: 300 mg orally twice a day

Duration of Therapy:

• Immunocompetent patients: 5 to 7 days
• Immunocompromised patients: 14 days (or longer if relapsing)

Comments:

• Recommended for non-typhi species of Salmonella if severe, patient is older than 50 years, or patient has prostheses, valvular heart disease, severe atherosclerosis, malignancy, or uremia
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Traveler's Diarrhea

IDSA recommendations: 200 mg orally twice a day
Duration of therapy: 24 hours to 3 days

Comments:

• Travelers should be provided with 3 days of treatment and should be advised to reevaluate themselves 24 hours after starting therapy; if not completely well at 24 hours, patients should be advised to continue therapy until well or until they have completed the 3-day regimen.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

CrCl 20 to 50 mL/min: After a normal initial dose, the usual recommended dose every 24 hours
CrCl less than 20 mL/min: After a normal initial dose, one-half the usual recommended dose every 24 hours

Comments:

• This drug should be used with caution in patients with renal dysfunction.
• Careful clinical monitoring and appropriate laboratory studies recommended before and during therapy.

Liver Dose Adjustments

Severe liver dysfunction (e.g., cirrhosis with or without ascites): Maximum dose should not exceed 400 mg/day.

Comments:

• This drug should be used with caution in patients with liver dysfunction.
• Careful clinical monitoring and appropriate laboratory studies recommended before and during therapy.

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 exacerbation of chronic bronchitis or uncomplicated cystitis.

CONTRAINDICATIONS:
History of hypersensitivity to the active component or other quinolones

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

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• According to some experts, since this drug is slightly removed during hemodialysis, the dose should be administered after dialysis.
• According to some experts, clearance may be significantly increased in patients undergoing continuous renal replacement therapy (CRRT); the dose should be individualized and based on calculated drug clearance during CRRT.

Other Comments

Administration advice:

• May administer without regard to food
• Administer this drug at least 2 hours before or 2 hours after iron-, zinc-, calcium-, aluminum-, or magnesium-containing products (e.g., antacids, sucralfate, mineral supplements/multivitamins, buffered didanosine).
• Maintain adequate hydration of patients to prevent formation of highly-concentrated urine.

Storage requirements:

• Store at 20C to 25C (68F to 77F) in well-closed container.

General:

• This drug is indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) due to susceptible strains 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 strains of P aeruginosa may develop resistance relatively quickly during therapy.

Monitoring:

• Hematologic: Organ system functions, including hematopoietic (periodically during prolonged therapy)
• Hepatic: Organ system functions, including hepatic (periodically during prolonged therapy)
• Infections/Infestations: Culture and susceptibility (periodically during therapy)
• Metabolic: Blood glucose in diabetics
• Renal: Organ system functions, including renal (periodically during prolonged therapy)

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 immediately if any muscle weakness worsens or respiratory problems develop or if watery and bloody stools occur; contact physician if persistent headache (with or without blurred vision) or signs/symptoms of liver injury occur.
• Stop this drug immediately at first sign of rash or other symptoms of allergic reaction.
• 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.
• Do not drive, operate machinery, or engage in other tasks that require mental alertness or coordination until you know how the drug affects you.