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.^{1 181 205 206 479 481 579 856}

Uses for Ciprofloxacin

Bone and Joint Infections

Treatment of bone and joint infections (including osteomyelitis)^{205 296 326 362 365 367 368 369 370 371 375 479 535 590 591 706} caused by susceptible Pseudomonas aeruginosa,^{1 205 296 300 326 359 362 368 369 370 371 380 433 479 535 579} Enterobacter cloacae,^{1 362 369 370 375 380 579 706} or Serratia marcescens;^{1 296 362 368 369 370 380 579} also has been used in bone and joint infections caused by E. aerogenes^{† [off-label]},^{369 370 706} Escherichia coli^{† [off-label]},^{362 368 369 370 474 535} Klebsiella pneumoniae^{† [off-label]},^{326 368 371} Morganella morganii^{† [off-label]},^{369 370} or Proteus mirabilis^{† [off-label]}.^{368 369 371 380 474 706}

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.^{590 591}

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of bone and joint infections.^{590 591}

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).⁴⁵⁰ AHA and IDSA recommend ceftriaxone (or other third or fourth generation cephalosporin),⁴⁵⁰ but state that a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) may be considered in patients who cannot tolerate cephalosporins.⁴⁵⁰ Consultation with an infectious disease specialist recommended.⁴⁵⁰

GI Infections

Treatment of infectious diarrhea caused by susceptible enterotoxigenic E. coli,^{1 211 297} Campylobacter,^{1 211 297 350 440 474 477} Salmonella^†,^{440 477} Shigella^{197 297 440 477 612} flexneri,^{1 612} S. boydii, S. sonnei,^{1 474} or S. dysenteriae.^{1 612} Active in vitro against many pathogens associated with infectious diarrhea; may be a drug of choice for empiric treatment.^{296 305 350 378 440 493 522 610 611} Consider increasing emergence of fluoroquinolone-resistant enteric pathogens (e.g., Campylobacter, Salmonella, Shigella) secondary to widespread use of the drugs.^{440 588 589} Base decision to use a fluoroquinolone for empiric treatment of infectious diarrhea on local susceptibility patterns.⁴⁷⁷

Treatment of campylobacteriosis caused by susceptible Campylobacter.^{292 440 477} Optimal treatment of campylobacteriosis in HIV-infected patients not identified.⁴⁴⁰ 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.⁴⁴⁰ In those with mild to moderate campylobacteriosis, treatment with a fluoroquinolone (preferably ciprofloxacin or, alternatively, levofloxacin or moxifloxacin) or azithromycin is reasonable.⁴⁴⁰ Modify anti-infective therapy based on results of in vitro susceptibility testing;⁴⁴⁰ resistance to fluoroquinolones reported in 22% of C. jejuni and 35% of C. coli isolates tested in the US.⁴⁴⁰

Alternative to co-trimoxazole for treatment of cyclosporiasis^† caused by Cyclospora cayetanensis.¹³⁴

Treatment of cystoisosporiasis (formerly isosporiasis) caused by Cystoisospora belli^† (formerly Isospora belli).^{440 441 477 533} In HIV-infected individuals, recommended as an alternative to co-trimoxazole for treatment and chronic maintenance therapy (secondary prophylaxis) of cystoisosporiasis.^{440 441}

Treatment of Salmonella gastroenteritis^†.^{440 477} 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.^{197 292 440 477 681} 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;⁴⁴⁰ other fluoroquinolones (levofloxacin, moxifloxacin) also likely to be effective, but data limited.⁴⁴⁰ Depending on in vitro susceptibility, alternatives are co-trimoxazole and third generation cephalosporins (ceftriaxone, cefotaxime).⁴⁴⁰ Role of long-term anti-infective treatment (secondary prophylaxis) against Salmonella in HIV-infected individuals with recurrent bacteremia not well established;⁴⁴⁰ weigh benefits of such prophylaxis against risks of long-term anti-infective therapy.⁴⁴⁰

Treatment of shigellosis caused by susceptible Shigella.^{440 477} 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.^{292 440} Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common.^{292 477} Fluoroquinolones (preferably ciprofloxacin or, alternatively, levofloxacin or moxifloxacin) have been recommended for treatment of shigellosis in HIV-infected adults,^{440 477} but consider that fluoroquinolone-resistant Shigella reported in the US, especially in international travelers, the homeless, and men who have sex with men (MSM).⁴⁴⁰ 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.^{197 292 440 477}

Treatment of GI infections caused by Yersinia enterocolitica^† or Y. pseudotuberculosis^†.⁶⁸¹ These infections usually self-limited, but some experts recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs.^{292 681} When treatment considered necessary, some clinicians recommend co-trimoxazole as drug of choice and cefotaxime and ciprofloxacin as alternatives.⁴⁷⁷

Treatment of travelers’ diarrhea^†.^{305 378 399 440 525 650 651 677 679} If caused by bacteria, may be self-limited and resolve within 3–7 days without anti-infective treatment.^{305 525} CDC states anti-infective treatment not recommended for mild travelers' diarrhea;⁵²⁵ 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.^{305 525 650 651 677 679} Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) generally have been considered anti-infectives of choice for empiric treatment, including self-treatment;^{305 440 525 611 612 650 677 679} alternatives include azithromycin and rifaximin.^{305 525} 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;⁵²⁵ 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).⁵²⁵

Prevention of travelers’ diarrhea^† in individuals traveling for relatively short periods to areas of risk.^{305 440 525 610 611 677 679} CDC and others do not recommend anti-infective prophylaxis in most travelers.^{305 440 525 611 677 679} 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.^{305 525} If anti-infective prophylaxis used, fluoroquinolones (e.g., ciprofloxacin, levofloxacin) usually have been recommended;^{305 440 525} alternatives include azithromycin and rifaximin.^{305 525} 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.⁵²⁵ Also consider increasing incidence of fluoroquinolone resistance in pathogens that cause travelers’ diarrhea (e.g., Campylobacter, Salmonella, Shigella).^{305 525}

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.^{1 579}

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of intra-abdominal infections.⁷⁰⁸

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).^{366 418 707 762 763 764 765 818}

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.⁴¹⁶

Safety and efficacy not established for CNS infections;^{211 481} only low ciprofloxacin concentrations attained in CSF (see Distribution under Pharmacokinetics).^{1 436 707} 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.^{418 762 818}

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of meningitis and other CNS infections.^{416 418}

Otic Infections

Treatment of malignant otitis externa^† caused by Ps. aeruginosa.^{781 782 783 784 785 816} Treatment of choice usually is ciprofloxacin or an antipseudomonal β-lactam (e.g., ceftazidime, imipenem).^{781 782 783 784} Consider the possibility of ciprofloxacin-resistant strains if there is an inadequate response to treatment.^{783 784 785}

Respiratory Tract Infections

Treatment of respiratory tract infections (including bronchiectasis,^{333 479 596} bronchitis,^{205 297 301 333 335 345 346 347 356 435 466 479} lung abscess,^{474 596} pneumonia)^{205 326 333 346 347 356 357 435 466 479 491 596} caused by susceptible E. cloacae,^{1 333 474 579} E. coli,^{1 333 345 355 491 579} Haemophilus influenzae,^{1 297 301 324 333 346 351 380 427 491 596 579} H. parainfluenzae,^{1 297 474 579} K. pneumoniae,^{1 297 301 333 345 351 380 579} P. mirabilis,^{1 380 579} Ps. aeruginosa,^{1 300 301 324 333 346 359 380 427 433 579} or S. pneumoniae;^{1 324 326 333 345 346 355 356 357 425 427 491} also has been used for respiratory tract infections caused by susceptible E. aerogenes^†,⁴⁷⁴ K. oxytoca^†,⁴⁷⁴ or S. aureus^†.^{333 345 380 491}

Treatment of acute sinusitis caused by susceptible H. influenzae, M. catarrhalis, or S. pneumoniae.^{1 579}

Treatment of acute exacerbations of chronic bronchitis caused by susceptible Moraxella catarrhalis.^{1 324 333 346 356 395 427 491 579}

Use for treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis only when no other treatment options available.^{1 140 145 579} 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)^{1 140 145 579} and because acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis may be self-limiting in some patients,^{1 579} risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with these infections.^{140 145}

Treatment of nosocomial pneumonia caused by susceptible H. influenzae or K. pneumoniae.⁵⁷⁹ 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.³¹⁵ 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.³¹⁵ 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.³¹⁵

