Ciprofloxacin Dosage

Drug Detail:Cipro i.v. (injection) (Ciprofloxacin (injection) [ sip-roe-flox-a-sin ])

Drug Class: Quinolones and fluoroquinolones

Usual Adult Dose for Inhalation Bacillus anthracis

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 60 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure.
Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized Bacillus anthracis

US CDC Recommendations:

IV: 400 mg IV every 8 hours
Oral: 500 mg orally every 12 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:

The preferred drug for pregnant women
Recommended as a preferred oral drug for postexposure prophylaxis and for the treatment of cutaneous anthrax without systemic involvement
Recommended as the preferred 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, 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

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 60 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure.
Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized Bacillus anthracis

US CDC Recommendations:

IV: 400 mg IV every 8 hours
Oral: 500 mg orally every 12 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:

The preferred drug for pregnant women
Recommended as a preferred oral drug for postexposure prophylaxis and for the treatment of cutaneous anthrax without systemic involvement
Recommended as the preferred 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, 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

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 60 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure.
Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized Bacillus anthracis

US CDC Recommendations:

IV: 400 mg IV every 8 hours
Oral: 500 mg orally every 12 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:

The preferred drug for pregnant women
Recommended as a preferred oral drug for postexposure prophylaxis and for the treatment of cutaneous anthrax without systemic involvement
Recommended as the preferred 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, 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 Febrile Neutropenia

Empirical therapy: 400 mg IV every 8 hours for 7 to 14 days

Comments:

Recommended for use with piperacillin (50 mg/kg IV every 4 hours)

Use: In combination with piperacillin, for the treatment of febrile neutropenia

Usual Adult Dose for Intraabdominal Infection

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

Use: In combination with metronidazole, for treatment of complicated intraabdominal infections due to Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis

Usual Adult Dose for Joint Infection

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 4 to 8 weeks

Uses: For treatment of bone and joint infections due to Enterobacter cloacae, Serratia marcescens, or P aeruginosa

Usual Adult Dose for Osteomyelitis

Usual Adult Dose for Plague

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 14 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure.
Indication based on efficacy study in animals only.

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

US CDC Recommendations:
Treatment:

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally twice a day

Duration of Therapy: 10 to 14 days, or until 2 days after fever subsides

Postexposure Prophylaxis: 500 mg orally twice a day for 7 days

Comments:

Appropriate IV therapy should be started as soon as plague is suspected; may switch to oral therapy once patient improves
Fluoroquinolones and gentamicin are generally first-line treatments in the US.
Postexposure prophylaxis is recommended for individuals with known exposure to plague (e.g., close contact with pneumonic plague patient, direct contact with infected body fluids/tissues).
In pregnant women, IV ciprofloxacin is a preferred agent for treatment and oral ciprofloxacin is a preferred agent for postexposure prophylaxis; postexposure prophylaxis is only recommended when benefits outweigh risks.
Current guidelines should be consulted for additional information.

Usual Adult Dose for Plague Prophylaxis

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 14 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure.
Indication based on efficacy study in animals only.

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

US CDC Recommendations:
Treatment:

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally twice a day

Duration of Therapy: 10 to 14 days, or until 2 days after fever subsides

Postexposure Prophylaxis: 500 mg orally twice a day for 7 days

Comments:

Appropriate IV therapy should be started as soon as plague is suspected; may switch to oral therapy once patient improves
Fluoroquinolones and gentamicin are generally first-line treatments in the US.
Postexposure prophylaxis is recommended for individuals with known exposure to plague (e.g., close contact with pneumonic plague patient, direct contact with infected body fluids/tissues).
In pregnant women, IV ciprofloxacin is a preferred agent for treatment and oral ciprofloxacin is a preferred agent for postexposure prophylaxis; postexposure prophylaxis is only recommended when benefits outweigh risks.
Current guidelines should be consulted for additional information.

Usual Adult Dose for Nosocomial Pneumonia

400 mg IV every 8 hours for 10 to 14 days

Comments:

Initial empiric treatment with broad-spectrum coverage according to the hospital's and/or ICU's antibiogram is recommended if multidrug-resistant organisms are suspected.

Use: For treatment of nosocomial pneumonia due to Haemophilus influenzae or K pneumoniae

Usual Adult Dose for Pneumonia

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

Comments:

This drug is not considered the drug of first choice for the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.
Since fluoroquinolones (including this drug) have been associated with serious side effects and acute exacerbations of chronic bronchitis (AECB) is self-limiting for some patients, this drug should be saved for treatment of AECB in patients with no alternative treatment options.

Uses: For treatment of lower respiratory tract infections due to E coli, K pneumoniae, E cloacae, P mirabilis, P aeruginosa, H influenzae, H parainfluenzae, or S pneumoniae; for the treatment of AECB due to Moraxella catarrhalis

Usual Adult Dose for Bronchitis

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

Comments:

This drug is not considered the drug of first choice for the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.
Since fluoroquinolones (including this drug) have been associated with serious side effects and acute exacerbations of chronic bronchitis (AECB) is self-limiting for some patients, this drug should be saved for treatment of AECB in patients with no alternative treatment options.

