Brand name: Cipro
Drug class: Quinolones
VA class: AM900
Chemical name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
CAS number: 85721-33-1

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

Antibacterial; fluoroquinolone.

Uses for Ciprofloxacin

Bone and Joint Infections

Treatment of bone and joint infections (including osteomyelitis) caused by susceptible Pseudomonas aeruginosa, Enterobacter cloacae, or Serratia marcescens; also has been used in bone and joint infections caused by E. aerogenes^{† [off-label]}, Escherichia coli^{† [off-label]}, Klebsiella pneumoniae^{† [off-label]}, Morganella morganii^{† [off-label]}, or Proteus mirabilis^{† [off-label]}.

IDSA recommends ciprofloxacin as a drug of choice or alternative for treatment of native vertebral osteomyelitis or prosthetic joint infections caused by Enterobacteriaceae or Ps. aeruginosa.

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of bone and joint infections.

Endocarditis

Alternative for treatment of endocarditis^† (native or prosthetic valve or other prosthetic material) caused by fastidious gram-negative bacilli known as the HACEK group (Haemophilus, Aggregatibacter, Cardiobacterium hominis, Eikenella corrodens, Kingella). AHA and IDSA recommend ceftriaxone (or other third or fourth generation cephalosporin), but state that a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) may be considered in patients who cannot tolerate cephalosporins. Consultation with an infectious disease specialist recommended.

GI Infections

Treatment of infectious diarrhea caused by susceptible enterotoxigenic E. coli, Campylobacter, Salmonella^†, Shigella flexneri, S. boydii, S. sonnei, or S. dysenteriae. Active in vitro against many pathogens associated with infectious diarrhea; may be a drug of choice for empiric treatment. Consider increasing emergence of fluoroquinolone-resistant enteric pathogens (e.g., Campylobacter, Salmonella, Shigella) secondary to widespread use of the drugs. Base decision to use a fluoroquinolone for empiric treatment of infectious diarrhea on local susceptibility patterns.

Treatment of campylobacteriosis caused by susceptible Campylobacter. Optimal treatment of campylobacteriosis in HIV-infected patients not identified. Some clinicians withhold anti-infective treatment in those with CD4⁺ T-cells >200 cells/mm³ if they have only mild campylobacteriosis, but initiate treatment if symptoms persist for more than several days. In those with mild to moderate campylobacteriosis, treatment with a fluoroquinolone (preferably ciprofloxacin or, alternatively, levofloxacin or moxifloxacin) or azithromycin is reasonable. Modify anti-infective therapy based on results of in vitro susceptibility testing; resistance to fluoroquinolones reported in 22% of C. jejuni and 35% of C. coli isolates tested in the US.

Alternative to co-trimoxazole for treatment of cyclosporiasis^† caused by Cyclospora cayetanensis.

Treatment of cystoisosporiasis (formerly isosporiasis) caused by Cystoisospora belli^† (formerly Isospora belli). In HIV-infected individuals, recommended as an alternative to co-trimoxazole for treatment and chronic maintenance therapy (secondary prophylaxis) of cystoisosporiasis.

Treatment of Salmonella gastroenteritis^†. Anti-infective treatment indicated in those with severe disease and in those at increased risk of invasive disease, including those <3–6 months of age or >50 years of age, those with hemoglobinopathies, severe atherosclerosis or valvular heart disease, prostheses, uremia, chronic GI disease, or severe colitis, and those immunocompromised because of malignancy, immunosuppressive therapy, HIV infection, or other immunosuppressive illness. CDC, NIH, and HIV Medicine Association of IDSA recommend ciprofloxacin as initial drug of choice for treatment of Salmonella gastroenteritis (with or without bacteremia) in HIV-infected adults; other fluoroquinolones (levofloxacin, moxifloxacin) also likely to be effective, but data limited. Depending on in vitro susceptibility, alternatives are co-trimoxazole and third generation cephalosporins (ceftriaxone, cefotaxime). Role of long-term anti-infective treatment (secondary prophylaxis) against Salmonella in HIV-infected individuals with recurrent bacteremia not well established; weigh benefits of such prophylaxis against risks of long-term anti-infective therapy.

Treatment of shigellosis caused by susceptible Shigella. Anti-infectives may not be required for mild infections, but generally indicated in addition to fluid and electrolyte replacement for treatment of patients with severe shigellosis, dysentery, or underlying immunosuppression. Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common. Fluoroquinolones (preferably ciprofloxacin or, alternatively, levofloxacin or moxifloxacin) have been recommended for treatment of shigellosis in HIV-infected adults, but consider that fluoroquinolone-resistant Shigella reported in the US, especially in international travelers, the homeless, and men who have sex with men (MSM). Depending on in vitro susceptibility, other drugs recommended for treatment of shigellosis include co-trimoxazole, ceftriaxone, azithromycin (not recommended in those with bacteremia), or ampicillin.

Treatment of GI infections caused by Yersinia enterocolitica^† or Y. pseudotuberculosis^†. These infections usually self-limited, but some experts recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs. When treatment considered necessary, some clinicians recommend co-trimoxazole as drug of choice and cefotaxime and ciprofloxacin as alternatives.

Treatment of travelers’ diarrhea^†. If caused by bacteria, may be self-limited and resolve within 3–7 days without anti-infective treatment. CDC states anti-infective treatment not recommended for mild travelers' diarrhea; CDC and others state empiric short-term anti-infective treatment (single dose or up to 3 days) may be used if diarrhea is moderate or severe, associated with fever or bloody stools, or extremely disruptive to travel plans. Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) generally have been considered anti-infectives of choice for empiric treatment, including self-treatment; alternatives include azithromycin and rifaximin. Consider that increasing incidence of enteric bacteria resistant to fluoroquinolones and other anti-infectives may limit usefulness of empiric treatment in individuals traveling in certain geographic areas; also consider possible adverse effects of the anti-infective and adverse consequences of such treatment (e.g., development of resistance, effect on normal gut microflora).

Prevention of travelers’ diarrhea^† in individuals traveling for relatively short periods to areas of risk. CDC and others do not recommend anti-infective prophylaxis in most travelers. May consider prophylaxis in short-term travelers who are high-risk individuals (e.g., HIV-infected or other immunocompromised individuals, travelers with poorly controlled diabetes mellitus or chronic renal failure) and those taking critical trips during which even a short episode of diarrhea could adversely affect purpose of trip. If anti-infective prophylaxis used, fluoroquinolones (e.g., ciprofloxacin, levofloxacin) usually have been recommended; alternatives include azithromycin and rifaximin. Weigh risks of use of anti-infective prophylaxis against use of prompt, early self-treatment with an empiric anti-infective if moderate to severe travelers' diarrhea occurs. Also consider increasing incidence of fluoroquinolone resistance in pathogens that cause travelers’ diarrhea (e.g., Campylobacter, Salmonella, Shigella).

Intra-abdominal Infections

Treatment of complicated intra-abdominal infections caused by E. coli, Ps. aeruginosa, P. mirabilis, K. pneumoniae, or Bacteroides fragilis; used in conjunction with oral metronidazole.

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of intra-abdominal infections.

Meningitis and CNS Infections

Has been used for treatment of meningitis and other CNS infections^† caused by susceptible gram-negative bacteria (e.g., Ps. aeruginosa, Salmonella) either alone or in conjunction with other drugs (e.g., an aminoglycoside, ceftriaxone, cefotaxime).

Recommended as an alternative for treatment of healthcare-associated ventriculitis and meningitis^† caused by Enterobacteriaceae or Ps. aeruginosa when drugs of choice cannot be used.

Safety and efficacy not established for CNS infections; only low ciprofloxacin concentrations attained in CSF (see Distribution under Pharmacokinetics). Fluoroquinolones (including ciprofloxacin) generally considered for treatment of meningitis only when the infection is caused by multidrug-resistant gram-negative bacilli or when usually recommended anti-infectives cannot be used or have been ineffective.

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of meningitis and other CNS infections.

Otic Infections

Treatment of malignant otitis externa^† caused by Ps. aeruginosa. Treatment of choice usually is ciprofloxacin or an antipseudomonal β-lactam (e.g., ceftazidime, imipenem). Consider the possibility of ciprofloxacin-resistant strains if there is an inadequate response to treatment.

Respiratory Tract Infections

Treatment of respiratory tract infections (including bronchiectasis, bronchitis, lung abscess, pneumonia) caused by susceptible E. cloacae, E. coli, Haemophilus influenzae, H. parainfluenzae, K. pneumoniae, P. mirabilis, Ps. aeruginosa, or S. pneumoniae; also has been used for respiratory tract infections caused by susceptible E. aerogenes^†, K. oxytoca^†, or S. aureus^†.

Treatment of acute sinusitis caused by susceptible H. influenzae, M. catarrhalis, or S. pneumoniae.

Treatment of acute exacerbations of chronic bronchitis caused by susceptible Moraxella catarrhalis.

Use for treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis only when no other treatment options available. Because systemic fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient (see Cautions) and because acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis may be self-limiting in some patients, risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with these infections.

Treatment of nosocomial pneumonia caused by susceptible H. influenzae or K. pneumoniae. Select regimen for empiric treatment of hospital-acquired pneumonia (HAP) not associated with mechanical ventilation or ventilator-associated pneumonia (VAP) based on local susceptibility data. For initial empiric treatment of HAP, use in conjunction with an anti-infective active against methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant or ORSA) if likelihood of MRSA increased or patient is at high risk of mortality or has received IV anti-infectives during prior 90 days. For initial empiric treatment of clinically suspected VAP, use in conjunction with an anti-infective active against MRSA plus an antipseudomonal β-lactam if likelihood of MRSA or multidrug-resistant gram-negative bacteria increased.

Most effective in treatment of respiratory tract infections caused by H. influenzae or M. catarrhalis; treatment failures have occurred when used in infections caused by S. pneumoniae or Ps. aeruginosa.

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of respiratory tract infections.

Skin and Skin Structure Infections

Treatment of skin and skin structure infections (e.g., cellulitis, abscesses, folliculitis, furunculosis, pyoderma, postoperative wound infections, infected ulcers, burns, or wounds) caused by susceptible C. freundii, E. cloacae, E. coli, K. oxytoca^†, K. pneumoniae, M. morganii, P. mirabilis, P. vulgaris, P. stuartii, Ps. aeruginosa, S. marcescens^†, S. aureus (methicillin-susceptible strains), S. epidermidis, or S. pyogenes (group A β-hemolytic streptococci).

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of skin and skin structure infections.