Most effective in treatment of respiratory tract infections caused by H. influenzae or M. catarrhalis;^{178 296 298 479 596} treatment failures have occurred when used in infections caused by S. pneumoniae^{178 324 358 425 427 479} or Ps. aeruginosa.^{178 324 346 358 427 479 596}

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of respiratory tract infections.^{315 512}

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,^{1 372 579} E. cloacae,^{1 362 579} E. coli,^{1 326 372 375 377 380 579} K. oxytoca^†,⁴⁷⁴ K. pneumoniae,^{1 362 372 377 380 579} M. morganii,^{1 579} P. mirabilis,^{1 362 364 372 377 380 579} P. vulgaris,^{1 372 474 579} P. stuartii,^{1 377 579} Ps. aeruginosa,^{1 280 300 326 359 362 372 375 377 382 433 579} S. marcescens^†,^{362 380} S. aureus (methicillin-susceptible strains),^{1 326 362 364 372 373 375 377 382 466 474 579} S. epidermidis,^{1 364 372 375 377 382 579} or S. pyogenes (group A β-hemolytic streptococci).^{1 362 373 579}

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of skin and skin structure infections.⁵⁴³

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.^{1 579} 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.^{1 579} (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),^{1 579} C. freundii,^{1 339 340 341 375 380 474 579} E. cloacae,^{1 327 332 380 579} E. coli,^{1 297 326 327 329 332 336 338 339 340 351 352 353 375 380 504 579 856} K. pneumoniae,^{1 297 327 329 336 338 340 341 353 375 504 579 856} M. morganii,^{1 340 341 579} P. mirabilis,^{1 327 332 336 340 352 353 504 579 856} Providencia rettgeri,^{1 474 579} Ps. aeruginosa,^{1 197 297 300 326 327 336 338 339 340 341 351 353 359 375 379 380 579 856} or S. marcescens;^{1 340 341 353 380 504 579} also has been used for UTIs caused by E. aerogenes^†,⁴⁷⁴ Klebsiella oxytoca^†,⁴⁷⁴ or P. stuartii^†.^{326 474}

Treatment of UTIs in adults caused by susceptible gram-positive bacteria, including S. aureus^†,^{327 353 380} S. epidermidis,^{1 327 336 340 579} S. saprophyticus,^{1 332 579} or E. faecalis.^{1 197 327 336 339 340 341 353 579 856}

Treatment of acute uncomplicated cystitis in adults caused by susceptible E. coli, P. mirabilis, S. saprophyticus, or E. faecalis.⁸⁵⁶

Treatment of acute uncomplicated pyelonephritis in adults caused by E. coli.⁸⁵⁶

Treatment of recurrent UTIs and chronic prostatitis in adults caused by E. coli or P. mirabilis in men.^{1 180 294 296 339 343 379 466 579}

Use for treatment of uncomplicated UTIs only when no other treatment options available.^{1 140 856} 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)^{1 140 145 856} and because uncomplicated UTIs may be self-limiting in some patients,^{1 856} risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with uncomplicated UTIs.^{140 145}

Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria.^{299 336 379 425 481 551}

Anthrax

Inhalational anthrax (postexposure) to reduce incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores.^{1 579 668 671 672 673 683} 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.^{668 672 673 683} Other oral fluoroquinolones (levofloxacin, moxifloxacin, ofloxacin) are alternatives for postexposure prophylaxis when ciprofloxacin or doxycycline cannot be used.^{668 671 672 673} 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.⁶⁷¹

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.^{668 671 672 673 683} 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).^{671 672 673} 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).^{671 672 673}

Treatment of uncomplicated cutaneous anthrax^† (without systemic involvement) that occurs following exposure to B. anthracis spores in the context of biologic warfare or bioterrorism.^{668 670 671 672 673 680} 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.^{672 673} AAP states that oral ciprofloxacin is the preferred drug for treatment of such infections in pediatric patients (including neonates).⁶⁷¹

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).^{668 683} 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;^{668 671 672 673 683} 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.^{668 683}

Treatment of GI and oropharyngeal anthrax^†.⁶⁸¹ If occurring in the context of biologic warfare or bioterrorism, use parenteral regimens recommended for inhalational anthrax.^{668 683 686 703}

Prophylaxis following ingestion of B. anthracis spores^† in contaminated meat.⁶⁶²

Consult CDC and AAP guidelines for additional information on management of anthrax, including postexposure prophylaxis of anthrax.^{671 672 673}

Brucellosis

Treatment of brucellosis^† caused by Brucella melitensis;^{197 624 683 771 772} used in conjunction with rifampin.^{197 683 771 772} Monotherapy with any drug usually associated with high relapse rate and not recommended.^{683 772}

Chancroid

Treatment of chancroid^† (genital ulcers caused by Haemophilus ducreyi).^{344 321 462}

CDC recommends azithromycin, ceftriaxone, ciprofloxacin, or erythromycin as drugs of choice for treatment of chancroid.³⁴⁴ HIV-infected patients and uncircumcised patients may not respond to treatment as well as those who are HIV-negative or circumcised.³⁴⁴

Crohn’s Disease

Management of Crohn’s disease^† as an adjunct to conventional therapies.^{737 742 743 744 745 746 747 748}

Has been used (with^{737 742 744 745 746 748} or without metronidazole^{743 747} ) for induction of remission of mildly to moderately active Crohn’s disease.^{737 742 743 744 745 746 747 748} May be more effective in patients with ileitis than in those with colitis.^{739 742}

Has been used in the management of refractory perianal Crohn’s disease^†.^{737 739 750 751} Relapse usually occurs when the drug is discontinued.^{739 750}

Gonorrhea and Associated Infections

Was used in the past for treatment of uncomplicated urethral, endocervical, rectal^†, or pharyngeal^† gonorrhea caused by susceptible Neisseria gonorrhoeae.^{1 314 317 322 428 619}

Because quinolone-resistant N. gonorrhoeae (QRNG) widely disseminated worldwide, including in the US^{114 344 754 835 839 857} (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).^{114 344 839}

Granuloma Inguinale† (Donovanosis†)

Alternative for treatment of granuloma inguinale^† (donovanosis) caused by Klebsiella granulomatis (formerly Calymmatobacterium granulomatis).³⁴⁴

CDC recommends azithromycin;³⁴⁴ alternatives are doxycycline, ciprofloxacin, erythromycin, and co-trimoxazole.³⁴⁴

Legionnaires’ Disease†

Treatment of Legionnaires’ Disease^† caused by Legionella pneumophila,⁷³⁴ including in immunocompromised patients (e.g., transplant recipients).^{197 512 622 704 734 735}

Mycobacterial Infections

Has been used in multiple-drug regimens for treatment of active tuberculosis^† caused by Mycobacterium tuberculosis.^{601 615 817}

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.^{218 440} If a fluoroquinolone is used in multiple-drug regimens for treatment of active tuberculosis, levofloxacin or moxifloxacin is recommended;^{218 231 276 440} some experts state ciprofloxacin is no longer recommended for treatment of tuberculosis.^{231 276}

Treatment of cutaneous infections caused by M. fortuitum^†; used alone or in conjunction with amikacin.^{607 817 675} 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).⁶⁷⁵

Has been used in multiple-drug regimens for treatment of pulmonary and extrapulmonary (localized or disseminated) M. avium complex^† (MAC) infections.^{197 602 607 614 616 617 817 819} Role of fluoroquinolones in treatment of MAC infections not been established.⁶⁷⁵ 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.⁶⁷⁵ 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.⁶⁷⁵

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^†.⁶⁷⁵ Because of considerations related to resistance, not recommended for treatment of M. marinum infections.⁶⁷⁵

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.^{292 374 376 406 409 411 538 545 569} CDC and AAP consider rifampin, ceftriaxone, or ciprofloxacin the drugs of choice for such carriers.^{292 374 376}

Chemoprophylaxis to prevent meningococcal disease in household or other close contacts of patients with invasive meningococcal disease^†.^{292 374 376}

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.^{292 374 376} All are 90–95% effective and any of these is an acceptable regimen;³⁷⁶ AAP suggests rifampin may be the drug of choice for most children.²⁹²

Consider that fluoroquinolone-resistant N. meningitidis has been reported rarely in the US and elsewhere (e.g., India).^{853 854} 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).^{292 853}