Usual Adult Dose for Skin or Soft Tissue Infection

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

Use: For treatment of skin and skin structure infections due to E coli, K pneumoniae, E cloacae, P mirabilis, P vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, P aeruginosa, Staphylococcus aureus (methicillin-susceptible), S epidermidis (methicillin-susceptible), or S pyogenes

Infectious Diseases Society of America (IDSA) Recommendations:
Incisional surgical site infection:

IV: 400 mg IV every 12 hour
Oral: 750 mg orally every 12 hours

Aeromonas hydrophila necrotizing infection: 400 mg IV every 12 hours

Infection after animal bite:

IV: 400 mg IV every 12 hour
Oral: 500 to 750 mg orally every 12 hours

Comments:

Recommended for use with metronidazole as a combination regimen for treatment of incisional surgical site infections after intestinal or genitourinary tract surgery
Recommended for use with metronidazole for treatment of incisional surgical site infections after surgery of axilla or perineum; coverage for methicillin-resistant S aureus (MRSA) may be needed.
In combination with doxycycline, recommended as a preferred IV drug for the treatment of A hydrophila necrotizing infections of the skin, fascia, and muscle
For animal bites, fluoroquinolones have good activity against Pasteurella multocida but do not provide coverage for MRSA and some anaerobes.
Current guidelines should be consulted for additional information.

Some Experts Recommend:

Vibrio vulnificus: 400 mg IV every 12 hours

Comments:

Recommended for use with ceftazidime (1 to 2 g IV every 8 hours) or cefotaxime (2 g IV every 8 hours)

Usual Adult Dose for Skin and Structure Infection

IV: 400 mg IV every 12 hour
Oral: 750 mg orally every 12 hours

Aeromonas hydrophila necrotizing infection: 400 mg IV every 12 hours

Infection after animal bite:

IV: 400 mg IV every 12 hour
Oral: 500 to 750 mg orally every 12 hours

Comments:

Recommended for use with metronidazole as a combination regimen for treatment of incisional surgical site infections after intestinal or genitourinary tract surgery
Recommended for use with metronidazole for treatment of incisional surgical site infections after surgery of axilla or perineum; coverage for methicillin-resistant S aureus (MRSA) may be needed.
In combination with doxycycline, recommended as a preferred IV drug for the treatment of A hydrophila necrotizing infections of the skin, fascia, and muscle
For animal bites, fluoroquinolones have good activity against Pasteurella multocida but do not provide coverage for MRSA and some anaerobes.
Current guidelines should be consulted for additional information.

Some Experts Recommend:

Vibrio vulnificus: 400 mg IV every 12 hours

Comments:

Recommended for use with ceftazidime (1 to 2 g IV every 8 hours) or cefotaxime (2 g IV every 8 hours)

Usual Adult Dose for Shigellosis

500 mg orally every 12 hours for 5 to 7 days

Use: When antibacterial therapy is indicated, for treatment of infectious diarrhea due to E coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii, S dysenteriae, S flexneri, or S sonnei

US CDC, National Institutes of Health (NIH), and HIV Medicine Association of the Infectious Diseases Society of America (HIVMA/IDSA) Recommendations for HIV-Infected Patients:
Shigellosis therapy:

IV: 400 mg IV every 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy:

Bacteremia: At least 14 days
Gastroenteritis: 7 to 10 days
Recurrent infections: 2 to 6 weeks

Comments:

Recommended as preferred therapy (if MIC is less than 0.12 mcg/mL) to shorten duration of illness and to possibly prevent spread to others
Increased resistance of Shigella to fluoroquinolones reported in the US; treatment of Shigella with fluoroquinolones should be avoided if ciprofloxacin MIC is 0.12 mcg/mL or greater, even if isolate identified as sensitive by laboratory.
Current guidelines should be consulted for additional information.

Usual Adult Dose for Infectious Diarrhea

IV: 400 mg IV every 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy:

Bacteremia: At least 14 days
Gastroenteritis: 7 to 10 days
Recurrent infections: 2 to 6 weeks

Comments:

Recommended as preferred therapy (if MIC is less than 0.12 mcg/mL) to shorten duration of illness and to possibly prevent spread to others
Increased resistance of Shigella to fluoroquinolones reported in the US; treatment of Shigella with fluoroquinolones should be avoided if ciprofloxacin MIC is 0.12 mcg/mL or greater, even if isolate identified as sensitive by laboratory.
Current guidelines should be consulted for additional information.

Usual Adult Dose for Sinusitis

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 10 days

Comments:

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

Use: For treatment of acute sinusitis due to H influenzae, S pneumoniae, or M catarrhalis

Usual Adult Dose for Salmonella Enteric Fever

500 mg orally every 12 hours for 10 days

Comments:

Efficacy in eradicating the chronic typhoid carrier state has not been established.

