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Ciprofloxacin Hydrochloride: Uses

Ciprofloxacin is used orally or IV in adults for the treatment of urinary tract infections, chronic bacterial prostatitis, acute sinusitis, lower respiratory tract infections, skin and skin structure infections, or bone and joint infections caused by susceptible gram-negative and gram-positive aerobic bacteria.

Ciprofloxacin is used orally or IV for inhalational anthrax (postexposure) following suspected or confirmed exposure to aerosolized Bacillus anthracis spores and also is used for prophylaxis following ingestion of B. anthracis spores and for the treatment of inhalational anthrax, cutaneous anthrax, or GI and oropharyngeal anthrax.

Ciprofloxacin also is used orally for the treatment of acute sinusitis, uncomplicated cervical and urethral gonorrhea, typhoid fever, and GI infections caused by susceptible bacteria. Ciprofloxacin is used in conjunction with metronidazole for the treatment of complicated intra-abdominal infections caused by E. coli, Ps. aeruginosa, P. mirabilis, K. pneumoniae, or Bacteroides fragilis.

Because ciprofloxacin is inactive against most anaerobic bacteria, the drug is ineffective in and should not be used alone if a mixed aerobic-anaerobic bacterial infection is suspected. IV ciprofloxacin is used in conjunction with IV piperacillin sodium (no longer commercially available in the US as a single-entity preparation) for empiric anti-infective therapy in febrile neutropenic patients.

Ciprofloxacin extended-release tablets are used in adults for the treatment of uncomplicated urinary tract infections (UTIs). Safety and efficacy of the extended-release tablets have been established only for the treatment of uncomplicated UTIs in adults and this preparation should not be used for the treatment of infections at other sites (e.g., respiratory tract, skin and skin structure, bone and joint, GI tract, intra-abdominal) that are treated with IV ciprofloxacin or with ciprofloxacin conventional tablets or oral suspension.

Prior to initiation of ciprofloxacin therapy, appropriate specimens should be obtained for identification of the causative organism(s) and in vitro susceptibility tests. Ciprofloxacin therapy may be started pending results of susceptibility tests, but should be discontinued and other appropriate anti-infective therapy substituted if the organism is found to be resistant to ciprofloxacin. Because resistant strains of Pseudomonas aeruginosa have developed during ciprofloxacin therapy, in vitro susceptibility tests probably should be performed periodically when the drug is used in the treatment of infections caused by this organism. Because staphylococci may develop resistance to ciprofloxacin during prolonged therapy with the drug, the National Committee for Clinical Laboratory Standards (NCCLS) and some clinicians suggest that in vitro susceptibility tests be repeated during therapy, especially when infections are caused by oxacillin-resistant strains of Staphylococcus aureus (previously known as methicillin-resistant S. aureus or MRSA).

Urinary Tract Infections and Prostatitis

Uncomplicated and Complicated Urinary Tract Infections

Ciprofloxacin (extended-release tablets) is used in adults for the treatment of uncomplicated urinary tract infections caused by susceptible Enterococcus faecalis (formerly Streptococcus faecalis), Escherichia coli, Proteus mirabilis, or Staphylococcus saprophyticus in adults. Ciprofloxacin (IV, conventional tablets, oral suspension) is used in adults for the treatment of complicated or uncomplicated urinary tract infections (UTIs) caused by susceptible Citrobacter diversus, C. freundii, Enterobacter cloacae, E. aerogenes, E. coli, Klebsiella oxytoca, K. pneumoniae, Morganella morganii, Proteus mirabilis, Providencia rettgeri, P. stuartii, Pseudomonas aeruginosa, or Serratia marcescens.

The drug also is used in adults for the treatment of UTIs caused by susceptible Staphylococcus aureus, S. epidermidis, S. saprophyticus, or E. faecalis. Some clinicians suggest that ciprofloxacin be reserved for the treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria, and that the drug generally not be used in the treatment of 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. In controlled studies in men and women, oral ciprofloxacin therapy was as effective as therapy with oral co-trimoxazole in the treatment of uncomplicated UTIs; bacteriologic cure rates and rate of relapse and/or reinfection were similar with both drugs.

Oral ciprofloxacin therapy generally results in a bacteriologic cure in 80-100% of patients with UTIs. Oral ciprofloxacin is more effective in the treatment of uncomplicated UTIs than in complicated infections, and most treatment failures occur in patients with underlying structural abnormalities of the urinary tract (e.g., obstructions, neurogenic bladder) or indwelling catheters.

Oral ciprofloxacin has been as effective as oral co-trimoxazole in the treatment of complicated UTIs, and has been effective in the treatment of UTIs caused by organisms resistant to co-trimoxazole. Prolonged, high-dose oral ciprofloxacin therapy (500-750 mg every 12 hours) has been effective in the treatment of complicated UTIs caused by multidrug-resistant Ps. aeruginosa. A 3-day regimen of oral ciprofloxacin (conventional tablets, extended-release tablets) generally is effective for the treatment of acute, uncomplicated cystitis caused by susceptible strains of E. coli, E. faecalis, P. mirabilis, or S. saprophyticus (bacteriologic eradication rate 81-100%). In 2 double-blind, controlled studies in women with acute, uncomplicated cystitis caused by these organisms, the clinical response rate to a 3-day regimen of 100 mg of ciprofloxacin conventional tablets twice daily was 87-95% and the response rate to a 7-day regimen of 250 mg of ciprofloxacin twice daily or alternative anti-infectives was 94-96%.

Oral ciprofloxacin has been effective in women for the treatment of uncomplicated UTIs when given as a single 100- or 250-mg dose. However, efficacy of a single dose of the drug for the treatment of these infections has not been clearly established; single-dose therapy was less effective in the treatment of UTIs caused by gram-positive bacteria than in those caused by gram-negative bacteria.

Prostatitis

Ciprofloxacin (IV, conventional tablets, oral suspension) is used in men for the treatment of recurrent UTIs and chronic prostatitis caused by E. coli or P. mirabilis. Ciprofloxacin has been most effective in the treatment of prostatitis caused by E. coli or other Enterobacteriaceae, and has been effective in infections that did not respond to co-trimoxazole therapy. Prostatitis caused by Ps. aeruginosa, enterococci, or staphylococci may respond poorly to the drug. Because high concentrations of ciprofloxacin are attained in prostatic tissues, the drug may become a drug of choice for the treatment of recurrent UTIs associated with prostatitis; however, further study is needed to compare efficacy of ciprofloxacin with that of other anti-infectives used in the treatment of these infections.

Respiratory Tract Infections

IV ciprofloxacin is used for the treatment of nosocomial pneumonia caused by susceptible H. influenzae or K. pneumoniae. Ciprofloxacin (IV, conventional tablets, oral suspension) is used in adults for the treatment of respiratory tract infections, including bronchiectasis, bronchitis, lung abscess, and pneumonia, caused by susceptible E. aerogenes, E. cloacae, E. coli, Haemophilus influenzae, H. parainfluenzae, K. oxytoca, K. pneumoniae, P. mirabilis, Ps. aeruginosa, S. aureus, or S. pneumoniae.

The drug also is used for the treatment of respiratory tract infections caused by susceptible Moraxella catarrhalis; however, ciprofloxacin, like other quinolones, generally should not be used in children. In controlled studies in adults with respiratory tract infections, oral ciprofloxacin therapy was as effective as therapy with oral amoxicillin, oral ampicillin, IV cefamandole, oral doxycycline, or IV imipenem and cilastatin sodium.

Oral ciprofloxacin therapy generally resulted in a bacteriologic cure rate of 80-98% in adults with respiratory tract infections. Oral ciprofloxacin has been most effective in the treatment of respiratory tract infections caused byH. influenzae or M. catarrhalis; treatment failures have occurred when the drug was used in the treatment of infections caused by S. pneumoniae or Ps. aeruginosa. Treatment failure of S. pneumoniae respiratory tract infections may be related to the moderate in vitro susceptibility of this organism to ciprofloxacin.

Although ciprofloxacin may be effective, it is not a drug of first choice for the treatment of pneumonia secondary to S. pneumoniae, and some clinicians suggest that ciprofloxacin generally not be used for empiric treatment of community-acquired pneumonia when S. pneumoniae is likely or suspected as the causative organism. A b-lactam antibiotic generally is preferred for empiric treatment of these infections and also is preferred in other respiratory tract infections known or suspected to be caused by pneumococci or streptococci. Ciprofloxacin probably should not be used in the treatment of aspiration pneumonia since these infections generally involve anaerobic bacteria.

Acute Exacerbations of Chronic Bronchitis

Clinical improvement has occurred when oral ciprofloxacin was used alone for the treatment of acute exacerbations of bronchopulmonary Ps. aeruginosa infections in adults with cystic fibrosis. 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.

Resistant strains of Ps. aeruginosa have developed during ciprofloxacin therapy; in one study, up to 45% of cystic fibrosis patients developed resistance after 2 weeks of therapy with the drug. Clinical improvement occurred in some patients despite the emergence of resistant Ps. aeruginosa; in some cases, the resistant organisms reverted to being susceptible after ciprofloxacin therapy was discontinued. Further study is necessary to determine if emergence of resistance will limit use of ciprofloxacin in the treatment of Ps. aeruginosa infections in cystic fibrosis patients.

Some clinicians caution against long-term use of ciprofloxacin in these patients and recommend that the drug be used in short courses (e.g., 14 days), alternated with other anti-infectives active against Ps. aeruginosa (e.g., aztreonam, extended-spectrum penicillins, third generation cephalosporins) and/or used in conjunction with one of these agents. If ciprofloxacin is used, it is important that susceptibility of isolates be tested carefully in subsequent exacerbations. Although many cystic fibrosis patients are children, ciprofloxacin, like other quinolones, generally should not be used in children younger than 18 years of age. Some clinicians suggest that the possible benefits of ciprofloxacin therapy may outweigh the possible risks in certain cystic fibrosis patients 9-18 years of age with infections that were known to be resistant to or failed to respond to other available anti-infectives.

Skin and Skin Structure Infections

Ciprofloxacin (IV, conventional tablets, oral suspension) is used in adults for the treatment of skin and skin structure infections caused by susceptible C. freundii, E. cloacae, E. coli, K. oxytoca, K. pneumoniae, M. morganii, P. mirabilis, P. vulgaris, P. stuartii, Ps. aeruginosa, Serratia marcescens, S. aureus (oxacillin-susceptible strains), S. epidermidis, or S. pyogenes (group A b-hemolytic streptococci). The drug has been effective in the treatment of cellulitis, abscesses, folliculitis, furunculosis, pyoderma, postoperative wound infections, and infected ulcers,burns, or wounds.

Ciprofloxacin may be particularly useful as an oral agent for the treatment of skin and skin structure infections caused by susceptible gram-negative bacteria. Because staphylococci, streptococci, and anaerobes are only moderately susceptible to ciprofloxacin, ciprofloxacin generally should not be used alone and other anti-infectives remain the drugs of choice for skin and skin structure infections caused by these bacteria.

Treatment failures have been reported in patients with skin or skin structure infections caused by S. aureus. In addition, the increasing emergence of strains of staphylococci resistant to quinolones limits the usefulness of the drugs in the treatment of these infections. Some clinicians suggest that ciprofloxacin therapy may be particularly useful for the treatment of hospital-acquired decubitus ulcers when anti-infective therapy is indicated. In several controlled studies, oral ciprofloxacin was at least as effective as IV cefotaxime in the treatment of skin and skin structure infections caused by susceptible organisms. Oral ciprofloxacin resulted in a bacteriologic cure rate of 80-92% in patients with skin and skin structure infections.

Although ciprofloxacin is active in vitro against most common aerobic pathogens isolated from animal and human bite wounds, including Flavobacterium and Eikenella corrodens, the in vitro activity of the drug against streptococci, which frequently are isolated from such wounds (usually in mixed cultures), and against anaerobes generally is poor. Therefore, use of the drug as monotherapy in these infections is not recommended pending accumulation of additional efficacy data.