Plague

Treatment of plague, including pneumonic and septicemic plague, caused by Yersinia pestis.^{1 292 579 683 688} Streptomycin (or gentamicin) historically has been considered regimen of choice for treatment of plague;^{197 292 683 688} 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).^{197 292 683 688} 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.^{683 688}

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).^{1 579 683 688} Drugs of choice for such prophylaxis are doxycycline (or tetracycline) or a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin).^{683 688}

Rickettsial Infections

Has been used for treatment of some rickettsial infections^†,^{197 393 568 625} including Mediterranean spotted fever^† caused by Rickettsia conorii.³⁹³

Doxycycline is the drug of choice for treatment of all tickborne rickettsial diseases.⁵⁰⁰ Although some fluoroquinolones have in vitro activity against Rickettsiae,⁵⁰⁰ CDC states that fluoroquinolones are not recommended for treatment of Rocky Mountain spotted fever.⁵⁰⁰

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.^{197 292 683 689} Considered an alternative to streptomycin (or gentamicin);^{197 292 683 689} risk of relapse may be higher than with aminoglycosides.⁶⁸⁹

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.^{683 689} 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.⁶⁸³

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.^{1 197 326 396 408 441 479 493 494 525 603 654 655 656 657 658 659 660} 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.⁵²⁵

Has been used for treatment of chronic typhoid carriers^†;^{197 211 292 391 403 438 466 473 603} however, manufacturer cautions that efficacy of ciprofloxacin in eradication of the chronic typhoid carrier state has not been demonstrated.¹

Recommended as a drug of choice for treatment of native vertebral osteomyelitis caused by Salmonella^†.⁵⁹⁰ (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^†.^{762 763 764 765} (See Meningitis and CNS Infections under Uses.)

Vibrio Infections

Treatment of cholera^† caused by Vibrio cholerae 01 or 0139.^{197 292 477 664 756 757 758} 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.^{197 292 477 664 758}

Alternative to tetracyclines for treatment of other Vibrio infections, including gastroenteritis or wound infections caused by V. parahaemolyticus^† or V. vulnificus^†.^{197 759} 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.⁷⁵⁹ Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.⁷⁵⁹

Perioperative Prophylaxis

Perioperative prophylaxis^† in patients undergoing certain GU surgery who are at high risk for postoperative infections.³⁶⁰ Because of increasing resistance of E. coli to fluoroquinolones, consider local susceptibility patterns when selecting an anti-infective for such prophylaxis.³⁶⁰

Perioperative prophylaxis not recommended for patients with sterile urine undergoing cystoscopy without manipulation.³⁶⁰ 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.³⁶⁰

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).³⁶⁰

Empiric Therapy in Febrile Neutropenic Patients

Empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients.^{579 786 787}

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.⁵⁷⁹

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).⁷⁸⁶

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.⁷⁸⁷ Use of a fluoroquinolone alone not recommended for initial empiric therapy in outpatients, but may be effective in low-risk outpatients.⁷⁸⁷

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.^{786 787}

Ciprofloxacin Dosage and Administration

Administration

Administer orally^{1 856} or by IV infusion.⁵⁷⁹

Patients receiving IV ciprofloxacin initially may be switched to oral ciprofloxacin when clinically appropriate.⁵⁷⁹

Because of risk of crystalluria, instruct patients receiving oral or IV ciprofloxacin that they should be adequately hydrated and should drink fluids liberally.^{1 579 856} (See Renal Effects under Cautions.)

Oral Administration

Administer conventional tablets, extended-release tablets, or oral suspension without regard to meals.^{1 856} (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.^{1 856} Doses should preferably be taken 2 hours before or after these calcium-fortified products or substantial calcium intake (>800 mg).^{1 856}

Conventional or extended-release tablets: Swallow whole;^{1 856} do not split, crush, or chew.^{1 856}

Oral suspension: Following reconstitution, administer using the graduated spoon provided by the manufacturer that has markings for 2.5 and 5 mL.¹ Swallow microcapsules contained in the reconstituted oral suspension;¹ do not chew.¹ May ingest water after the oral suspension is swallowed.¹

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.¹ 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.¹ Use only the diluent supplied in the kit;¹ do not add water.¹

Prior to administration of each dose, shake oral suspension vigorously for about 15 seconds.¹

IV Infusion

IV infusions should be given into a large vein to minimize discomfort and reduce the risk of venous irritation.⁵⁷⁹ If a Y-type administration set is used, the other IV solution flowing through the tubing should be discontinued while ciprofloxacin is being infused.⁵⁷⁹

Ciprofloxacin concentrate containing 10 mg/mL: Must be diluted with compatible IV solution prior to IV infusion.⁵⁷⁹

Ciprofloxacin premixed solution for IV infusion containing 2 mg/mL in 5% dextrose injection: May be administered without further dilution.⁵⁷⁹

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

Ciprofloxacin preparations for IV administration contain lactic acid as a solubilizing agent.⁵⁷⁹

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.⁵⁷⁹ (See Compatibility under Stability.)

Rate of Administration

Administer by IV infusion over 1 hour.⁵⁷⁹

Dosage

Available as ciprofloxacin (IV, oral suspension),^{1 579} ciprofloxacin hydrochloride (conventional tablets),¹ and a mixture of ciprofloxacin and ciprofloxacin hydrochloride (extended-release tablets);⁸⁵⁶ dosage expressed in terms of ciprofloxacin.^{1 579 856}

Unless otherwise specified, oral dosage is for conventional tablets or oral suspension.¹

Use extended-release tablets only for treatment of certain urinary tract infections (UTIs) in adults; do not use in pediatric patients.⁸⁵⁶ Extended-release tablets are not interchangeable with other oral ciprofloxacin preparations (conventional tablets, oral suspension).⁸⁵⁶

Dosage of oral and IV ciprofloxacin is not identical.^{1 579} 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.^{1 579}

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.¹

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.¹

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.¹

IV

Children 1–17 years of age: 6–10 mg/kg (up to 400 mg) every 8 hours.⁵⁷⁹

Switch to oral route when clinically indicated; manufacturers recommend total treatment duration (IV and/or oral) of 10–21 days.^{1 579}

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.⁶⁷¹

Pediatric patients ≥1 month of age: AAP recommends 15 mg/kg (up to 500 mg) every 12 hours.⁶⁷¹

Neonates, infants, and children ≤17 years of age: Manufacturer recommends 15 mg/kg (up to 500 mg) every 12 hours.¹

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.¹

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.¹

Initiate prophylaxis as soon as possible following suspected or confirmed anthrax exposure.^{1 668 673 683}

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.^{1 579 668 671 672 673 683}

IV

Neonates, infants, and children ≤17 years of age: Manufacturer recommends 10 mg/kg (up to 400 mg) every 12 hours for 60 days.⁵⁷⁹

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.⁶⁷¹

Pediatric patients ≥1 month of age: AAP recommends 10 mg/kg (up to 400 mg) every 8 hours.⁶⁷¹

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).⁶⁷¹ Continue parenteral regimen for ≥2–3 weeks until patient is clinically stable and can be switched to appropriate oral anti-infective.⁶⁷¹

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.⁶⁷¹

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.⁶⁷¹

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.⁶⁷¹

Initial multiple-drug parenteral treatment regimen recommended;^{668 671 683} use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).^{668 671 683}

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.⁶⁷¹

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.⁶⁷¹

Pediatric patients ≥1 month of age: AAP recommends 15 mg/kg (up to 500 mg) every 12 hours.⁶⁷¹

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.⁶⁷¹ Duration of 7–10 days may be sufficient if uncomplicated cutaneous anthrax occurred as the result of naturally occurring or endemic exposure.⁶⁷¹

Neisseria meningitidis Infections†

Elimination of Pharyngeal Carrier State†

Oral

20 mg/kg (up to 500 mg) as a single dose.²⁹²

Chemoprophylaxis in Household or Other Close Contacts†

Oral

20 mg/kg (up to 500 mg) as a single dose.²⁹²

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.¹

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.¹

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.¹

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.^{683 688}

Initial parenteral regimen preferred;^{683 688} use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).^{683 688}

Manufacturer recommends total treatment duration (IV and oral) of 10–21 days in pediatric patients;⁵⁷⁹ some experts state total treatment duration should be at least 10–14 days.^{683 688}