Urinary Tract Infections (UTIs) and Prostatitis

Treatment of complicated UTIs and pyelonephritis caused by susceptible E. coli in pediatric patients 1–17 years of age. Not a drug of first choice in pediatric patients because of increased risk of adverse events (e.g., events related to joints and/or surrounding tissues) in this age group. (See Musculoskeletal Effects under Cautions.)

Treatment of complicated or uncomplicated UTIs in adults caused by susceptible gram-negative bacteria, including Citrobacter koseri (formerly C. diversus), C. freundii, E. cloacae, E. coli, K. pneumoniae, M. morganii, P. mirabilis, Providencia rettgeri, Ps. aeruginosa, or S. marcescens; also has been used for UTIs caused by E. aerogenes^†, Klebsiella oxytoca^†, or P. stuartii^†.

Treatment of UTIs in adults caused by susceptible gram-positive bacteria, including S. aureus^†, S. epidermidis, S. saprophyticus, or E. faecalis.

Treatment of acute uncomplicated cystitis in adults caused by susceptible E. coli, P. mirabilis, S. saprophyticus, or E. faecalis.

Treatment of acute uncomplicated pyelonephritis in adults caused by E. coli.

Treatment of recurrent UTIs and chronic prostatitis in adults caused by E. coli or P. mirabilis in men.

Use for treatment of uncomplicated UTIs only when no other treatment options available. Because systemic fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient (see Cautions) and because uncomplicated UTIs may be self-limiting in some patients, risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with uncomplicated UTIs.

Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria.

Anthrax

Inhalational anthrax (postexposure) to reduce incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores. CDC, US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend oral ciprofloxacin and oral doxycycline as initial drugs of choice for prophylaxis following such exposures that occur in the context of biologic warfare or bioterrorism. Other oral fluoroquinolones (levofloxacin, moxifloxacin, ofloxacin) are alternatives for postexposure prophylaxis when ciprofloxacin or doxycycline cannot be used. AAP states that oral ciprofloxacin is the drug of choice for anthrax postexposure prophylaxis in neonates ≤4 weeks of age and oral ciprofloxacin or doxycycline are the drugs of choice for such prophylaxis in pediatric patients ≥1 month of age.

Treatment of systemic anthrax (inhalational, GI, meningitis, or cutaneous with systemic involvement, head or neck lesions, or extensive edema) that occurs in the context of biologic warfare or bioterrorism. CDC and AAP state that the preferred multiple-drug parenteral regimen for initial treatment of systemic anthrax with possible or confirmed meningitis in adults and pediatric patients (including neonates) is IV ciprofloxacin in conjunction with another IV bactericidal anti-infective (preferably meropenem) and an IV protein synthesis inhibitor (preferably linezolid). If meningitis excluded, these experts recommend an initial multiple-drug parenteral regimen of IV ciprofloxacin in conjunction with an IV protein synthesis inhibitor (preferably clindamycin or linezolid in adults or clindamycin in pediatric patients).

Treatment of uncomplicated cutaneous anthrax^† (without systemic involvement) that occurs following exposure to B. anthracis spores in the context of biologic warfare or bioterrorism. CDC states that oral ciprofloxacin, doxycycline, levofloxacin, and moxifloxacin are the preferred drugs in adults for treatment of uncomplicated cutaneous anthrax that occurs in the context of biologic warfare or bioterrorism. AAP states that oral ciprofloxacin is the preferred drug for treatment of such infections in pediatric patients (including neonates).

Oral ciprofloxacin has been suggested as possible alternative for treatment of inhalational anthrax^† when a parenteral regimen not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass-casualty setting). A multiple-drug parenteral regimen should be used for initial treatment of inhalational anthrax that occurs as the result of exposure to B. anthracis spores in the context of biologic warfare or bioterrorism; parenteral regimen may not be possible if large numbers of individuals require treatment in a mass casualty setting and it may be necessary to use an oral regimen.

Treatment of GI and oropharyngeal anthrax^†. If occurring in the context of biologic warfare or bioterrorism, use parenteral regimens recommended for inhalational anthrax.

Prophylaxis following ingestion of B. anthracis spores^† in contaminated meat.

Consult CDC and AAP guidelines for additional information on management of anthrax, including postexposure prophylaxis of anthrax.

Brucellosis

Treatment of brucellosis^† caused by Brucella melitensis; used in conjunction with rifampin. Monotherapy with any drug usually associated with high relapse rate and not recommended.

Chancroid

Treatment of chancroid^† (genital ulcers caused by Haemophilus ducreyi).

CDC recommends azithromycin, ceftriaxone, ciprofloxacin, or erythromycin as drugs of choice for treatment of chancroid. HIV-infected patients and uncircumcised patients may not respond to treatment as well as those who are HIV-negative or circumcised.

Crohn’s Disease

Management of Crohn’s disease^† as an adjunct to conventional therapies.

Has been used (with or without metronidazole ) for induction of remission of mildly to moderately active Crohn’s disease. May be more effective in patients with ileitis than in those with colitis.

Has been used in the management of refractory perianal Crohn’s disease^†. Relapse usually occurs when the drug is discontinued.

Gonorrhea and Associated Infections

Was used in the past for treatment of uncomplicated urethral, endocervical, rectal^†, or pharyngeal^† gonorrhea caused by susceptible Neisseria gonorrhoeae.

Because quinolone-resistant N. gonorrhoeae (QRNG) widely disseminated worldwide, including in the US (see Resistance in Neisseria gonorrhoeae under Cautions), CDC states fluoroquinolones no longer recommended for treatment of gonorrhea and should not be used routinely for any associated infection that may involve N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).

Granuloma Inguinale† (Donovanosis†)

Alternative for treatment of granuloma inguinale^† (donovanosis) caused by Klebsiella granulomatis (formerly Calymmatobacterium granulomatis).

CDC recommends azithromycin; alternatives are doxycycline, ciprofloxacin, erythromycin, and co-trimoxazole.

Legionnaires’ Disease†

Treatment of Legionnaires’ Disease^† caused by Legionella pneumophila, including in immunocompromised patients (e.g., transplant recipients).

Mycobacterial Infections

Has been used in multiple-drug regimens for treatment of active tuberculosis^† caused by Mycobacterium tuberculosis.

ATS, CDC, and IDSA state that use of fluoroquinolones as alternative (second-line) agents can be considered for treatment of active tuberculosis in patients intolerant of certain first-line agents and in those with relapse, treatment failure, or M. tuberculosis resistant to certain first-line agents. If a fluoroquinolone is used in multiple-drug regimens for treatment of active tuberculosis, levofloxacin or moxifloxacin is recommended; some experts state ciprofloxacin is no longer recommended for treatment of tuberculosis.

Treatment of cutaneous infections caused by M. fortuitum^†; used alone or in conjunction with amikacin. ATS and IDSA recommend that M. fortuitum pulmonary infections be treated with a regimen consisting of at least 2 anti-infectives selected based on results of in vitro susceptibility testing and tolerability (e.g., amikacin, ciprofloxacin or ofloxacin, a sulfonamide, cefoxitin, imipenem, doxycycline).

Has been used in multiple-drug regimens for treatment of pulmonary and extrapulmonary (localized or disseminated) M. avium complex^† (MAC) infections. Role of fluoroquinolones in treatment of MAC infections not been established. Moxifloxacin may be preferred if a fluoroquinolone is used in conjunction with other antimycobacterial anti-infectives for the treatment of MAC infections, but many strains are resistant in vitro. Treatment of MAC infections is complicated and should be directed by clinicians familiar with mycobacterial diseases; consultation with a specialist is particularly important when the patient cannot tolerate first-line drugs or when the infection has not responded to prior therapy or is caused by macrolide-resistant MAC.

Based on results of in vitro susceptibility testing, ciprofloxacin may be considered for use in combination antimycobacterial regimens used for treatment of infections caused by M. chelonae^†, M. haemophilum^†, or M. terrae^†. Because of considerations related to resistance, not recommended for treatment of M. marinum infections.

Neisseria meningitidis Infections

Elimination of nasopharyngeal carriage of N. meningitidis^† in patients with invasive meningococcal disease who did not receive treatment with ceftriaxone or other third generation cephalosporin. CDC and AAP consider rifampin, ceftriaxone, or ciprofloxacin the drugs of choice for such carriers.

Chemoprophylaxis to prevent meningococcal disease in household or other close contacts of patients with invasive meningococcal disease^†.

Ceftriaxone, rifampin (not recommended in pregnant women), or ciprofloxacin (not recommended in those <18 years of age unless no other regimen can be used, not recommended in pregnant or lactating women) are the drugs of choice for elimination of N. meningitidis carriage and for chemoprophylaxis of meningococcal disease. All are 90–95% effective and any of these is an acceptable regimen; AAP suggests rifampin may be the drug of choice for most children.

Consider that fluoroquinolone-resistant N. meningitidis has been reported rarely in the US and elsewhere (e.g., India). Do not use ciprofloxacin for prophylaxis in close contacts of individuals with meningococcal disease in areas where fluoroquinolone-resistant strains have been reported (e.g., selected counties of North Dakota and Minnesota).

Plague

Treatment of plague, including pneumonic and septicemic plague, caused by Yersinia pestis. Streptomycin (or gentamicin) historically has been considered regimen of choice for treatment of plague; alternatives are doxycycline (or tetracycline), chloramphenicol (a drug of choice for plague meningitis), fluoroquinolones (ciprofloxacin [a drug of choice for plague meningitis], levofloxacin, moxifloxacin), or co-trimoxazole (may be less effective than other alternatives). Regimens recommended for treatment of naturally occurring or endemic bubonic, septicemic, or pneumonic plague also recommended for plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.

Postexposure prophylaxis following high-risk exposure to Y. pestis (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure in the context of biologic warfare or bioterrorism). Drugs of choice for such prophylaxis are doxycycline (or tetracycline) or a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin).

Rickettsial Infections

Has been used for treatment of some rickettsial infections^†, including Mediterranean spotted fever^† caused by Rickettsia conorii.

Doxycycline is the drug of choice for treatment of all tickborne rickettsial diseases. Although some fluoroquinolones have in vitro activity against Rickettsiae, CDC states that fluoroquinolones are not recommended for treatment of Rocky Mountain spotted fever.

Tularemia

Treatment of tularemia^† caused by Francisella tularensis, including naturally occurring or endemic tularemia or tularemia that occurs following exposure to F. tularensis in the context of biologic warfare or bioterrorism. Considered an alternative to streptomycin (or gentamicin); risk of relapse may be higher than with aminoglycosides.