Bone and Joint Infections

Ciprofloxacin (IV, conventional tablets, oral suspension) is used in adults for the treatment of bone and joint infections, including osteomyelitis, caused by susceptible E. aerogenes, E. cloacae, E. coli, K. pneumoniae, M. morganii, P. mirabilis, Ps. aeruginosa, or S. marcescens. The drug also has been used in adults for the treatment of bone and joint infections caused by susceptible S. aureus, S. epidermidis, other coagulase-negative staphylococci, or Enterococcus faecalis (formerly S. faecalis), but other anti-infectives generally are preferred for these infections.

Although resistance to ciprofloxacin has been reported in some strains of oxacillin-resistant S. aureus, oral ciprofloxacin may be a useful alternative to parenteral anti-infectives for the treatment of infections caused by susceptible oxacillin-resistant staphylococci. Clinical response has been reported in 61-86% and bacteriologic cure has been reported in 75-81% of patients with bone and joint infections (caused principally by gram-negative aerobes) who received oral ciprofloxacin. Treatment failures have been reported most frequently in patients with an underlying metal appliance at the site of infection and in patients with ciprofloxacin-resistant Ps. aeruginosa or S. aureus. However, there is evidence from a randomized, controlled study in patients with culture-proven staphylococcal infections associated with stable orthopedic implants that a long-term regimen (3-6 weeks) of ciprofloxacin and rifampin given after initial debridement and a 2-week IV regimen of flucloxacillin (not commercially available in the US) or vancomycin with rifampin or placebo can result in cure of the infection without removal of the implant.

GI Infections

Ciprofloxacin (conventional tablets, oral suspension) is used in adults for the treatment of infectious diarrhea caused by susceptible strains of enterotoxigenic E. coli, Campylobacter fetus subsp. jejuni, Salmonella (see Uses: Typhoid Fever and other Salmonella Infections), Shigella flexneri, S. boydii, S. sonnei, or S. dysenteriae. Because ciprofloxacin is active in vitro against most pathogens associated with infectious diarrhea, including E. coli, Shigella, Salmonella, Aeromonas, Vibrio, Yersinia enterocolitica, and some strains of Campylobacter, it may be a drug of choice for the empiric treatment of the disease. However, because of concerns about increasing emergence of fluoroquinolone-resistant strains of Campylobacter secondary to widespread use of the drugs, judicious use of fluoroquinolones for the treatment and prevention of enteropathogenic diarrhea is warranted.

Cholera

While tetracyclines generally are the anti-infectives of choice for the treatment of cholera in conjunction with fluid and electrolyte replacement therapy, when the infection is caused by strains of V. cholerae resistant to tetracyclines, alternative agents include co-trimoxazole, fluoroquinolones, or furazolidone. In one study in men infected with V. cholerae 01 or V. cholerae 0139, a single 1-g dose of oral ciprofloxacin was more effective than a single 300-mg oral dose of doxycycline in eradicating V. cholerae from stool. In patients infected with V. cholerae 0139, there was no difference between the regimens in terms of duration of diarrhea; however, in those with V. cholerae 01 infections, the duration of diarrhea was shorter in those who received ciprofloxacin.

Cyclospora and Isospora Infections

Although co-trimoxazole generally is the drug of choice for GI infections caused by Cyclospora or Isospora, ciprofloxacin has been used for the treatment of these infections in patients who could not tolerate co-trimoxazole.

Shigella Infections

Ciprofloxacin (conventional tablets, oral suspension) is used for the treatment of shigellosis caused by susceptible Shigella. Anti-infective therapy generally is indicated in addition to fluid and electrolyte replacement for the treatment of severe cases of shigellosis since anti-infectives appear to shorten the duration of diarrhea and period of fecal excretion of Shigella. A fluoroquinolone (e.g., ciprofloxacin, norfloxacin, ofloxacin) or ceftriaxone are considered drugs of choice for the treatment of shigellosis when the susceptibility of the isolate is unknown; azithromycin also has been recommended and co-trimoxazole or ampicillin may be effective if the strain is known to be susceptible to these drugs.

Yersinia Infections

Although GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis usually are self-limited and anti-infective therapy unnecessary, the American Academy of Pediatrics (AAP), US Centers for Disease Control and Prevention (CDC), Infectious Diseases Society of America (IDSA), and others recommend use of anti-infectives in immunocompromised individuals or for the treatment of severe infections or when septicemia or other invasive disease occurs. GI infections caused by Y. enterocolitica or Y. pseudotuberculosis can occur as the result of ingesting undercooked pork, unpasteurized milk, or contaminated water; infection has occurred in infants whose caregivers handled contaminated chitterlings (raw pork intestines) or tofu.

The incubation period usually is 24-48 hours. Use of co-trimoxazole, an aminoglycoside (e.g., amikacin, gentamicin, tobramycin), a fluoroquinolone (e.g., ciprofloxacin), doxycycline, cefotaxime, or ceftizoxime has been recommended when treatment is considered necessary; combination therapy may be necessary. Some clinicians suggest that the role of anti-infectives in the management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.

Travelers’ Diarrhea

Ciprofloxacin (conventional tablets, oral suspension) has been used for the prevention or empiric treatment of travelers’ diarrhea. In a controlled study, ciprofloxacin was as effective as co-trimoxazole in the treatment of the condition.

The principal cause of travelers’ diarrhea is infection with enterotoxigenic E. coli, but other infectious agents (e.g., Shigella, Salmonella, Campylobacter spp, Vibrio parahaemolyticus) also have been associated with the disease. Treatment of travelers’ diarrhea depends on the severity of the illness. In individuals with mild to moderate disease, replacement therapy with oral fluids and electrolytes may be sufficient, although therapy with nonspecific or antimotility agents (e.g., bismuth subsalicylate, loperamide) may be useful for temporary relief of associated symptoms (e.g., abdominal cramps and diarrhea).

Travelers who develop diarrhea with at least 3 loose stools in an 8-hour period, especially if associated with nausea, vomiting, abdominal cramps, fever, or bloody stools, may benefit from short-term treatment with an anti-infective agent. Therapy with an effective anti-infective agent can reduce a typical 3- to 5-day illness to 1-1. days. When use of an anti-infective agent is indicated for treatment of travelers’ diarrhea, ciprofloxacin, levofloxacin, norfloxacin, or ofloxacin generally is recommended.

Some clinicians suggest that azithromycin can be used as an alternative agent in children and pregnant women and may be a drug of choice for travelers in areas with a high prevalence of Campylobacter resistant to fluoroquinolones (e.g., Thailand). Co-trimoxazole also can be used for treatment of travelers’ diarrhea and is considered an alternative for this use in pregnant women and in children who cannot receive fluoroquinolones; however, resistance to co-trimoxazole has been reported in many areas. Efficacy of anti-infective therapy may depend on the etiologic agent and its susceptibility to anti-infectives.

Nausea and vomiting without diarrhea should not be treated with anti-infectives. Travelers should consult a physician, rather than attempt self-medication, if the diarrhea is severe or fails to respond to several days of therapy, the stools contain blood and/or mucus, fever with shaking chills occurs, or dehydration and persistent diarrhea develop.

Because travelers’ diarrhea is a relatively nonthreatening illness that is usually mild and self-limiting and can be treated effectively and because of the risks of widespread prophylactic use of anti-infectives (i.e., potential adverse drug reactions, selection of resistant organisms and increased susceptibility to infections caused by these or other organisms), the CDC and most experts recommend that anti-infectives not be used prophylactically by most individuals traveling to areas of risk. In addition, although controlled studies have indicated that various anti-infectives when taken prophylactically have been 52-95% effective in preventing travelers’ diarrhea in several developing areas of the world, efficacy depends on resistance patterns of pathogenic bacteria in each travel area, and such information seldom is available. While fluoroquinolone resistance for bacteria causing travelers’ diarrhea currently is least common, this could change as use of these drugs increases worldwide.

The CDC states that although use of anti-infectives for prophylaxis of travelers’ diarrhea in certain high-risk groups, such as travelers with immunosuppression or immunodeficiency, may seem reasonable, there currently are no specific data to support such prevention in these populations. Anti-infectives that have been used for prophylaxis of travelers’ diarrhea are not effective in preventing diarrhea caused by viral or parasitic infections, and use of such prophylaxis may give a false sense of security to the traveler about the risk associated with consuming certain local foods and beverages. The principal preventive measure is prudent dietary practices.

If prophylaxis is used, ciprofloxacin, levofloxacin, norfloxacin, or ofloxacin can be given for a maximum of 3 weeks.

HIV-Infected Individuals The Prevention of Opportunistic Infections

Working Group of the US Public Health Service and the Infectious Diseases Society of America (USPHS/IDSA) states that, while prophylaxis against travelers’ diarrhea is not generally recommended for travelers, such prophylaxis may be considered for some travelers with human immunodeficiency virus (HIV) infection, depending on the individual’s level of immunosuppression and the region and duration of travel.

These clinicians suggest that oral fluoroquinolones (e.g., ciprofloxacin) can be used in HIV-infected adults when prophylaxis of travelers’ diarrhea is considered necessary (e.g., in those at high risk of infection when the period of travel is brief). HIV-infected individuals receiving co-trimoxazole for prophylaxis of Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia (PCP) may be protected to some degree from travelers’ diarrhea; however, co-trimoxazole probably should not be administered solely for prophylaxis of travelers’ diarrhea in HIV-infected patients because of the risk of adverse effects and because use of the drug should be reserved for future prophylaxis of PCP. The USPHS/IDSA also suggests that all HIV-infected individuals traveling to developing countries be provided with an appropriate anti-infective regimen (e.g., ciprofloxacin [500 mg twice daily for 3-7 days] or co-trimoxazole [for children, pregnant women]) to carry with them to use empirically if they develop travelers’ diarrhea. However, these individuals should be instructed to consult a physician of their diarrhea is severe and does not respond to the empiric regimen, if their stools contain blood, if fever is accompanied by shaking or chills, or if dehydration develops.

Intra-abdominal Infections

Ciprofloxacin (IV initially followed by oral therapy with conventional tablets or oral suspension) is used in conjunction with oral metronidazole for the treatment of complicated intra-abdominal infections caused by E. coli, Ps. aeruginosa, P. mirabilis, K. pneumoniae, or Bacteroides fragilis.

Typhoid Fever and Other Salmonella Infections

Typhoid Fever Ciprofloxacin (conventional tablets, oral suspension) is used in adults for the treatment of typhoid fever (enteric fever) caused by susceptible strains of Salmonella typhi, including chloramphenicol-resistant strains. Oral ciprofloxacin has been effective when used to treat chronic typhoid carriers; the drug achieves high biliary concentrations and short-term cure rates have been high in typhoid carriers.

Although some clinicians consider ciprofloxacin a drug of choice for the treatment of typhoid carriers, the manufacturer of ciprofloxacin cautions that the efficacy of the drug in the eradication of the chronic typhoid carriers state has not been demonstrated. In addition, some clinicians state that further study is needed to compare the relative efficacy in patients with or without biliary tract disease, to determine the precise role of the drug compared with other anti-infectives usually recommended for treatment of typhoid carriers (e.g., oral amoxicillin or ampicillin and oral probenecid, co-trimoxazole), and to determine the optimal dosage and duration of treatment.

Salmonella Gastroenteritis

Anti-infective therapy generally is not indicated in otherwise healthy individuals with uncomplicated (noninvasive) gastroenteritis caused by Salmonella since such therapy may prolong the duration of fecal excretion of the organism and there is no evidence that it shortens the duration of the disease; however, the CDC, AAP, IDSA, and others recommend anti-infective therapy in individuals with severe Salmonella gastroenteritis and in those who are at increased risk of invasive disease. These individuals include infants younger than 3-6 months of age; individuals older than 50 years of age; individuals with hemoglobinopathies, severe atherosclerosis or valvular heart disease, prostheses, uremia, chronic GI disease, or severe colitis; and individuals who are immunocompromised because of malignancy, immunosuppressive therapy, HIV infection, or other immunosuppressive illness. When an anti-infective agent is considered necessary in an individual with Salmonella gastroenteritis, the CDC, AAP, IDSA, and others recommend use of ceftriaxone, cefotaxime, a fluoroquinolone (should be used in children only if the benefits outweigh the risks and no other alternative exists), ampicillin, amoxicillin, co-trimoxazole, or chloramphenicol, depending on the susceptibility of the causative organism.