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.⁵⁷⁹

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.^{683 688}

When clinical improvement occurs, may switch to oral regimen.^{683 688}

Manufacturer recommends total treatment duration (IV and oral) of 10–21 days in pediatric patients;⁵⁷⁹ some experts state total treatment duration should be at least 10–14 days.^{683 688}

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.¹

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.¹

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.¹

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.^{683 688}

Initiate prophylaxis as soon as possible after suspected or confirmed exposure.¹

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.^{683 688} If fever or cough develops during prophylaxis, switch to regimen recommended for treatment of plague.^{683 688}

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.⁵⁷⁹

Tularemia†

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

Oral

15 mg/kg twice daily (up to 1 g daily).^{683 689}

Initial parenteral regimen preferred; use oral regimen after improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).^{683 689}

Total treatment duration (IV and oral) of at least 10–14 days.^{683 689}

IV, then Oral

15 mg/kg IV every 12 hours (up to 1 g daily).^{683 689}

When clinical improvement occurs, may switch to oral regimen.^{683 689}

Total treatment duration (IV and oral) of at least 10–14 days.^{683 689}

Postexposure Prophylaxis Following High-risk Exposure to Tularemia†

Oral

15 mg/kg every 12 hours (up to 1 g daily).^{683 689}

Initiate prophylaxis within 24 hours of exposure and continue for at least 14 days.^{683 689}

Cystoisospora Infections

Oral

HIV-infected: 10–20 mg/kg (up to 500 mg) twice daily for 7 days.⁴⁴¹

Chronic maintenance therapy (secondary prophylaxis) in HIV-infected: 10–20 mg/kg (up to 500 mg) 3 times weekly.⁴⁴¹ 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.⁴⁴¹

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.⁴¹⁶

Neisseria meningitidis Infections†

Elimination of Nasopharyngeal Carrier State†

Oral

AAP recommends single dose of 20 mg/kg.²⁹² Do not use if fluoroquinolone-resistant N. meningitis identified in the community.²⁹²

Chemoprophylaxis in Household or Other Close Contacts†

Oral

AAP recommends single dose of 20 mg/kg.²⁹² Do not use if fluoroquinolone-resistant N. meningitis identified in the community.²⁹²

Vibrio Infections†

Cholera†

Oral

15 mg/kg (up to 500 mg) twice daily for 3 days.²⁹²

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 0139.⁷⁵⁸

Adults

Bone and Joint Infections

Oral

Manufacturer recommends 500–750 mg every 12 hours for 4–8 weeks.¹

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.⁵⁹⁰

Prosthetic joint infections: IDSA recommends 750 mg twice daily for 4–6 weeks for Ps. aeruginosa and for Enterobacter or other Enterobacteriaceae.⁵⁹¹

IV

Manufacturer recommends 400 mg every 8 to 12 hours for 4–8 weeks.⁵⁷⁹

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.⁵⁹⁰

Prosthetic joint infections: IDSA recommends 400 mg every 12 hours for 4–6 weeks for Ps. aeruginosa or Enterobacter.⁵⁹¹

Endocarditis†

Endocarditis Caused by the HACEK Group†

Oral

1 g daily given in 2 equally divided doses recommended by AHA and IDSA.⁴⁵⁰ Duration of treatment is 4 weeks for native valve endocarditis or 6 weeks for endocarditis involving prosthetic cardiac valves or other prosthetic cardiac material.⁴⁵⁰

IV

800 mg daily given in 2 equally divided doses recommended by AHA and IDSA.⁴⁵⁰ Duration of treatment is 4 weeks for native valve endocarditis or 6 weeks for endocarditis involving prosthetic cardiac valves or other prosthetic cardiac material.⁴⁵⁰

GI Infections

Infectious Diarrhea

Oral

Manufacturer recommends 500 mg every 12 hours for 5–7 days.^{1 350 378 612}

Campylobacter Infections†

Oral

HIV-infected: 500–750 mg every 12 hours.⁴⁴⁰

Recommended treatment duration is 7–10 days for gastroenteritis or ≥14 days for bacteremic infections.⁴⁴⁰ Duration of 2–6 weeks recommended for recurrent infections.⁴⁴⁰

IV

HIV-infected: 400 mg every 12 hours.⁴⁴⁰

Recommended treatment duration is 7–10 days for gastroenteritis or ≥14 days for bacteremic infections.⁴⁴⁰ Duration of 2–6 weeks recommended for recurrent infections.⁴⁴⁰

Cyclospora Infections†

Oral

500 mg twice daily for 7 days.¹³⁴

Cystoisospora Infections†

Oral

HIV-infected: 500 mg twice daily for 7 days.⁴⁴⁰

Chronic maintenance therapy (secondary prophylaxis) if CD4⁺ T-cells <200 cells/mm³: 500 mg 3 times weekly.⁴⁴⁰ Consider discontinuing if CD4⁺ T-cells remain >200 cells/mm³ for >6 months in response to antiretroviral therapy.⁴⁴⁰

Salmonella Gastroenteritis in HIV-infected Patients

Oral

500–750 mg every 12 hours.⁴⁴⁰

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/mm³.⁴⁴⁰

Consider secondary prophylaxis in those with recurrent bacteremia;⁴⁴⁰ also may consider in those with recurrent gastroenteritis (with or without bacteremia) or with CD4⁺ T-cells <200 cells/mm³ and severe diarrhea.⁴⁴⁰ Discontinue secondary prophylaxis if Salmonella infection resolves and there has been a sustained response to antiretroviral therapy with CD4⁺ T-cells >200 cells/mm³.⁴⁴⁰

IV

400 mg every 12 hours.⁴⁴⁰

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/mm³.⁴⁴⁰

Shigella Infections

Oral

HIV-infected: 500–750 mg every 12 hours.⁴⁴⁰

Recommended treatment duration is 7–10 days for gastroenteritis or ≥14 days for bacteremic infections.⁴⁴⁰ Up to 6 weeks may be required for recurrent infections, especially if CD4⁺ T-cells <200 cells/mm³.⁴⁴⁰

IV

HIV infected: 400 mg every 12 hours.⁴⁴⁰

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.³⁰⁵

Extended-release tablets: 500 mg or 1 g once daily for 1–3 days.³⁰⁵

HIV-infected (conventional tablets or oral suspension): 500–750 mg every 12 hours.⁴⁴⁰ If no clinical response after 3–4 days, consider stool culture and in vitro susceptibility testing.⁴⁴⁰

IV

HIV-infected: 400 mg every 12 hours.⁴⁴⁰

If no clinical response after 3–4 days, consider stool culture and in vitro susceptibility testing.⁴⁴⁰

Prevention of Travelers’ Diarrhea†

Oral

Conventional tablets or oral suspension: 500 mg once daily.^{305 650 651 677}

Anti-infective prophylaxis generally discouraged (see GI Infections under Uses);^{305 525} 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.^{305 650 651 677}

Intra-abdominal Infections

Complicated Infections

Oral

500 mg every 12 hours given in conjunction with metronidazole.¹

Manufacturers recommend total treatment duration of 7–14 days.¹ IDSA recommends treatment duration of 4–7 days;⁷⁷³ longer duration not associated with improved outcome and not recommended unless adequate source control difficult to achieve.⁷⁷³

IV

400 mg IV every 12 hours given in conjunction with metronidazole.⁵⁷⁹

Manufacturers recommends total treatment duration of 7–14 days.⁵⁷⁹ 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.⁷⁷³

Meningitis and CNS Infections†

Gram-negative Meningitis†

IV

400 mg every 8 hours has been used alone or in conjunction with an aminoglycoside.⁷⁶⁶ Alternatively, 800–1200 mg daily has been recommended.⁴¹⁸

Healthcare-associated ventriculitis and meningitis: IDSA recommends 800–1200 mg daily given in divided doses every 8–12 hours.⁴¹⁶

Otic Infections†

Malignant Otitis Externa†

Oral

750 mg twice daily has been used.^{784 816} Although rapid relief of symptoms (pain, otorrhea) may occur, continue treatment for 6–8 weeks.^{784 816}

Because ciprofloxacin-resistant Ps. aeruginosa have been isolated from patients with malignant otitis externa with increasing frequency,^{783 784 785} in vitro susceptibility testing is indicated, especially if there is an inadequate response to treatment.⁷⁸⁵

Respiratory Tract Infections

Acute Bacterial Sinusitis

Oral

500 mg every 12 hours for 10 days.¹ (See Respiratory Tract Infections under Uses.)