Postexposure prophylaxis of tularemia^† following a high-risk laboratory exposure to F. tularensis (e.g., spill, centrifuge accident, needlestick injury) or in individuals exposed to the organism in the context of biologic warfare or bioterrorism. Postexposure prophylaxis usually not recommended after exposure to natural or endemic tularemia (e.g., tick bite, rabbit or other animal exposure) and is unnecessary in close contacts of tularemia patients since human-to-human transmission does not occur.

Typhoid Fever and Other Invasive Salmonella Infections

Treatment of typhoid fever (enteric fever) or paratyphoid fever^† caused by susceptible Salmonella enterica serovars Typhi or Paratyphi, respectively. Although fluoroquinolones have been recommended for empiric treatment of Salmonella enteric fever in adults, resistance to fluoroquinolones reported in >80% of such infections in travelers to South and Southeast Asia and treatment failures will occur.

Has been used for treatment of chronic typhoid carriers^†; however, manufacturer cautions that efficacy of ciprofloxacin in eradication of the chronic typhoid carrier state has not been demonstrated.

Recommended as a drug of choice for treatment of native vertebral osteomyelitis caused by Salmonella^†. (See Bone and Joint Infections under Uses.)

Has been used alone or in conjunction with a third generation cephalosporin (cefotaxime, ceftriaxone) for treatment of meningitis and other CNS infections caused by susceptible Salmonella^†. (See Meningitis and CNS Infections under Uses.)

Vibrio Infections

Treatment of cholera^† caused by Vibrio cholerae 01 or 0139. Doxycycline generally considered drug of choice when an anti-infective indicated as an adjunct to fluid and electrolyte replacement; alternatives include azithromycin, co-trimoxazole, ciprofloxacin, or ceftriaxone.

Alternative to tetracyclines for treatment of other Vibrio infections, including gastroenteritis or wound infections caused by V. parahaemolyticus^† or V. vulnificus^†. Optimum anti-infective therapy has not been identified for V. vulnificus^†; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime), a fluoroquinolone, or aminoglycoside has been recommended. Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.

Perioperative Prophylaxis

Perioperative prophylaxis^† in patients undergoing certain GU surgery who are at high risk for postoperative infections. Because of increasing resistance of E. coli to fluoroquinolones, consider local susceptibility patterns when selecting an anti-infective for such prophylaxis.

Perioperative prophylaxis not recommended for patients with sterile urine undergoing cystoscopy without manipulation. Some clinicians recommend that those with positive (or unavailable) urine cultures or preoperative indwelling urinary catheters and those undergoing cystoscopy with manipulation (dilation, biopsy, fulguration, resection, ureteral instrumentation) be treated to sterilize the urine before surgery or receive a single preoperative dose of an anti-infective (e.g., ciprofloxacin) active against the most likely urologic pathogens.

Perioperative prophylaxis using an appropriate anti-infective (e.g., ciprofloxacin) recommended in patients undergoing transurethral prostatectomy, transrectal prostatic biopsies, ureteroscopy, shock wave lithotripsy, percutaneous renal surgery, open laparoscopic procedures, or procedures that involve placement of a urologic prosthesis (e.g., penile transplant, artificial sphincter, synthetic pubovaginal sling, bone anchors for pelvic floor reconstruction).

Empiric Therapy in Febrile Neutropenic Patients

Empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients.

IV ciprofloxacin has been used in conjunction with IV piperacillin (no longer commercially available in the US as a single-entity preparation) for empiric therapy in febrile neutropenic patients.

Some experts recommend fluoroquinolone prophylaxis during periods of expected neutropenia in patients at high risk for febrile neutropenia or profound, protracted neutropenia (e.g., most patients with acute myeloid leukemia/myelodysplastic syndromes [AML/MDS] or hematopoietic stem-cell transplantation [HSCT] treated with myeloablative conditioning regimens).

Empiric regimen that includes a fluoroquinolone (ciprofloxacin or levofloxacin) in conjunction with the fixed combination of amoxicillin and clavulanate (or clindamycin) recommended for outpatient management of febrile neutropenic adults receiving treatment for malignancy. Use of a fluoroquinolone alone not recommended for initial empiric therapy in outpatients, but may be effective in low-risk outpatients.

Consult published protocols on anti-infective prophylaxis in febrile neutropenic patients for specific recommendations when anti-infective prophylaxis is appropriate for immunosuppressed patients with cancer and options for such prophylaxis.

Ciprofloxacin Dosage and Administration

Administration

Administer orally or by IV infusion.

Patients receiving IV ciprofloxacin initially may be switched to oral ciprofloxacin when clinically appropriate.

Because of risk of crystalluria, instruct patients receiving oral or IV ciprofloxacin that they should be adequately hydrated and should drink fluids liberally. (See Renal Effects under Cautions.)

Oral Administration

Administer conventional tablets, extended-release tablets, or oral suspension without regard to meals. (See Pharmacokinetics.)

Do not administer conventional tablets, extended-release tablets, or oral suspension concurrently with dairy products (e.g., milk, yogurt) or calcium-fortified products (e.g., juices) alone (without a meal) since absorption of the drug may be substantially reduced. Doses should preferably be taken 2 hours before or after these calcium-fortified products or substantial calcium intake (>800 mg).

Conventional or extended-release tablets: Swallow whole; do not split, crush, or chew.

Oral suspension: Following reconstitution, administer using the graduated spoon provided by the manufacturer that has markings for 2.5 and 5 mL. Swallow microcapsules contained in the reconstituted oral suspension; do not chew. May ingest water after the oral suspension is swallowed.

Reconstitution

Ciprofloxacin for oral suspension is provided in a kit containing a bottle of microcapsules, a bottle of oral suspension diluent, and a graduated dosing spoon. At time of dispensing, add contents of bottle containing the microcapsules (either 5 or 10 g of ciprofloxacin) to the bottle of diluent according to manufacturer's directions and shake vigorously for about 15 seconds to provide a suspension containing either 250 mg/5 mL or 500 mg/5 mL, respectively. Use only the diluent supplied in the kit; do not add water.

Prior to administration of each dose, shake oral suspension vigorously for about 15 seconds.

IV Infusion

IV infusions should be given into a large vein to minimize discomfort and reduce the risk of venous irritation. If a Y-type administration set is used, the other IV solution flowing through the tubing should be discontinued while ciprofloxacin is being infused.

Ciprofloxacin concentrate containing 10 mg/mL: Must be diluted with compatible IV solution prior to IV infusion.

Ciprofloxacin premixed solution for IV infusion containing 2 mg/mL in 5% dextrose injection: May be administered without further dilution.

For solution and drug compatibility information, see Compatibility under Stability.

Ciprofloxacin preparations for IV administration contain lactic acid as a solubilizing agent.

Dilution

Dilute ciprofloxacin concentrate containing 10 mg/mL with compatible IV solution (e.g., 0.9% sodium chloride, 5 or 10% dextrose, 5% dextrose and 0.225 or 0.45% sodium chloride, lactated Ringer’s) to provide a solution containing 1–2 mg/mL. (See Compatibility under Stability.)

Rate of Administration

Administer by IV infusion over 1 hour.

Dosage

Available as ciprofloxacin (IV, oral suspension), ciprofloxacin hydrochloride (conventional tablets), and a mixture of ciprofloxacin and ciprofloxacin hydrochloride (extended-release tablets); dosage expressed in terms of ciprofloxacin.

Unless otherwise specified, oral dosage is for conventional tablets or oral suspension.

Use extended-release tablets only for treatment of certain urinary tract infections (UTIs) in adults; do not use in pediatric patients. Extended-release tablets are not interchangeable with other oral ciprofloxacin preparations (conventional tablets, oral suspension).

Dosage of oral and IV ciprofloxacin is not identical. Based on pharmacokinetic parameters (i.e., AUC), the following oral and IV regimens are considered equivalent: 250 mg orally every 12 hours (conventional tablets) is equivalent to 200 mg IV every 12 hours; 500 mg orally every 12 hours (conventional tablets) is equivalent to 400 mg IV every 12 hours; 750 mg orally every 12 hours (conventional tablets) is equivalent to 400 mg IV every 8 hours.

Pediatric Patients

Urinary Tract Infections (UTIs)

Complicated UTIs and Pyelonephritis

Oral

Children 1–17 years of age: 10–20 mg/kg (up to 750 mg) every 12 hours for 10–21 days.

Children 1–17 years of age (oral suspension containing 250 mg/5 mL): 125 mg every 12 hours in those weighing 9–12 kg, 250 mg every 12 hours in those weighing 13–18 kg, 250–375 mg every 12 hours in those weighing 19–24 kg, 375–500 mg every 12 hours in those weighing 25–31 kg, 375–625 mg every 12 hours in those weighing 32–37 kg, and 500–750 mg every 12 hours in those weighing ≥38 kg.

Children 1–17 years of age (oral suspension containing 500 mg/5 mL): 250 mg every 12 hours in those weighing 13–24 kg, 250–500 mg every 12 hours in those weighing 25 kg, 500 mg every 12 hours in those weighing 26–37 kg, and 500–750 mg every 12 hours in those weighing ≥38 kg.

IV

Children 1–17 years of age: 6–10 mg/kg (up to 400 mg) every 8 hours.

Switch to oral route when clinically indicated; manufacturers recommend total treatment duration (IV and/or oral) of 10–21 days.

Anthrax

Postexposure Prophylaxis of Anthrax (Biologic Warfare or Bioterrorism Exposure)

Oral

Neonates ≤4 weeks of age: AAP recommends 10 mg/kg every 12 hours in preterm neonates (gestational age 32–37 weeks) and 15 mg/kg every 12 hours in full-term neonates.

Pediatric patients ≥1 month of age: AAP recommends 15 mg/kg (up to 500 mg) every 12 hours.

Neonates, infants, and children ≤17 years of age: Manufacturer recommends 15 mg/kg (up to 500 mg) every 12 hours.

Neonates, infants, and children ≤17 years of age (oral suspension containing 250 mg/5 mL): Manufacturer recommends 125 mg every 12 hours in those weighing 9–12 kg, 250 mg every 12 hours in those weighing 13–18 kg, 250–375 mg every 12 hours in those weighing 19–24 kg, and 500 mg every 12 hours in those weighing ≥25 kg.

Neonates, infants, and children ≤17 years of age (oral suspension containing 500 mg/5 mL): Manufacturer recommends 250 mg every 12 hours in those weighing 13–24 kg and 500 mg every 12 hours in those weighing ≥25 kg.

Initiate prophylaxis as soon as possible following suspected or confirmed anthrax exposure.