HIV-Infected Individuals

While no controlled study has demonstrated a beneficial effect of such treatment and there is evidence from some studies in immunocompetent individuals that anti-infective agent therapy may prolong the duration of fecal excretion of the organism, the USPHS/IDSA recommends that an anti-infective be administered to HIV-infected adults, HIV-exposed infants younger than 3 months of age, and severely immunosuppressive HIV-infected children with Salmonella gastroenteritis to prevent extraintestinal spread of the infection.

The USPHS/IDSA suggests that the drug of choice for the treatment of salmonella gastroenteritis in HIV-infected adults is oral ciprofloxacin; however, pregnant HIV-infected women with Salmonella gastroenteritis should receive ampicillin, cefotaxime, ceftriaxone, or co-trimoxazole. In children, co-trimoxazole, ampicillin, cefotaxime, ceftriaxone, or chloramphenicol are possible choices; fluoroquinolones should be used in children with caution and only if no alternatives exist.

The USPHS/IDSA currently recommends that HIV-infected children and adults who have been treated for nontyphi Salmonella septicemia receive long-term suppressive or maintenance anti-infective therapy (secondary prophylaxis) to prevent recurrence. The choice of anti-infective agent for long-term prophylaxis should be based on results of in vitro susceptibility testing of the causative organism. The USPHS/IDSA suggests use of a fluoroquinolone (usually ciprofloxacin) for long-term prophylaxis of Salmonella bacteremia in adults. In HIV-infected children, co-trimoxazole is the drug of choice and ampicillin or chloramphenicol are alternatives when the causative organism is susceptible. In addition, the USPHS/IDSA recommends that household contacts of HIV-infected individuals treated for salmonellosis or shigellosis should be evaluated for asymptomatic carriage of these bacteria so that strict hygienic measures and/or anti-infective prophylaxis can be instituted to prevent recurrent transmission to the HIV-infected individual.

Gonorrhea and Associated Infections

Uncomplicated Gonorrhea

A single oral dose of ciprofloxacin (conventional tablets, oral suspension) is used for the treatment of uncomplicated urethral or endocervical gonorrhea caused by susceptible Neisseria gonorrhoeae. The CDC and many clinicians currently recommend that uncomplicated cervical, urethral, or rectal gonorrhea in adults and adolescents be treated with a single IM dose of ceftriaxone, a single oral dose of cefixime, or a single oral dose of certain fluoroquinolones (ciprofloxacin, ofloxacin, levofloxacin) given in conjunction with 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).

Alternative regimens recommended by the CDC for the treatment of uncomplicated cervical, urethral, or rectal gonorrhea in adults and adolescents include a single IM dose of spectinomycin, a single IM dose of certain cephalosporins (ceftizoxime, cefotaxime, cefoxitin), or a single oral dose of certain fluoroquinolones (gatifloxacin, lomefloxacin, norfloxacin), given in conjunction with an anti-infective regimen effective for presumptive treatment of chlamydia.

Fluoroquinolones should not be used for the treatment of gonorrhea acquired in Asia or the Pacific islands (including Hawaii) and may be inadvisable for infections acquired in other areas where quinolone-resistant N. gonorrhoeae (QRNG) have been reported (including California).

Although most strains of N. gonorrhoeae are susceptible to ciprofloxacin and the drug generally is effective in the treatment of uncomplicated gonorrhea, strains of the organism with decreased susceptibility to ciprofloxacin and other fluoroquinolones have been reported within the last several years. The clinical importance of this reduced susceptibility to fluoroquinolones has not been fully determined, and it is unclear whether uncomplicated gonococcal infections caused by these strains respond to currently recommended single-dose fluoroquinolone regimens.

Treatment failures have been reported with the currently recommended single-dose ciprofloxacin regimen; the likelihood of treatment failure seems greatest when the gonococcal strain has a ciprofloxacin MIC of 1 mcg/mL or greater. Although current evidence does not warrant changing recommendations on the place of certain fluoroquinolones (ciprofloxacin, ofloxacin, levofloxacin) as preferred regimens for uncomplicated gonorrhea in the US, the CDC and Hawaii Department of Health state that fluoroquinolones should not be used to treat gonorrhea in Hawaii. In addition, all US patients with gonorrhea should be questioned regarding their personal travel history and the travel history of their sex partner(s). If patients or their sex partners are likely to have acquired gonorrhea in Hawaii, the Pacific Islands, or Asia, they should not be treated with fluoroquinolones. These individuals should be treated with ceftriaxone or cefixime (or spectinomycin if they cannot tolerate cephalosporins).

Clinicians treating patients believed to have been infected with isolates from or Australia also should consider using other anti-infectives (e.g., ceftriaxone). The CDC states that it will continue to monitor susceptibility patterns of N. gonorrhoeae and will reassess the role of fluoroquinolones in the treatment of gonorrhea in the US as needed. While patients receiving any of the currently recommended regimens for the treatment of gonorrhea generally do not need to return for a test-of-cure, patients should be advised to return for reevaluation if symptoms persist. Patients who are reevaluated and have gonococcal infection within 2 weeks after treatment should be interviewed regarding possible reinfection, and a specimen should be collected for culture and susceptibility testing.

If susceptibility testing cannot be performed locally, isolates should be forwarded to a reference laboratory for testing. The CDC requests that any treatment failures or resistant strains of N. gonorrhoeae be reported to local health departments or the National Center for HIV, STD and TB Prevention (404-639-8373). The CDC also recommends that local health laboratories with the capacity to perform in vitro susceptibility testing on N. gonorrhoeae routinely test for susceptibility to the anti-infectives that are used locally for the treatment of gonorrhea.

A single 500-mg dose of oral ciprofloxacin provides sustained bactericidal levels in the blood and in published clinical trials has cured 99.% of uncomplicated urogenital and anorectal infections. A single 100- or 250-mg oral dose of ciprofloxacin has been effective when used alone in men for the treatment of uncomplicated urethral gonorrhea caused by penicillinase- and nonpenicillinase-producing Neisseria gonorrhoeae and a single 250-mg oral dose has been effective in women with uncomplicated endocervical infections caused by penicillinase- and nonpenicillinase-producing N. gonorrhoeae. However, because strains of N. gonorrhoeae with decreased susceptibility to ciprofloxacin have been reported, the CDC and many clinicians recommend that only the 500-mg dose of ciprofloxacin be used for the treatment of uncomplicated gonorrhea.

Single-dose oral therapy with ciprofloxacin has been effective when used in a limited number of men and women for the treatment of anorectal or pharyngeal gonorrhea.

Although some treatment failures have been reported and some clinicians suggest that efficacy of the drug for the treatment of anorectal or pharyngeal gonococcal infections has not been clearly established, the CDC states that uncomplicated pharyngeal gonococcal infections should be treated with a single IM dose of ceftriaxone, or, alternatively, a single oral dose of ciprofloxacin given in conjunction with an anti-infective regimen effective for presumptive treatment of chlamydia. Although chlamydia coinfection of the pharynx is unusual, coinfection at genital sites sometimes occurs in patients with pharyngeal gonococcal infection.

Disseminated Gonococcal Infections

Ciprofloxacin (IV, conventional tablets, oral suspension) is used as an alternative agent for the treatment of disseminated gonococcal infections.

A multiple-dose regimen of IM or IV ceftriaxone is recommended by the CDC and many clinicians as the treatment of choice for the initial treatment of disseminated gonococcal infections in adults and adolescents. Alternatively, a multiple-dose parenteral regimen of certain IV cephalosporins (cefotaxime, ceftizoxime), certain IV fluoroquinolones (ciprofloxacin, levofloxacin), or IM spectinomycin can be used for the initial treatment of disseminated gonococcal infections in adults and adolescents.

The initial parenteral regimen should be continued for 24-48 hours after improvement begins; therapy can then be switched to oral cefixime, oral ciprofloxacin, oral ofloxacin, or oral levofloxacin and continued to complete at least 1 week of treatment. The CDC recommends that the patient be hospitalized for initial treatment, especially when compliance may be a problem, when the diagnosis is uncertain, or when the patient has purulent synovial effusions or other complications. Patients should be examined for clinical evidence of endocarditis and meningitis; the recommended regimen for these infections is IV ceftriaxone. Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, an anti-infective regimen effective for presumptive treatment of chlamydia should be given in conjunction with the regimen for disseminated gonococcal infections.

Chlamydial and Mycoplasmal Infections

Single-dose oral ciprofloxacin therapy for gonorrhea generally is ineffective in the treatment of coexisting chlamydial or mycoplasmal infections and generally does not prevent postgonococcal urethritis. Results have been conflicting when multiple-dose oral ciprofloxacin therapy has been used for the treatment of nongonococcal urethritis. Although 7-10 days of therapy with oral ciprofloxacin appeared to be effective for the treatment of nongonococcal urethritis in some men, efficacy of the drug was unpredictable when Chlamydia was present, and the rate of relapse was high. If a fluoroquinolone is used as an alternative for the treatment of nongonococcal urethritis when the regimens of choice (azithromycin, doxycycline) are not used, the CDC recommends a 7-day regimen of oral ofloxacin or oral levofloxacin. Oral ciprofloxacin was used with some success in a limited number of women for the treatment of urethral and cervical infections caused by C. trachomatis or Mycoplasma hominis. The drug generally has been ineffective in both men and women for the treatment of urogenital infections caused by Ureaplasma urealyticum.

Chancroid

Ciprofloxacin (conventional tablets, oral suspension) has been effective in men for the treatment of chancroid, genital ulcers caused by Haemophilus ducreyi. Although a single 500-mg oral dose of the drug was effective in some men for the treatment of chancroid, multiple-dose regimens generally have been associated with fewer treatment failures. The CDC states that a single IM dose of ceftriaxone, a single oral dose of azithromycin, a 3-day regimen of oral ciprofloxacin (contraindicated in pregnant or lactating women), or a 7-day regimen of oral erythromycin are the regimens of choice for the treatment of chancroid.

All 4 regimens generally are effective for the treatment of chancroid; however, patients with human immunodeficiency virus (HIV) infection and patients who are uncircumcised may not respond to treatment as well as those who are HIV-negative or circumcised.

Because data on efficacy of the single-dose ceftriaxone or single-dose azithromycin regimen for the treatment of chancroid in patients with HIV infection are limited, the CDC recommends that these regimens be used in HIV patients only if follow-up can be ensured; some experts recommend that HIV-infected individuals with chancroid receive the 7-day erythromycin regimen. In the US, chancroid usually occurs in discrete outbreaks but the disease is endemic in some areas.

Approximately 10% of patients with chancroid acquired in the US also are coinfected with Treponema pallidum or herpes simplex virus (HSV); this percentage is higher in individuals who acquired the infection outside the US. In addition, high rates of HIV-infection have been reported in patients with chancroid, and the disease appears to be a cofactor for HIV transmission. Evaluation of the physical features of genital ulcers (without laboratory evaluation and testing) usually is inadequate to provide a differential diagnosis between chancroid, primary syphilis, and genital HSV infection. Ideally, diagnostic evaluation of patients with genital ulcers should include a serologic test for syphilis and darkfield examination or direct immunofluorescence test for T. pallidum, culture for H. ducreyi, and culture or antigen test for HSV.

A definitive diagnosis of chancroid requires identification of H. ducreyi on special culture media that is not widely available. However, a probable diagnosis of chancroid can be made if the patient has 1 or more painful genital ulcers, there is no evidence of T. pallidum infection based on a negative darkfield examination of ulcer exudate or a negative serologic test for syphilis (performed at least 7 days after onset of ulcers), culture or antigen test for HSV is negative, and the clinical presentation, appearance of genital ulcers, and regional lymphadenopathy (if present) are typical for chancroid. While the presence of a painful ulcer and tender inguinal adenopathy suggests a diagnosis of chancroid, the additional presence of suppurative inguinal adenopathy is a clearer indication of the disease.