IV

400 mg every 12 hours for 10 days.⁵⁷⁹ (See Respiratory Tract Infections under Uses.)

Lower Respiratory Tract Infections

Oral

500–750 mg every 12 hours for 7–14 days.¹

IV

400 mg every 8 to 12 hours;⁵⁷⁹ use 400 mg IV every 8 hours for severe or complicated infections. Usual treatment duration is 7–14 days.⁵⁷⁹

Nosocomial Pneumonia

IV

400 mg every 8 hours for HAP and VAP.^{315 579}

Manufacturer recommends a treatment duration of 10–14 days.⁵⁷⁹ IDSA recommends treatment duration of 7 days, but longer or shorter duration may be indicated depending on clinical response.³¹⁵

Skin and Skin Structure Infections

Oral

500–750 mg every 12 hours for 7–14 days.¹

IV

400 mg every 8 to 12 hours for 7–14 days.⁵⁷⁹

Urinary Tract Infections (UTIs) and Prostatitis

Acute, Uncomplicated Cystitis

Oral

Conventional tablets or oral suspension: 250 mg every 12 hours for 3 days.¹ (See Urinary Tract Infections [UTIs] and Prostatitis under Uses.)

Extended-release tablets: 500 mg once every 24 hours for 3 days.⁸⁵⁶ (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.¹

Extended-release tablets: 1 g once every 24 hours for 7–14 days.⁸⁵⁶

IV

200–400 mg every 8 or 12 hours for 7–14 days.⁵⁷⁹

Chronic Bacterial Prostatitis

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 28 days.¹

IV

400 mg every 12 hours for 28 days.⁵⁷⁹

Anthrax

Postexposure Prophylaxis of Anthrax (Biologic Warfare or Bioterrorism Exposure)

Oral

500 mg every 12 hours.^{1 668 672 673 683}

Initiate prophylaxis as soon as possible following suspected or confirmed exposure.^{1 668 673 683}

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).^{668 672 673 683}

IV

400 mg every 12 hours for 60 days.⁵⁷⁹

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

IV

400 mg IV every 8 hours.^{672 673}

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).^{672 673} Continue parenteral regimen for ≥2–3 weeks until patient is clinically stable and can be switched to appropriate oral anti-infective.^{672 673}

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.^{672 673}

Oral

500 mg every 12 hours given for ≥60 days.⁶⁶⁸

Initial multiple-drug parenteral regimen recommended;^{668 672 673 683} use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).^{668 672 673 683}

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.^{668 672 673 683}

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

Oral

500 mg every 12 hours.^{672 673}

Recommended duration is 60 days if cutaneous anthrax occurred after exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism.^{668 672 673 683}

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

Oral

500 mg every 12 hours.⁶⁸⁰

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).^{668 672 673 680 683}

IV

400 mg every 12 hours.⁶⁸⁰

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).^{668 673 670 680 683}

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

Oral

500 mg every 12 hours has been recommended.⁶⁶²

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).⁶⁶³

Brucella Infections†

Oral

500 mg twice daily in conjunction with oral rifampin (600 mg once daily).^{771 772} 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.⁶²⁴ Monotherapy or treatment regimens <4–6 weeks not recommended.^{683 772}

Chancroid†

Oral

500 mg twice daily for 3 days recommended by CDC.³⁴⁴

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.^{742 744 745 746 749}

Gonorrhea and Associated Infections

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

Oral

250 mg as a single dose recommended by manufacturer.¹

No longer recommended by CDC for treatment of gonorrhea.^{114 344 839} (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;³⁴⁴ consider adding IV aminoglycoside (gentamicin 1 mg/kg IV every 8 hours) if improvement not evident within first few days of treatment.³⁴⁴

Relapse can occur 6–18 months after apparently effective treatment.³⁴⁴

Legionnaires’ Disease†

Oral

500 mg every 12 hours for 2–3 weeks.⁶²²

IV

400 mg every 12 hours for 2–3 weeks.⁶²²

Mycobacterial Infections†

Oral

750 mg twice daily has been used in multiple-drug regimens for treatment of infections caused by M. avium complex (MAC).^{616 617 675}

Neisseria meningitidis Infections†

Elimination of Pharyngeal Carrier State†

Oral

500 mg as a single dose.³⁷⁶

Chemoprophylaxis in Household or Other Close Contacts†

Oral

500 mg as a single dose.³⁷⁶

Plague

Treatment of Plague

Oral

500–750 mg every 12 hours for 14 days.¹

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.^{683 688}

Initial parenteral regimen preferred;^{683 688} use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).^{683 688} Total treatment duration should be at least 10–14 days.^{683 688}

IV, then Oral

400 mg IV every 8 to 12 hours for 14 days.⁵⁷⁹

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.^{683 688}

When clinical improvement occurs, IV ciprofloxacin may be switched to oral ciprofloxacin.^{683 688} Total treatment duration should be at least 10–14 days.^{683 688}

Postexposure Prophylaxis of Plague

Oral

500–750 mg every 12 hours for 14 days.¹

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.^{683 688}

Initiate prophylaxis as soon as possible after suspected or confirmed exposure.¹

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.^{683 688} If fever or cough develops during prophylaxis, switch to regimen recommended for treatment of plague.^{683 688}

IV

400 mg every 8 to 12 hours for 14 days.⁵⁷⁹

Tularemia†

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

Oral

500 mg twice daily.^{683 689}

Initial parenteral regimen preferred; use oral regimen after improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).^{683 689} Total treatment duration should be at least 10–14 days.^{683 689}

IV, then Oral

400 mg IV every 12 hours.^{683 689}

When clinical improvement occurs, switch IV ciprofloxacin to oral ciprofloxacin.^{683 689} Total treatment duration should be at least 10–14 days.^{683 689}

Postexposure Prophylaxis Following High-risk Exposure†

Oral

500 mg every 12 hours.^{683 689}

Initiate prophylaxis within 24 hours of exposure and continue for at least 14 days.^{683 689}

Typhoid Fever and Other Invasive Salmonella Infections

Mild to Moderate Typhoid Fever

Oral

500 mg every 12 hours for 10 days.¹

Chronic Typhoid Carriers†

Oral

750 mg every 12 hours for 28 days.^{391 403 438 466 473}

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.^{664 757}

Perioperative Prophylaxis†

Oral

Single 500-mg dose given prior to the procedure.³⁶⁰ (See Perioperative Prophylaxis under Uses.)

IV

Single 400-mg dose given within 1–2 hours prior to the procedure or initial incision.³⁶⁰ (See Perioperative Prophylaxis under Uses.)

Empiric Therapy in Febrile Neutropenic Patients

IV

400 mg every 8 hours for 7–14 days;⁵⁷⁹ 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).⁵⁷⁹

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.¹

IV

Children 1–17 years of age: Maximum 400 mg every 8 hours, even in those weighing >51 kg.⁵⁷⁹

Treatment or Postexposure Prophylaxis of Anthrax or Plague

Oral

Neonates, infants, and children ≤17 years of age: Maximum 500 mg per dose.^{1 668 671}

IV

Neonates, infants, and children ≤17 years of age: Maximum 400 mg per dose.^{579 668 671}

Special Populations

Hepatic Impairment

Manufacturers make no specific dosage recommendations for patients with impaired hepatic function.^{1 579} Carefully monitor patients who have both hepatic and renal impairment.⁵⁷⁹ (See Renal Impairment under Dosage and Administration.)

No clinically important pharmacokinetic changes in patients with stable chronic cirrhosis;^{1 579 856} pharmacokinetics not fully studied in those with acute hepatic insufficiency.^{1 579 856}

Renal Impairment

Dosage adjustments may be necessary in adults with renal impairment, especially those with severe impairment.^{1 579 856} Dosage recommendations not available for pediatric patients with moderate to severe renal impairment (Cl_cr <50 mL/minute per 1.73 m²).^{1 579}

Conventional tablets or oral suspension: Decrease dosage in adults with Cl_cr ≤50 mL/minute.¹ (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.¹

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.⁸⁵⁶ Decreased dosage recommended when used for treatment of complicated UTIs or acute uncomplicated pyelonephritis in adults with Cl_cr ≤30 mL/minute.⁸⁵⁶ (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.⁸⁵⁶

IV ciprofloxacin: Decrease dosage in those with Cl_cr <30 mL/minute.⁵⁷⁹ (See Table 3.)