Because of possible persistence of B. anthracis spores in lung tissue following an aerosol exposure, CDC, AAP, and others recommend that anti-infective postexposure prophylaxis be continued for 60 days following a confirmed exposure.

IV

Neonates, infants, and children ≤17 years of age: Manufacturer recommends 10 mg/kg (up to 400 mg) every 12 hours for 60 days.

Treatment of Systemic Anthrax (Biologic Warfare or Bioterrorism Exposure)†

IV

Neonates ≤4 weeks of age: AAP recommends 10 mg/kg every 12 hours in preterm neonates (gestational age 32–37 weeks) and 15 mg/kg every 12 hours in full-term neonates.

Pediatric patients ≥1 month of age: AAP recommends 10 mg/kg (up to 400 mg) every 8 hours.

Used in multiple-drug parenteral regimen for initial treatment of systemic anthrax (inhalational, GI, meningitis, or cutaneous with systemic involvement, lesions on the head or neck, or extensive edema). Continue parenteral regimen for ≥2–3 weeks until patient is clinically stable and can be switched to appropriate oral anti-infective.

If systemic anthrax occurred after exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism, continue oral follow-up regimen until 60 days after illness onset.

Oral

Neonates ≤4 weeks of age (follow-up after initial multiple-drug parenteral regimen): AAP recommends 10 mg/kg every 12 hours in preterm neonates (gestational age 32–37 weeks) and 15 mg/kg every 12 hours in full-term neonates.

Pediatric patients ≥1 month of age (follow-up after initial multiple-drug parenteral regimen): AAP recommends 15 mg/kg (up to 500 mg) every 12 hours.

Initial multiple-drug parenteral treatment regimen recommended; use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).

If systemic anthrax occurred after exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism, continue oral follow-up regimen until 60 days after illness onset.

Treatment of Uncomplicated Cutaneous Anthrax (Biologic Warfare or Bioterrorism Exposure)†

Oral

Neonates ≤1 month of age: AAP recommends 10 mg/kg every 12 hours in preterm neonates (gestational age 32–37 weeks) and 15 mg/kg every 12 hours in full-term neonates.

Pediatric patients ≥1 month of age: AAP recommends 15 mg/kg (up to 500 mg) every 12 hours.

Recommended duration is 60 days after illness onset if cutaneous anthrax occurred after exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism. Duration of 7–10 days may be sufficient if uncomplicated cutaneous anthrax occurred as the result of naturally occurring or endemic exposure.

Neisseria meningitidis Infections†

Elimination of Pharyngeal Carrier State†

Oral

20 mg/kg (up to 500 mg) as a single dose.

Chemoprophylaxis in Household or Other Close Contacts†

Oral

20 mg/kg (up to 500 mg) as a single dose.

Plague

Treatment of Plague

Oral

Neonates, infants, and children ≤17 years of age: Manufacturer recommends 15 mg/kg (up to 500 mg) every 8 or 12 hours for 10–21 days.

Neonates, infants, and children ≤17 years of age (oral suspension containing 250 mg/5 mL): Manufacturer recommends 125 mg every 12 hours in those weighing 9–12 kg, 250 mg every 12 hours in those weighing 13–18 kg, 250–375 mg every 12 hours in those weighing 19–24 kg, 375–500 mg every 12 hours in those weighing 25–31 kg, 375–625 mg every 12 hours in those weighing 32–37 kg, and 500–750 mg every 12 hours in those weighing ≥38 kg.

Neonates, infants, and children ≤17 years of age (oral suspension containing 500 mg/5 mL): Manufacturer recommends 250 mg every 12 hours in those weighing 13–24 kg, 250–500 mg every 12 hours in those weighing 25 kg, 500 mg every 12 hours in those weighing 26–37 kg, and 500–750 mg every 12 hours in those weighing ≥38 kg.

Some experts (e.g., US Working Group on Civilian Biodefense, USAMRIID) recommend 20 mg/kg twice daily (up to 1 g daily) for treatment of plague that occurs as the result of exposure to Y. pestis in the context of biologic warfare or bioterrorism.

Initial parenteral regimen preferred; use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).

Manufacturer recommends total treatment duration (IV and oral) of 10–21 days in pediatric patients; some experts state total treatment duration should be at least 10–14 days.

IV

Neonates, infants, and children ≤17 years of age: Manufacturer recommends 10 mg/kg (up to 400 mg) IV every 8 or 12 hours for 10–21 days.

Some experts (e.g., US Working Group on Civilian Biodefense, USAMRIID) recommend 15 mg/kg IV every 12 hours (up to 1 g daily) for treatment of plague that occurs as the result of exposure to Y. pestis in the context of biologic warfare or bioterrorism.

When clinical improvement occurs, may switch to oral regimen.

Manufacturer recommends total treatment duration (IV and oral) of 10–21 days in pediatric patients; some experts state total treatment duration should be at least 10–14 days.

Postexposure Prophylaxis of Plague

Oral

Neonates, infants, and children ≤17 years of age: Manufacturer recommends 15 mg/kg (up to 500 mg) every 8 or 12 hours for 10–21 days.

Neonates, infants, and children ≤17 years of age (oral suspension containing 250 mg/5 mL): Manufacturer recommends 125 mg every 12 hours in those weighing 9–12 kg, 250 mg every 12 hours in those weighing 13–18 kg, 250–375 mg every 12 hours in those weighing 19–24 kg, 375–500 mg every 12 hours in those weighing 25–31 kg, 375–625 mg every 12 hours in those weighing 32–37 kg, and 500–750 mg every 12 hours in those weighing ≥38 kg.

Neonates, infants, and children ≤17 years of age (oral suspension containing 500 mg/5 mL): Manufacturer recommends 250 mg every 12 hours in those weighing 13–24 kg, 250–500 mg every 12 hours in those weighing 25 kg, 500 mg every 12 hours in those weighing 26–37 kg, and 500–750 mg every 12 hours in those weighing ≥38 kg.

Some experts (e.g., US Working Group on Civilian Biodefense, USAMRIID) recommend 20 mg/kg twice daily (up to 1 g daily) following exposures that occur in the context of biologic warfare or bioterrorism.

Initiate prophylaxis as soon as possible after suspected or confirmed exposure.

Close contacts of patients with pneumonic plague or individuals exposed to plague aerosol (e.g., in the context of biologic warfare or bioterrorism): Continue prophylaxis for 7 days or for duration of risk of exposure plus 7 days. If fever or cough develops during prophylaxis, switch to regimen recommended for treatment of plague.

IV

Neonates, infants, and children ≤17 years of age: Manufacturer recommends 10 mg/kg (up to 400 mg) IV every 8 or 12 hours for 10–21 days.

Tularemia†

Treatment of Tularemia Occurring in the Context of Biologic Warfare or Bioterrorism†

Oral

15 mg/kg twice daily (up to 1 g daily).

Initial parenteral regimen preferred; use oral regimen after improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).

Total treatment duration (IV and oral) of at least 10–14 days.

IV, then Oral

15 mg/kg IV every 12 hours (up to 1 g daily).

When clinical improvement occurs, may switch to oral regimen.

Total treatment duration (IV and oral) of at least 10–14 days.

Postexposure Prophylaxis Following High-risk Exposure to Tularemia†

Oral

15 mg/kg every 12 hours (up to 1 g daily).

Initiate prophylaxis within 24 hours of exposure and continue for at least 14 days.

Cystoisospora Infections

Oral

HIV-infected: 10–20 mg/kg (up to 500 mg) twice daily for 7 days.

Chronic maintenance therapy (secondary prophylaxis) in HIV-infected: 10–20 mg/kg (up to 500 mg) 3 times weekly. Consider discontinuing if no evidence of active Cystoisospora infection and there has been sustained improvement in immunologic status (CDC immunologic category 1 or 2) for >6 months in response to antiretroviral therapy.

Meningitis and Other CNS Infections†

IV

Healthcare-associated ventriculitis and meningitis caused by susceptible gram-negative bacteria: IDSA recommends 30 mg/kg daily in divided doses every 8–12 hours.

Neisseria meningitidis Infections†

Elimination of Nasopharyngeal Carrier State†

Oral

AAP recommends single dose of 20 mg/kg. Do not use if fluoroquinolone-resistant N. meningitis identified in the community.

Chemoprophylaxis in Household or Other Close Contacts†

Oral

AAP recommends single dose of 20 mg/kg. Do not use if fluoroquinolone-resistant N. meningitis identified in the community.

Vibrio Infections†

Cholera†

Oral

15 mg/kg (up to 500 mg) twice daily for 3 days.

Children 2–12 years of age: A single dose of 20 mg/kg (up to 750 mg) has been used for treatment of cholera caused by V. cholerae 01 or 0139.

Adults

Bone and Joint Infections

Oral

Manufacturer recommends 500–750 mg every 12 hours for 4–8 weeks.

Native vertebral osteomyelitis: IDSA recommends 750 mg every 12 hours for 6 weeks for Ps. aeruginosa, 500 mg every 12 hours for 6–8 weeks for Salmonella, and 500–750 mg every 12 hours for 6 weeks for other Enterobacteriaceae.

Prosthetic joint infections: IDSA recommends 750 mg twice daily for 4–6 weeks for Ps. aeruginosa and for Enterobacter or other Enterobacteriaceae.

IV

Manufacturer recommends 400 mg every 8 to 12 hours for 4–8 weeks.

Native vertebral osteomyelitis: IDSA recommends 400 mg every 8 hours for 6 weeks for Ps. aeruginosa and 400 mg every 12 hours for 6 weeks for Enterobacteriaceae.

Prosthetic joint infections: IDSA recommends 400 mg every 12 hours for 4–6 weeks for Ps. aeruginosa or Enterobacter.

Endocarditis†

Endocarditis Caused by the HACEK Group†

Oral

1 g daily given in 2 equally divided doses recommended by AHA and IDSA. Duration of treatment is 4 weeks for native valve endocarditis or 6 weeks for endocarditis involving prosthetic cardiac valves or other prosthetic cardiac material.

IV

800 mg daily given in 2 equally divided doses recommended by AHA and IDSA. Duration of treatment is 4 weeks for native valve endocarditis or 6 weeks for endocarditis involving prosthetic cardiac valves or other prosthetic cardiac material.

GI Infections

Infectious Diarrhea

Oral

Manufacturer recommends 500 mg every 12 hours for 5–7 days.

Campylobacter Infections†

Oral

HIV-infected: 500–750 mg every 12 hours.

Recommended treatment duration is 7–10 days for gastroenteritis or ≥14 days for bacteremic infections. Duration of 2–6 weeks recommended for recurrent infections.