Patient Follow-up and Management of Sexual Partners

The CDC recommends that all patients diagnosed with chancroid be tested for HIV and, if initial tests for syphilis and HIV are negative, the tests repeated 3 months later. Patients with chancroid should be examined 3-7 days after initiation of anti-infective therapy. If the regimen was effective, symptomatic improvement in the ulcers is evident within 3 days and objective improvement is evident within 7 days. If clinical improvement is not evident within 3-7 days, consideration should be given to the possibility that the diagnosis was incorrect, there is coinfection with another sexually transmitted disease, the patient was noncompliant with the regimen, the strain of H. ducreyi is resistant to the anti-infective agent used, or the patient is HIV seropositive. T

he time required for complete healing is related to the size of the ulcer; large ulcers may require more than 2 weeks to heal. Healing of ulcers may be slower in uncircumcised men who have ulcers under the foreskin. Resolution of fluctuant lymphadenopathy is slower than that of ulcers, and needle aspiration or incisional drainage may be necessary even during otherwise effective anti-infective therapy. While needle aspiration of buboes is a simpler procedure, incision and drainage of buboes may be preferred. Any individual who had sexual contact with a patient with chancroid within 10 days before the onset of the patient’s symptoms should be examined and treated for the disease, even if no symptoms are present.

Granuloma Inguinale (Donovanosis)

Oral ciprofloxacin (750 mg twice daily for a minimum of 3 weeks) is considered an alternative agent for the treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis. The CDC recommends that donovanosis be treated with a regimen of oral doxycycline or oral co-trimoxazole or, alternatively, a regimen of oral ciprofloxacin, oral erythromycin, or oral azithromycin. Anti-infective treatment of donovanosis should be continued until all lesions have healed completely; a minimum of 3 weeks of treatment usually is necessary. If lesions do not respond within the first few days of therapy, the CDC recommends that a parenteral aminoglycoside (e.g., 1 mg/kg of gentamicin IV every 8 hours) be added to the regimen.

Anti-infective therapy appears to halt progressive destruction of tissue, although prolonged duration of therapy often is required to enable granulation and re-epithelization of ulcers. Despite effective anti-infective therapy, donovanosis may relapse 6-18 months later. Individuals with HIV infection should receive the same treatment regimens recommended for other individuals with donovanosis; however, the CDC suggests that addition of a parenteral aminoglycoside to the regimen should be strongly considered in HIV-infected patients.

Any individual who had sexual contact with a patient with donovanosis should be examined and treated if they had sexual contact with the patient during the 60 days preceding the onset of symptoms in the patient and they have clinical signs and symptoms of the disease. The value of empiric therapy in the absence of clinical signs and symptoms has not been established.

Neisseria meningitidis Infections

Ciprofloxacin (conventional tablets, oral suspension) is used in adults to eliminate nasopharyngeal carriage of Neisseria meningitidis. The drug has been effective when given as a single 500- or 750-mg oral dose or as multiple oral doses (250 mg twice daily for 2 days or 500 mg twice daily for 5 days). A single 500-mg oral dose of ciprofloxacin is 90-95% effective in eradicating nasopharyngeal carriage of N. meningitidis. Although rifampin generally has been considered the drug of choice for eliminating nasopharyngeal carriage of N. meningitidis, ciprofloxacin is an effective oral alternative. Oral ciprofloxacin also is used for chemoprophylaxis in contacts of individuals with invasive meningococcal disease when the risk of infection is high.Uses: Neisseria meningitidis Infections, in Ceftriaxone 8:12.06.12.

Anthrax

Ciprofloxacin (conventional tablets, oral suspension) is used for inhalational anthrax (postexposure) to reduce the incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores.

Ciprofloxacin (IV, conventional tablets, oral suspension) is used for the treatment of clinically apparent inhalational anthrax, cutaneous anthrax, or GI and oropharyngeal anthrax, and for prophylaxis following ingestion of B. anthracis spores in contaminated meat. Naturally occurring or endemic cutaneous anthrax in humans can occur after exposure to B. anthracis spores following contact with contaminated soil or infected animals (e.g., goats, sheep, cattle, swine, horses, buffalo, deer) or animal by-products (e.g., hides, carcasses, hair, wool, bone meal); GI or oropharyngeal anthrax can occur after ingestion of anthrax spores (e.g., in contaminated, undercooked meat); and inhalational anthrax can occur after exposure to B. anthracis spores aerosolized during industrial processing of contaminated animal by-products or in the laboratory. Inhalational or cutaneous anthrax also may occur as the result of exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism, including exposure to mail or other fomites contaminated with anthrax spores.

Following exposure to aerosolized B. anthracis spores, inhalational anthrax may develop if spore-bearing particles are deposited into alveolar spaces. Macrophages ingest the spores and some undergo lysis and destruction. Surviving spores are transported via the lymph system to mediastinal lymph nodes where germination may occur after a period of spore dormancy.

Monkey studies have demonstrated viable spores in the mediastinal lymph nodes for up to 100 days after exposure. The process responsible for the delayed transformation of spores to vegetative cells remains to be elucidated. Once germination occurs, disease follows rapidly.Replicating B. anthracis release toxins that can result in hemorrhage, edema, and necrosis. Cutaneous anthrax may occur if B. anthracis spores are introduced into a cut or abrasion (e.g., on the face, neck, or arms). Septicemia and meningeal anthrax result from hematogenous spread of the organism from the primary site.

Person-to-person transmission of anthrax has not been documented to date. For the treatment of clinically apparent inhalational, GI, or meningeal anthrax and anthrax septicemia that occurs as the result of natural or endemic exposures to B. anthracis, parenteral penicillin generally has been considered the drug of choice and IV ciprofloxacin or IV doxycycline have been suggested as alternatives.

However, it has been postulated that exposures to B. anthracis that occur in the context of biologic warfare or bioterrorism may involve bioengineered resistant strains and this concern should be considered when selecting initial anti-infective regimens for treatment of anthrax that occurs as the result of bioterrorism-related exposures or when selecting anti-infectives for postexposure prophylaxis following such exposures. B. anthracis B. anthracis with natural resistance to penicillins have been reported and there are published reports of B. anthracisstrains that have been engineered to have tetracycline and penicillin resistance as well as resistance to other anti-infectives (e.g., macrolides, chloramphenicol, rifampin).

In addition, reduced susceptibility to ofloxacin (4-fold increase in MICs from baseline) has been produced in vitro following sequential subculture of the Sterne strain of B. anthracis in subinhibitory concentrations of the fluoroquinolone. Recommendations for the treatment and prophylaxis of anthrax have evolved based on experience gained in treating US patients who developed inhalational or cutaneous anthrax during September and October 2001 following bioterrorism-related exposures to B. anthracis spores as well results of animal studies and concerns related to treating large numbers of individuals in a mass casualty setting. In addition to the information contained in the following sections, infectious disease and public health experts should be consulted for the most recent information on public health ramifications of bioterrorism-related exposures to anthrax spores and possible changes in recommendations for the treatment or prophylaxis of anthrax following such exposures. Information on ongoing developments also can be obtained at www.ahfsdruginformation.com, at the Counterterrorism Resource Center at www.ashp.org, and at www.bt.cdc.gov.

Postexposure Prophylaxis

Ciprofloxacin is used for inhalational anthrax (postexposure) to reduce the incidence or progression of disease following suspected or confirmed exposure to aerosolized B. anthracis spores. Ciprofloxacin or doxycycline are considered the initial drugs of choice for postexposure prophylaxis following exposure to aerosolized anthrax spores that occurs in the context of biologic warfare or bioterrorism.

Some experts (e.g., US Working Group on Civilian Biodefense, IDSA) suggest that other fluoroquinolones (e.g., gatifloxacin, moxifloxacin, ofloxacin, levofloxacin) can be considered alternatives for postexposure prophylaxis. However, this recommendation is based on in vitro data only and these fluoroquinolones are not included in CDC recommendations for postexposure prophylaxis. There is no evidence to date that ciprofloxacin is more or less effective than doxycycline for such postexposure prophylaxis.

The US Working Group on Civilian Biodefense recommends ciprofloxacin as the initial drug of choice for postexposure prophylaxis. These experts recommend doxycycline as an alternative if the organism is susceptible. During the bioterrorism-related exposures to B. anthracis spores in September and October 2001, the CDC initially recommended postexposure prophylaxis with either ciprofloxacin or doxycycline; however, the CDC subsequently revised these recommendations because of the large number of individuals exposed to B. anthracis who required postexposure prophylaxis.Widespread use of any anti-infective agent can promote resistance to that drug and because many common pathogens already are resistant to tetracycline but fluoroquinolone resistance is not yet common among these same organisms, the CDC suggested that use of doxycycline for postexposure prophylaxis was preferable for this event since it would preserve effectiveness of ciprofloxacin against other organisms.

Ultimately, however, selection of an anti-infective agent for postexposure prophylaxis should be based on the clinical setting, susceptibility, and reported adverse effects associated with the drugs and either doxycycline or ciprofloxacin (or another fluoroquinolone) may be preferable for an individual patient. Anti-infective prophylaxis should be continued until exposure to B. anthracis has been excluded. If subsequent epidemiologic and laboratory test data indicate that individuals started on prophylaxis were not exposed, the anti-infective regimen should be stopped. If exposure is confirmed, postexposure vaccination with anthrax vaccine (if available) may be indicated in conjunction with prophylaxis.

Because of the possible persistence of anthrax spores in lung tissue following an aerosol exposure, the CDC and other experts recommend that postexposure prophylaxis following a confirmed exposure should be continued for 60 days. A 60-day regimen also is recommended for postexposure prophylaxis in laboratory workers exposed to confirmed B. anthracis cultures. Anti-infective prophylaxis is not necessary for unvaccinated workers employed in biosafety level 3 laboratories that maintain recommended conditions.

Infants and Children

Although ciprofloxacin generally is not recommended for use in infants and children, the benefits of ciprofloxacin prophylaxis outweigh the risks for inhalational anthrax (postexposure) and the drug may be used in children to reduce the incidence or progression of disease following exposure to aerosolized B. anthracis spores. The CDC and other experts recommend that infants and children receive ciprofloxacin or doxycycline for initial anti-infective prophylaxis following suspected bioterrorism-related exposures to B. anthracis spores; however, if exposure has been confirmed and in vitro tests indicate that the organism is susceptible to penicillin, the postexposure prophylaxis regimen in children may be switched to oral amoxicillin or oral penicillin V. Although monotherapy with a penicillin is not recommended for treatment of inhalational anthrax when high concentrations of the organism are likely to be present, penicillins (e.g., amoxicillin, penicillin G procaine) may be considered an option for anti-infective prophylaxis, including when ciprofloxacin or doxycycline are contraindicated. The likelihood of b-lactamase induction resulting in an increase in penicillin MICs is lower when only a small number of vegetative cells are present and, therefore, penicillin monotherapy can be considered for postexposure prophylaxis.

Pregnant and Breast-feeding Women

The possible benefits of postexposure prophylaxis against anthrax should be weighed against the possible risks to the fetus when choosing an anti-infective for postexposure prophylaxis in pregnant women. The CDC and other experts state that ciprofloxacin should be considered the drug of choice for initial postexposure prophylaxis in pregnant women exposed to B. anthracis spores and that, if in vitro studies indicate that the organism is susceptible to penicillin, then consideration can be given to changing the postexposure regimen to amoxicillin.

Women who become pregnant while receiving anti-infective prophylaxis should continue the existing regimen and consult with a healthcare provider or public health official to discuss whether an alternative regimen might be more appropriate. The AAP considers ciprofloxacin to be usually compatible with breast-feeding since the amount of the quinolone potentially absorbed by nursing infants would be small and no observable change in infants associated with such exposure has been reported to date.

Because the long-term safety of prolonged exposure of nursing infants (e.g., during a 60-day regimen for anthrax) to breast milk from ciprofloxacin-treated women currently is not known, the CDC recommends that lactating women who are concerned about the use of ciprofloxacin during anthrax prophylaxis consider expressing and then discarding their breast milk so that breast-feeding can be resumed once anti-infective prophylaxis is complete. (See Cautions: Pregnancy, Fertility, and Lactation.)

Individuals at Contaminated Sites

For the bioterrorism-related exposures to B. anthracis spores that occurred in the US during the fall of 2001, the CDC recommended that anti-infective prophylaxis be initiated (pending additional information) in individuals exposed to an air space where a suspicious material may have been aerosolized (e.g., near a suspicious powder-containing letter during opening) and in individuals who shared the air spaces likely to be the source of an inhalational anthrax case. While culture of nasal swabs can occasionally document exposure and provide clues to help assess the exposure circumstances, these nasal swabs are investigative tools only and results cannot be used to rule out exposure to B. anthracis.