Geriatric Patients

No dosage adjustments except those related to renal impairment.^{1 579 856} (See Renal Impairment under Dosage and Administration.)

Select dosage with caution because of possible age-related decreases in renal impairment.^{1 579 856}

Cautions for Ciprofloxacin

Contraindications

• Known hypersensitivity to ciprofloxacin, any quinolone, or any ingredient in the formulation.^{1 579 856}

• Concomitant use with tizanidine.^{1 579 856} (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.^{1 140 145 579 856} May occur within hours to weeks after systemic fluoroquinolone initiated;^{1 579 856} have occurred in all age groups and in patients without preexisting risk factors for such adverse reactions.^{1 579 856}

Immediately discontinue ciprofloxacin at first signs or symptoms of any serious adverse reactions.^{1 140 145 579 856}

Avoid systemic fluoroquinolones, including ciprofloxacin, in patients who have experienced any of the serious adverse reactions associated with fluoroquinolones.^{1 140 145 579 856}

Tendinitis and Tendon Rupture

Systemic fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.^{1 579 856}

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.^{1 579 856} (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.^{1 579 856} Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any risk factors for such adverse reactions.^{1 579 856}

Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon;^{1 579 856} also reported in rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites.^{1 579 856}

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.^{1 579 856}

Immediately discontinue ciprofloxacin if pain, swelling, inflammation, or rupture of a tendon occurs.^{1 579 851 852 856} (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.^{1 579 856}

Peripheral Neuropathy

Systemic fluoroquinolones, including ciprofloxacin, are associated with an increased risk of peripheral neuropathy.^{1 579 856}

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with systemic fluoroquinolones, including ciprofloxacin.^{1 130 579 856} Symptoms may occur soon after initiation of the drug and, in some patients, may be irreversible.^{1 130 579 856}

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.^{1 130 579 856} (See Advice to Patients.)

Avoid systemic fluoroquinolones, including ciprofloxacin, in patients who have experienced peripheral neuropathy.^{1 579 856}

CNS Effects

Systemic fluoroquinolones, including ciprofloxacin, are associated with increased risk of adverse psychiatric effects, including toxic psychosis,^{1 579} psychotic reactions progressing to suicidal ideations/thoughts,^{1 579} hallucinations,^{1 579} paranoia,^{1 579} depression,^{1 579} self-injurious behavior such as attempted or completed suicide,^{1 579} anxiety,^{1 579} agitation,^{1 171 579} delirium,^{1 171 579} confusion,^{1 579} disorientation,^{1 171 579} disturbances in attention,^{1 171 579} nervousness,^{1 171 579} insomnia,^{1 579} nightmares,^{1 579} and memory impairment.^{1 171 579} These adverse effects may occur after first dose.^{1 579}

Systemic fluoroquinolones, including ciprofloxacin, are associated with increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors.^{1 579 856} Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold.^{1 579 856} Status epilepticus reported.^{1 579 856}

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).^{1 579 856}

If psychiatric or other CNS effects occur, immediately discontinue ciprofloxacin and institute appropriate measures.^{1 579 856} (See Advice to Patients.)

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in myasthenia gravis patients;^{1 579 856} death or need for ventilatory support reported.^{1 579 856}

Avoid use in patients with known history of myasthenia gravis.^{1 579 856} (See Advice to Patients.)

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported in patients receiving fluoroquinolones, including ciprofloxacin.^{1 579 856} These reactions may occur with first dose.^{1 579 856}

Some hypersensitivity reactions have been accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.^{1 579 856}

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.^{1 579 856}

Immediately discontinue ciprofloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity.^{1 579 856} Initiate appropriate therapy (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen) as indicated.^{1 579 856}

Photosensitivity Reactions

Moderate to severe photosensitivity/phototoxicity reactions reported with fluoroquinolones, including ciprofloxacin.^{1 579 856}

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).^{1 579 856}

Avoid unnecessary or excessive exposure to sunlight or artificial UV light (sunlamps, tanning beds, UVA/UVB treatment) while receiving ciprofloxacin.^{1 579 856} If patient needs to be in sunlight, they should use sunscreen and wear a hat and clothing that protects skin from sun exposure.^{1 579 856} (See Advice to Patients.)

Discontinue ciprofloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.^{1 579 856}

Other Warnings/Precautions

Hepatotoxicity

Severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, reported.^{1 579 856} Most fatalities have occurred in adults >55 years of age.^{1 579 856}

Acute liver injury has rapid onset (range 1–39 days) and is often associated with hypersensitivity.^{1 579 856} Pattern of injury can be hepatocellular, cholestatic, or mixed.^{1 579 856}

Temporary increases in aminotransferase or alkaline phosphatase concentrations or cholestatic jaundice may occur, especially in patients with previous liver damage.^{1 579 856}

Immediately discontinue ciprofloxacin if any signs or symptoms of hepatitis (e.g., anorexia, jaundice, dark urine, pruritus, tender abdomen) occur.^{1 579 856} (See Advice to Patients.)

Risk of Aortic Aneurysm and Dissection

Rupture or dissection of aortic aneurysms reported in patients receiving systemic fluoroquinolones.¹⁷² Epidemiologic studies indicate an increased risk of aortic aneurysm and dissection within 2 months following use of systemic fluoroquinolones, particularly in elderly patients.^{1 579} Cause for this increased risk not identified.^{1 172 579}

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.^{1 172 579} This includes elderly patients and patients with peripheral atherosclerotic vascular disease, hypertension, or certain genetic conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome).¹⁷²

If patient reports adverse effects suggestive of aortic aneurysm or dissection, immediately discontinue the fluoroquinolone.¹⁷² (See Advice to Patients.)

Prolongation of QT Interval

Prolonged QT interval leading to ventricular arrhythmia, including torsades de pointes, reported with fluoroquinolones, including ciprofloxacin.^{1 579 856}

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).^{1 579 856}

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).^{1 579 856}

Risk of prolonged QT interval may be increased in geriatric patients.^{1 579 856} (See Geriatric Use under Cautions.)

Hypoglycemia or Hyperglycemia

Systemic fluoroquinolones are associated with alterations in blood glucose concentrations, including symptomatic hypoglycemia and hyperglycemia.^{1 171 579} Blood glucose disturbances during fluoroquinolone therapy usually have occurred in patients with diabetes mellitus receiving an oral antidiabetic agent (e.g., glyburide) or insulin.^{1 171 579}

Severe cases of hypoglycemia resulting in coma or death reported with some systemic fluoroquinolones.^{1 171 579} 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.¹⁷¹

Carefully monitor blood glucose concentrations when ciprofloxacin used in diabetic patients receiving antidiabetic agents.^{1 171 579}

If hypoglycemic reaction occurs, discontinue ciprofloxacin and immediately initiate appropriate therapy.^{1 579} (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.^{1 579 856} 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.^{1 579} Use ciprofloxacin in pediatric patients <18 years of age only for certain indications.^{1 579} (See Pediatric Use under Cautions.)

Fluoroquinolones, including ciprofloxacin, cause arthropathy and osteochondrosis in immature animals of various species.^{1 183 186 213 455 479 579 841 842 843 844 845 846 847 848 849 850 856} Permanent lesions of the cartilage and lameness reported in ciprofloxacin studies in immature dogs.^{1 579 856}

Superinfection/C. difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.^{297 300 338 346 348 390 426 466 479 856}

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridioides difficile (formerly known as Clostridium difficile).^{1 302 303 304 348 579 796 856} 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.^{1 302 303 304 579 792 793 797 798 856} 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.^{1 579 856}

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.^{1 302 303 304 579 856} Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.^{1 302 303 304 579 856}

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile as soon as possible.³⁰² 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.^{1 302 303 304 579 579 856}

Interactions

Pharmacokinetic interaction with CYP1A2 substrates (e.g., clozapine, methylxanthines [e.g., caffeine, theophylline], olanzapine, ropinirole, tizanidine).^{1 579 856}

Concomitant use with tizanidine contraindicated.^{1 579 856} Avoid concomitant use with theophylline since serious and sometimes fatal reactions (e.g., cardiac arrest, seizure, status epilepticus, respiratory failure) reported.^{1 195 297 552 579 856} In addition, concomitant use with other CYP1A2 substrates should be avoided or requires particular caution.^{1 579 856} (See Specific Drugs under Interactions.)