Use: For treatment of typhoid fever (enteric fever) due to Salmonella typhi

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:

IV: 400 mg IV every 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:

If CD4 count at least 200 cells/mm3: 7 to 14 days
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

For gastroenteritis with bacteremia:

If CD4 count at least 200 cells/mm3: 14 days; longer if persistent bacteremia or complicated infection (e.g., metastatic foci of infection present)
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

Comments:

Recommended as preferred empiric therapy for bacterial enteric infections (pending diagnostic studies) and as preferred therapy for salmonella gastroenteritis with or without bacteremia
Empiric therapy for bacterial enteric infections recommended for patients with advanced HIV (CD4 count less than 200 cells/mm3 or concomitant AIDS-defining illnesses) and clinically severe diarrhea (at least 6 liquid stools/day or bloody stool and/or associated fever/chills). Fecal samples should be obtained for diagnostic testing before starting therapy; therapy should be adjusted based on those results.
All HIV-infected patients with salmonellosis should receive antibiotic therapy; increased risk of bacteremia (by 20- to 100-fold) and mortality (by up to 7-fold) compared to HIV-negative subjects.
Current guidelines should be consulted for additional information.

Usual Adult Dose for Salmonella Gastroenteritis

500 mg orally every 12 hours for 10 days

Comments:

Efficacy in eradicating the chronic typhoid carrier state has not been established.

Use: For treatment of typhoid fever (enteric fever) due to Salmonella typhi

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:

IV: 400 mg IV every 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:

If CD4 count at least 200 cells/mm3: 7 to 14 days
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

For gastroenteritis with bacteremia:

If CD4 count at least 200 cells/mm3: 14 days; longer if persistent bacteremia or complicated infection (e.g., metastatic foci of infection present)
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

Comments:

Recommended as preferred empiric therapy for bacterial enteric infections (pending diagnostic studies) and as preferred therapy for salmonella gastroenteritis with or without bacteremia
Empiric therapy for bacterial enteric infections recommended for patients with advanced HIV (CD4 count less than 200 cells/mm3 or concomitant AIDS-defining illnesses) and clinically severe diarrhea (at least 6 liquid stools/day or bloody stool and/or associated fever/chills). Fecal samples should be obtained for diagnostic testing before starting therapy; therapy should be adjusted based on those results.
All HIV-infected patients with salmonellosis should receive antibiotic therapy; increased risk of bacteremia (by 20- to 100-fold) and mortality (by up to 7-fold) compared to HIV-negative subjects.
Current guidelines should be consulted for additional information.

Usual Adult Dose for Typhoid Fever

500 mg orally every 12 hours for 10 days

Comments:

Efficacy in eradicating the chronic typhoid carrier state has not been established.

Use: For treatment of typhoid fever (enteric fever) due to Salmonella typhi

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:

IV: 400 mg IV every 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:

If CD4 count at least 200 cells/mm3: 7 to 14 days
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

For gastroenteritis with bacteremia:

If CD4 count at least 200 cells/mm3: 14 days; longer if persistent bacteremia or complicated infection (e.g., metastatic foci of infection present)
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

Comments:

Recommended as preferred empiric therapy for bacterial enteric infections (pending diagnostic studies) and as preferred therapy for salmonella gastroenteritis with or without bacteremia
Empiric therapy for bacterial enteric infections recommended for patients with advanced HIV (CD4 count less than 200 cells/mm3 or concomitant AIDS-defining illnesses) and clinically severe diarrhea (at least 6 liquid stools/day or bloody stool and/or associated fever/chills). Fecal samples should be obtained for diagnostic testing before starting therapy; therapy should be adjusted based on those results.
All HIV-infected patients with salmonellosis should receive antibiotic therapy; increased risk of bacteremia (by 20- to 100-fold) and mortality (by up to 7-fold) compared to HIV-negative subjects.
Current guidelines should be consulted for additional information.

Usual Adult Dose for Urinary Tract Infection

IV: 200 to 400 mg IV every 8 to 12 hours for 7 to 14 days

Oral:
Immediate-release: 250 to 500 mg orally every 12 hours for 7 to 14 days

Extended-release:

Uncomplicated infection (Cipro[R] XR, Proquin[R] XR): 500 mg orally every 24 hours for 3 days
Complicated infection (Cipro[R] XR): 1000 mg orally every 24 hours for 7 to 14 days

Uses:

IV, Immediate-release: For treatment of urinary tract infections (UTIs) due to E coli, K pneumoniae, E cloacae, S marcescens, P mirabilis, P rettgeri, M morganii, C koseri, C freundii, P aeruginosa, S epidermidis (methicillin-susceptible), S saprophyticus, or Enterococcus faecalis
Cipro(R) XR: For the treatment of uncomplicated UTIs due to E coli, P mirabilis, E faecalis, or S saprophyticus; for the treatment of complicated UTIs due to E coli, K pneumoniae, E faecalis, P mirabilis, or P aeruginosa
Proquin(R) XR: For the treatment of uncomplicated UTIs due to E coli or K pneumoniae