Following confirmation of the presence of B. anthracis spores, the CDC recommended that the full 60-day postexposure regimen be completed in individuals exposed to an air space known to be contaminated with aerosolized B. anthracis, in individuals exposed to an air space known to be the source of an inhalational anthrax case, and in individuals along the transit path of an envelope or other vehicle containing B. anthracis that may have been aerosolized (e.g., a postal sorting facility in which an envelope containing B. anthracis was processed).

The CDC states that anti-infective prophylaxis is not necessary for workers in contaminated environments who wear appropriate personal protective equipment and who have received the complete anthrax vaccine regimen, unless a breach of respiratory protection occurs. 716 However, remediation workers involved in clean up and decontamination of B. anthracis-contaminated sites who have not been vaccinated with the complete recommended regimen of anthrax vaccine should receive anti-infective prophylaxis, regardless of other methods being used to protect these individuals from exposure.

This recommendation also applies to workers entering areas that already have been remediated but have not yet been cleared for general occupancy. Unvaccinated or incompletely vaccinated remediation workers should begin anti-infective prophylaxis at the time of first entry into the contaminated area, and such prophylaxis should be continued until at least 60 days after last entry into the area for unvaccinated workers.

Remediation workers who have received all or part of the 6-dose vaccine regimen should continue anti-infective prophylaxis for at least 30 days and should complete the vaccine regimen. In addition, it might be prudent to continue anti-infective prophylaxis until 7-14 days after the third vaccine dose is administered. Remediation workers with repeated entries into contaminated sites over a prolonged period of time will require anti-infective prophylaxis for considerably longer than the 60 days recommended for individuals with a single exposure.

To date, some remediation workers have received anti-infective prophylaxis for more than 6 months. If anthrax vaccine is administered to an individual while their risk of exposure to anthrax spores continues, the CDC recommends concomitant anti-infective prophylaxis throughout the period of risk and for 60 days after the risk of exposure has ended, unless the 6-dose series of anthrax vaccine has been completed and annual boosters are up-to-date.

Other Individuals

Following a bioterrorism-related event, use of anti-infective prophylaxis in asymptomatic individuals in the general population is not indicated unless appropriate public health or law-enforcement agencies have ascertained that a risk of exposure to B. anthracis spores exists. In addition, the CDC states that postexposure prophylaxis is not indicated for the prevention of cutaneous anthrax, for autopsy personnel examining bodies infected with anthrax when appropriate isolation precautions and procedures are followed, for hospital personnel caring for patients with anthrax, or for individuals who routinely open or handle mail in the absence of a suspicious letter or credible threat.

Clinical Experience

Although controlled studies evaluating ciprofloxacin for aerosolized anthrax exposure in humans have not been conducted for ethical reasons, the indication for use of ciprofloxacin is based on serum concentrations of the drug achieved in humans, a surrogate end point reasonably likely to predict clinical benefit. Efficacy of ciprofloxacin has been evaluated in a rhesus monkey model of inhalational anthrax. In this study, rhesus monkeys were exposed to an inhaled mean dose of 11 LD50 (approximately 5.5 x 105) spores (range: 5-30 LD50) of B. anthracis and then received a 30-day regimen of placebo or oral ciprofloxacin beginning 24 hours after exposure. Mortality due to anthrax was significantly lower in monkeys that received ciprofloxacin (1/9) compared with those that received placebo (9/10); the one ciprofloxacin-treated monkey that died of anthrax did so following the 30-day drug administration period.

In the monkeys studied, mean serum concentrations of ciprofloxacin 1 hour after dosing (at the expected time of peak serum concentrations) following oral dosing to steady state ranged from 0.98-1.69 mcg/mL; mean steady-state trough concentrations at 12 hours after dosing ranged from 0.12-0.19 mcg/mL. The mean serum concentrations of ciprofloxacin associated with a statistically significant improvement in survival in this rhesus monkey model of inhalational anthrax are reached or exceeded in adult and pediatric patients receiving oral or IV ciprofloxacin.

Data regarding efficacy of ciprofloxacin for postexposure prophylaxis in humans following exposure to aerosolized B. anthracis spores is becoming available since the drug was used for postexposure prophylaxis in individuals in the US who were exposed to B. anthracis spores in bioterrorism-related incidences that occurred during September and October 2001. As of November 14, 2001, approximately 300 postal or other facilities were tested for B. anthracis spores and anti-infective prophylaxis with ciprofloxacin or other anti-infectives was initiated in approximately 32,000 individuals in Florida, New Jersey, New York, and the District of Columbia who had potential exposures. The full 60-day postexposure prophylaxis regimen was recommended for approximately 8424 of these individuals. To date, no individual who received anti-infective prophylaxis following these bioterrorism-related exposures developed microbiologically-confirmed anthrax. Although only limited data are available to date regarding adverse effects reported in individuals receiving postexposure prophylaxis regimens, adverse effects were reportedly common but generally were well tolerated.

Treatment of Inhalational Anthrax

The rapid course of symptomatic inhalational anthrax and high mortality rate make early initiation of anti-infective therapy essential. Because of the difficulty in making a rapid microbiologic diagnosis of anthrax, high-risk individuals who develop fever or other evidence of systemic infection should promptly receive therapy for possible anthrax infection while waiting for results of laboratory studies.

Based on clinical experience from the bioterrorism-related anthrax exposures of 2001 and the possibility that a B. anthracis strain resistant to one or more anti-infectives might be used in a future bioterrorism event, the CDC and other experts (e.g., US Working Group on Civilian Biodefense) recommend that treatment of clinically apparent inhalational anthrax in adults, adolescents, or children that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism be initiated with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline and 1 or 2 additional anti-infectives predicted to be effective.

Other drugs to be included in the initial treatment regimen with ciprofloxacin or doxycycline should be selected based on in vitro susceptibility, possibility of efficacy, adverse effects, and cost. Based on in vitro data, other drugs that have been suggested as possibilities to augment ciprofloxacin or doxycycline in such multiple-drug regimens include chloramphenicol, clindamycin, rifampin, vancomycin, clarithromycin, imipenem, penicillin, or ampicillin. If meningitis is established or suspected, some clinicians suggest a multiple-drug regimen that includes ciprofloxacin rather than doxycycline (because of better CNS distribution) and chloramphenicol, rifampin, or penicillin. Results of in vitro susceptibility testing of strains of B. anthracis that were associated with cases of inhalational or cutaneous anthrax that occurred in the US (Florida, New York, District of Columbia) during September and October 2001 in the context of bioterrorism-related exposures to anthrax spores indicate that these strains were susceptible to ciprofloxacin, doxycycline, tetracycline, rifampin, clindamycin, vancomycin, and chloramphenicol.

However, only limited or no clinical data are available regarding use of these drugs in the treatment of anthrax. A multiple-drug parenteral regimen that was used in 2 patients who survived inhalational anthrax following the bioterrorism-related exposures in 2001 was a 3-drug regimen of ciprofloxacin (400 mg every 8 hours), rifampin (300 mg every 12 hours), and clindamycin (900 mg every 8 hours).

Other multiple-drug regimens that were used for the initial treatment of patients who survived inhalational anthrax following these bioterrorism-related anthrax exposures were ciprofloxacin/cefotaxime/azithromycin (1 patient); levofloxacin/rifampin initially then ciprofloxacin rifampin/vancomycin (1 patient); and oral levofloxacin (prior to diagnosis), then ciprofloxacin/azithromycin, then clindamycin/ceftriaxone/azithromycin, then doxycycline (1 patient).

Although it is unclear whether the deaths were related to ineffective regimens and/or delays in initiation of therapy, the regimens used in patients who died of inhalational anthrax following these exposures were levofloxacin/clindamycin/penicillin G (1 patient, initiated on the second day of hospitalization after various anti-infectives, died 3 days after admission); levofloxacin monotherapy (1 patient, died day of admission); levofloxacin/rifampin/penicillin G/ceftriaxone (1 patient, died day of admission); levofloxacin monotherapy, then levofloxacin/rifampin/gentamicin/nafcillin, then ciprofloxacin/rifampin/clindamycin/ceftazidime (1 patient, died 3 days after admission); ampicillin-sulbactam/ciprofloxacin/clindamycin (1 patient, initiated on the third day of hospitalization after various other regimens, died 4 days after admission) and ampicillin-sulbactam/ciprofloxacin (1 patient, initiated on the day of hospitalization and clindamycin added on the third day, died 4 days after admission).

Although B. anthracis strains isolated during these bioterrorism-related exposures were susceptible to penicillin and amoxicillin in vitro, additional tests indicated that some of these strains had constitutive and inducible b-lactamases and there is in vitro evidence that exposure of some penicillin-susceptible B. anthracis strains to penicillins can induce b-lactamases.

Therefore, the CDC states that use of a penicillin alone is not recommended for the treatment of anthrax that occurs as the result of biologic warfare or bioterrorism when high concentrations of the organism are likely to be present, although penicillin can be included in appropriate combination regimens. Isolates from these bioterrorism-related exposures were susceptible to clarithromycin, azithromycin (borderline susceptibility), and imipenem, but had only intermediate susceptibility to erythromycin. B. anthracis strains resistant to sulfamethoxazole, trimethoprim, cephalosporins (i.e., cefuroxime, cefotaxime, ceftazidime), or aztreonam have been reported, and these anti-infectives should not be used in the treatment of anthrax.

Because of the possible persistence of anthrax spores in lung tissue, anti-infective therapy for the treatment of inhalational anthrax that occurs as the result of exposure to aerosolized spores in the context of biologic warfare or bioterrorism should be continued for 60 days. An oral regimen can be substituted for IV therapy as soon as the patient’s condition improved.

Although the optimum oral regimen for completing treatment currently remains to be established, several adults who contracted inhalational anthrax in the context of bioterrorism exposures in 2001 received combination therapy with ciprofloxacin and rifampin to complete a 60-day course. After clinical improvement in infants and children being treated with IV anti-infectives for inhalational anthrax, oral therapy with 1 or 2 anti-infectives (including either ciprofloxacin or doxycycline) may be used to complete the initial 14-21 or 7-10 days of therapy for inhalational or uncomplicated cutaneous anthrax, respectively, continuing anti-infective therapy for 60 days total when anthrax resulted from biologic warfare or bioterrorism. Because of potential adverse effects from prolonged use of ciprofloxacin or doxycycline in infants and children, amoxicillin is an option for completion of the remaining 60 days of therapy but is not recommended for initial treatment. Recommendations for the treatment of inhalational anthrax in immunocompromised patients are the same as those for patients who are immunocompetent.

Treatment of Cutaneous Anthrax

Natural penicillins (e.g., oral penicillin V, IM penicillin G benzathine, IM penicillin G procaine) generally have been considered drugs of choice for the treatment of mild, uncomplicated cutaneous anthrax caused by susceptible strains of B. anthracis that occurs as the result of naturally occurring or endemic exposure to anthrax, although some clinicians suggest use of oral fluoroquinolones (ciprofloxacin, ofloxacin, levofloxacin), oral amoxicillin, or oral doxycycline if in vitro tests indicate susceptibility. For the treatment of uncomplicated, localized cutaneous anthrax that occurs following exposure to B. anthracis spores in the context of biologic warfare or bioterrorism, the CDC and other experts (e.g., US Working Group on Civilian Biodefense) recommend use of oral ciprofloxacin or oral doxycycline for initial therapy in adults and children.

Because of the potential adverse effects of prolonged ciprofloxacin or doxycycline therapy in children, therapy may be changed to oral amoxicillin if results of in vitro testing indicate that the organism is susceptible to the drug and the patient is improving.

Treatment of cutaneous anthrax should be initiated with a parenteral multiple-drug anti-infective regimen if there are signs of systemic involvement, extensive edema, or lesions on the head and neck. In addition, initial therapy with a parenteral multiple-drug regimen is recommended for the treatment of cutaneous anthrax in infants younger than 2 years of age. Although it is not known whether infants are at increased risk for systemic dissemination of cutaneous infection, systemic illness developed after onset of cutaneous anthrax in an infant 7 months of age exposed to B. anthracis spores.

