Generic Name: ciprofloxacin

Brand Names: Cipro, Ciprofloxacin Extended Release, Proquin XR, Cipro XR, Cipro I.V., Ciprofloxacin Hydrochloride, Cipro Cystitis Pack

Uses

Bone and Joint Infections

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

Has been used for treatment of bone and joint infections caused by susceptible gram-positive bacteria, including Staphylococcus aureus†, S. epidermidis†, other coagulase-negative staphylococci†, or Enterococcus faecalis†. Other anti-infectives generally preferred for these gram-positive infections, but ciprofloxacin may be a useful alternative for treatment of infections caused by susceptible oxacillin-resistant (methicillin-resistant) staphylococci.

Endocarditis

Alternative for treatment of native or prosthetic valve endocarditis† caused by fastidious gram-negative bacilli known as the HACEK group (Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Haemophilus aphrophilus, H. influenzae, H. parainfluenzae, H. paraphrophilus, Kingella denitrificans, K. kingae). AHA and IDSA recommend ceftriaxone or ampicillin-sulbactam as drugs of choice, but a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) may be considered when β-lactam anti-infectives cannot be used. Consultation with an infectious disease specialist is recommended.

Alternative for treatment of uncomplicated right-sided S. aureus native valve endocarditis†. For native valve staphylococcal endocarditis, AHA and IDSA recommend IV nafcillin or oxacillin (with or without gentamicin) as regimen of choice and IV cefazolin (with or without gentamicin) as an alternative; IV vancomycin is recommended when staphylococci are oxacillin-resistant. An oral regimen of ciprofloxacin and rifampin can be considered in IV drug abusers who will not comply with a parenteral regimen.

Alternative to gentamicin in regimens used for treatment of coagulase-negative staphylococcal endocarditis in the presence of prosthetic valves or materials†. For prosthetic valve staphylococcal endocarditis, AHA and IDSA recommend IV nafcillin or oxacillin with oral or IV rifampin and parenteral gentamicin; IV vancomycin with oral or IV rifampin and parenteral gentamicin is recommended when staphylococci are oxacillin-resistant. If causative organism is resistant to aminoglycosides, AHA and IDSA suggest a fluoroquinolone replace gentamicin in these regimens, provided in vitro susceptibility tests indicate the organism is susceptible to the fluoroquinolone.

Empiric treatment of culture-negative endocarditis†. For empiric treatment of native valve culture-negative endocarditis, AHA and IDSA recommend a regimen of ampicillin-sulbactam with gentamicin or a regimen of vancomycin, gentamicin, and ciprofloxacin. Selection of the most appropriate anti-infective regimen is difficult and should be guided by epidemiologic features and clinical course of the infection. Consultation with an infectious diseases specialist is recommended.

GI Infections

Treatment of infectious diarrhea caused by susceptible enterotoxigenic E. coli, Campylobacter fetus subsp. jejuni, Salmonella (see Typhoid Fever and other Salmonella Infections under Uses), Shigella flexneri, S. boydii, S. sonnei, or S. dysenteriae. Active in vitro against most pathogens associated with infectious diarrhea; may be a drug of choice for empiric treatment. Consider increasing emergence of fluoroquinolone-resistant Campylobacter secondary to widespread use of the drugs; use judiciously for treatment and prevention of enteropathogenic diarrhea.

Alternative to co-trimoxazole for treatment of GI infections caused by Cyclospora† or Isospora†.

Treatment of GI infections caused by Yersinia enterocolitica† or Y. pseudotuberculosis†. These infections usually self-limited, but IDSA, AAP, and others recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs. Some suggest that the role of anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.

Treatment of travelers’ diarrhea†. Generally self-limited and may resolve within 3–4 days without anti-infective treatment; if diarrhea is moderate or severe, persists for >3 days, or is associated with fever or bloody stools, short-term (1–3 days) anti-infective treatment may be indicated. Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, is indicated. Azithromycin is a treatment alternative for those who should not receive fluoroquinolones (e.g., children, pregnant women) and may be a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., Thailand, India) or those who have not responded after 48 hours of fluoroquinolone treatment. Rifaximin is another alternative for treatment of travelers’ diarrhea caused by noninvasive E. coli.

Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug. CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk; the principal preventive measures are prudent dietary practices. If anti-infective prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is recommended for nonpregnant adults, although the increasing incidence of quinolone resistance in pathogens that cause travelers’ diarrhea (e.g., Campylobacter) should be considered.

Intra-abdominal Infections

Parenteral 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.

For immunosuppressed patients or those with severe intra-abdominal infections, IDSA recommends an initial empiric regimen with broad spectrum of activity such as meropenem or imipenem; a third or fourth generation cephalosporin (cefepime, cefotaxime, ceftazidime, ceftizoxime, ceftriaxone) in conjunction with metronidazole; ciprofloxacin in conjunction with metronidazole; piperacillin-tazobactam; or aztreonam in conjunction with metronidazole. For mild to moderate community-acquired intra-abdominal infections, IDSA recommends an initial empiric regimen with narrower spectrum of activity such as ampicillin-sulbactam; cefazolin or cefuroxime in conjunction with metronidazole; ticarcillin-clavulanate; ertapenem; or a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) in conjunction with metronidazole.

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., aminoglycoside, ceftriaxone or cefotaxime).

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

Otic Infections

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

Respiratory Tract Infections

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

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

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

Parenteral treatment of nosocomial pneumonia caused by susceptible H. influenzae or K. pneumoniae.

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

Not a drug of first choice for pneumonia caused by S. pneumoniae; generally should not be used for empiric treatment of community-acquired pneumonia (CAP) when S. pneumoniae is likely or suspected. IDSA and ATS state that other fluoroquinolones with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) are drugs of choice for empiric treatment of CAP in outpatients at risk for infections caused by drug-resistant S. pneumoniae (DRSP) and also are drugs of choice for empiric treatment of CAP in inpatients.

Treatment of acute exacerbations of bronchopulmonary Ps. aeruginosa infections in cystic fibrosis patients. As with other anti-infectives, Ps. aeruginosa may be cleared temporarily from the sputum, but a bacteriologic cure rarely is obtained and should not be expected in these patients.

Probably should not be used for treatment of aspiration pneumonia since these infections generally involve anaerobic bacteria.

Skin and Skin Structure Infections

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

Urinary Tract Infections (UTIs) and Prostatitis

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

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

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

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

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

Treatment of recurrent UTIs and chronic prostatitis in adults caused by E. coli or P. mirabilis in men. May be a drug of choice because high concentrations are attained in prostatic tissue.

Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria; generally not recommended for uncomplicated UTIs (e.g., acute cystitis) unless more commonly employed urinary anti-infectives are likely to be ineffective or other equally effective, less expensive anti-infectives are contraindicated or not tolerated.

Anthrax

Postexposure prophylaxis to reduce the incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax). Initial drug of choice for such prophylaxis is ciprofloxacin or doxycycline. Based on in vitro data, other fluoroquinolones (e.g., moxifloxacin, ofloxacin, levofloxacin) are considered alternatives to ciprofloxacin when needed.

Treatment of inhalational anthrax. Monotherapy may be effective for anthrax that occurs as the result of natural or endemic exposures, but a multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is recommended for inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism. Other drugs suggested as possibilities to augment ciprofloxacin or doxycycline in such multiple-drug regimens include chloramphenicol, clindamycin, rifampin, vancomycin, macrolides (azithromycin, clarithromycin, erythromycin), imipenem, meropenem, penicillin, ampicillin, daptomycin, quinupristin and dalfopristin, linezolid, and aminoglycosides (gentamicin). If meningitis is established or suspected, some clinicians suggest a multiple-drug regimen that includes a fluoroquinolone (e.g., ciprofloxacin) and 1 or 2 additional agents with good CSF penetration (e.g., ampicillin or penicillin, meropenem, rifampin, vancomycin, chloramphenicol).

Treatment of cutaneous anthrax†, including that occurring following exposure to B. anthracis spores in the context of biologic warfare or bioterrorism. Parenteral multiple-drug regimen recommended for initial treatment when there are signs of systemic involvement, extensive edema, or lesions on the head and neck or when cutaneous anthrax occurs in children <2 years of age.

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

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

Although ciprofloxacin not usually used in children <18 years of age or in pregnant women, CDC and others state ciprofloxacin can be used when necessary in these patients for postexposure prophylaxis or treatment of anthrax since the benefits of ciprofloxacin outweigh the risks.

Bartonella Infections

Treatment of infections caused by Bartonella henselae† (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis).

Cat scratch disease generally self-limited in immunocompetent individuals and may resolve spontaneously in 2–4 months; some clinicians suggest that anti-infectives be considered for acutely or severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and probably is indicated in immunocompromised patients. Anti-infectives also indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome. Optimum regimens have not been identified; some clinicians recommend azithromycin, ciprofloxacin, erythromycin, doxycycline, rifampin, co-trimoxazole, gentamicin, or third generation cephalosporins.

Brucellosis

Treatment of brucellosis† caused by Brucella melitensis. Ciprofloxacin used in conjunction with rifampin is an alternative to a regimen of a tetracycline and rifampin.

Capnocytophaga Infections

Alternative to penicillin G for treatment of infections caused by Capnocytophaga canimorsus†.

Chancroid

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

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

Crohn’s Disease

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

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

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

Gonorrhea and Associated Infections

Has been used for treatment of uncomplicated urethral, endocervical, rectal†, or pharyngeal† gonorrhea caused by susceptible Neisseria gonorrhoeae.

Has been used for treatment of disseminated gonococcal infections† caused by susceptible N. gonorrhoeae.

Although fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin) were previously considered drugs of choice for treatment of uncomplicated gonorrhea, CDC currently states fluoroquinolones should not be used for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).

Quinolone-resistant N. gonorrhoeae (QRNG) has been reported with increasing frequency worldwide and is widespread in the US. (See Resistance in Neisseria gonorrhoeae under Cautions.)

For treatment of uncomplicated cervical, urethral, or rectal gonorrhea, CDC and others recommend IM ceftriaxone or oral cefixime; IM ceftriaxone is drug of choice for pharyngeal infections.

For initial treatment of disseminated gonococcal infections, CDC recommends IM or IV ceftriaxone as drug of choice and IV cefotaxime, IV ceftizoxime (no longer commercially available in the US), or IM spectinomycin (not currently commercially available in the US) as alternatives. Initial parenteral regimen should be continued for 24–48 hours after improvement begins; therapy can be switched to oral cefixime or oral cefpodoxime and continued to complete ≥1 week of treatment. CDC states that fluoroquinolones (ciprofloxacin, ofloxacin, levofloxacin) may be alternative treatment option for disseminated infections only if in vitro susceptibility can be documented by culture.

Granuloma Inguinale (Donovanosis)

Alternative for treatment of granuloma inguinale† (donovanosis) caused by Klebsiella granulomatis (formerly Calymmatobacterium granulomatis). CDC recommends doxycycline or co-trimoxazole as drugs of choice; ciprofloxacin, erythromycin, and azithromycin are alternatives.

Legionnaires’ Disease

Treatment of Legionnaires’ disease† caused by Legionella pneumophila. A drug of choice, especially in immunocompromised patients (e.g., transplant recipients).

Malaria

Although ciprofloxacin reportedly has in vitro activity against Plasmodium falciparum, it has been ineffective when used alone in the treatment of uncomplicated malaria caused by chloroquine-resistant P. falciparum†.

Mycobacterial Infections

Alternative for use in multiple-drug regimens for treatment of active tuberculosis†.

CDC, ATS, and IDSA state that use of fluoroquinolones can be considered in patients with relapse, treatment failure, or Mycobacterium tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated. There have been recent reports of extensively drug-resistant tuberculosis (XDR tuberculosis). XDR tuberculosis is caused by M. tuberculosis resistant to rifampin and isoniazid (multiple-drug resistant strains) that also are resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial (capreomycin, kanamycin, amikacin).

Although there is clinical experience with several fluoroquinolones in the treatment of tuberculosis (e.g., ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin), levofloxacin and moxifloxacin are the fluoroquinolones recommended by CDC, ATS, and IDSA and levofloxacin may be preferred on the basis of cumulative experience. Consult the most recent CDC, ATS, and IDSA recommendations for treatment of tuberculosis for more specific information.

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

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

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

Nasal Carriage of Staphylococcus aureus

Has been used for temporary elimination of oxacillin-resistant (methicillin-resistant) S. aureus colonization† in patients with serious diseases at risk for infection. Consider that management of oxacillin-resistant S. aureus colonization is controversial, permanent eradication of nasal carriage of staphylococci following topical or systemic anti-infectives is unlikely, ciprofloxacin resistance has been reported in some oxacillin-resistant S. aureus, and there is some evidence that ciprofloxacin may be an independent risk factor for colonization with oxacillin-resistant S. aureus in HIV-infected patients.