Usual Adult Dose for Pyelonephritis

Cipro(R) XR: 1000 mg orally every 24 hours for 7 to 14 days

Use: For the treatment of acute uncomplicated pyelonephritis due to E coli

Usual Adult Dose for Cystitis

Immediate-release: 250 mg orally every 12 hours
Extended-release: 500 mg orally every 24 hours

Duration of Therapy: 3 days

Comments:

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

Uses:

Immediate-release: In female patients, for treatment of acute uncomplicated cystitis due to E coli or S saprophyticus
Cipro(R) XR: For the treatment of uncomplicated UTI (acute cystitis) due to E coli, P mirabilis, E faecalis, or S saprophyticus
Proquin(R) XR: For the treatment of uncomplicated UTI (acute cystitis) due to E coli or K pneumoniae

Usual Adult Dose for Prostatitis

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 28 days

Use: For treatment of chronic bacterial prostatitis due to E coli or P mirabilis

Usual Adult Dose for Gonococcal Infection - Uncomplicated

250 mg orally once

Uses: For treatment of 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 Meningococcal Meningitis Prophylaxis

US CDC Recommendations: 500 mg orally once

Usual Adult Dose for Tularemia

IDSA Recommendations:

Mild to moderate illness: 750 mg orally twice a day for at least 14 days

Working Group on Civilian Biodefense Recommendations for Management of Tularemia Used as a Biological Weapon:

IV: 400 mg IV twice a day for 10 days
Oral: 500 mg orally twice a day for 14 days

Comments:

May switch to oral therapy when clinically indicated
Recommended as an alternative IV drug for treatment of tularemia in a contained casualty setting; recommended as an alternative agent in pregnant women
Recommended as a preferred oral drug for treatment of tularemia in a mass casualty setting and for postexposure prophylaxis; recommended as a preferred agent in pregnant women
Current guidelines should be consulted for additional information.

Usual Adult Dose for Chancroid

US CDC Recommendations: 500 mg orally twice a day for 3 days

Comments:

Alternative therapy recommended during pregnancy and lactation.
The patient's sexual partner(s) should also be evaluated/treated.
Current guidelines should be consulted for additional information.

Usual Adult Dose for Granuloma Inguinale

US CDC Recommendations: 750 mg orally twice a day
Duration of Therapy: At least 3 weeks and until all lesions have completely healed

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 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 IV once, starting within 120 minutes before surgical incision

Comments:

A single prophylactic dose is usually sufficient; if prophylaxis is continued postoperatively, duration should be less than 24 hours.
Readministration may be needed for unusually long procedures to ensure adequate serum and tissue drug levels.
Redosing may be needed if drug half-life is shortened (e.g., extensive burns) or if prolonged/excessive bleeding during surgery; redosing may not be needed if drug half-life is prolonged (e.g., renal dysfunction).
Before use, local susceptibility should be reviewed due to increasing resistance of E coli to fluoroquinolones.
Coadministration with other agents may be recommended, depending on type of procedure.
Current guidelines should be consulted for additional information.

Uses: For surgical prophylaxis for the following procedures:

Gastroduodenal (as part of an alternative regimen): Procedures involving entry into lumen of gastrointestinal tract (bariatric, pancreaticoduodenectomy); Procedures without entry into gastrointestinal tract (antireflux, highly selective vagotomy) for high-risk patients
Biliary tract (as part of an alternative regimen): Open procedure; elective, high-risk laparoscopic procedure
Appendectomy (as part of an alternative regimen): Uncomplicated appendicitis
Small intestine (as part of an alternative regimen): Nonobstructed; obstructed
Colorectal (as part of an alternative regimen)
Hysterectomy (as part of an alternative regimen): Vaginal or abdominal
Urologic: Lower tract instrumentation with risk factors for infection, including transrectal prostate biopsy (recommended regimen); clean with entry into urinary tract or clean-contaminated (as part of an alternative regimen)
Transplantation (as part of an alternative regimen): Liver; pancreas; pancreas-kidney

Usual Pediatric Dose for Inhalation Bacillus anthracis

IV: 10 mg/kg IV every 12 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Recommended dose of the 5% oral suspension using the co-packaged graduated spoon:

Weight 9 to 12 kg: 125 mg orally every 12 hours
Weight 13 to 18 kg: 250 mg orally every 12 hours
Weight 19 to 24 kg: 250 to 375 mg orally every 12 hours
Weight at least 25 kg: 500 mg orally every 12 hours

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:

Weight 13 to 24 kg: 250 mg orally every 12 hours
Weight at least 25 kg: 500 mg orally every 12 hours

Total Duration of Therapy: 60 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure.
Indication based on efficacy studies in animals.