Renal Effects

Possible crystalluria;^{1 234 339 355 373 426 466 479 579 856} generally associated with alkaline urine and high dosage.^{1 183 188 455 479 579 856}

Adequate fluid intake necessary to ensure proper hydration and adequate urinary output;^{1 455 579 856} avoid alkaline urine.^{1 455 579 856}

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.^{114 344 632 634 635 637 638 639 669 754 857}

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.^{114 857}

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).^{114 344 839}

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.^{1 140 145 579 856} 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.^{140 145}

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.^{1 579 856}

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^{1 579 856} In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.^{1 579 856}

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].¹

Specific Populations

Pregnancy

No adequate and controlled studies in pregnant women;^{1 579 856} 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.^{1 579 856}

Use during pregnancy only if potential benefits justify potential risks to fetus and mother.^{1 579 856}

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.⁶⁷² 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.⁶⁷²

Animal studies (rats and mice) using oral ciprofloxacin did not reveal evidence of harm to the fetus.^{1 579 856} In rabbits, oral ciprofloxacin caused GI toxicity resulting in maternal weight loss and increased incidence of abortion, but no evidence of teratogenicity;^{1 579 856} IV ciprofloxacin did not result in maternal toxicity, embryotoxicity, or teratogenicity.^{1 579}

Lactation

Distributed into milk;^{1 567 579 830 856} discontinue nursing or the drug.^{1 579 856}

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.^{703 705}

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.⁶⁷²

Pediatric Use

Ciprofloxacin causes arthropathy and histologic changes in weight-bearing joints of juvenile animals.^{1 579 856} An increased incidence of musculoskeletal disorders related to joints and/or surrounding tissues reported in pediatric patients.^{1 579} (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.^{1 579} Safety and efficacy not established for any other indication in pediatric patients.^{1 579}

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.^{292 293 450 522 654}

Extended-release tablets: Safety and efficacy not established for any indication in children and adolescents <18 years of age;⁸⁵⁶ do not use for any indication in pediatric patients.⁸⁵⁶

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.^{1 579 856}

Risk of fluoroquinolone-associated disorders, including tendon rupture, is increased in geriatric adults >60 years of age.^{1 579 851 852 856} This risk is further increased in those receiving concomitant corticosteroids.^{1 579 851 852 856} (See Tendinitis and Tendon Rupture under Cautions.) Use caution in geriatric adults, especially those receiving concomitant corticosteroids.^{1 579 856}

Risk of prolonged QT interval leading to ventricular arrhythmias may be increased in geriatric patients.^{1 579 856} 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).^{1 579 856}

Risk of fluoroquinolone-associated aortic aneurysm and dissection may be increased in geriatric patients.¹ (See Risk of Aortic Aneurysm and Dissection under Cautions.)

Age-related decline in renal function may increase risk of adverse reactions.^{1 579 856}

Hepatic Impairment

Carefully monitor patients with both hepatic and renal impairment.⁵⁷⁹

Renal Impairment

Increased ciprofloxacin concentrations and prolonged half-life;^{1 180 205 214 237 254 255 256 257 260 479 524 534 856} possible increased risk of adverse reactions.^{1 524}

Dosage adjustments necessary in patients with renal impairment.^{1 579 856} (See Renal Impairment under Dosage and Administration.)

Carefully monitor patients with both hepatic and renal impairment.⁵⁷⁹

Common Adverse Effects

GI effects (nausea, diarrhea, vomiting, abdominal pain/discomfort), headache, dizziness, restlessness, rash.^{1 178 183 289 237 297 301 307 308 317 329 336 363 424 425 426 428 462 466 473 478 479 579 856}

Drug Interactions

Inhibits CYP1A2.^{1 579 856}

Drugs Metabolized by Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction with CYP1A2 substrates (increased concentrations and increased pharmacologic or adverse effects of CYP1A2 substrate).^{1 579 856}

Drugs that Prolong QT Interval

Potential pharmacologic interactions (additive effect on QT interval prolongation).^{1 579 856} Avoid use in patients receiving drugs known to prolong QT interval.^{1 579 856} If concomitant use necessary, use with caution.^{1 579 856} (See Prolongation of QT Interval under Cautions.)

Specific Drugs

Ciprofloxacin Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed from GI tract;^{1 177 178 180 182 212 214 226 229 272 281 286 479} undergoes minimal first-pass metabolism.^{1 182 205 214 412 479 534}

Oral bioavailability of conventional tablets is 50–85% in healthy, fasting adults;^{1 177 178 180 212 214 235 236 238 281 412 474 479} peak serum concentrations attained within 0.5–2.3 hours.^{1 178 180 182 212 214 215 219 220 221 223 224 229 230 233 234 235 237 238 239 262 281 474 479 531}

A 500-mg dose given as the oral suspension containing 250 mg/5 mL is bioequivalent to a 500-mg conventional tablet.¹ 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.¹

Extended-release tablets: Peak plasma concentrations attained within 1–4 hours.⁸⁵⁶ Extended-release tablets contain approximately 35% of the dose within an immediate-release component; the remaining 65% is contained in a slow-release matrix.⁸⁵⁶

Extended-release tablets are not bioequivalent to conventional tablets.⁸⁵⁶

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.^{1 81 177 178 180 182 214 219 240 412 474 479 791 810}

Administration of ciprofloxacin conventional tablets with food results in a delay in absorption of the drug, but overall absorption not substantially affected.^{1 81 177 178 180 182 214 219 240 412 474 479}

Manufacturer states food does not affect pharmacokinetics of ciprofloxacin oral suspension.¹

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).⁸⁵⁶

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.^{1 856} Manufacturers state oral ciprofloxacin can be taken with dairy products or calcium-fortified juices that are part of a meal.^{1 856}

Concomitant administration of conventional ciprofloxacin tablets with a nutritional supplement may decrease peak plasma concentrations and/or AUC of the drug.^{791 820}

Special Populations

Bioavailability of oral suspension is approximately 60% in pediatric patients.^{1 579}

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.^{1 248 250 251 442 531 579 856} Not considered clinically important.^{1 579 856}

Distribution

Extent

Widely distributed into body tissues and fluids following oral or IV administration.^{1 180 205 214 281 474 479} Highest concentrations^{205 474 479} attained in bile,^{1 178 214 272 277 474 479 530} lungs,^{205 265 445 474 479} kidney,^{205 479} liver,⁴⁷⁹ gallbladder,^{205 277 479 530} uterus,^{205 214 282 474} seminal fluid,⁴⁷⁴ prostatic tissue and fluid,^{1 177 178 180 205 264 267 269 270 275 281 283 437 474 479} tonsils,^{273 281 474 479} endometrium,^{282 446 474} fallopian tubes,^{282 446 474} and ovaries.^{282 446 474} Concentrations achieved in most of these tissues and fluids substantially exceed those in serum.^{1 177 180 205 277 437 474 479 530}

Also distributed into bone,^{1 178 214 261 281 474 479} aqueous humor,^{214 278 431 479} sputum,^{1 178 241 242 244 245 246 281 439} saliva,^{1 214 221 226 263 442} nasal secretions,^{1 829} skin,^{1 268} muscle,^{1 232 261 268 274 281 479} adipose tissue,^{1 232 268 274 281} cartilage,¹ heart tissue (heart valves, myocardia),⁸³¹ and pleural,^{281 826 827} peritoneal,^{1 178 252 253 281 479} ascitic,^{479 828} blister,^{1 224 230 239 262 266 269 281 479} lymphatic,^{1 214 266 479} and renal cyst fluid.⁴⁷⁰

Low concentrations distributed into CSF;^{1 178 214 281 412 436 766} peak CSF concentrations may be 6–10% of peak serum concentrations.^{1 436}

Crosses the placenta and is distributed into amniotic fluid.⁵⁶⁷

Distributed into milk.^{567 830}

Plasma Protein Binding

16–43%.^{1 179 180 205 214 223 474 479}

Elimination

Metabolism

Partially metabolized^{1 180 209 214 271 272 412 474 490 530} in liver⁵³⁰ to at least 4 metabolites.^{1 180 209 214 271 412 474 479 488 534} Metabolites have microbiologic activity less than that of the parent drug,^{1 205 214 238 272 412 474 488 530} but some have activity similar to or greater than that of some other quinolones.^{272 488}