Neisseria meningitidis Infections

Elimination of nasopharyngeal carriage of N. meningitidis†. CDC and AAP consider rifampin, ceftriaxone, or ciprofloxacin the drugs of choice for such carriers.

Postexposure prophylaxis to prevent meningococcal disease in household or other close contacts of patients with invasive meningococcal disease†. Recommended regimens for such prophylaxis are rifampin (not recommended in pregnant women), ceftriaxone, or ciprofloxacin (not recommended in individuals <18 years of age unless no other regimen can be used and not recommended for pregnant or lactating women).

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

Plague

Alternative for treatment of plague† caused by Yersinia pestis, including naturally occurring plague and plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism. Regimen of choice is streptomycin (or gentamicin) with or without doxycycline; alternatives are doxycycline, chloramphenicol (drug of choice for plague meningitis), fluoroquinolones, or co-trimoxazole (may be less effective than other alternatives).

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

Rickettsial Infections

Treatment of rickettsial infections†. Has been effective for Q fever endocarditis caused by Coxiella burnetii† and Mediterranean spotted fever caused by Rickettsia conorii†. Tetracyclines (usually doxycycline) are drugs of choice for treatment of most rickettsial infections; fluoroquinolones are alternatives when tetracyclines cannot be used. Because of better CNS penetration, some experts suggest fluoroquinolones may be a better choice than tetracyclines for patients with meningoencephalitis. (See Distribution under Pharmacokinetics.)

Selective Decontamination of the GI Tract

Selective decontamination of the GI tract† in granulocytopenic patients or other debilitated patients (e.g., those with cirrhosis).

Tularemia

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

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

Typhoid Fever and Other Salmonella Infections

Treatment of typhoid fever (enteric fever) caused by susceptible Salmonella typhi, including chloramphenicol-resistant strains.

Treatment of chronic typhoid carriers†. Considered a drug of choice by some clinicians, but manufacturer cautions that efficacy of ciprofloxacin in eradication of the chronic typhoid carrier state has not been demonstrated.

Treatment of gastroenteritis caused by non-typhi Salmonella (e.g., S. enteritidis, S. typhimurium). Anti-infective treatment is indicated only 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. Choice of anti-infective is based on in vitro susceptibility.

Treatment of HIV-infected adults with Salmonella gastroenteritis to prevent extraintestinal spread of the infection. Recommended by USPHS/IDSA as drug of choice for treatment of salmonella gastroenteritis in HIV-infected adults, but pregnant HIV-infected women with Salmonella gastroenteritis should receive ampicillin, cefotaxime, ceftriaxone, or co-trimoxazole and children should receive co-trimoxazole, ampicillin, cefotaxime, ceftriaxone, or chloramphenicol.

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

Long-term suppressive or maintenance therapy (secondary prophylaxis) in HIV-infected adults to prevent recurrence of nontyphi Salmonella septicemia†.

Vibrio Infections

Treatment of cholera† caused by Vibrio cholerae 01 or 0139. Tetracyclines generally drugs of choice for treatment of cholera in conjunction with fluid and electrolyte replacement therapy; ciprofloxacin is an alternative, especially for infections caused by V. cholerae resistant to tetracyclines.

Alternative to tetracyclines for treatment of other Vibrio infections, including gastroenteritis or wound infections caused by V. parahaemolyticus† or V. vulnificus†.

Treatment of infections caused by V. vulnificus†. Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime), a fluoroquinolone, or aminoglycoside has been recommended. Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.

Perioperative Prophylaxis

Perioperative prophylaxis† in high risk patients undergoing genitourinary surgery.

Not recommended for patients with sterile urine undergoing most urologic surgical procedures. Those who have positive (or unavailable) urine cultures and those with preoperative catheters should be treated to sterilize the urine before surgery or receive a single preoperative dose of an anti-infective (e.g., ciprofloxacin) active against the most likely urologic pathogens.

Perioperative prophylaxis using an appropriate anti-infective (e.g., ciprofloxacin) also recommended in patients undergoing transurethral prostatectomy, transrectal prostatic biopsies, or a procedure that involves placement of a urologic prosthesis (e.g., penile transplant, artificial sphincter, synthetic pubovaginal sling, bone anchors for pelvic floor reconstruction).

Empiric Therapy in Febrile Neutropenic Patients

Empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients; used in conjunction with IV piperacillin (no longer commercially available in the US as a single-entity preparation).

Dosage and Administration

Administration

Administer orally or by IV infusion.

IV route generally reserved for patients who do not tolerate or are unable to take the drug orally and for other patients in whom IV route offers a clinical advantage. Patients receiving IV ciprofloxacin initially may be switched to oral ciprofloxacin when clinically appropriate.

Patients receiving ciprofloxacin orally or IV should be well hydrated and should be instructed to drink fluids liberally.

Oral Administration

Administer conventional tablets or oral suspension without regard to meals. (See Pharmacokinetics.)

Administer extended-release tablets containing the hydrochloride and base (Cipro^® XR) without regard to meals. Administer extended-release tablets containing ciprofloxacin hydrochloride (ProQuin^® XR) with a meal (preferably the evening meal) to maximize absorption. (See Pharmacokinetics.)

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

Extended-release tablets should not be split, crushed, or chewed.

The microcapsules are used to prepare oral suspensions and should not be chewed. The oral suspension should not be administered through feeding tubes.

Reconstitution

Prepare oral suspensions by mixing the microcapsules for suspension with the diluent provided by the manufacturer. Shake vigorously for approximately 15 seconds prior to administration of each dose.

IV Infusion

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

Ciprofloxacin concentrate containing 10 mg/mL must be diluted prior to IV infusion.

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

The 1.2-g pharmacy bulk package containing 10 mg/mL must be diluted prior to use. The pharmacy bulk package is intended for use in a pharmacy admixture program and should be used only for the preparation of admixtures for IV infusion.

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

Dilution

Dilute ciprofloxacin containing 10 mg/mL in 0.9% sodium chloride injection or 5% dextrose injection to provide a solution containing 1–2 mg/mL.

The 1.2-g pharmacy bulk package containing 10 mg/mL must be diluted in 0.9% sodium chloride injection or 5% dextrose injection to provide a solution containing 0.5–2 mg/mL.

Rate of Administration

Administer by IV infusion over 1 hour.

Dosage

Available as ciprofloxacin, ciprofloxacin hydrochloride, a mixture of ciprofloxacin and ciprofloxacin hydrochloride, and as ciprofloxacin lactate; dosage expressed in terms of ciprofloxacin.