IV

HIV-infected: 400 mg every 12 hours.

Recommended treatment duration is 7–10 days for gastroenteritis or ≥14 days for bacteremic infections. Duration of 2–6 weeks recommended for recurrent infections.

Cyclospora Infections†

Oral

500 mg twice daily for 7 days.

Cystoisospora Infections†

Oral

HIV-infected: 500 mg twice daily for 7 days.

Chronic maintenance therapy (secondary prophylaxis) if CD4⁺ T-cells <200 cells/mm³: 500 mg 3 times weekly. Consider discontinuing if CD4⁺ T-cells remain >200 cells/mm³ for >6 months in response to antiretroviral therapy.

Salmonella Gastroenteritis in HIV-infected Patients

Oral

500–750 mg every 12 hours.

Recommended treatment duration is 7–14 days if CD4⁺ T-cells ≥200 cells/mm³ (≥14 days if bacteremic or infection is complicated) or 2–6 weeks if CD4⁺ T-cells <200 cells/mm³.

Consider secondary prophylaxis in those with recurrent bacteremia; also may consider in those with recurrent gastroenteritis (with or without bacteremia) or with CD4⁺ T-cells <200 cells/mm³ and severe diarrhea. Discontinue secondary prophylaxis if Salmonella infection resolves and there has been a sustained response to antiretroviral therapy with CD4⁺ T-cells >200 cells/mm³.

IV

400 mg every 12 hours.

Recommended treatment duration is 7–14 days if CD4⁺ T-cells ≥200 cells/mm³ (≥14 days if bacteremic or infection is complicated) or 2–6 weeks if CD4⁺ T-cells <200 cells/mm³.

Shigella Infections

Oral

HIV-infected: 500–750 mg every 12 hours.

Recommended treatment duration is 7–10 days for gastroenteritis or ≥14 days for bacteremic infections. Up to 6 weeks may be required for recurrent infections, especially if CD4⁺ T-cells <200 cells/mm³.

IV

HIV infected: 400 mg every 12 hours.

Treatment of Travelers’ Diarrhea†

Oral

Conventional tablets or oral suspension: 500 once or twice daily for 1–3 days or 750 mg once daily for 1–3 days.

Extended-release tablets: 500 mg or 1 g once daily for 1–3 days.

HIV-infected (conventional tablets or oral suspension): 500–750 mg every 12 hours. If no clinical response after 3–4 days, consider stool culture and in vitro susceptibility testing.

IV

HIV-infected: 400 mg every 12 hours.

If no clinical response after 3–4 days, consider stool culture and in vitro susceptibility testing.

Prevention of Travelers’ Diarrhea†

Oral

Conventional tablets or oral suspension: 500 mg once daily.

Anti-infective prophylaxis generally discouraged (see GI Infections under Uses); if such prophylaxis used, give during period of risk (not exceeding 2–3 weeks) beginning day of travel and continuing for 1 or 2 days after leaving area of risk.

Intra-abdominal Infections

Complicated Infections

Oral

500 mg every 12 hours given in conjunction with metronidazole.

Manufacturers recommend total treatment duration of 7–14 days. IDSA recommends treatment duration of 4–7 days; longer duration not associated with improved outcome and not recommended unless adequate source control difficult to achieve.

IV

400 mg IV every 12 hours given in conjunction with metronidazole.

Manufacturers recommends total treatment duration of 7–14 days. IDSA recommends treatment duration of 4–7 days; longer duration not associated with improved outcome and not recommended unless adequate source control difficult to achieve.

Meningitis and CNS Infections†

Gram-negative Meningitis†

IV

400 mg every 8 hours has been used alone or in conjunction with an aminoglycoside. Alternatively, 800–1200 mg daily has been recommended.

Healthcare-associated ventriculitis and meningitis: IDSA recommends 800–1200 mg daily given in divided doses every 8–12 hours.

Otic Infections†

Malignant Otitis Externa†

Oral

750 mg twice daily has been used. Although rapid relief of symptoms (pain, otorrhea) may occur, continue treatment for 6–8 weeks.

Because ciprofloxacin-resistant Ps. aeruginosa have been isolated from patients with malignant otitis externa with increasing frequency, in vitro susceptibility testing is indicated, especially if there is an inadequate response to treatment.

Respiratory Tract Infections

Acute Bacterial Sinusitis

Oral

500 mg every 12 hours for 10 days. (See Respiratory Tract Infections under Uses.)

IV

400 mg every 12 hours for 10 days. (See Respiratory Tract Infections under Uses.)

Lower Respiratory Tract Infections

Oral

500–750 mg every 12 hours for 7–14 days.

IV

400 mg every 8 to 12 hours; use 400 mg IV every 8 hours for severe or complicated infections. Usual treatment duration is 7–14 days.

Nosocomial Pneumonia

IV

400 mg every 8 hours for HAP and VAP.

Manufacturer recommends a treatment duration of 10–14 days. IDSA recommends treatment duration of 7 days, but longer or shorter duration may be indicated depending on clinical response.

Skin and Skin Structure Infections

Oral

500–750 mg every 12 hours for 7–14 days.

IV

400 mg every 8 to 12 hours for 7–14 days.

Urinary Tract Infections (UTIs) and Prostatitis

Acute, Uncomplicated Cystitis

Oral

Conventional tablets or oral suspension: 250 mg every 12 hours for 3 days. (See Urinary Tract Infections [UTIs] and Prostatitis under Uses.)

Extended-release tablets: 500 mg once every 24 hours for 3 days. (See Urinary Tract Infections [UTIs] and Prostatitis under Uses.)

Complicated UTIs and Pyelonephritis

Oral

Conventional tablets or oral suspension: 250–500 mg every 12 hours for 7–14 days.

Extended-release tablets: 1 g once every 24 hours for 7–14 days.

IV

200–400 mg every 8 or 12 hours for 7–14 days.

Chronic Bacterial Prostatitis

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 28 days.

IV

400 mg every 12 hours for 28 days.

Anthrax

Postexposure Prophylaxis of Anthrax (Biologic Warfare or Bioterrorism Exposure)

Oral

500 mg every 12 hours.

Initiate prophylaxis as soon as possible following suspected or confirmed exposure.

Because of possible persistence of B. anthracis spores in lung tissue following an aerosol exposure, CDC and others recommend that postexposure prophylaxis be continued for 60 days following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures).

IV

400 mg every 12 hours for 60 days.

Treatment of Systemic Anthrax (Biologic Warfare or Bioterrorism Exposure)†

IV

400 mg IV every 8 hours.

Used in multiple-drug parenteral regimen for initial treatment of systemic anthrax (inhalational, GI, meningitis, or cutaneous with systemic involvement, lesions on the head or neck, or extensive edema). Continue parenteral regimen for ≥2–3 weeks until patient is clinically stable and can be switched to appropriate oral anti-infective.

If systemic anthrax occurred after exposure to B. anthracis spores in the context of biologic warfare or bioterrorism, continue oral follow-up regimen until 60 days after illness onset.

Oral

500 mg every 12 hours given for ≥60 days.

Initial multiple-drug parenteral regimen recommended; use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).

If systemic anthrax occurred after exposure to B. anthracis spores in the context of biologic warfare or bioterrorism, continue oral follow-up regimen until 60 days after illness onset.

Treatment of Uncomplicated Cutaneous Anthrax (Biologic Warfare or Bioterrorism Exposure)†

Oral

500 mg every 12 hours.

Recommended duration is 60 days if cutaneous anthrax occurred after exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism.

Treatment of Uncomplicated Cutaneous Anthrax (Naturally Occurring or Endemic Exposure)†

Oral

500 mg every 12 hours.

Duration of 3–10 days may be sufficient if uncomplicated cutaneous anthrax occurred as the result of naturally occurring or endemic exposure (e.g., known exposure to infected livestock or their products).

IV

400 mg every 12 hours.

Duration of 3–10 days may be sufficient if uncomplicated cutaneous anthrax occurred as the result of naturally occurring or endemic exposure (e.g., known exposure to infected livestock or their products).

Postexposure Prophylaxis Following Ingestion of B. anthracis Spores in Contaminated Meat†

Oral

500 mg every 12 hours has been recommended.

Duration of 7–14 days can be considered for prophylaxis following a naturally occurring GI exposure (e.g., ingestion of meat from undercooked carcass of an anthrax-infected animal).

Brucella Infections†

Oral

500 mg twice daily in conjunction with oral rifampin (600 mg once daily). Alternatively, 500 mg 2 or 3 times daily for 6–12 weeks or 750 mg 3 times daily for 6–8 weeks has been used for brucellosis or acute brucella arthritis-diskitis. Monotherapy or treatment regimens <4–6 weeks not recommended.

Chancroid†

Oral

500 mg twice daily for 3 days recommended by CDC.

Crohn’s Disease†

Oral

500 mg twice daily (with or without metronidazole) has been used as an adjunct to conventional therapies for induction of remission of mildly to moderately active disease.

Gonorrhea and Associated Infections

Uncomplicated Urethral, Endocervical, Rectal†, or Pharyngeal† Gonorrhea

Oral

250 mg as a single dose recommended by manufacturer.

No longer recommended by CDC for treatment of gonorrhea. (See Gonorrhea and Associated Infections under Uses.)

Granuloma Inguinale (Donovanosis)†

Oral

750 mg twice daily for ≥3 weeks and until all lesions have healed completely; consider adding IV aminoglycoside (gentamicin 1 mg/kg IV every 8 hours) if improvement not evident within first few days of treatment.

Relapse can occur 6–18 months after apparently effective treatment.

Legionnaires’ Disease†

Oral

500 mg every 12 hours for 2–3 weeks.

IV

400 mg every 12 hours for 2–3 weeks.

Mycobacterial Infections†

Oral

750 mg twice daily has been used in multiple-drug regimens for treatment of infections caused by M. avium complex (MAC).

Neisseria meningitidis Infections†

Elimination of Pharyngeal Carrier State†

Oral

500 mg as a single dose.

Chemoprophylaxis in Household or Other Close Contacts†

Oral

500 mg as a single dose.

Plague

Treatment of Plague

Oral

500–750 mg every 12 hours for 14 days.

Some experts (e.g., US Working Group on Civilian Biodefense, USAMRIID) recommend 500–750 mg twice daily for treatment of plague that occurs as the result of exposure to Y. pestis in the context of biologic warfare or bioterrorism.

Initial parenteral regimen preferred; use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting). Total treatment duration should be at least 10–14 days.

IV, then Oral

400 mg IV every 8 to 12 hours for 14 days.