Elimination Route

Eliminated by renal and nonrenal mechanisms.^{180 182 214 245 259 260 412 474 479 490}

Excreted in urine by both glomerular filtration and tubular secretion (15–50% of dose is unchanged drug and 10–15% is metabolites).^{1 177 178 180 205 209 214 215 219 221 224 230 234 235 237 238 239 240 258 259 271 286 412 474 479 490 530 534} Approximately 20–40% of dose is excreted in feces as unchanged drug and metabolites;^{1 479 490} most of unchanged ciprofloxacin in feces results from biliary excretion.^{530 534}

Only small amounts removed by hemodialysis^{178 180 214 254 256 412 474 479} or peritoneal dialysis.^{214 252}

Half-life

Adults with normal renal function: 3–7 hours.^{1 178 182 212 214 219 220 224 229 230 235 238 239 240 412 474 479 530 534 579 856}

Special Populations

Pediatric patients: Predicted mean half-life is 4–5 hours.^{1 579}

Geriatric patients: Elimination half-life is slightly longer compared with younger adults.^{1 178 215 214 248 249 250 251 579 856} Half-life is 3.3–6.8 hours in adults 60–91 years of age with renal function normal for their age.^{248 249 250 251 531 596}

Adults with hepatic impairment: Half-life may be slightly prolonged.^{479 532}

Patients with impaired renal function: Serum concentrations are higher and half-life prolonged.^{1 180 205 214 237 254 255 256 257 260 474 479 524 534 579 856} Half-life is 4.4–12.6 hours in adults with Cl_cr ≤30 mL/minute.^{180 256 524}

Stability

Storage

Oral

Tablets

Conventional tablets: 20–25°C (may be exposed to 15–30°C).¹

Extended-release tablets: 20–25°C in tight, light-resistant container.⁸⁵⁶

For Suspension

<25°C (may be exposed to 15–30°C).¹ Following reconstitution, stable at 25°C (may be exposed to 15–30°C) for 14 days.¹ Do not freeze.¹

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.⁵⁷⁹ Protect from light and excessive heat; do not freeze.⁵⁷⁹

Compatibility

Parenteral

Solution CompatibilityHID

Drug Compatibility

Actions and Spectrum

• Usually bactericidal.^{1 15 57 148 151 176 179 180 181 479 481 856}

• Like other fluoroquinolones, ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV.^{1 47 147 148 149 154 167 180 181 467 479 481 497 519 722 723 724 725 726 835 856}

• 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).^{1 3 4 5 7 8 9 10 33 34 56 57 58 100 178 180 181 189 205 207 295 459 460 467 479 481} Inactive against fungi and viruses.¹⁵³

• Generally less active against gram-positive than gram-negative bacteria.^{56 57 58 178 180 181 189 207 479 481}

• Gram-positive aerobic cocci: Active in vitro and in clinical infections against S. aureus (methicillin-susceptible [oxacillin-susceptible] strains only),¹ S. epidermidis (oxacillin-susceptible strains only), S. pneumoniae (penicillin-susceptible strains),¹ S. pyogenes (group A β-hemolytic streptococci), S. saprophyticus, and Enterococcus faecalis.^{1 4 5 7 8 9 10 13 20 21 33 34 36 38 41 45 56 57 58 60 84 90 100 187 189 205 447 459 460} 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.^{1 3 4 5 7 8 9 10 13 18 20 33 34 38 41 45 46 57 58 60 80 84 90 94 96 100 187 189 205 447 459 460 563}

• Gram-positive aerobic bacilli: Active against Bacillus anthracis,^{1 686 692 712} Corynebacterium,^{9 10 33 36 74 102 213 460} and Listeria monocytogenes.^{5 9 10 33 34 41 56 60 100 213 447 459 460} Nocardia asteroides are resistant.^{10 108 213 447}

• 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).^{1 4 8 19 20 21 33 34 37 38 45 46 56 58 64 100 104 187 189 205 213 447 459 460 620} Also active in vitro against Acinetobacter,¹ Aeromonas,¹ Brucella,¹ Francisella tularensis,¹ Legionella pneumophila,¹ Vibrio,¹ and Yersinia pestis.¹ However, Burkholderia cepacia and Stenotrophomonas maltophilia are resistant.¹

• Other organisms: Active in vitro and in clinical infections against by C. pneumoniae,^{37 52 64 67 70 78 413} M. pneumoniae,⁷⁸ M. tuberculosis,^{28 32 812 68} and other mycobacteria.^{1 2 28 32 68 106 180 181 205 518 554 607}

• N. gonorrhoeae with decreased susceptibility to ciprofloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) widely disseminated worldwide, including in the US.^{114 344 632 634 635 637 638 639 754}

• 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.^{141 151 181 458 469 479 503 505 519 564 565 722 724 725 726 833 834}

• Some cross-resistance occurs between ciprofloxacin and other fluoroquinolones.^{77 86 148 161 181 205 214 295 479 521 564 632 635 638}

Advice to Patients

• Advise patients to read manufacturer’s patient information (medication guide) prior to initiating ciprofloxacin therapy and each time prescription refilled.^{1 579}

• 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).^{1 579 856}

• Importance of completing full course of therapy, even if feeling better after a few days.^{1 579 856}

• 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.^{1 579 856}

• 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.^{1 856}

• 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).^{1 856}

• Importance of drinking fluids liberally during therapy to avoid formation of highly concentrated urine and crystal formation in urine.^{1 579 856}

• 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.^{1 513 579 856}

• 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.^{1 140 145 579 856} 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.^{1 140 145 579} Advise patients to talk with clinician if they have any questions or concerns.^{1 140 145 579 856}

• 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.^{1 579 851 852 856} Symptoms may be irreversible.^{1 579 856} 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.^{1 579 856} (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.^{1 130 579 856} Importance of immediately discontinuing ciprofloxacin and contacting a clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur.^{1 130 579 856}

• Inform patients that systemic fluoroquinolones, including ciprofloxacin, have been associated with CNS effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure).^{1 579 856} Importance of informing clinician about any history of convulsions before initiating therapy with the drug.^{1 579 856} Importance of contacting a clinician if persistent headache with or without blurred vision occurs.^{1 579 856}

• Advise patients that ciprofloxacin may cause dizziness and lightheadedness;^{1 579 856} 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.^{1 579 856}

• Advise patients that systemic fluoroquinolones, including ciprofloxacin, may worsen myasthenia gravis symptoms;^{1 579 856} importance of informing clinician of any history of myasthenia gravis.^{1 579 856} Importance of immediately contacting a clinician if any symptoms of muscle weakness, including respiratory difficulties, occur.^{1 579 856}

• Inform patients that ciprofloxacin may be associated with hypersensitivity reactions (including anaphylactic reactions), even after first dose.^{1 579 856} 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.^{1 579 856}

• Inform patients that photosensitivity/phototoxicity reactions reported following exposure to sun or UV light in patients receiving fluoroquinolones.^{1 579 856} 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.^{1 579 856} Importance of discontinuing ciprofloxacin and contacting a clinician if a sunburn-like reaction or skin eruption occurs.^{1 579 856}

• Inform patients that systemic fluoroquinolones may increase risk of aortic aneurysm and dissection;¹⁷² 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.¹⁷² Advise patients to seek immediate medical treatment if they experience sudden, severe, and constant pain in the stomach, chest, or back.^{1 172 579}

• Advise patients that hypoglycemia has been reported in patients receiving ciprofloxacin and oral antidiabetic agents.^{1 579 856} If low blood glucose occurs, importance of contacting clinician to determine whether the anti-infective should be changed.^{1 579 856}

• Inform patients that severe hepatotoxicity, including acute hepatitis and some fatalities, reported.^{1 579 856} 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.^{1 579 856}

• 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.^{1 579 856} Importance of contacting clinician if any symptoms of prolongation of QT interval (e.g., prolonged heart palpitations, loss of consciousness) occur.^{1 579 856}

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.^{1 579 856} 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.^{1 579 856}

• 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.^{1 579 856} Importance of parent contacting a clinician if the child develops any joint-related problems during or following ciprofloxacin therapy.^{1 579 856}

• 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.^{1 579 856}

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 579 856}

• Importance of advising patients of other important precautionary information.^{1 579 856} (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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