Extended-release tablet preparations (Cipro^® XR, ProQuin^® XR) are used only for the treatment of certain urinary tract infections (UTIs). These extended-release preparations are not interchangeable with each other and are not interchangeable with other oral ciprofloxacin preparations (conventional tablets, oral suspension).

Based on pharmacokinetic parameters (i.e., AUC), the following regimens are considered equivalent: ciprofloxacin conventional tablets 250 mg every 12 hours—ciprofloxacin 200 mg IV every 12 hours; ciprofloxacin conventional tablets 500 mg every 12 hours—ciprofloxacin 400 mg IV every 12 hours; ciprofloxacin conventional tablets 750 mg every 12 hours—ciprofloxacin 400 mg IV every 8 hours.

Pediatric Patients

Urinary Tract Infections (UTIs)

Complicated UTIs and Pyelonephritis

Oral

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

IV

Children 1–17 years of age: 6–10 mg/kg (up to 400 mg) every 8 hours. Switch to oral route when clinically indicated; total duration of IV and oral therapy 10–21 days.

Endocarditis

Endocarditis Caused by the HACEK Group

Oral

20–30 mg/kg daily given in 2 equally divided doses recommended by AHA and IDSA. Duration of treatment is 4 weeks for native valve endocarditis or 6 weeks for endocarditis involving prosthetic cardiac valves or other prosthetic cardiac material.†

IV

20–30 mg/kg daily given in 2 equally divided doses recommended by AHA and IDSA. Duration of treatment is 4 weeks for native valve endocarditis or 6 weeks for endocarditis involving prosthetic cardiac valves or other prosthetic cardiac material.†

Culture-negative Endocarditis

Oral

20–30 mg/kg daily given in 2 equally divided doses in conjunction with vancomycin (40 mg/kg daily given IV in 2 equally divided doses) and gentamicin (3 mg/kg daily given IM or IV in 3 equally divided doses) recommended by AHA and IDSA. All 3 drugs should be given for 4–6 weeks.†

IV

20–30 mg/kg daily given in 2 equally divided doses in conjunction with vancomycin (40 mg/kg daily given IV in 2 equally divided doses) and gentamicin (3 mg/kg daily given IM or IV in 3 equally divided doses) recommended by AHA and IDSA. All 3 drugs should be given for 4–6 weeks.†

Meningitis and CNS Infections

Salmonella Meningitis

IV

10–30 mg/kg daily has been given alone or in conjunction with cefotaxime.†

Anthrax

Postexposure Prophylaxis Following Exposure in the Context of Biologic Warfare or Bioterrorism

Oral

15 mg/kg (up to 500 mg) every 12 hours ≥60 days. Because of concerns regarding long-term use of ciprofloxacin in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the full duration of postexposure prophylaxis if the strain is found to be susceptible to penicillin.

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear, but prolonged postexposure prophylaxis usually required. A duration of 60 days may be adequate for a low-dose exposure, but a duration >4 months may be necessary to reduce the risk following a high-dose exposure. CDC, US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend that postexposure prophylaxis in unvaccinated individuals be continued for ≥60 days following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures). The USPHS Advisory Committee on Immunization Practices (ACIP) and USAMRIID recommend that individuals who are partially or fully vaccinated against anthrax receive postexposure prophylaxis for ≥30 days; if given in conjunction with anthrax vaccine, continue prophylaxis for at least 7–14 days after the third vaccine dose.

IV

10 mg/kg (up to 400 mg) every 12 hours for ≥60 days.

Treatment of Inhalational, GI, or Oropharyngeal Anthrax

Oral

15 mg/kg (up to 500 mg) every 12 hours given for ≥60 days.†

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting). Continue for total duration of ≥60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism. Because of concerns regarding long-term use of ciprofloxacin in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the treatment regimen if penicillin susceptibility is confirmed.†

IV, then Oral

10 mg/kg (up to 400 mg) IV every 12 hours.†

Used in conjunction with 1 or 2 other anti-infectives predicted to be effective. When clinical improvement occurs, switch IV ciprofloxacin to oral ciprofloxacin in a dosage of 15 mg/kg (up to 500 mg) twice daily and continue for a total duration of ≥60 days. Because of concerns regarding long-term use of ciprofloxacin in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the treatment regimen if penicillin susceptibility is confirmed.†

Treatment of Cutaneous Anthrax

Oral

15 mg/kg (up to 500 mg) every 12 hour.†

For mild, uncomplicated cutaneous anthrax that occurs following natural or endemic exposure (e.g., known exposure to infected livestock or their products), 5–10 days of treatment may be sufficient.†

For cutaneous anthrax that occurs following exposure in the context of biologic warfare or bioterrorism, duration of treatment is ≥60 days. Because of concerns regarding long-term use of ciprofloxacin in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the treatment regimen if penicillin susceptibility is confirmed.†

Oral regimen should not be used for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or head and neck lesions or in infants <2 years of age.†

IV, then Oral

10 mg/kg (up to 400 mg) IV every 12 hours.†

Used in conjunction with 1 or 2 other anti-infectives predicted to be effective. When clinical improvement occurs, switch IV ciprofloxacin to oral ciprofloxacin in a dosage of 500 mg twice daily and continue for a total duration of ≥60 days. Because of concerns regarding long-term use of ciprofloxacin in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the treatment regimen if penicillin susceptibility is confirmed.†

Gonorrhea and Associated Infections

Uncomplicated Urethral, Endocervical, Rectal, or Pharyngeal Gonorrhea

Oral

Adolescents and children weighing >45 kg: 500 mg as a single dose has been used for infections caused by susceptible Neisseria gonorrhoeae.†

Because of increased prevalence of quinolone-resistant N. gonorrhoeae (QRNG), CDC no longer recommends ciprofloxacin or other fluoroquinolones for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis). (See Gonorrhea and Associated Infections under Uses.)†

Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients being treated for gonorrhea also should receive an anti-infective regimen effective for presumptive treatment of chlamydia (e.g., a single dose of oral azithromycin or a 7-day regimen of oral doxycycline).†

Disseminated Gonococcal Infections

IV, then Oral

Adolescents and children weighing >45 kg: 400 mg IV every 12 hours has been used for initial treatment. IV regimen is continued for 24–48 hours after improvement begins, then switched to 500 mg orally twice daily to complete ≥1 week of treatment.†