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

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

Gestational age 32 to 37 weeks: 10 mg/kg orally or IV every 12 hours
Term neonate: 15 mg/kg orally or IV every 12 hours

1 month or older:
IV: 10 mg/kg IV every 8 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection (all ages): 60 days after exposure

Systemic anthrax:

Severe anthrax (up to 4 weeks of age): At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
With possible/confirmed meningitis (1 month or older): At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
When meningitis has been excluded (1 month or older): 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 10 to 14 days or longer (up to 4 weeks of age) or to complete a regimen of 14 days or longer (1 month or older)

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

Comments:

Recommended as the preferred oral drug for postexposure prophylaxis and for the treatment of cutaneous anthrax without systemic involvement
Recommended as the preferred IV drug for the treatment of systemic/severe anthrax (including follow-up)
Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic/severe 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 beta-lactam (all patients) or a bactericidal glycopeptide (patients 1 month or older) is recommended with possible/confirmed meningitis.
Systemic/severe 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

Weight 9 to 12 kg: 125 mg orally every 12 hours
Weight 13 to 18 kg: 250 mg orally every 12 hours
Weight 19 to 24 kg: 250 to 375 mg orally every 12 hours
Weight at least 25 kg: 500 mg orally every 12 hours

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:

Weight 13 to 24 kg: 250 mg orally every 12 hours
Weight at least 25 kg: 500 mg orally every 12 hours

Total Duration of Therapy: 60 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure.
Indication based on efficacy studies in animals.

Gestational age 32 to 37 weeks: 10 mg/kg orally or IV every 12 hours
Term neonate: 15 mg/kg orally or IV every 12 hours

Severe anthrax (up to 4 weeks of age): At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
With possible/confirmed meningitis (1 month or older): At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
When meningitis has been excluded (1 month or older): 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 10 to 14 days or longer (up to 4 weeks of age) or to complete a regimen of 14 days or longer (1 month or older)

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

Comments:

Recommended as the preferred oral drug for postexposure prophylaxis and for the treatment of cutaneous anthrax without systemic involvement
Recommended as the preferred IV drug for the treatment of systemic/severe anthrax (including follow-up)
Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic/severe 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 beta-lactam (all patients) or a bactericidal glycopeptide (patients 1 month or older) is recommended with possible/confirmed meningitis.
Systemic/severe 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

Weight 9 to 12 kg: 125 mg orally every 12 hours
Weight 13 to 18 kg: 250 mg orally every 12 hours
Weight 19 to 24 kg: 250 to 375 mg orally every 12 hours
Weight at least 25 kg: 500 mg orally every 12 hours

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:

Weight 13 to 24 kg: 250 mg orally every 12 hours
Weight at least 25 kg: 500 mg orally every 12 hours

Total Duration of Therapy: 60 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure.
Indication based on efficacy studies in animals.

Gestational age 32 to 37 weeks: 10 mg/kg orally or IV every 12 hours
Term neonate: 15 mg/kg orally or IV every 12 hours

Severe anthrax (up to 4 weeks of age): At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
With possible/confirmed meningitis (1 month or older): At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
When meningitis has been excluded (1 month or older): 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 10 to 14 days or longer (up to 4 weeks of age) or to complete a regimen of 14 days or longer (1 month or older)

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

Comments:

Recommended as the preferred oral drug for postexposure prophylaxis and for the treatment of cutaneous anthrax without systemic involvement
Recommended as the preferred IV drug for the treatment of systemic/severe anthrax (including follow-up)
Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic/severe 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 beta-lactam (all patients) or a bactericidal glycopeptide (patients 1 month or older) is recommended with possible/confirmed meningitis.
Systemic/severe 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 Pyelonephritis

1 year or older:
IV: 6 to 10 mg/kg IV every 8 hours
Maximum dose: 400 mg/dose

Oral: 10 to 20 mg/kg orally every 12 hours
Maximum dose: 750 mg/dose

Recommended dose of the 5% oral suspension using the co-packaged graduated spoon:

Weight 9 to 12 kg: 125 mg orally every 12 hours
Weight 13 to 18 kg: 250 mg orally every 12 hours
Weight 19 to 24 kg: 250 to 375 mg orally every 12 hours
Weight 25 to 31 kg: 375 to 500 mg orally every 12 hours
Weight 32 to 37 kg: 375 to 625 mg orally every 12 hours
Weight at least 38 kg: 500 to 750 mg orally every 12 hours

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:

Weight 13 to 24 kg: 250 mg orally every 12 hours
Weight 25 kg: 250 to 500 mg orally every 12 hours
Weight 26 to 37 kg: 500 mg orally every 12 hours
Weight at least 38 kg: 500 to 750 mg orally every 12 hours

Total Duration of Therapy: 10 to 21 days

Comments:

Dose and initial route of therapy should be based on severity of infection.
Due to an increased incidence of side effects compared to controls (including those related to joints and/or surrounding tissues), this drug is not a drug of first choice in pediatric patients.