Although 5-10 days of anti-infective therapy usually is recommended for the treatment of mild, uncomplicated cutaneous anthrax that occurs as the result of natural or endemic exposures to anthrax, the CDC and other experts recommend that therapy be continued for 60 days if the cutaneous infection occurred as the result of exposure to aerosolized anthrax spores since the possibility of inhalational anthrax would also exist. Anti-infective therapy may limit the size of the cutaneous anthrax lesion and it usually becomes sterile within the first 24 hours of treatment, but the lesion will still progress through the black eschar stage despite effective treatment. Recommendations for treatment of cutaneous anthrax in immunocompromised patients are the same as those for patients who are immunocompetent.

Treatment of GI and Oropharyngeal Anthrax

Although penicillin usually is considered the drug of choice for the treatment of GI anthrax that occurs as the result of ingesting contaminated, undercooked meat, ciprofloxacin is considered an alternative for the treatment of these infections.

Ciprofloxacin has been used for prophylaxis following ingestion of B. anthracis spores in contaminated meat. The CDC and other experts (US Working Group on Civilian Biodefense) recommend that the same parenteral multiple-drug regimens recommended for the treatment of inhalational anthrax be used for the treatment of GI and oropharyngeal anthrax that occurs in the context of biologic warfare or bioterrorism.

Plague

Ciprofloxacin (IV, conventional tablets, oral suspension) is recommended as an alternative agent for the treatment of plague caused by Yersinia pestis and also is recommended for postexposure prophylaxis following a high-risk exposure to Y. pestis, including exposure in the context of biologic warfare or bioterrorism.

The recommendation for use of fluoroquinolones (e.g., ciprofloxacin, levofloxacin, ofloxacin) for treatment or prophylaxis of plague is based on results of in vitro and animal testing. Although human studies are not available, results of in vitro studies indicate that ciprofloxacin is active against Y. pestis and the drug has been effective for the treatment of murine plague infections. For the treatment of plague, IM streptomycin (or IM or IV gentamicin) generally is considered the regimen of choice. Alternative drugs recommended for the treatment of plague when aminoglycosides are not used include IV doxycycline, IV chloramphenicol (drug of choice for plague meningitis), an IV fluoroquinolone (e.g., ciprofloxacin, levofloxacin), or co-trimoxazole (may be less effective than other alternatives).

Anti-infective regimens recommended for the treatment of naturally occurring or endemic bubonic, septicemic, or pneumonic plague also are recommended for the treatment of plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism. Such exposures would most likely result in primary pneumonic plague, and prompt initiation of anti-infective therapy (within 18-24 hours of onset of symptoms) is essential in the treatment of pneumonic plague. Some experts (e.g., the US Working Group on Civilian Biodefense, US Army Medical Research Institute of Infectious Diseases [USAMRIID]) recommend that treatment of plague in the context of biologic warfare or bioterrorism be initiated with a parenteral anti-infective regimen of streptomycin (or gentamicin) or, alternatively, doxycycline, a fluoroquinolone (e.g., ciprofloxacin, levofloxacin) or chloramphenicol.

However, an oral regimen of doxycycline (or tetracycline) or a fluoroquinolone (e.g., ciprofloxacin, levofloxacin, ofloxacin) may be substituted when the patient’s condition improves or when a parenteral regimen is unavailable (e.g., when there are supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting); oral chloramphenicol is considered an alternative in these situations.

In the context of biologic warfare or bioterrorism, some experts (e.g., the US Working Group on Civilian Biodefense, US Army Medical Research Institute of Infectious Diseases) recommend that asymptomatic individuals with exposure to plague aerosol or asymptomatic individuals with household, hospital, or other close contact (within about 2 m) with an individual who has pneumonic plague receive an oral anti-infective regimen for postexposure prophylaxis; however, any exposed individual who develops a temperature of 38.°C or higher or new cough should promptly receive a parenteral anti-infective for treatment of the disease.

If postexposure prophylaxis is indicated, these experts recommend a regimen of oral doxycycline (or tetracycline) or an oral fluoroquinolone (e.g., ciprofloxacin, levofloxacin, ofloxacin); oral chloramphenicol is considered an alternative. Although plague vaccine (no longer commercially available in the US) was previously recommended to provide protection against Y. pestis infection, the vaccine was effective for preventing or ameliorating bubonic plague but was not effective for prophylaxis against exposure to aerosolized Y. pestis and therefore did not provide protection against pneumonic plague.

Tularemia

Ciprofloxacin (IV, conventional tablets, oral suspension) is recommended as an alternative to aminoglycosides (streptomycin or gentamicin) for the treatment of tularemia caused by Francisella tularensis. Streptomycin generally has been considered the drug of choice for the treatment of tularemia; however, gentamicin is more readily available and is considered an alternative drug of choice when streptomycin is unavailable.

Other alternatives for the treatment of tularemia include tetracyclines (doxycycline), chloramphenicol, or ciprofloxacin.Anti-infective regimens recommended for the treatment of naturally occurring or endemic tularemia also are recommended for the treatment of tularemia that occurs following exposure to F. tularensis in the context of biologic warfare or bioterrorism.

However, the fact that a fully virulent streptomycin-resistant strain of F. tularensis was developed in the past for use in biologic warfare should be considered. Exposures to F. tularensis in the context of biologic warfare or bioterrorism would most likely result in inhalational tularemia with pleuropneumonitis, although the organism also can infect humans through the skin, mucous membranes, and GI tract.

Postexposure prophylaxis with anti-infectives usually is not recommended after possible 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 of the disease is not known to occur. However, postexposure prophylaxis is recommended following a high-risk laboratory exposure to F. tularensis (e.g., spill, centrifuge accident, needlestick injury). In the context of biologic warfare or bioterrorism, some experts (e.g., the US Working Group on Civilian Biodefense, US Army Medical Research Institute of Infectious Diseases [USAMRIID]) recommend that asymptomatic individuals with exposure to F. tularensis receive postexposure anti-infective prophylaxis; however, any individual who develops an otherwise unexplained fever or flu-like illness within 14 days of presumed exposure should promptly receive a parenteral anti-infective for treatment of the disease. Oral ciprofloxacin or oral doxycycline (or oral tetracycline) usually is recommended for postexposure prophylaxis following such exposures.

Mycobacterial Infections

Although further study is needed to more fully evaluate efficacy of the drug, oral ciprofloxacin (conventional tablets, oral suspension) is used in the treatment of mycobacterial infections, including those caused by Mycobacterium tuberculosis, M fortuitum, or M. avium complex (MAC).

Treatment of Active Tuberculosis

Although the potential role of fluoroquinolones and the optimal length of therapy have not been fully defined, the CDC, American Thoracic Society (ATS), and Infectious Diseases Society of America (IDSA) state that use of fluoroquinolones as alternative agents for the treatment of active tuberculosis can be considered in patients with relapse, treatment failure, or M. tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated.For further information on use of fluoroquinolones in the treatment of active tuberculosis, see Treatment of Active Tuberculosis under Uses: Mycobacterial Infections, in Levofloxacin 8:12.18.

Other Mycobacterial Infections

Ciprofloxacin has been used alone or in conjunction with amikacin for the treatment of cutaneous infections caused by M. fortuitum. Although ciprofloxacin appeared to be effective in a few patients with M. fortuitum infections, ciprofloxacin-resistant strains of the organism have developed when the drug was used alone or in conjunction with amikacin in the treatment of these infections. Oral ciprofloxacin has been used in multiple-drug regimens for the treatment of pulmonary and extrapulmonary (localized or disseminated) M. avium complex (MAC) infections.

Rickettsial Infections

Ciprofloxacin has been used with some success in a limited number of patients for the treatment of various rickettsial infections. Although tetracyclines generally are the drugs of choice for the treatment of rickettsial infections, some clinicians suggest that either ciprofloxacin or ofloxacin may be considered an alternative for the treatment of these infections when tetracyclines cannot be used. Oral ciprofloxacin (500 mg twice daily) has been effective in at least one patient for the long-term treatment of Q fever endocarditis caused by Coxiella burnetii.

In a few patients, IV ciprofloxacin followed by oral ciprofloxacin therapy has been effective in the treatment of Mediterranean spotted fever caused by Rickettsia conorii. In another study, a 2-day regimen of oral ciprofloxacin was effective in the treatment of Mediterranean spotted fever in adults with mild to moderate infections; however, the defervescence period was shorter and clinical symptoms such as headache, arthralgia, and myalgia resolved faster in patients receiving a 2-day regimen of oral doxycycline.

Empiric Therapy in Febrile Neutropenic Patients

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

Safety and efficacy of combination therapy with ciprofloxacin and piperacillin sodium for empiric therapy in febrile neutropenic patients have been evaluated in a multicenter, randomized study in adults. Patients were randomized to receive a regimen of ciprofloxacin (400 mg IV every 8 hours) and piperacillin sodium (50 mg/kg IV every 4 hours) or a regimen of tobramycin (2 mg/kg IV every 8 hours) and piperacillin sodium (50 mg/kg IV every 4 hours). There was clinical resolution of the initial febrile episode (resolution of fever, microbiologic eradication of infection if such infection was microbiologically documented, resolution of signs and symptoms of infection) without modification of the empiric regimen in 27% of those who received ciprofloxacin and piperacillin and in 21.% of those who received tobramycin and piperacillin; the overall survival rate was 96.1 or 94.1%, respectively.

Bartonella Infections

Ciprofloxacin has been used in the treatment of cat scratch disease caused by Bartonella henselae (formerly Rochalimaea henselae). The role of anti-infectives in the treatment of infections caused by B. henselae (cat scratch disease, bacillary angiomatosis, peliosis hepatitis) has not been determined. Cat scratch disease generally is a self-limited illness in immunocompetent individuals and may resolve spontaneously in 2-4 months; however, some clinicians suggest that anti-infective therapy be considered for acutely or severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and such therapy probably is indicated in immunocompromised patients. Anti-infective agents also are indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome. While the optimum anti-infective regimen for the treatment of cat scratch disease or other B. henselae infections has not been identified, some clinicians recommend use of azithromycin, ciprofloxacin, erythromycin, doxycycline, rifampin, co-trimoxazole, or gentamicin.

Brucella Infections

Oral ciprofloxacin has been used in a few patients for the treatment of acute systemic brucellosis or acute brucella arthritis-diskitis caused by Brucella melitensis. Although oral ciprofloxacin therapy resulted in an initial apparent response in most patients and defervescence within 7 days, at least one patient was considered a treatment failure because blood cultures remained positive and about 25% of patients (generally those with arthritis-diskitis) had relapse or reinfection within 8-32 weeks after the drug was discontinued. Although further study is needed to evaluate efficacy of ciprofloxacin in the treatment of brucellosis, some clinicians suggest that a regimen of ciprofloxacin and rifampin can be used as an alternative regimen for the treatment of the disease.

Nasal Carriage of Staphylococcus aureus

Although resistance to ciprofloxacin has been reported in strains of oxacillin-resistant S. aureus, oral ciprofloxacin (750 mg every 12 hours for 7-28 days) has been used to temporarily eliminate oxacillin-resistant S. aureus colonization in patients with serious diseases who were at risk for infection. While ciprofloxacin appeared to successfully eradicate oxacillin-resistant S. aureus colonization in some patients, further study is needed to evaluate efficacy of the drug and to determine the rate of recolonization. In addition, results of a study in Taiwan indicate that use of ciprofloxacin is an independent risk factor for colonization with oxacillin-resistant S. aureus in HIV-infected patients. The management of oxacillin-resistant S. aureus colonization is controversial and permanent eradication of nasal carriage of staphylococci following topical or systemic anti-infective therapy is unlikely; recolonization generally occurs in 63-100% of patients regardless of the anti-infective agent used. In addition, because fluoroquinolone therapy usually does not eradicate nasal carriage but may promote emergence of resistant staphylococci, there are concerns about such use of these drugs.

Legionnaires’ Disease

Ciprofloxacin has been effective for the treatment of Legionnaires’ disease caused by Legionella pneumophila, and some clinicians suggest that ciprofloxacin may be considered a drug of choice for this infection, especially in immunocompromised patients (e.g., transplant recipients).