Because of increased prevalence of QRNG, CDC no longer recommends ciprofloxacin or other fluoroquinolones for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., PID, epididymitis). Use as an alternative treatment option for disseminated infections only if in vitro susceptibility can be documented by culture. (See Gonorrhea and Associated Infections under Uses.)†

Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients being treated for gonorrhea also should receive an anti-infective regimen effective for presumptive treatment of chlamydia (e.g., a single dose of oral azithromycin or a 7-day regimen of oral doxycycline).†

Plague

Treatment of Pneumonic Plague Occurring in Context of Biologic Warfare or Bioterrorism

Oral

Conventional tablets or oral suspension: 20 mg/kg twice daily. Usual duration of treatment is 10 days; some experts recommend a duration of at least 10–14 days.†

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).†

IV, then Oral

15 mg/kg IV twice daily. When clinical improvement occurs, IV ciprofloxacin may be switched to oral ciprofloxacin in a dosage of 20 mg/kg twice daily.†

Usual duration of treatment is 10 days; some experts recommend a duration of at least 10–14 days.†

Postexposure Prophylaxis Following High-risk Exposure

Oral

Conventional tablets or oral suspension: 20 mg/kg twice daily for 7 days.†

Tularemia

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

Oral

Conventional tablets or oral suspension: 15 mg/kg twice daily. Usual duration of treatment is 10 days; some experts recommend a duration of at least 10–14 days.†

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).†

IV, then Oral

15 mg/kg IV twice daily.†

When clinical improvement occurs, switch IV ciprofloxacin to oral ciprofloxacin in a dosage of 15 mg/kg twice daily. Usual total duration of treatment is 10 days; some experts recommend a duration of at least 10–14 days.†

Postexposure Prophylaxis Following High-risk Exposure

Oral

Conventional tablets or oral suspension: 15 mg/kg twice daily for 14 days.†

Vibrio Infections

Cholera

Oral

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

Adults

Bone and Joint Infections

Mild to Moderate Infections

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for at least 4–6 weeks.

IV

400 mg every 12 hours for ≥4–6 weeks.

Severe or Complicated Infections

Oral

Conventional tablets or oral suspension: 750 mg every 12 hours for at least 4–6 weeks.

IV

400 mg every 8 hours for ≥4–6 weeks.

Endocarditis

Endocarditis Caused by the HACEK Group

Oral

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

IV

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

Staphylococcal Endocarditis in the Absence of Prosthetic Materials

Oral

750 mg twice daily in conjunction with rifampin (300 mg orally twice daily) given for 28 days has been used for uncomplicated right-sided S. aureus endocarditis in IV drug abusers who will not comply with usually recommended parenteral regimens.†

Culture-negative Endocarditis

Oral

1 g daily given in 2 equally divided doses in conjunction with vancomycin (30 mg/kg daily given IV in 2 equally divided doses) and gentamicin (3 mg/kg daily given IM or IV in 3 equally divided doses) recommended by AHA and IDSA. All 3 drugs should be given for 4–6 weeks.†

IV

800 mg daily given in 2 equally divided doses in conjunction with vancomycin (30 mg/kg daily given IV in 2 equally divided doses) and gentamicin (3 mg/kg daily given IM or IV in 3 equally divided doses) recommended by AHA and IDSA. All 3 drugs should be given for 4–6 weeks.†

GI Infections

Infectious Diarrhea

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 5–7 days.

Cyclospora or Isospora Infections

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 7 days.†

Treatment of Travelers’ Diarrhea

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 1–3 days. Duration of 3–7 days recommended for empiric treatment in HIV-infected adults.†

Prevention of Travelers’ Diarrhea

Oral

Conventional tablets or oral suspension: 500 mg once daily.†

Although anti-infective prophylaxis generally is discouraged, some clinicians state that it can be given during the period of risk (for ≤3 weeks) beginning the day of travel and continuing for 1 or 2 days after leaving the area of risk.†

Intra-abdominal Infections

Complicated Infections

IV, then Oral

Initiate therapy with 400 mg IV every 12 hours given in conjunction with IV metronidazole. When appropriate, switch to oral ciprofloxacin in a dosage of 500 mg every 12 hours in conjunction with oral metronidazole. Total duration of therapy is 7–14 days.

Meningitis and CNS Infections

Gram-negative Meningitis

IV

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

Otic Infections

Malignant Otitis Externa

Oral

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

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

Respiratory Tract Infections

Acute Sinusitis

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 10 days.

IV

400 mg every 12 hours for 10 days.

Mild to Moderate Infections

Oral

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

IV

400 mg every 12 hours for 7–14 days.

Severe or Complicated Infections

Oral

Conventional tablets or oral suspension: 750 mg every 12 hours for 7–14 days.

IV

400 mg every 8 hours for 7–14 days.

Mild, Moderate, or Severe Nosocomial Pneumonia

IV

400 mg every 8 hours for 10–14 days.

Skin and Skin Structure Infections

Mild to Moderate Infections

Oral

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

IV

400 mg every 12 hours for 7–14 days.

Severe or Complicated Infections

Oral

Conventional tablets or oral suspension: 750 mg every 12 hours for 7–14 days.

IV

400 mg every 8 hours for 7–14 days.

Urinary Tract Infections (UTIs) and Prostatitis

Uncomplicated UTIs (Acute Cystitis)

Oral

Conventional tablets or oral suspension: 250 mg every 12 hours for 3 days.

Extended-release tablets (Cipro^® XR): 1 tablet (500 mg) once daily for 3 days, preferably given with the evening meal.

Extended-release tablets (ProQuin^® XR): 1 tablet (500 mg) once daily for 3 days.

Mild to Moderate UTIs

Oral

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

IV

200 mg every 12 hours for 7–14 days.

Complicated UTIs

Oral

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

Extended-release tablets (Cipro^® XR): 1 tablet (1 g) once every 24 hours for 7–14 days.

IV

400 mg every 12 hours for 7–14 days.

Acute Uncomplicated Pyelonephritis

Oral

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

Mild to Moderate Chronic Prostatitis

Oral

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

IV

400 mg every 12 hours for 28 days.

Anthrax

Postexposure Prophylaxis Following Exposure in the Context of Biologic Warfare or Bioterrorism

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for ≥60 days.

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear, but prolonged postexposure prophylaxis usually required. A duration of 60 days may be adequate for a low-dose exposure, but a duration >4 months may be necessary to reduce the risk following a high-dose exposure. CDC, US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend that postexposure prophylaxis in unvaccinated individuals be continued for ≥60 days following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures). The USPHS Advisory Committee on Immunization Practices (ACIP) and USAMRIID recommend that individuals who are partially or fully vaccinated against anthrax receive postexposure prophylaxis for ≥30 days; if given in conjunction with anthrax vaccine, continue prophylaxis for at least 7–14 days after the third vaccine dose.

