The licensed uses for ciprofloxacin in the United States are as follows:
In the adult population, ciprofloxacin is limited to the treatment of proven bacterial infections such as:
* Urinary tract infections (not recommended as a first line antibiotic)[11]
* Acute uncomplicated cystitis in females
* Chronic bacterial prostatitis (not recommended as a first line antibiotic choice)[12][13]
* Lower respiratory tract infections (not recommended as a first line antibiotic choice)[14][15][16]
* Acute sinusitis (not recommended as a first line antibiotic choice)[17]
* Skin and skin structure infections
* Bone and joint infections
* Infectious diarrhea
* Typhoid fever (enteric fever) caused by Salmonella typhi
* Uncomplicated cervical and urethra gonorrhea (due to N. gonorrhoeae) – however, this indication is no longer effective in some areas (i.e. Asian countries,[18] United States (including Hawaii), Canada ,[19] and Scotland)[20] due to bacterial resistance. Fluoroquinolones are no longer recommended in the USA for this indication.[21]
Ciprofloxacin is not recommended for the treatment of tuberculosis.[22]
As well as in combination with other specific drugs:
* Complicated intra-abdominal infections (in combination with metronidazole);
* Empirical therapy for febrile neutropenic patients (in combination with piperacillin)
Oral and I.V. fluoroquinolones are not licensed by the U.S. FDA for use in children due to the risk of permanent injury to the musculoskeletal system, with two exceptions as outlined below. Within the studies submitted in response to a Pediatric Written Request (Ciprofloxacin, circa 2004) the rate of atrophy was reported to be 9.3% at one month and 13.6% at one year.[23] As such the pediatric use of ciprofloxacin is restricted to proven complicated urinary tract infections and pyelonephritis due to E. coli and inhalation anthrax.[24] Although claimed to be effective, ciprofloxacin is not to be considered a first line agent for inhalation anthrax in the pediatric population.[23][25][26][27] The CDC revoked its recommendation regarding the use of ciprofloxacin as a first line agent in treating anthrax due to the unacceptable risk documented within the Antimicrobial Postexposure Prophylaxis for Anthrax study (aka Cipro 60 day study).[28] However, the fluoroquinolones are licensed to treat lower respiratory infections in children with cystic fibrosis in the UK.
Current recommendations by the American Academy of Pediatrics note that the systemic use of ciprofloxacin in children should be restricted to infections caused by multidrug resistant pathogens or when no safe or effective alternatives.[29]
Indications include:
* Complicated urinary tract infections and pyelonephritis due to Escherichia coli[30]
* Inhalational anthrax (post-exposure)[31]
Ciprofloxacin is not recommended to treat CAP (community acquired pneumonia) as a stand alone first line agent. The current guidelines (Infectious Diseases Society of America 2007) state that in very limited circumstances ciprofloxacin or levofloxacin should be combined with other drugs such as a b-lactam drug to treat specific CAP infections, but neither drug is recommended to be used separately as a stand alone first line agent. Additionally the current guidelines state that: “Data exist suggesting that resistance to macrolides and older fluoroquinolones (ciprofloxacin and levofloxacin) results in clinical failure. Other studies have shown that repeated use of fluoroquinolones predicts an increased risk of infection with fluoroquinolone-resistant pneumococci....”[32]
As such the general opinion stated in 1994 that ciprofloxacin “is not to be considered a suitable agent for use in general practice for the blind initial treatment of chest infections....”[33][34] does not appear to have changed within these current guidelines.
Antibiotics may not improve the long-term clinical outcome for sinusitis.[35] When prescribed for chronic bronchitis and acute bacterial sinusitis, the use of the fluoroquinolone class offers no compelling advantages over established treatment.[36] Nor does antibiotic treatment help sore throats.[37] The use of antibiotics such as ciprofloxacin to treat bronchitis is to be considered unnecessary and as such exposes the patient to an unacceptable risk of suffering a severe adverse reaction.[38] Additionally, antibiotics have no effect upon viral infections, such as the common head cold or viral respiratory infections.
Note: Ciprofloxacin may be licensed for other uses, or restricted, by the various regulatory agencies worldwide.