Uses: For treatment of complicated UTIs and pyelonephritis due to E coli

Usual Pediatric Dose for Urinary Tract Infection

Weight 9 to 12 kg: 125 mg orally every 12 hours
Weight 13 to 18 kg: 250 mg orally every 12 hours
Weight 19 to 24 kg: 250 to 375 mg orally every 12 hours
Weight 25 to 31 kg: 375 to 500 mg orally every 12 hours
Weight 32 to 37 kg: 375 to 625 mg orally every 12 hours
Weight at least 38 kg: 500 to 750 mg orally every 12 hours

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:

Weight 13 to 24 kg: 250 mg orally every 12 hours
Weight 25 kg: 250 to 500 mg orally every 12 hours
Weight 26 to 37 kg: 500 mg orally every 12 hours
Weight at least 38 kg: 500 to 750 mg orally every 12 hours

Total Duration of Therapy: 10 to 21 days

Comments:

Dose and initial route of therapy should be based on severity of infection.
Due to an increased incidence of side effects compared to controls (including those related to joints and/or surrounding tissues), this drug is not a drug of first choice in pediatric patients.

Uses: For treatment of complicated UTIs and pyelonephritis due to E coli

Usual Pediatric Dose for Plague

IV: 10 mg/kg IV every 8 to 12 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 8 to 12 hours
Maximum dose: 500 mg/dose

Recommended dose of the 5% oral suspension using the co-packaged graduated spoon:

Weight 9 to 12 kg: 125 mg orally every 8 to 12 hours
Weight 13 to 18 kg: 250 mg orally every 8 to 12 hours
Weight 19 to 24 kg: 250 to 375 mg orally every 8 to 12 hours
Weight 25 to 31 kg: 375 to 500 mg orally every 8 to 12 hours
Weight 32 to 37 kg: 375 to 625 mg orally every 8 to 12 hours
Weight at least 38 kg: 500 to 750 mg orally every 8 to 12 hours

Maximum dose: 1500 mg/day

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:

Weight 13 to 24 kg: 250 mg orally every 8 to 12 hours
Weight 25 kg: 250 to 500 mg orally every 8 to 12 hours
Weight 26 to 37 kg: 500 mg orally every 8 to 12 hours
Weight at least 38 kg: 500 to 750 mg orally every 8 to 12 hours

Maximum dose: 1500 mg/day

Total Duration of Therapy: 10 to 21 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure to Y pestis.
Indication based on efficacy study in animals only.

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

US CDC Recommendations:
Treatment:

IV: 15 mg/kg IV every 12 hours
Maximum dose: 400 mg/dose
Oral: 20 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Duration of Therapy: 10 to 14 days, or until 2 days after fever subsides

Postexposure Prophylaxis: 20 mg/kg orally twice a day for 7 days

Maximum dose: 1000 mg/day

Comments:

Appropriate IV therapy should be started as soon as plague is suspected; may switch to oral therapy once patient improves
Fluoroquinolones and gentamicin are generally first-line treatments in the US.
Postexposure prophylaxis is recommended for individuals with known exposure to plague (e.g., close contact with pneumonic plague patient, direct contact with infected body fluids/tissues).
Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Plague Prophylaxis

Weight 9 to 12 kg: 125 mg orally every 8 to 12 hours
Weight 13 to 18 kg: 250 mg orally every 8 to 12 hours
Weight 19 to 24 kg: 250 to 375 mg orally every 8 to 12 hours
Weight 25 to 31 kg: 375 to 500 mg orally every 8 to 12 hours
Weight 32 to 37 kg: 375 to 625 mg orally every 8 to 12 hours
Weight at least 38 kg: 500 to 750 mg orally every 8 to 12 hours

Maximum dose: 1500 mg/day

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:

Weight 13 to 24 kg: 250 mg orally every 8 to 12 hours
Weight 25 kg: 250 to 500 mg orally every 8 to 12 hours
Weight 26 to 37 kg: 500 mg orally every 8 to 12 hours
Weight at least 38 kg: 500 to 750 mg orally every 8 to 12 hours

Maximum dose: 1500 mg/day

Total Duration of Therapy: 10 to 21 days

Comments:

Therapy should be started as soon as possible after suspected/confirmed exposure to Y pestis.
Indication based on efficacy study in animals only.

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

US CDC Recommendations:
Treatment:

IV: 15 mg/kg IV every 12 hours
Maximum dose: 400 mg/dose
Oral: 20 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Duration of Therapy: 10 to 14 days, or until 2 days after fever subsides

Postexposure Prophylaxis: 20 mg/kg orally twice a day for 7 days

Maximum dose: 1000 mg/day

Comments:

Appropriate IV therapy should be started as soon as plague is suspected; may switch to oral therapy once patient improves
Fluoroquinolones and gentamicin are generally first-line treatments in the US.
Postexposure prophylaxis is recommended for individuals with known exposure to plague (e.g., close contact with pneumonic plague patient, direct contact with infected body fluids/tissues).
Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Tularemia

Working Group on Civilian Biodefense Recommendations for Management of Tularemia Used as a Biological Weapon:

IV: 15 mg/kg IV twice a day for 10 days
Maximum dose: 400 mg/dose
Oral: 15 mg/kg orally twice a day for 14 days
Maximum dose: 500 mg/dose

Comments:

May switch to oral therapy when clinically indicated
Recommended as an alternative IV drug for treatment of tularemia in a contained casualty setting
Recommended as a preferred oral drug for treatment of tularemia in a mass casualty setting and for postexposure prophylaxis
Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Surgical Prophylaxis

ASHP, IDSA, SIS, and SHEA Recommendations:
1 year or older:
Preoperative dose: 10 mg/kg IV once, starting within 120 minutes before surgical incision
Maximum dose: 400 mg/dose

Comments:

A single prophylactic dose is usually sufficient; if prophylaxis is continued postoperatively, duration should be less than 24 hours.
Readministration may be needed for unusually long procedures to ensure adequate serum and tissue drug levels.
Redosing may be needed if drug half-life is shortened (e.g., extensive burns) or if prolonged/excessive bleeding during surgery; redosing may not be needed if drug half-life is prolonged (e.g., renal dysfunction).
Before use, local susceptibility should be reviewed due to increasing resistance of E coli to fluoroquinolones.
Coadministration with other agents may be recommended, depending on type of procedure.
Pediatric dose should not exceed adult dose.
Current guidelines should be consulted for additional information.

Uses: For surgical prophylaxis for the following procedures:

Gastroduodenal (as part of an alternative regimen): Procedures involving entry into lumen of gastrointestinal tract (bariatric, pancreaticoduodenectomy); Procedures without entry into gastrointestinal tract (antireflux, highly selective vagotomy) for high-risk patients
Biliary tract (as part of an alternative regimen): Open procedure; elective, high-risk laparoscopic procedure
Appendectomy (as part of an alternative regimen): Uncomplicated appendicitis
Small intestine (as part of an alternative regimen): Nonobstructed; obstructed
Colorectal (as part of an alternative regimen)
Hysterectomy (as part of an alternative regimen): Vaginal or abdominal
Urologic: Lower tract instrumentation with risk factors for infection, including transrectal prostate biopsy (recommended regimen); clean with entry into urinary tract or clean-contaminated (as part of an alternative regimen)
Transplantation (as part of an alternative regimen): Liver; pancreas; pancreas-kidney

Usual Pediatric Dose for Shigellosis

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
Shigellosis therapy:

IV: 400 mg IV every 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy:

Bacteremia: At least 14 days
Gastroenteritis: 7 to 10 days
Recurrent infections: 2 to 6 weeks

Comments:

Recommended as preferred therapy (if MIC is less than 0.12 mcg/mL) to shorten duration of illness and to possibly prevent spread to others
Increased resistance of Shigella to fluoroquinolones reported in the US; treatment of Shigella with fluoroquinolones should be avoided if ciprofloxacin MIC is 0.12 mcg/mL or greater, even if isolate identified as sensitive by laboratory.
Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Salmonella Enteric Fever

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:

IV: 400 mg IV every 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:

If CD4 count at least 200 cells/mm3: 7 to 14 days
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

For gastroenteritis with bacteremia:

If CD4 count at least 200 cells/mm3: 14 days; longer if persistent bacteremia or complicated infection (e.g., metastatic foci of infection present)
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

Comments:

Recommended as preferred empiric therapy for bacterial enteric infections (pending diagnostic studies) and as preferred therapy for salmonella gastroenteritis with or without bacteremia
Empiric therapy for bacterial enteric infections recommended for patients with advanced HIV (CD4 count less than 200 cells/mm3 or concomitant AIDS-defining illnesses) and clinically severe diarrhea (at least 6 liquid stools/day or bloody stool and/or associated fever/chills). Fecal samples should be obtained for diagnostic testing before starting therapy; therapy should be adjusted based on those results.
All HIV-infected patients with salmonellosis should receive antibiotic therapy; increased risk of bacteremia (by 20- to 100-fold) and mortality (by up to 7-fold) compared to HIV-negative subjects.
Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Salmonella Gastroenteritis

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:

IV: 400 mg IV every 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:

If CD4 count at least 200 cells/mm3: 7 to 14 days
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

For gastroenteritis with bacteremia:

If CD4 count at least 200 cells/mm3: 14 days; longer if persistent bacteremia or complicated infection (e.g., metastatic foci of infection present)
If CD4 count less than 200 cells/mm3: 2 to 6 weeks

Comments:

Recommended as preferred empiric therapy for bacterial enteric infections (pending diagnostic studies) and as preferred therapy for salmonella gastroenteritis with or without bacteremia
Empiric therapy for bacterial enteric infections recommended for patients with advanced HIV (CD4 count less than 200 cells/mm3 or concomitant AIDS-defining illnesses) and clinically severe diarrhea (at least 6 liquid stools/day or bloody stool and/or associated fever/chills). Fecal samples should be obtained for diagnostic testing before starting therapy; therapy should be adjusted based on those results.
All HIV-infected patients with salmonellosis should receive antibiotic therapy; increased risk of bacteremia (by 20- to 100-fold) and mortality (by up to 7-fold) compared to HIV-negative subjects.
Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Pneumonia with Cystic Fibrosis

Study (n=67)
5 years or older: 10 mg/kg IV every 8 hours for 1 week followed by 20 mg/kg orally every 12 hours
Total Duration of Therapy: 10 to 21 days

Comments:

Efficacy for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established.