IV

400 mg every 12 hours for ≥60 days.

Postexposure Prophylaxis Following Ingestion of Bacillus anthracis Spores in Contaminated Meat

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours has been recommended.†

Treatment of Inhalational, GI, or Oropharyngeal Anthrax

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours given for ≥60 days.†

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting). Continue for total duration of ≥60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.†

IV, then Oral

400 mg IV every 12 hours.†

Used in conjunction with 1 or 2 other anti-infectives predicted to be effective. When clinical improvement occurs, switch IV ciprofloxacin to oral ciprofloxacin in a dosage of 500 mg twice daily and continue for a total duration of ≥60 days.†

Treatment of Cutaneous Anthrax

Oral

Conventional tablets or oral suspension: 500 mg every 12 hour.†

For mild, uncomplicated cutaneous anthrax that occurs following natural or endemic exposure, 5–10 days of treatment has been recommended.†

For cutaneous anthrax that occurs following exposure in the context of biologic warfare or bioterrorism, duration of treatment is ≥60 days.†

Oral regimen should not be used for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or head and neck lesions.†

IV, then Oral

400 mg IV every 12 hours.†

Used in conjunction with 1 or 2 other anti-infectives predicted to be effective. When clinical improvement occurs, switch IV ciprofloxacin to oral ciprofloxacin in a dosage of 500 mg twice daily and continue for a total duration of ≥60 days.†

Bartonella Infections

Cat Scratch Disease Caused by Bartonella henselae

Oral

Conventional tablets or oral suspension: 500 mg twice daily for 10–16 days has been used.†

Brucella Infections

Oral

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

Chancroid

Oral

Conventional tablets or oral suspension: 500 mg twice daily for 3 days recommended by CDC and others.†

Crohn’s Disease

Oral

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

Gonorrhea and Associated Infections

Uncomplicated Urethral, Endocervical, Rectal, or Pharyngeal Gonorrhea

Oral

Conventional tablets or oral suspension: 500 mg as a single dose has been used for infections caused by susceptible N. gonorrhoeaee. Lower doses not recommended.†

Conventional tablets or oral suspension: 250 mg as a single dose recommended by manufacturer.†

Because of increased prevalence of QRNG, CDC no longer recommends ciprofloxacin or other fluoroquinolones for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., PID, epididymitis). (See Gonorrhea and Associated Infections under Uses.)†

Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients being treated for gonorrhea also should receive an anti-infective regimen effective for presumptive treatment of chlamydia (e.g., a single dose of oral azithromycin or a 7-day regimen of oral doxycycline).†

Disseminated Gonococcal Infections

IV, then Oral

400 mg IV every 12 hours has been used for initial treatment. IV regimen is continued for 24–48 hours after improvement begins, then switched to 500 mg orally twice daily to complete ≥1 week of treatment.†

Because of increased prevalence of QRNG, CDC no longer recommends ciprofloxacin or other fluoroquinolones for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis). Use as an alternative treatment option for disseminated infections only if in vitro susceptibility can be documented by culture. (See Gonorrhea and Associated Infections under Uses.)†

Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients being treated for gonorrhea also should receive an anti-infective regimen effective for presumptive treatment of chlamydia (e.g., a single dose of oral azithromycin or a 7-day regimen of oral doxycycline).†

Granuloma Inguinale (Donovanosis)

Oral

Conventional tablets or oral suspension: 750 mg twice daily for ≥3 weeks or until all lesions have healed completely; consider adding IV aminoglycoside (e.g., gentamicin) if improvement is not evident within the first few days of therapy and in HIV-infected patients.†

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

Legionnaires’ Disease

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 2–3 weeks.†

IV

400 mg every 12 hours for 2–3 weeks.†

Mycobacterial Infections

Oral

Conventional tablets or oral suspension: 750 mg twice daily has been used in treatment of active tuberculosis caused by M. tuberculosis or treatment of infections caused by M. avium complex.†

Neisseria meningitidis Infections

Elimination of Pharyngeal Carrier State

Oral

Conventional tablets or oral suspension: 500 or 750 mg as a single dose. Alternatively, 250 mg twice daily for 2 days or 500 mg twice daily for 5 days.†

Prophylaxis in Household or Other Close Contacts

Oral

Conventional tablets or oral suspension: 500 mg as a single dose.†

Plague

Treatment of Pneumonic Plague Occurring in Context of Biologic Warfare or Bioterrorism

Oral

Conventional tablets or oral suspension: 500 mg twice daily. Usual duration of treatment is 10 days; some experts recommend a duration of at least 10–14 days.†

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).†

IV, then Oral

400 mg twice daily. When clinical improvement occurs, IV ciprofloxacin may be switched to oral ciprofloxacin in a dosage of 500 mg twice daily.†

Usual duration of treatment is 10 days; some experts recommend a duration of at least 10–14 days.†

Postexposure Prophylaxis Following High-risk Exposure

Oral

Conventional tablets or oral suspension: 500 mg twice daily for 7 days.†

Tularemia

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

Oral

Conventional tablets or oral suspension: 500 mg twice daily. Usual duration of treatment is 10 days; some experts recommend a duration of at least 10–14 days.†

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).†

IV, then Oral

400 mg IV twice daily.†

When clinical improvement occurs, switch IV ciprofloxacin to oral ciprofloxacin in a dosage of 500 mg twice daily. Usual total duration of treatment is 10 days; some experts recommend a duration of at least 10–14 days.†

Postexposure Prophylaxis Following High-risk Exposure

Oral

Conventional tablets or oral suspension: 500 mg twice daily for 14 days.†

Typhoid Fever and Other Salmonella Infections

Mild to Moderate Typhoid Fever

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 10 days.

Chronic Typhoid Carriers

Oral

Conventional tablets or oral suspension: 750 mg every 12 hours for 28 days.†

Prevention of Recurrence (Secondary Prophylaxis) in HIV-infected Patients

Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for several months.†

Vibrio Infections

Cholera

Oral

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

Perioperative Prophylaxis

Oral

Single 500-mg dose given prior to the procedure.†

IV

Single 400-mg dose given prior to the procedure. Begin IV infusion 1–2 hours prior to time of incision.†

Empiric Therapy in Febrile Neutropenic Patients

IV

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

Usual duration of treatment is 7–14 days.