Selective Decontamination of the GI Tract

Oral ciprofloxacin has been used effectively for selective decontamination of the GI tract in granulocytopenic patients or other debilitated patients (e.g., those with cirrhosis). Although further study is needed, it has been suggested that ciprofloxacin may be particularly useful in these patients since it generally does not affect normal anaerobic fecal flora.

However, results of a randomized study in patients with acute myelogenous leukemia receiving chemotherapy indicate that use of a selective decontamination regimen that included ciprofloxacin did not decrease the overall incidence of infection or infection-associated deaths. In addition, gram-negative infections that did occur were resistant to ciprofloxacin.

Malaria

Although ciprofloxacin reportedly has some activity in vitro against Plasmodium falciparum, oral ciprofloxacin (750 mg every 12 hours) has been ineffective when used alone in the treatment of uncomplicated malaria caused by chloroquine-resistant P. falciparum.

CNS Infections

Although IV ciprofloxacin has been used successfully alone or combined with other drugs (e.g., antipseudomonal aminoglycosides) to treat CNS infections caused by susceptible organisms (e.g., Ps. aeruginosa) in several patients, only low concentrations of ciprofloxacin are distributed into CSF, and further study is needed before efficacy and safety of the drug in the treatment of CNS infections can be determined.

Ophthalmic and Otic Infections

For use of ciprofloxacin hydrochloride in the topical treatment of ophthalmic and otic infections caused by susceptible bacteria.

Ciprofloxacin Hydrochloride: Dosage and Administration

Administration

Ciprofloxacin is administered orally as conventional tablets containing the hydrochloride, as an oral suspension containing the base, or as extended-release tablets containing both the hydrochloride and the base. Ciprofloxacin is given by IV infusion as the lactate salt. IV therapy with the drug generally is reserved for patients who do not tolerate or are unable to take the drug orally and for other patients in whom the IV route offers a clinical advantage.

Patients receiving initial therapy with IV ciprofloxacin may be switched to oral ciprofloxacin (conventional tablets, oral suspension) when clinically appropriate. Patients receiving ciprofloxacin orally or IV should be well hydrated and should be instructed to drink fluids liberally.

Oral Administration Ciprofloxacin and ciprofloxacin hydrochloride may be given orally without regard to meals. However, ciprofloxacin and ciprofloxacin hydrochloride should not be taken 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.

The manufacturer states that doses of oral ciprofloxacin should be taken 2 hours before or after these calcium-fortified products. The commercially available extended-release tablets containing ciprofloxacin should not be split, crushed, or chewed. The commercially available microcapsules containing ciprofloxacin should be mixed with the diluent provided by the manufacturer to provide an oral suspension of the drug; the microcapsules should not be chewed.

The oral suspension should not be administered through feeding tubes. IV Infusion Prior to IV infusion, commercially available ciprofloxacin lactate concentrate for injection containing 10 mg/mL must be diluted in 0.9% sodium chloride injection or 5% dextrose injection to provide a solution containing 1-2 mg/mL. Alternatively, commercially available ciprofloxacin lactate injection for IV infusion containing 2 mg/mL in 5% dextrose injection may be used without further dilution.

The commercially available 1.2-g pharmacy bulk package of the drug 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. 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. IV infusions of ciprofloxacin lactate should be infused over 60 minutes.

The infusion 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 lactate is being infused.

Because local reactions (e.g., thrombophlebitis, burning, pain, pruritus, paresthesia, erythema, swelling) at the site of IV infusion are more frequent when the drug is administered rapidly (e.g., over 30 minutes) or via a small vein, ciprofloxacin lactate should be infused IV slowly over a period of 60 minutes as a dilute solution (1-2 mg of ciprofloxacin per mL) via a large vein. If such reactions occur despite these precautions, they generally resolve rapidly following completion of the infusion; the manufacturer states that subsequent IV administration of ciprofloxacin lactate is not contraindicated unless the reaction recurs or worsens.

Dosage

Dosage of ciprofloxacin hydrochloride and ciprofloxacin lactate is expressed in terms of ciprofloxacin. Because of the risk of crystalluria, the manufacturer recommends that the usual dosage of the drug not be exceeded.

Ciprofloxacin conventional tablets are not interchangeable with ciprofloxacin extended-release tablets. Safety and efficacy of ciprofloxacin extended-release tablets have been established only for the treatment of uncomplicated urinary tract infections (UTIs) in adults; safety and efficacy of the extended-release formulation of the drug have not been established for the treatment of other infections that are treated with IV ciprofloxacin or with ciprofloxacin conventional tablets or oral suspension.

Based on pharmacokinetic parameters (i.e., area under the plasma concentration-time curve [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. The duration of ciprofloxacin therapy depends on the type and severity of infection, and should be determined by the clinical and bacteriologic response of the patient.

Urinary Tract Infections and Prostatitis Urinary Tract Infections

The usual adult oral dosage of ciprofloxacin extended-release tablets for the treatment of uncomplicated urinary tract infections (cystitis) caused by susceptible Enterobacter faecalis, Escherichia coli, Proteus mirabilis, or Staphylococcus saprophyticus is 500 mg every 24 hours for 3 days.

The usual adult oral dosage of ciprofloxacin conventional tablets or oral suspension for the treatment of mild to moderate urinary tract infections (UTIs) is 250 mg every 12 hours for 7-14 days and the usual adult oral dosage of these preparations for complicated UTIs is 500 mg every 12 hours for 7-14 days. An oral dosage of conventional tablets or oral suspension of 100 or 250 mg every 12 hours for 3 days can be used for the treatment of acute, uncomplicated cystitis in women. The usual adult IV dosage of ciprofloxacin for the treatment of mild to moderate UTIs caused by susceptible organisms is 200 mg every 12 hours for 7-14 days, and the usual adult IV dosage for severe or complicated UTIs is 400 mg every 12 hours for 7-14 days.

Prostatitis

For the treatment of mild to moderate chronic bacterial prostatitis in men, the usual oral dosage of ciprofloxacin conventional tablets or oral suspension is 500 mg every 12 hours for 28 days. The usual IV dosage for the treatment of mild to moderate chronic prostatitis is 400 mg every 12 hours for 28 days.

Respiratory Tract Infections

The usual adult oral dosage of ciprofloxacin conventional tablets or oral suspension for acute sinusitis is 500 mg every 12 hours for 10 days. For the treatment of lower respiratory tract infections, the usual adult oral dosage of these ciprofloxacin preparations is 500 mg every 12 hours for 7-14 days for mild to moderate infections or 750 mg every 12 hours for 7-14 days for severe or complicated infections. For the treatment of mild to moderate lower respiratory tract infections caused by susceptible bacteria, the usual adult IV dosage of ciprofloxacin is 400 mg every 12 hours for 7-14 days; more severe or complicated lower respiratory tract infections should be treated with 400 mg every 8 hours for 7-14 days. The usual adult IV dosage of ciprofloxacin for the treatment of mild, moderate, or severe nosocomial pneumonia is 400 mg every 8 hours for 10-14 days. For the treatment of acute sinusitis, the usual IV dosage of ciprofloxacin is 400 mg every 12 hours for 28 days.

Skin and Skin Structure Infections

For the treatment of skin and skin structure infections caused by susceptible bacteria, the usual adult oral dosage of ciprofloxacin conventional tablets or oral suspension is 500 mg every 12 hours for mild to moderate infections and 750 mg every 12 hours for severe or complicated infections. The usual duration is 7-14 days. The usual adult IV dosage of ciprofloxacin for the treatment of skin and skin structure infections caused by susceptible bacteria is 400 mg every 12 hours for mild to moderate infections and 400 mg every 8 hours for more severe or complicated infections. The usual duration of therapy is 7-14 days.

Bone and Joint Infections

For the treatment of bone and joint infections caused by susceptible bacteria, the usual adult oral dosage of ciprofloxacin conventional tablets or oral suspension is 500 mg every 12 hours for mild to moderate infections and 750 mg every 12 hours for severe or complicated infections. The usual duration is at least 4-6 weeks. The usual adult IV dosage of ciprofloxacin for the treatment of bone and joint infections caused by susceptible bacteria is 400 mg every 12 hours for mild to moderate infections and 400 mg every 8 hours for more severe or complicated infections. The usual duration of therapy is at least 4-6 weeks.

GI Infections

The usual adult oral dosage of ciprofloxacin conventional tablets or oral suspension for infectious diarrhea is 500 mg every 12 hours for 5-7 days. A single 1-g dose or two 1-g doses of ciprofloxacin conventional tablets or oral suspension administered 24 hours apart have been effective for the treatment of infectious diarrhea secondary to Shigella strains other than S. dysenteriae type 1; more prolonged therapy (e.g., 500 mg every 12 hours for 5 days) generally appears necessary for diarrhea secondary to this latter strain.

For the treatment of GI infections caused by Cyclospora or Isospora, ciprofloxacin conventional tablets or oral suspension have been given in a dosage of 500 mg twice daily for 7 days. For the treatment of travelers’ diarrhea that is severe or associated with high fever or bloody stools, some clinicians recommend that 500 mg of ciprofloxacin conventional tablets or oral suspension be given twice daily for 3 days.

If ciprofloxacin is used for empiric treatment of travelers’ diarrhea in individuals with human immunodeficiency virus (HIV) infection, a dosage of 500 mg of ciprofloxacin conventional tablets or oral suspension twice daily for 3-7 days is recommended. Although the use of anti-infectives for prophylaxis of travelers’ diarrhea is generally discouraged, if ciprofloxacin is used, the recommended adult oral dosage is 500 mg of ciprofloxacin conventional tablets or oral suspension once daily during the period of risk (for up to 3 weeks) beginning the day of travel and continuing for 1 or 2 days after leaving the area of risk.

Intra-abdominal Infections

When ciprofloxacin is used for the treatment of complicated intra-abdominal infections, therapy should be initiated using an IV ciprofloxacin dosage of 400 mg every 12 hours given in conjunction with IV metronidazole. When appropriate, therapy is changed to oral ciprofloxacin conventional tablets or oral suspension given in a dosage of 500 mg every 12 hours in conjunction with oral metronidazole for a total duration of therapy of 7-14 days.

Typhoid Fever and Other Salmonella Infections

The usual adult oral dosage of ciprofloxacin conventional tablets or oral suspension for the treatment of mild to moderate typhoid fever is 500 mg every 12 hours for 10 days. Although the optimum dosage and duration of therapy have not been established, oral ciprofloxacin dosages of 750 mg twice daily for 28 days have been used in adults for the treatment of chronic typhoid carriers. If oral ciprofloxacin is used in individuals with human immunodeficiency virus (HIV) infection for long-term prophylaxis to prevent recurrence in those who have been treated for septicemia caused by nontyphi Salmonella, the Prevention of Opportunistic Infections Working Group of the US Public Health Service and the Infectious Diseases Society of America (USPHS/IDSA) recommend that adults receive a dosage of 500 mg of ciprofloxacin conventional tablets or oral suspension every 12 hours for several months. (See HIV-infected Individuals under Uses: Typhoid Fever and Other Salmonella Infections.)

Gonorrhea and Associated Infections

Although the manufacturer states that a single 250-mg dose of oral ciprofloxacin conventional tablets or oral suspension can be used for the treatment of uncomplicated urethral or endocervical gonorrhea caused by susceptible Neisseria gonorrhoeae, the CDC and other clinicians recommend that adults receive a single 500-mg oral dose of ciprofloxacin for the treatment of uncomplicated urethral, endocervical, rectal, or pharyngeal gonorrhea in adults and adolescents. (See Uses: Gonorrhea and Associated Infections.)

If ciprofloxacin is used for the treatment of disseminated gonococcal infections in adults and adolescents, the CDC recommends an initial IV dosage of 400 mg every 12 hours continued for 24-48 hours after improvement begins; therapy may then be switched to an oral regimen of 500 mg of ciprofloxacin conventional tablets or oral suspension twice daily to complete at least 1 week of therapy. Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients receiving ciprofloxacin for the treatment of uncomplicated gonorrhea or disseminated gonococcal infections 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).