Some experts (e.g., US Working Group on Civilian Biodefense, USAMRIID) recommend 400 mg IV every 12 hours for treatment of plague that occurs as the result of exposure to Y. pestis in the context of biologic warfare or bioterrorism.

When clinical improvement occurs, IV ciprofloxacin may be switched to oral ciprofloxacin. Total treatment duration should be at least 10–14 days.

Postexposure Prophylaxis of Plague

Oral

500–750 mg every 12 hours for 14 days.

Some experts (e.g., US Working Group on Civilian Biodefense, USAMRIID) recommend 500 mg twice daily following exposures that occur in the context of biologic warfare or bioterrorism.

Initiate prophylaxis as soon as possible after suspected or confirmed exposure.

Close contacts of patients with pneumonic plague or individuals exposed to plague aerosol (e.g., in the context of biologic warfare or bioterrorism): Continue prophylaxis for 7 days or for duration of risk of exposure plus 7 days. If fever or cough develops during prophylaxis, switch to regimen recommended for treatment of plague.

IV

400 mg every 8 to 12 hours for 14 days.

Tularemia†

Treatment of Tularemia Occurring in the Context of Biologic Warfare or Bioterrorism†

Oral

500 mg twice daily.

Initial parenteral regimen preferred; use oral regimen after improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting). Total treatment duration should be at least 10–14 days.

IV, then Oral

400 mg IV every 12 hours.

When clinical improvement occurs, switch IV ciprofloxacin to oral ciprofloxacin. Total treatment duration should be at least 10–14 days.

Postexposure Prophylaxis Following High-risk Exposure†

Oral

500 mg every 12 hours.

Initiate prophylaxis within 24 hours of exposure and continue for at least 14 days.

Typhoid Fever and Other Invasive Salmonella Infections

Mild to Moderate Typhoid Fever

Oral

500 mg every 12 hours for 10 days.

Chronic Typhoid Carriers†

Oral

750 mg every 12 hours for 28 days.

Vibrio Infections†

Cholera†

Oral

1 g given as a single dose or in 2 divided doses 12 hours apart has been used for treatment of cholera caused by V. cholerae 01 or 0139.

Perioperative Prophylaxis†

Oral

Single 500-mg dose given prior to the procedure. (See Perioperative Prophylaxis under Uses.)

IV

Single 400-mg dose given within 1–2 hours prior to the procedure or initial incision. (See Perioperative Prophylaxis under Uses.)

Empiric Therapy in Febrile Neutropenic Patients

IV

400 mg every 8 hours for 7–14 days; has been used in conjunction with IV piperacillin (50 mg/kg every 4 hours, not to exceed 24 g/daily or 300 mg/kg daily).

Prescribing Limits

Pediatric Patients

Urinary Tract Infections (UTIs)

Complicated UTIs and Pyelonephritis

Oral

Children 1–17 years of age: Maximum 750 mg every 12 hours, even in those weighing >51 kg.

IV

Children 1–17 years of age: Maximum 400 mg every 8 hours, even in those weighing >51 kg.

Treatment or Postexposure Prophylaxis of Anthrax or Plague

Oral

Neonates, infants, and children ≤17 years of age: Maximum 500 mg per dose.

IV

Neonates, infants, and children ≤17 years of age: Maximum 400 mg per dose.

Special Populations

Hepatic Impairment

Manufacturers make no specific dosage recommendations for patients with impaired hepatic function. Carefully monitor patients who have both hepatic and renal impairment. (See Renal Impairment under Dosage and Administration.)

No clinically important pharmacokinetic changes in patients with stable chronic cirrhosis; pharmacokinetics not fully studied in those with acute hepatic insufficiency.

Renal Impairment

Dosage adjustments may be necessary in adults with renal impairment, especially those with severe impairment. Dosage recommendations not available for pediatric patients with moderate to severe renal impairment (Cl_cr <50 mL/minute per 1.73 m²).

Conventional tablets or oral suspension: Decrease dosage in adults with Cl_cr ≤50 mL/minute. (See Table 1.) Manufacturer states a dosage of 750 mg given at the intervals noted in Table 1 may be used with close monitoring in adults with severe infections and severe renal impairment.

Extended-release tablets: Dosage adjustments not needed when 500-mg extended-release tablet used for treatment of uncomplicated UTIs (acute cystitis) in adults with renal impairment. Decreased dosage recommended when used for treatment of complicated UTIs or acute uncomplicated pyelonephritis in adults with Cl_cr ≤30 mL/minute. (See Table 2.) Do not use 1-g extended-release tablets in adults who have Cl_cr ≤30 mL/minute or are undergoing hemodialysis or peritoneal dialysis.

IV ciprofloxacin: Decrease dosage in those with Cl_cr <30 mL/minute. (See Table 3.)

Geriatric Patients

No dosage adjustments except those related to renal impairment. (See Renal Impairment under Dosage and Administration.)

Select dosage with caution because of possible age-related decreases in renal impairment.

Cautions for Ciprofloxacin

Contraindications

• Known hypersensitivity to ciprofloxacin, any quinolone, or any ingredient in the formulation.

• Concomitant use with tizanidine. (See Interactions.)

Warnings/Precautions

Warnings

Disabling and Potentially Irreversible Serious Adverse Reactions

Systemic fluoroquinolones, including ciprofloxacin, associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient. May occur within hours to weeks after systemic fluoroquinolone initiated; have occurred in all age groups and in patients without preexisting risk factors for such adverse reactions.

Immediately discontinue ciprofloxacin at first signs or symptoms of any serious adverse reactions.

Avoid systemic fluoroquinolones, including ciprofloxacin, in patients who have experienced any of the serious adverse reactions associated with fluoroquinolones.

Tendinitis and Tendon Rupture

Systemic fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.

Risk of fluoroquinolone-associated tendinitis and tendon rupture is increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients. (See Geriatric Use under Cautions.)

Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any risk factors for such adverse reactions.

Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon; also reported in rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites.

Tendinitis or tendon rupture can occur within hours or days after ciprofloxacin initiated or as long as several months after completion of therapy and can occur bilaterally.

Immediately discontinue ciprofloxacin if pain, swelling, inflammation, or rupture of a tendon occurs. (See Advice to Patients.)

Avoid systemic fluoroquinolones, including ciprofloxacin, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.

Peripheral Neuropathy

Systemic fluoroquinolones, including ciprofloxacin, are associated with an increased risk of peripheral neuropathy.

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with systemic fluoroquinolones, including ciprofloxacin. Symptoms may occur soon after initiation of the drug and, in some patients, may be irreversible.

Immediately discontinue ciprofloxacin if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur or if there are other alterations in sensations (e.g., light touch, pain, temperature, position sense, vibratory sensation) and/or motor strength. (See Advice to Patients.)

Avoid systemic fluoroquinolones, including ciprofloxacin, in patients who have experienced peripheral neuropathy.

CNS Effects

Systemic fluoroquinolones, including ciprofloxacin, are associated with increased risk of adverse psychiatric effects, including toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, paranoia, depression, self-injurious behavior such as attempted or completed suicide, anxiety, agitation, delirium, confusion, disorientation, disturbances in attention, nervousness, insomnia, nightmares, and memory impairment. These adverse effects may occur after first dose.

Systemic fluoroquinolones, including ciprofloxacin, are associated with increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors. Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. Status epilepticus reported.

Use with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower seizure threshold (e.g., severe cerebral arteriosclerosis, history of convulsions, reduced cerebral blood flow, altered brain structure, stroke) or other risk factors that may predispose to seizures or lower seizure threshold (e.g., certain drug therapy, renal dysfunction).

If psychiatric or other CNS effects occur, immediately discontinue ciprofloxacin and institute appropriate measures. (See Advice to Patients.)

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in myasthenia gravis patients; death or need for ventilatory support reported.

Avoid use in patients with known history of myasthenia gravis. (See Advice to Patients.)

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported in patients receiving fluoroquinolones, including ciprofloxacin. These reactions may occur with first dose.

Some hypersensitivity reactions have been accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.

Other serious and sometimes fatal adverse reactions reported with fluoroquinolones, including ciprofloxacin, that may or may not be related to hypersensitivity reactions include one or more of the following: fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome); vasculitis, arthralgia, myalgia, serum sickness; allergic pneumonitis; interstitial nephritis, acute renal insufficiency or failure; hepatitis, jaundice, acute hepatic necrosis or failure; anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia, and/or other hematologic effects.

Immediately discontinue ciprofloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity. Initiate appropriate therapy (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen) as indicated.

Photosensitivity Reactions

Moderate to severe photosensitivity/phototoxicity reactions reported with fluoroquinolones, including ciprofloxacin.

Phototoxicity may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) on areas exposed to sun or artificial ultraviolet (UV) light (usually the face, neck, extensor surfaces of forearms, dorsa of hands).

Avoid unnecessary or excessive exposure to sunlight or artificial UV light (sunlamps, tanning beds, UVA/UVB treatment) while receiving ciprofloxacin. If patient needs to be in sunlight, they should use sunscreen and wear a hat and clothing that protects skin from sun exposure. (See Advice to Patients.)

Discontinue ciprofloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.

Other Warnings/Precautions

Hepatotoxicity

Severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, reported. Most fatalities have occurred in adults >55 years of age.

Acute liver injury has rapid onset (range 1–39 days) and is often associated with hypersensitivity. Pattern of injury can be hepatocellular, cholestatic, or mixed.

Temporary increases in aminotransferase or alkaline phosphatase concentrations or cholestatic jaundice may occur, especially in patients with previous liver damage.

Immediately discontinue ciprofloxacin if any signs or symptoms of hepatitis (e.g., anorexia, jaundice, dark urine, pruritus, tender abdomen) occur. (See Advice to Patients.)

Risk of Aortic Aneurysm and Dissection

Rupture or dissection of aortic aneurysms reported in patients receiving systemic fluoroquinolones. Epidemiologic studies indicate an increased risk of aortic aneurysm and dissection within 2 months following use of systemic fluoroquinolones, particularly in elderly patients. Cause for this increased risk not identified.

Unless there are no other treatment options, do not use systemic fluoroquinolones, including ciprofloxacin, in patients who have an aortic aneurysm or are at increased risk for an aortic aneurysm. This includes elderly patients and patients with peripheral atherosclerotic vascular disease, hypertension, or certain genetic conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome).

If patient reports adverse effects suggestive of aortic aneurysm or dissection, immediately discontinue the fluoroquinolone. (See Advice to Patients.)