Prescribing Limits

Pediatric Patients

Urinary Tract Infections (UTIs)

Complicated UTIs and Pyelonephritis

Oral

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

IV

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

Anthrax

Postexposure Prophylaxis Following Exposure in the Context of Biologic Warfare or Bioterrorism

Oral

Maximum 500 mg every 12 hours.

IV

Maximum 400 mg every 12 hours.

Adults

Do not exceed usual dosage because of risk of crystalluria. (See Renal Effects under Cautions.)

Special Populations

Hepatic Impairment

Dosage adjustments not required in patients with stable chronic cirrhosis; pharmacokinetics not fully studied in those with acute hepatic insufficiency.

Monitor ciprofloxacin concentrations in patients with both hepatic and renal impairment. (See Renal Impairment under Dosage and Administration.)

Renal Impairment

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

Dosage of conventional tablets or oral suspension should be decreased in adults with Cl_cr ≤50 mL/minute and dosage of IV ciprofloxacin should be decreased in those with Cl_cr <30 mL/minute. (See Tables.)

Dosage adjustment unnecessary when extended-release tablets (ProQuin^® XR) are used for uncomplicated UTIs in adults with mild to moderate renal impairment; efficacy not studied in severe renal impairment.

Dosage adjustment unnecessary when extended-release tablets (Cipro^® XR) are used for uncomplicated UTIs (acute cystitis), but dosage of this preparation should be reduced when used for complicated UTIs or acute uncomplicated pyelonephritis in adults with Cl_cr <30 mL/minute. (See Table.)

If available, measurement of serum ciprofloxacin concentrations is the most reliable method for determining dosage, especially in those with severe renal impairment, changing renal function, or both renal and hepatic impairment. Peak ciprofloxacin concentrations (1–2 hours after an oral dose or immediately after completion of IV infusion) generally should range from 2–4 mcg/mL.

Geriatric Patients

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

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

Cautions

Contraindications

• Known hypersensitivity to ciprofloxacin or any quinolone.
• Concomitant use with tizanidine. (See Interactions.)

Warnings/Precautions

Warnings

Tendinopathy and Tendon Rupture

Fluoroquinolones, including ciprofloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups. This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.

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

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

Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.

Discontinue if pain, swelling, inflammation, or rupture of a tendon occurs. Advise patients to rest and refrain from exercise and contact a clinician 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). (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. Use in pediatric patients <18 years of age only for certain indications. (See Pediatric Use under Cautions.)

Fluoroquinolones, including ciprofloxacin, cause arthropathy and osteochondrosis in immature animals of various species. Permanent lesions of the cartilage and lameness reported in ciprofloxacin studies in immature dogs. Relevance of these adverse effects in immature animals to use in humans unknown. Safety and efficacy not established in pregnant or lactating women (see Pregnancy and see Lactation under Cautions) and safety and efficacy for any indication other than complicated UTIs and pyelonephritis caused by susceptible E. coli or inhalational anthrax (postexposure) not established in children and adolescents <18 years of age (see Pediatric Use under Cautions).

CNS Effects

Possibility of CNS effects, including seizures, increased intracranial pressure, toxic psychoses, and CNS stimulation leading to dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These may occur following first dose.

Use with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that may predispose to seizures (e.g., certain drug therapy, renal dysfunction).

Discontinue ciprofloxacin and institute appropriate measures if CNS effects occur.

Peripheral Neuropathy

Possibility of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness.

To prevent development of an irreversible condition, discontinue ciprofloxacin if symptoms of neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur or if there are deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength.

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Institute appropriate therapy if superinfection occurs.

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including ciprofloxacin, and may range in severity from mild diarrhea to fatal colitis. Hyper toxin-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. Outbreaks of severe CDAD caused by fluoroquinolone-resistant C. difficile have been reported with increasing frequency over the last several years.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued. Some mild cases may respond to discontinuance alone. Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.

Interactions

Pharmacokinetic interaction with cytochrome P-450 (CYP) isoenzyme 1A2 substrates (e.g., theophylline, methylxanthines, tizanidine). (See Interactions.)

Concomitant use with theophylline has been associated with serious adverse effects (cardiac arrest, seizure, status epilepticus, respiratory failure). (See Specific Drugs under Interactions.)

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal (anaphylactic) hypersensitivity reactions, which may occur following first dose, reported with some quinolones.

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

If a hypersensitivity reaction occurs, discontinue ciprofloxacin and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).

Photosensitivity Reactions

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

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

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

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

General Precautions

Renal Effects

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

Adequate fluid intake necessary to ensure proper hydration and adequate urinary output; avoid alkaline urine and do not exceed usual dosage.

Selection and Use of Anti-infectives

When prescribing a fluoroquinolone, consider potential benefits and risks for the individual patient. Most patients tolerate the drugs, but serious adverse reactions (e.g., CNS effects, QT prolongation, C. difficile-associated diarrhea and colitis, damage to liver, kidneys, or bone marrow, alterations in glucose homeostatis) may occur rarely.

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

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

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.

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

CDC states that fluoroquinolones should not be used to treat proven or suspected gonorrhea, including infections acquired within the US or acquired while traveling abroad.

Laboratory Monitoring

Periodically assess organ system function, including renal, hepatic, and hematopoietic, during prolonged therapy.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk; discontinue nursing or the drug.

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

Pediatric Use

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

Safety and efficacy of extended-release tablets (Cipro^® XR) not established for any indication in children and adolescents <18 years of age.

Conventional tablets or oral suspension (Cipro^®) or parenteral ciprofloxacin (Cipro^® I.V.) may be used for complicated UTIs and pyelonephritis caused by susceptible E. coli or for inhalational anthrax (postexposure) in children and adolescents <18 years of age. Safety and efficacy not established for any other indication in this age group.

AAP states use of fluoroquinolones may be justified in children <18 years of age in special circumstances after careful assessment of the risks and benefits for the individual patient and after these benefits and risks have been explained to the parents or caregivers. Some clinicians suggest that the potential benefits of ciprofloxacin may outweigh the possible risks in certain children 9–18 years of age with serious infections (e.g., cystic fibrosis, typhoid fever) when the causative organism is resistant to other available anti-infectives.

Geriatric Use

Retrospective analysis of controlled clinical trials indicates no substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

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

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

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

Hepatic Impairment

Possible increased half-life.

Use with caution and monitor serum ciprofloxacin concentrations in patients with both hepatic and renal impairment.

Renal Impairment

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

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

Use with caution and monitor serum ciprofloxacin concentrations in patients with changing renal function or with both hepatic and renal impairment.