Chancroid

When ciprofloxacin is used in the treatment of chancroid, the CDC and many clinicians recommend that adults receive 500 mg as conventional tablets or oral suspension orally twice daily for 3 days. 606, 631

Granuloma Inguinale (Donovanosis)

For the treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis, 750 mg of oral ciprofloxacin as conventional tablets or oral suspension should be given twice daily for a minimum of 3 weeks. Neisseria meningitidis Infections When ciprofloxacin conventional tablets or oral suspension have been used to eliminate nasal carriage of Neisseria meningitidis in adults, a dosage of 500 or 750 mg given as a single dose has been used. Alternatively, 250 mg has been given twice daily for 2 days or 500 mg has been given twice daily for 5 days. When ciprofloxacin as conventional tablets or oral suspension is used in adults for chemoprophylaxis following high-risk exposure to individuals with invasive meningococcal disease, a single 500-mg oral dose is recommended.

Anthrax Postexposure Prophylaxis

When oral ciprofloxacin as conventional tablets or oral suspension is used for inhalational anthrax (postexposure) to reduce the incidence or progression of disease following exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism, adults should receive 500 mg every 12 hours and children should receive 15 mg/kg (maximum: 500 mg per dose) every 12 hours. If IV ciprofloxacin is used for inhalational anthrax (postexposure), adults should receive 400 mg IV every 12 hours and children should receive 10 mg/kg (maximum: 400 mg per dose) every 12 hours.

Anti-infective prophylaxis should be initiated as soon as possible following suspected or confirmed anthrax exposure. If subsequent epidemiologic and laboratory test data indicate that individuals started on prophylaxis were not exposed, the anti-infective regimen should be stopped. If exposure is confirmed, postexposure vaccination with anthrax vaccine (if available) may be indicated in conjunction with anti-infective prophylaxis. Because of the possible persistence of spores in lung tissue following an aerosol exposure, the CDC and other experts recommend that anti-infective prophylaxis be continued for 60 days. However, because of potential adverse effects from prolonged use of ciprofloxacin in infants and children, amoxicillin is an alternative to ciprofloxacin or doxycycline prophylaxis when susceptibility to penicillin is known. For prophylaxis following ingestion of B. anthracis spores in contaminated meat, an oral dosage of 500 mg of ciprofloxacin twice daily has been recommended for adults.

Treatment of Inhalational Anthrax

When ciprofloxacin is used for the treatment of inhalational anthrax following exposure to B. anthracis spores in the context of biologic warfare or bioterrorism, adults should receive an initial regimen of 400 mg IV every 12 hours and infants and children should receive 10 mg/kg IV every 12 hours (maximum: 400 mg per dose). When clinically appropriate, therapy can be changed to oral ciprofloxacin conventional tablets or oral suspension and adults should receive 500 mg orally twice daily and children should receive 15 mg/kg every 12 hours (maximum: 500 mg per dose).

The CDC and other experts (US Working Group on Civilian Biodefense) recommend that treatment of inhalational anthrax be initiated with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective.

A parenteral regimen of ciprofloxacin (400 mg every 8 hours), rifampin (300 mg every 12 hours), and clindamycin (900 mg every 8 hours) has been used for initial treatment of inhalation anthrax in at least 2 adults. If oral ciprofloxacin conventional tablets or oral suspension is used for the treatment of inhalational anthrax when a parenteral regimen is not available (e.g., when there are supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting), some experts (US Working Group on Civilian Biodefense) recommend that adults receive an oral dosage of 500 mg every 12 hours and that children receive a dosage of 15 mg/kg every 12 hours (maximum 500 mg per dose).

Because of the possible persistence of anthrax spores in lung tissue following an aerosol exposure, the CDC and other experts recommend that anti-infective therapy of inhalational anthrax that occurs as the result of exposure to B. anthracis in the context of biologic warfare or bioterrorism should be continued for 60 days. Because of potential adverse effects from prolonged use of ciprofloxacin in infants and children, amoxicillin is an option for completion of the remaining 60 days of therapy (i.e., after an initial 14-21 days of multiple-drug therapy for inhalational anthrax that included ciprofloxacin or doxycycline) when susceptibility to penicillin is known; amoxicillin is not recommended for initial treatment.

Treatment of Cutaneous Anthrax

For the treatment of uncomplicated, localized cutaneous anthrax that occurs following exposure to B. anthracis spores in the context of biologic warfare or bioterrorism, the CDC and other experts (US Working Group on Civilian Biodefense) recommend that adults receive 500 mg of oral ciprofloxacin conventional tablets or oral suspension twice daily and that children receive 15 mg/kg orally every 12 hours (maximum 500 mg per dose). However, if there are signs of systemic involvement, extensive edema, or head and neck lesions or if cutaneous anthrax occurs in an infant younger than 2 years of age, therapy should be initiated with the same parenteral multiple-drug regimen recommended for treatment of inhalational anthrax.(See Treatment of Inhalational Anthrax under Dosage: Anthrax.)

Although the usual duration of treatment for mild uncomplicated cutaneous anthrax that occurs as the result of naturally occurring or endemic anthrax exposures is 5-10 days; the CDC and other experts recommend that anti-infective therapy be continued for 60 days for treatment of cutaneous anthrax that occurs as the result of exposure to aerosolized anthrax spores in the context of biologic warfare or bioterrorism since the possibility of inhalational anthrax would also exist. Because of potential adverse effects from prolonged use of ciprofloxacin in infants and children, amoxicillin is an option for completion of the remaining 60 days of therapy (i.e., after an initial 14-21 or 7-10 days of multiple-drug therapy for complicated or uncomplicated cutaneous anthrax, respectively, that included ciprofloxacin or doxycycline) when susceptibility to penicillin is known; amoxicillin is not recommended for initial treatment.

Treatment of GI and Oropharyngeal Anthrax

For treatment of GI and oropharyngeal anthrax that occurs in the context of biologic warfare or bioterrorism, the CDC and other experts (US Working Group on Civilian Biodefense) recommend that therapy be initiated with the same parenteral multiple-drug regimen recommended for treatment of inhalational anthrax. Plague If ciprofloxacin is used for the treatment of pneumonic plague that occurs as the result of exposure to Yersinia pestis in the context of biologic warfare or bioterrorism, some experts (e.g., the US Working Group on Civilian Biodefense, US Army Medical Research Institute of Infectious Diseases [USAMRIID]) recommend that adults receive a dosage of 400 mg IV twice daily and that children receive 15 mg/kg IV twice daily (maximum 1 g daily).

Oral therapy may be substituted when the patient’s condition improves. If oral ciprofloxacin conventional tablets or oral suspension is used for the treatment of plague when the patient’s clinical condition improves or when a parenteral regimen is not available (e.g., in mass casualty settings), these experts recommend that adults receive 500 mg orally twice daily and that children receive 20 mg/kg orally twice daily (maximum 1 g daily). The usual duration of treatment for plague is 10 days; some experts recommend a duration of 10-14 days. If ciprofloxacin conventional tablets or oral suspension is used for postexposure prophylaxis following exposure to Y. pestis in the context of biologic warfare or bioterrorism, some experts recommend that adults receive 500 mg orally twice daily and that children receive 20 mg/kg twice daily (maximum 1 g daily) for 7 days.

Tularemia

If ciprofloxacin is used for the treatment of tularemia that occurs as the result of exposure to Francisella tularensis in the context of biologic warfare or bioterrorism, some experts (e.g., the US Working Group on Civilian Biodefense, US Army Medical Research Institute of Infectious Diseases [USAMRIID]) recommend that adults receive a dosage of 400 mg IV twice daily and that children receive 15 mg/kg IV twice daily (maximum 1 g daily).

Oral therapy may be substituted when the patient’s condition improves. If oral ciprofloxacin conventional tablets or oral suspension is used for the treatment of tularemia when the patient’s clinical condition improves or if a parenteral regimen is not available, these experts recommend that adults receive 500 mg orally twice daily and that children receive 15 mg/kg twice daily (maximum 1 g daily). The usual duration of treatment for tularemia is 10 days; some experts recommend a duration of 10-14 days. If ciprofloxacin conventional tablets or oral suspension is used for postexposure prophylaxis following exposure to F. tularensis that occurs in the context of biologic warfare or bioterrorism, some experts recommend that adults receive 500 mg orally twice daily and that children receive 15 mg/kg orally twice daily (maximum 1 g daily) for 14 days.

Mycobacterial Infections Treatment of Active Tuberculosis

When used in conjunction with other drugs for the treatment of mycobacterial infections, including tuberculosis caused by multidrug-resistant Mycobacterium tuberculosis or M. avium complex infections, oral ciprofloxacin has been given to adults in a dosage of 750 mg twice daily. Empiric Therapy in Febrile Neutropenic Patients For empiric anti-infective therapy in febrile neutropenic patients, the manufacturer recommends that adults should receive ciprofloxacin in a dosage of 400 mg IV every 8 hours given in conjunction with piperacillin sodium (50 mg/kg IV every 4 hours, not to exceed 24 g/daily or 300 mg/kg daily; no longer commercially available in the US as a single-entity preparation). The usual duration of therapy for this indication is 7-14 days.

Bartonella Infections

For the treatment of cat scratch disease caused by Bartonella henselae, oral ciprofloxacin has been given in a dosage of 500 mg twice daily for 10-16 days. Brucella Infections Oral ciprofloxacin has been given in a dosage of 500 mg 2 or 3 times daily for 6-12 weeks or 750 mg 3 times daily for 6-8 weeks for the treatment of acute systemic brucellosis or acute brucella arthritis-diskitis caused by Brucella melitensis. Legionnaires’ Disease For the treatment of Legionnaires’ disease, some clinicians recommend that 500 mg of ciprofloxacin be given orally or 400 mg be given IV every 12 hours for 2-3 weeks.

Dosage in Renal and Hepatic Impairment

When ciprofloxacin extended-release tablets are administered for the treatment of uncomplicated urinary tract infections, the manufacturer states that dosage adjustment is not necessary in patients with renal impairment. Modification of the usual oral dosage of ciprofloxacin conventional tablets or oral suspension generally is unnecessary when creatinine clearances exceed 50 mL/minute; modification of the usual IV dosage of ciprofloxacin generally is unnecessary when creatinine clearances are 30 mL/minute or more. In patients with lower creatinine clearances, doses and/or frequency of administration of ciprofloxacin IV, conventional tablets, or oral suspension should be modified in response to the degree of renal impairment and the site and severity of infection.

However, some clinicians suggest that the dose but not the frequency of administration be reduced so that periods in which drug concentrations might be less than the MIC can be minimized. Although methods and facilities for monitoring serum concentrations of ciprofloxacin may not be readily available, such monitoring is the most reliable method for determining dosage of the drug, especially in patients with severe renal impairment, changing renal function, or both renal and hepatic impairment.

The manufacturer states that peak serum ciprofloxacin concentrations (obtained 1-2 hours after an oral dose or at the completion of IV infusion) generally should range from 2-4 mcg/mL. For dosage of conventional tablets or oral suspension, the manufacturer states that adults with creatinine clearances of 30-50 mL/minute can receive 250-500 mg of ciprofloxacin orally every 12 hours and adults with creatinine clearances of 5-29 mL/minute can receive 250-500 mg orally every 18 hours. The patient’s creatinine clearance (Ccr) can be estimated by using the following formulas: The manufacturer states that patients with severe infections and severe renal impairment may be given 750 mg of ciprofloxacin as conventional tablets or oral suspension every 12 or 18 hours; however, these patients should be monitored carefully and serum ciprofloxacin concentrations determined periodically. For dosage of IV ciprofloxacin, the manufacturer states that adults with creatinine clearances of 5-29 mL/minute can receive 200-400 mg every 18-24 hours.

Alternatively, some clinicians suggest that usual doses of ciprofloxacin be reduced in response to the degree of renal impairment and the site and severity of infection while maintaining the usual frequencies of administration (i.e., every 8-12 hours). For example, adults with creatinine clearances of 20 mL/minute or less can receive doses two-thirds the usual doses at the usual frequencies. Adults undergoing hemodialysis or peritoneal dialysis can receive the usual dosage of ciprofloxacin extended-release tablets, but the daily dose should be given after the dialysis procedure is completed. Adults undergoing hemodialysis or peritoneal dialysis may receive ciprofloxacin conventional tablets or oral suspension in a dosage of 250-500 mg every 24 hours. Additional supplemental doses of the drug are unnecessary in patients undergoing hemodialysis.