Prolongation of QT Interval

Prolonged QT interval leading to ventricular arrhythmia, including torsades de pointes, reported with fluoroquinolones, including ciprofloxacin.

Avoid use in patients with history of prolonged QT interval or with risk factors for QT interval prolongation or torsades de pointes (e.g., congenital long QT syndrome, uncorrected electrolyte imbalance such as hypokalemia or hypomagnesemia, cardiac disease such as heart failure, MI, or bradycardia).

Avoid in patients receiving class IA (e.g., quinidine, procainamide) or III (e.g., amiodarone, sotalol) antiarrhythmic agents or other drugs known to prolong QT interval (e.g., macrolides, antipsychotic agents, tricyclic antidepressants).

Risk of prolonged QT interval may be increased in geriatric patients. (See Geriatric Use under Cautions.)

Hypoglycemia or Hyperglycemia

Systemic fluoroquinolones are associated with alterations in blood glucose concentrations, including symptomatic hypoglycemia and hyperglycemia. Blood glucose disturbances during fluoroquinolone therapy usually have occurred in patients with diabetes mellitus receiving an oral antidiabetic agent (e.g., glyburide) or insulin.

Severe cases of hypoglycemia resulting in coma or death reported with some systemic fluoroquinolones. Although most reported cases of hypoglycemic coma involved patients with risk factors for hypoglycemia (e.g., older age, diabetes mellitus, renal insufficiency, concomitant use of antidiabetic agents [especially sulfonylureas]), some involved patients receiving a fluoroquinolone who were not diabetic and not receiving an oral antidiabetic agent or insulin.

Carefully monitor blood glucose concentrations when ciprofloxacin used in diabetic patients receiving antidiabetic agents.

If hypoglycemic reaction occurs, discontinue ciprofloxacin and immediately initiate appropriate therapy. (See Advice to Patients.)

Musculoskeletal Effects

Increased incidence of musculoskeletal disorders related to joints and/or surrounding tissues (e.g., arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, myalgia, arm pain, decreased range of motion in a joint) reported in pediatric patients receiving ciprofloxacin. Usually mild to moderate in intensity; events occurring within first 6 weeks of ciprofloxacin treatment usually resolve (clinical resolution of signs and symptoms) within 30 days after treatment ends. Use ciprofloxacin in pediatric patients <18 years of age only for certain indications. (See Pediatric Use under Cautions.)

Fluoroquinolones, including ciprofloxacin, cause arthropathy and osteochondrosis in immature animals of various species. Permanent lesions of the cartilage and lameness reported in ciprofloxacin studies in immature dogs.

Superinfection/C. difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridioides difficile (formerly known as Clostridium difficile). C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including ciprofloxacin, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile as soon as possible. Manage using appropriate anti-infective therapy directed against C. difficile (e.g., vancomycin, fidaxomicin, metronidazole), supportive therapy (e.g., fluid and electrolyte management, protein supplementation), and surgical evaluation as clinically indicated.

Interactions

Pharmacokinetic interaction with CYP1A2 substrates (e.g., clozapine, methylxanthines [e.g., caffeine, theophylline], olanzapine, ropinirole, tizanidine).

Concomitant use with tizanidine contraindicated. Avoid concomitant use with theophylline since serious and sometimes fatal reactions (e.g., cardiac arrest, seizure, status epilepticus, respiratory failure) reported. In addition, concomitant use with other CYP1A2 substrates should be avoided or requires particular caution. (See Specific Drugs under Interactions.)

Renal Effects

Possible crystalluria; generally associated with alkaline urine and high dosage.

Adequate fluid intake necessary to ensure proper hydration and adequate urinary output; avoid alkaline urine.

Resistance in Neisseria gonorrhoeae

N. gonorrhoeae with decreased susceptibility to ciprofloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) has been reported with increasing frequency over the past several years.

US data indicate that QRNG has continued to increase among men who have sex with men and among heterosexual males and is now present in all regions of the country.

CDC states that fluoroquinolones, including ciprofloxacin, are no longer recommended for treatment of gonorrhea and should not be used routinely for any associated infections that may involve N. gonorrhoeae (e.g., PID, epididymitis).

Selection and Use of Anti-infectives

Use for treatment of acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, or uncomplicated UTIs only when no other treatment options available. Because ciprofloxacin, like other systemic fluoroquinolones, has been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient, risks of serious adverse reactions outweigh benefits for patients with these infections.

To reduce development of drug-resistant bacteria and maintain effectiveness of ciprofloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

Information on test methods and quality control standards for in vitro susceptibility testing of antibacterial agents and specific interpretive criteria for such testing recognized by FDA is available at [Web].

Specific Populations

Pregnancy

No adequate and controlled studies in pregnant women; expert review of published data concluded that therapeutic doses of ciprofloxacin during pregnancy unlikely to pose a substantial teratogenic risk, but data insufficient to state that there is no risk.

Use during pregnancy only if potential benefits justify potential risks to fetus and mother.

CDC states oral ciprofloxacin is preferred drug for initial anti-infective postexposure prophylaxis in pregnant and postpartum women exposed to B. anthracis spores in the context of biologic warfare or bioterrorism. CDC also states oral ciprofloxacin is preferred drug for treatment of uncomplicated cutaneous anthrax and IV ciprofloxacin is preferred bactericidal component of multiple-drug regimens for treatment of systemic anthrax in pregnant and postpartum women.

Animal studies (rats and mice) using oral ciprofloxacin did not reveal evidence of harm to the fetus. In rabbits, oral ciprofloxacin caused GI toxicity resulting in maternal weight loss and increased incidence of abortion, but no evidence of teratogenicity; IV ciprofloxacin did not result in maternal toxicity, embryotoxicity, or teratogenicity.

Lactation

Distributed into milk; discontinue nursing or the drug.

AAP states maternal use of ciprofloxacin usually is compatible with breast-feeding since absorption of the drug by nursing infants would be negligible and adverse effects in infants have not been reported to date following such exposures.

CDC states recommendations for use of ciprofloxacin in breast-feeding women for postexposure prophylaxis following a suspected or confirmed exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism and treatment of uncomplicated cutaneous anthrax or systemic anthrax in such situations are the same as those for other adults.

Pediatric Use

Ciprofloxacin causes arthropathy and histologic changes in weight-bearing joints of juvenile animals. An increased incidence of musculoskeletal disorders related to joints and/or surrounding tissues reported in pediatric patients. (See Musculoskeletal Effects under Cautions.)

IV, conventional tablets, oral suspension: Labeled by FDA for treatment of complicated UTIs and pyelonephritis caused by susceptible E. coli in pediatric patients 1–17 years of age, inhalational anthrax (postexposure) in infants and children ≤17 years of age, and treatment or prophylaxis of plague in infants and children ≤17 years of age. Safety and efficacy not established for any other indication in pediatric patients.

AAP and other experts (e.g., AHA, IDSA) state that use of ciprofloxacin (IV, conventional tablets, oral suspension) may also be justified in children <18 years of age in certain specific circumstances when there are no safe and effective alternatives (e.g., endocarditis, typhoid fever, multidrug-resistant gram-negative infections) and after careful assessment of the risks and benefits for the individual patient.

Extended-release tablets: Safety and efficacy not established for any indication in children and adolescents <18 years of age; do not use for any indication in pediatric patients.

Geriatric Use

Retrospective analysis of controlled clinical trials and results of a prospective, randomized study indicate no substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

Risk of fluoroquinolone-associated disorders, including tendon rupture, is increased in geriatric adults >60 years of age. This risk is further increased in those receiving concomitant corticosteroids. (See Tendinitis and Tendon Rupture under Cautions.) Use caution in geriatric adults, especially those receiving concomitant corticosteroids.

Risk of prolonged QT interval leading to ventricular arrhythmias may be increased in geriatric patients. Use with caution in those receiving concurrent therapy with drugs that can prolong QT interval (e.g., class IA or III antiarrhythmic agents) or those with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia).

Risk of fluoroquinolone-associated aortic aneurysm and dissection may be increased in geriatric patients. (See Risk of Aortic Aneurysm and Dissection under Cautions.)

Age-related decline in renal function may increase risk of adverse reactions.

Hepatic Impairment

Carefully monitor patients with both hepatic and renal impairment.

Renal Impairment

Increased ciprofloxacin concentrations and prolonged half-life; possible increased risk of adverse reactions.

Dosage adjustments necessary in patients with renal impairment. (See Renal Impairment under Dosage and Administration.)

Carefully monitor patients with both hepatic and renal impairment.

Common Adverse Effects

GI effects (nausea, diarrhea, vomiting, abdominal pain/discomfort), headache, dizziness, restlessness, rash.

Drug Interactions

Inhibits CYP1A2.

Drugs Metabolized by Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction with CYP1A2 substrates (increased concentrations and increased pharmacologic or adverse effects of CYP1A2 substrate).

Drugs that Prolong QT Interval

Potential pharmacologic interactions (additive effect on QT interval prolongation). Avoid use in patients receiving drugs known to prolong QT interval. If concomitant use necessary, use with caution. (See Prolongation of QT Interval under Cautions.)

Specific Drugs

Ciprofloxacin Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed from GI tract; undergoes minimal first-pass metabolism.

Oral bioavailability of conventional tablets is 50–85% in healthy, fasting adults; peak serum concentrations attained within 0.5–2.3 hours.

A 500-mg dose given as the oral suspension containing 250 mg/5 mL is bioequivalent to a 500-mg conventional tablet. A 500-mg dose given as 10 mL of the oral suspension containing 250 mg/5 mL is bioequivalent to 500-mg dose given as 5 mL of the oral suspension containing 500 mg/5 mL.

Extended-release tablets: Peak plasma concentrations attained within 1–4 hours. Extended-release tablets contain approximately 35% of the dose within an immediate-release component; the remaining 65% is contained in a slow-release matrix.

Extended-release tablets are not bioequivalent to conventional tablets.

Food or Milk

Effect of food and/or milk on GI absorption of ciprofloxacin varies depending on the specific preparation (conventional tablets, extended-release tablets, oral solution) and situation.

Administration of ciprofloxacin conventional tablets with food results in a delay in absorption of the drug, but overall absorption not substantially affected.

Manufacturer states food does not affect pharmacokinetics of ciprofloxacin oral suspension.

Manufacturers state that, based on pharmacokinetic studies, extended-release tablets can be administered with or without food (e.g., with a high- or low-fat meal or under fasting conditions).

Concomitant administration with dairy products (e.g., milk, yogurt) or calcium-fortified juices alone (i.e., without a meal) or with substantial calcium intake (>800 mg) may affect absorption. Manufacturers state oral ciprofloxacin can be taken with dairy products or calcium-fortified juices that are part of a meal.