Common Adverse Effects

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

Interactions

Specific Drugs

Pharmacokinetics

Absorption

Bioavailability

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

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

500-mg dose of oral suspension containing 250 mg/5 mL is bioequivalent to a 500-mg conventional tablet.

Conventional tablets are not bioequivalent to extended-release tablets.

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

Food or Milk

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

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

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

Manufacturer of extended-release tablets containing ciprofloxacin hydrochloride and base (Cipro^® XR) states that administration with a high- or low-fat meal does not substantially affect pharmacokinetics.

Manufacturer of extended-release tablets containing ciprofloxacin hydrochloride (ProQuin^® XR) states that administration with a standardized meal (1000 calories, 50% fat) increases the AUC and peak plasma concentration by 170 and 120%, respectively.

Concomitant administration with dairy products or calcium-fortified juices alone (i.e., without a meal) or with substantial calcium intake (>800 mg) may affect absorption. Manufacturer states that absorption may not be affected substantially by dietary calcium that is part of a meal.

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

Special Populations

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

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

Distribution

Extent

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

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

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

Crosses the placenta and is distributed into amniotic fluid.

Distributed into milk.

Plasma Protein Binding

16–43%.

Elimination

Metabolism

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

Elimination Route

Eliminated by renal and nonrenal mechanisms.

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

Only small amounts removed by hemodialysis or peritoneal dialysis.

Half-life

Adults with normal renal function: 3–7 hours.

Special Populations

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

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

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

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

Stability

Storage

Oral

Tablets

Conventional tablets: <30°C.

Extended-release tablets: 25°C (may be exposed to 15–30°C).

For Suspension

<25°C. Following reconstitution, <30°C for 14 days. Do not freeze.

Parenteral

Concentrate for Infusion

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.

Injection

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

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Drug Compatibility

Actions

• Usually bactericidal.
• Like other fluoroquinolones, ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV.
• Spectrum of activity includes many gram-positive aerobic bacteria, many gram-negative aerobic bacteria, a few anaerobic bacteria, and some other organisms (e.g., Chlamydia, Mycoplasma, Mycobacterium, Rickettsia). Inactive against fungi and viruses.
• Generally less active against gram-positive than gram-negative bacteria.
• Gram-positive aerobic cocci: Active in vitro and in clinical infections against S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only), S. epidermidis (oxacillin-susceptible strains only), S. pneumoniae (penicillin-susceptible strains), S. pyogenes (group A β-hemolytic streptococci), S. saprophyticus, and Enterococcus faecalis. Also active in vitro against some other staphylococci (e.g., S. haemolyticus, S. hominis), some penicillin-resistant S. pneumoniae, viridans streptococci, groups C, F, and G streptococci, and nonenterococcal group D streptococci.
• Gram-positive aerobic bacilli: Active against Bacillus anthracis, Corynebacterium, and Listeria monocytogenes. Nocardia asteroides are resistant.
• Gram-negative aerobes: Active in vitro and in clinical infections against Campylobacter jejuni, H. influenzae, H. parainfluenzae, M. catarrhalis, Ps. aeruginosa, and most Enterobacteriaceae (including Citrobacter, Edwardsiella, Enterobacter, E. coli, Klebsiella, M. morganii, P. mirabilis, P. vulgaris, Providencia, Salmonella, Shigella, Serratia, Yersinia enterocolitica). Also active in vitro against Acinetobacter, Aeromonas, Brucella, Francisella tularensis, Legionella pneumophila, Vibrio, and Yersinia pestis. However, Burkholderia cepacia and Stenotrophomonas maltophilia are resistant.
• Other organisms: Active in vitro and in clinical infections against by C. pneumoniae, M. pneumoniae, M. tuberculosis, and other mycobacteria.
• Strains of N. gonorrhoeae with decreased susceptibility to ciprofloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) reported with increasing frequency.
• Some cross-resistance occurs between ciprofloxacin and other fluoroquinolones.

Advice to Patients

• Advise patients that antibacterials (including ciprofloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).
• Importance of completing full course of therapy, even if feeling better after a few days.
• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ciprofloxacin or other antibacterials in the future.
• 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 didanosine chewable/dispersible buffered tablets, buffered powder for oral solution, or pediatric powder for oral solution prepared as an admixture with antacid.
• May be taken without regard to meals, but do not take alone with dairy products (e.g., milk, yogurt) or calcium-fortified juices since absorption of the drug may be decreased.
• Importance of drinking sufficient quantities of fluids during therapy.
• Increased risk of tendinitis and tendon rupture in all age groups and further increased risk in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients. 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, weakness or inability to use a joint) and discontinuing the drug and contacting a clinician regarding changing to an anti-infective that is not a fluoroquinolone. (See Tendinopathy and Tendon Rupture under Cautions.)
• Potential for ciprofloxacin to cause dizziness and lightheadedness; need for caution when operating machinery or driving a motor vehicle until effects of drug on individual are known.
• May be associated with hypersensitivity reactions (including anaphylactic reactions), even after a single dose. Importance of immediately discontinuing ciprofloxacin and informing clinician at first sign of rash, jaundice, or any other sign of hypersensitivity.
• Risk of photosensitivity/phototoxicity reactions following exposure to sun or UV light while receiving fluoroquinolones. Importance of avoiding or minimizing exposure to sunlight or artificial UV light (e.g., sunlamps, tanning beds, UVA/UVB treatment) and using protective measures (e.g., sunscreen, wearing a hat and clothing that covers the skin) if in sunlight during ciprofloxacin therapy. Discontinue ciprofloxacin and inform a clinician if a sunburn-like reaction or skin eruption occurs.
• Advise patients that seizures have been reported and to contact clinicians before taking ciprofloxacin if they have a history of seizures.
• Potential for ciprofloxacin to cause peripheral neuropathies; importance of discontinuing ciprofloxacin and contacting clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness and/or weakness) occur.
• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.
• 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.
• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, and concomitant illnesses.
• If use in a pediatric patient <18 years of age is being considered, advise parents and caregivers that ciprofloxacin may be associated with an increased rate of adverse events involving joints and surrounding tissue structures (like tendons) in this age group. Importance of informing clinician prior to use of ciprofloxacin if the child has a history of joint-related problems and importance of notifying clinician if any joint-related problems occur during or following treatment with the drug.
• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
• Importance of advising patients of other important precautionary information. (See Cautions.)

Preparations

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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

AHFS Drug Information. © Copyright, 1959-2009, Selected Revisions February 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.