Renal Dose Adjustments

Adult Patients:
IV:

CrCl 5 to 29 mL/min: 200 to 400 mg IV every 18 to 24 hours

Oral:
Immediate-release:

CrCl 30 to 50 mL/min: 250 to 500 mg orally every 12 hours
CrCl 5 to 29 mL/min: 250 to 500 mg orally every 18 hours

Extended-release:
Cipro(R) XR:

CrCl 30 mL/min or less: 500 mg orally every 24 hours

Proquin(R) XR:

Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Data not available

Pediatric Patients:

CrCl less than 50 mL/min: Data not available

Comments:

Patients with severe infections and severe renal dysfunction may be given an oral dose of 750 mg (immediate-release) at the intervals noted above.
Patients with severe infections and severe renal dysfunction should be monitored carefully.

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 acute exacerbation of chronic bronchitis, acute uncomplicated cystitis/uncomplicated urinary tract infections (acute cystitis), or acute sinusitis.

CONTRAINDICATIONS:
History of hypersensitivity to the active component, other quinolones, or any of the ingredients; coadministration with tizanidine

Extended-release tablets: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis, peritoneal dialysis:
Adult Patients:
IV: Data not available

Oral:
Immediate-release: 250 to 500 mg orally every 24 hours

Extended-release:

Cipro(R) XR: 500 mg orally every 24 hours
Proquin(R) XR: Data not available

Pediatric Patients: Data not available

Comments:

Dose should be administered after dialysis.

Other Comments

Administration advice:

Infuse IV doses over at least 60 minutes; slow infusion of dilute solution into larger vein will minimize patient discomfort and reduce risk of venous irritation.
May switch from IV to oral therapy when clinically indicated at the physician's discretion
May administer immediate-release tablets and oral suspension and Cipro(R) XR without regard to meals; administer Proquin(R) XR with a main meal, preferably the evening meal.
In general, continue this drug (immediate-release) for at least 2 days after signs/symptoms of infection have disappeared, except for inhalation anthrax (postexposure).
Swallow extended-release tablets whole; do not split, crush, or chew.
Shake the oral suspension vigorously for about 15 seconds before each dose.
Use the co-packaged graduated spoon to administer the oral suspension; after use, clean under running water with dish detergent and dry thoroughly.
Swallow the microcapsules in the oral suspension whole; do not chew. May take water afterwards
Do not administer the oral suspension through feeding or nasogastric tubes.
May administer oral doses with meals that include dairy products (like milk, yogurt) or calcium-fortified juices; do not administer with such products alone.
Administer oral doses at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (e.g., sevelamer, lanthanum carbonate), sucralfate, buffered didanosine, other highly buffered drugs, or other products containing calcium, iron, or zinc; administer Proquin(R) XR at least 4 hours before or 2 hours after such products.
To determine dose and duration, consider the nature and severity of the infection, pathogen susceptibility, integrity of patient's host-defense mechanisms, and renal and liver function status; may administer this drug to adult patients when clinically indicated at physician's discretion.
Maintain adequate hydration of patients to prevent formation of highly-concentrated urine.

Storage requirements:

IV injection: Store between 5C to 25C (41F to 77F); protect from light; avoid excessive heat; protect from freezing.
Oral formulations: Store at 20C to 25C (68C to 77F); excursions permitted to 15C to 30C (59F to 86F). Protect oral suspension from freezing; discard reconstituted suspension after 14 days.

Reconstitution/preparation techniques:

The manufacturer product information should be consulted.

General:

Unless otherwise specified, the dose provided is for immediate-release formulations.
In patients younger than 18 years, this drug is only US FDA-approved for complicated UTIs, prevention of inhalation anthrax (postexposure), and plague.
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.
If suspected pathogens include anaerobic organisms, appropriate therapy should be used.
Some isolates of P aeruginosa may develop resistance relatively quickly during therapy.
The 10% oral suspension is not appropriate for children less than 13 kg.
Nothing should be added to the mixed final oral suspension.
The extended-release tablets are not interchangeable with immediate-release tablets or oral suspension; extended-release tablets made by different manufacturers are not interchangeable due to different pharmacokinetics (e.g., Cipro[R] XR and Proquin[R] XR).

Monitoring:

Infections/Infestations: Culture and susceptibility (periodically during therapy); syphilis serology in gonorrhea patients (at diagnosis and 3 months after therapy)
Renal: Renal function in elderly 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. 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.

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