Concomitant administration of conventional ciprofloxacin tablets with a nutritional supplement may decrease peak plasma concentrations and/or AUC of the drug.

Special Populations

Bioavailability of oral suspension is approximately 60% in pediatric patients.

Peak serum concentrations and AUCs are slightly higher in geriatric patients than in younger adults; this may occur because of increased bioavailability, reduced volume of distribution, and/or reduced renal clearance. Not considered clinically important.

Distribution

Extent

Widely distributed into body tissues and fluids following oral or IV administration. Highest concentrations attained in bile, lungs, kidney, liver, gallbladder, uterus, seminal fluid, prostatic tissue and fluid, tonsils, endometrium, fallopian tubes, and ovaries. Concentrations achieved in most of these tissues and fluids substantially exceed those in serum.

Also distributed into bone, aqueous humor, sputum, saliva, nasal secretions, skin, muscle, adipose tissue, cartilage, heart tissue (heart valves, myocardia), and pleural, peritoneal, ascitic, blister, lymphatic, and renal cyst fluid.

Low concentrations distributed into CSF; peak CSF concentrations may be 6–10% of peak serum concentrations.

Crosses the placenta and is distributed into amniotic fluid.

Distributed into milk.

Plasma Protein Binding

16–43%.

Elimination

Metabolism

Partially metabolized in liver to at least 4 metabolites. Metabolites have microbiologic activity less than that of the parent drug, but some have activity similar to or greater than that of some other quinolones.

Elimination Route

Eliminated by renal and nonrenal mechanisms.

Excreted in urine by both glomerular filtration and tubular secretion (15–50% of dose is unchanged drug and 10–15% is metabolites). Approximately 20–40% of dose is excreted in feces as unchanged drug and metabolites; most of unchanged ciprofloxacin in feces results from biliary excretion.

Only small amounts removed by hemodialysis or peritoneal dialysis.

Half-life

Adults with normal renal function: 3–7 hours.

Special Populations

Pediatric patients: Predicted mean half-life is 4–5 hours.

Geriatric patients: Elimination half-life is slightly longer compared with younger adults. Half-life is 3.3–6.8 hours in adults 60–91 years of age with renal function normal for their age.

Adults with hepatic impairment: Half-life may be slightly prolonged.

Patients with impaired renal function: Serum concentrations are higher and half-life prolonged. Half-life is 4.4–12.6 hours in adults with Cl_cr ≤30 mL/minute.

Stability

Storage

Oral

Tablets

Conventional tablets: 20–25°C (may be exposed to 15–30°C).

Extended-release tablets: 20–25°C in tight, light-resistant container.

For Suspension

<25°C (may be exposed to 15–30°C). Following reconstitution, stable at 25°C (may be exposed to 15–30°C) for 14 days. Do not freeze.

Parenteral

Concentrate for IV Infusion

Vials: 5–30°C. Protect from light and excessive heat; do not freeze.

IV infusions containing 0.5–2 mg/mL prepared using sterile water, 0.9% sodium chloride, 5 or 10% dextrose, 5% dextrose and 0.225 or 0.45% sodium chloride, or lactated Ringer’s are stable for up to 14 days refrigerated or at room temperature.

Premixed Injection in 5% Dextrose

5–25°C. Protect from light and excessive heat; do not freeze.

Compatibility

Parenteral

Solution CompatibilityHID

Drug Compatibility

Actions and Spectrum

• Usually bactericidal.

• Like other fluoroquinolones, ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV.

• Spectrum of activity includes many gram-positive aerobic bacteria, many gram-negative aerobic bacteria, a few anaerobic bacteria, and some other organisms (e.g., Chlamydia, Mycoplasma, Mycobacterium, Rickettsia). Inactive against fungi and viruses.

• Generally less active against gram-positive than gram-negative bacteria.

• Gram-positive aerobic cocci: Active in vitro and in clinical infections against S. aureus (methicillin-susceptible [oxacillin-susceptible] strains only), S. epidermidis (oxacillin-susceptible strains only), S. pneumoniae (penicillin-susceptible strains), S. pyogenes (group A β-hemolytic streptococci), S. saprophyticus, and Enterococcus faecalis. Also active in vitro against some other staphylococci (e.g., S. haemolyticus, S. hominis), some penicillin-resistant S. pneumoniae, viridans streptococci, groups C, F, and G streptococci, and nonenterococcal group D streptococci.

• Gram-positive aerobic bacilli: Active against Bacillus anthracis, Corynebacterium, and Listeria monocytogenes. Nocardia asteroides are resistant.

• Gram-negative aerobes: Active in vitro and in clinical infections against Campylobacter jejuni, H. influenzae, H. parainfluenzae, M. catarrhalis, Ps. aeruginosa, and most Enterobacteriaceae (including Citrobacter, Edwardsiella, Enterobacter, E. coli, Klebsiella, M. morganii, P. mirabilis, P. vulgaris, Providencia, Salmonella, Shigella, Serratia, Yersinia enterocolitica). Also active in vitro against Acinetobacter, Aeromonas, Brucella, Francisella tularensis, Legionella pneumophila, Vibrio, and Yersinia pestis. However, Burkholderia cepacia and Stenotrophomonas maltophilia are resistant.

• Other organisms: Active in vitro and in clinical infections against by C. pneumoniae, M. pneumoniae, M. tuberculosis, and other mycobacteria.

• N. gonorrhoeae with decreased susceptibility to ciprofloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) widely disseminated worldwide, including in the US.

• Resistance to fluoroquinolones, including ciprofloxacin, can occur as the result of mutations in the target DNA type II topoisomerase enzymes and mutations that result in alterations in membrane permeability and/or efflux pumps.

• Some cross-resistance occurs between ciprofloxacin and other fluoroquinolones.

Advice to Patients

• Advise patients to read manufacturer’s patient information (medication guide) prior to initiating ciprofloxacin therapy and each time prescription refilled.

• Advise patients that antibacterials (including ciprofloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).

• Importance of completing full course of therapy, even if feeling better after a few days.

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ciprofloxacin or other antibacterials in the future.

• May be taken without regard to meals, but do not take with dairy products (e.g., milk, yogurt) or calcium-fortified juices alone (without a meal) since absorption of the drug may be decreased.

• Importance of taking ciprofloxacin at least 2 hours before or 6 hours after multivitamins containing calcium, magnesium, or zinc; aluminum- or magnesium-containing antacids; or buffered didanosine (pediatric oral suspension admixed with antacids).

• Importance of drinking fluids liberally during therapy to avoid formation of highly concentrated urine and crystal formation in urine.

• Advise patients that regular consumption of large quantities of coffee, tea, or caffeine-containing soft drinks or drugs during treatment may result in exaggerated or prolonged caffeine effects.

• Inform patients that systemic fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that may occur together in same patient. Advise patients to immediately discontinue ciprofloxacin and contact a clinician if they experience any signs or symptoms of serious adverse effects (e.g., unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness of the arms or legs, confusion, hallucinations) while taking the drug. Advise patients to talk with clinician if they have any questions or concerns.

• Inform patients that systemic fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups and this risk is increased risk in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients. Symptoms may be irreversible. Importance of resting and refraining from exercise at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint) and importance of immediately discontinuing the drug and contacting a clinician. (See Tendinitis and Tendon Rupture under Cautions.)

• Inform patients that peripheral neuropathies have been reported with systemic fluoroquinolones, including ciprofloxacin, and that symptoms may occur soon after initiation of the drug and may be irreversible. Importance of immediately discontinuing ciprofloxacin and contacting a clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur.

• Inform patients that systemic fluoroquinolones, including ciprofloxacin, have been associated with CNS effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure). Importance of informing clinician about any history of convulsions before initiating therapy with the drug. Importance of contacting a clinician if persistent headache with or without blurred vision occurs.

• Advise patients that ciprofloxacin may cause dizziness and lightheadedness; caution patients not to engage in activities requiring mental alertness and motor coordination (e.g., driving a vehicle, operating machinery) until effects of the drug on the individual are known.

• Advise patients that systemic fluoroquinolones, including ciprofloxacin, may worsen myasthenia gravis symptoms; importance of informing clinician of any history of myasthenia gravis. Importance of immediately contacting a clinician if any symptoms of muscle weakness, including respiratory difficulties, occur.

• Inform patients that ciprofloxacin may be associated with hypersensitivity reactions (including anaphylactic reactions), even after first dose. Importance of immediately discontinuing ciprofloxacin and informing a clinician at first sign of rash, hives, other skin reaction, jaundice, rapid heartbeat, difficulty swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of lips, tongue, or face; tightness of throat; hoarseness), or any other sign of hypersensitivity.

• Inform patients that photosensitivity/phototoxicity reactions reported following exposure to sun or UV light in patients receiving fluoroquinolones. Importance of avoiding or minimizing exposure to sunlight or artificial UV light (e.g., sunlamps, tanning beds, UVA/UVB treatment) and using protective measures (e.g., sunscreen, wearing a hat and clothing that covers the skin) if in sunlight during ciprofloxacin therapy. Importance of discontinuing ciprofloxacin and contacting a clinician if a sunburn-like reaction or skin eruption occurs.

• Inform patients that systemic fluoroquinolones may increase risk of aortic aneurysm and dissection; importance of informing clinician of any history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome. Advise patients to seek immediate medical treatment if they experience sudden, severe, and constant pain in the stomach, chest, or back.

• Advise patients that hypoglycemia has been reported in patients receiving ciprofloxacin and oral antidiabetic agents. If low blood glucose occurs, importance of contacting clinician to determine whether the anti-infective should be changed.

• Inform patients that severe hepatotoxicity, including acute hepatitis and some fatalities, reported. Importance of immediately discontinuing ciprofloxacin and contacting a clinician if any signs or symptoms of hepatotoxicity (e.g., loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of skin or eyes, light colored bowel movements, dark colored urine) occur.

• Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia) or current therapy with any class IA (e.g., quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmic agents. Importance of contacting clinician if any symptoms of prolongation of QT interval (e.g., prolonged heart palpitations, loss of consciousness) occur.

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

• If considering ciprofloxacin for a pediatric patient (see Pediatric Use under Cautions), importance of parent informing clinician if the child has a history of joint-related problems. Importance of parent contacting a clinician if the child develops any joint-related problems during or following ciprofloxacin therapy.

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., drugs that may affect QT interval, tizanidine, theophylline, antidiabetic agent, warfarin), as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of advising patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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