Indicated for:

Adult Patients

Skin and Skin Structure Infections:

• Adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections:

• Adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia
marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections:

• Adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Infectious Diarrhea:

• Adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic
isolates), Campylobacter jejuni, Shigella boydii † Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated.

† Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

Typhoid Fever (Enteric Fever):

• Adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

Uncomplicated Cervical and Urethral Gonorrhea:

• Adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae

Chronic Bacterial Prostatitis:

• Adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

Lower Respiratory Tract Infections:

• Adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae.

CIPRO is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

CIPRO is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.

Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions and for some patients AECB is self-limiting, reserve CIPRO for treatment of AECB in patients who have no alternative treatment options.

Urinary Tract Infections:

• Adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Acute Uncomplicated Cystitis in Female Patients:

• Adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.

Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions and for some patients acute uncomplicated cystitis is self-limiting, reserve CIPRO for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.

Acute Sinusitis:

• Adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus
pneumoniae, or Moraxella catarrhalis.

Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions and for some patients acute sinusitis is self-limiting, reserve CIPRO for treatment of acute sinusitis in patients who have no alternative treatment options.

Pediatric Patients: (1 to 17 years of age)

Complicated Urinary Tract Infection and Pyelonephritis in Pediatric Patients:

• Pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections
(cUTI) and pyelonephritis due to Escherichia coli.

Although effective in clinical trials, CIPRO is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. CIPRO, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.

Adult and Pediatric Patients (adults and birth to 17 years of age)

Inhalational Anthrax (Post-Exposure):

• Adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure)
to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.

Plague (Including treatment and prophylaxis of pneumonic and septicemic plague):

• Treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis)
and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age.

Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only.

The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute exacerbation of chronic bronchitis, and acute uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options.

CIPRO has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Perform a serologic test for syphilis in all patients with gonorrhea at the time of diagnosis. Perform follow-up serologic test for syphilis three months after CIPRO treatment.

Fluoroquinolones, including CIPRO, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).These reactions can occur within hours to weeks after starting CIPRO. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Fluoroquinolones, including CIPRO, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting CIPRO, or as long as several months after completion of fluoroquinolone therapy.Tendinitis and tendon rupture can occur bilaterally.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.

Fluoroquinolones, including CIPRO, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including CIPRO. Symptoms may occur soon after initiation of CIPRO and may be irreversible in some patients.

Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Cipro in patients with known history of myasthenia gravis.

Fluoroquinolones, including CIPRO, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, or paranoia; depression, or self-injurious behavior such as attempted or completed suicide; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. These reactions may occur following the first dose.

Fluoroquinolones, including CIPRO, have been associated with an increased risk of central nervous system (CNS) effects, including. convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis CIPRO may also cause central nervous system (CNS) events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide. These reactions may occur following the first dose.

Clostridium difficile (C. difficile)-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CIPRO, and may range in severity from mild diarrhea to fatal colitis.

Some fluoroquinolones, including CIPRO, have been associated with prolongation of the QT interval on the electrocardiogram and cases of arrhythmia. Cases of torsade de pointes have been reported during postmarketing surveillance in patients receiving fluoroquinolones, including CIPRO.

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones including CIPRO after sun or UV light exposure.

Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve CIPRO for use only when there are no alternative antibacterial treatments available.

Assure adequate hydration of patients receiving CIPRO to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Fluoroquinolones, including CIPRO, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported.

Cases of severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, have been reported with CIPRO. Acute liver injury is rapid in onset (range 1–39 days), and is often associated with hypersensitivity.

Concomitant administration with tizanidine is contraindicated.

Co-administration of CIPRO and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine and zolpidem), results in increased plasma concentrations of the co-administered drug and could lead to clinically significant pharmacodynamic adverse reactions of the co-administered drug.

Serious and fatal reactions have been reported in patients receiving concurrent administration of CIPRO and theophylline. Avoid use with theophylline.

Concomitant administration of CIPRO with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, CIPRO may be taken with a meal that contains these products.

Administer CIPRO at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.

Avoid use with drugs that prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).

Avoid use with duloxetine.

Avoid use with zolpidem.

Hypoglycemia sometimes severe has been reported when CIPRO and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. Fatalities have been reported.

Use with caution with phenytoin, cyclosporine, anticoagulant drugs, methotrexate, ropinirole, clozapine, NSAIDs, sildenafil, probenecid and caffeine/xanthine derivatives.

There are no adequate and well-controlled studies in pregnant women. Animal studies: increased incidence of abortion.

Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking CIPRO, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under 18 years of age for conditions other than complicated urinary tract infections, pyelonephritis, plague and inhalational anthrax (post exposure). GoToSource

• Non-bacterial prostatitis. GoToSource

• Periodontitis. GoToSource

• Chlamydia and pelvic inflammatory disease. GoToSource

• Inflammatory bowel disease. GoToSource

• Chronic suppurative otitis media. GoToSource

• Salmonellosis. GoToSource

• Legionella pneumonia. GoToSource

• Chronic infections of the airways in cystic fibrosis. GoToSource

• Malaria, cancer, AIDS and tuberculosis. GoToSource

• Brucellosis. GoToSource

• Cat scratch fever. GoToSource 

• Cholera. GoToSource

• Tularemia. GoToSource

Toxic epidermal necrolysis (life-threatening skin reaction). GoToSource

Tendinitis and tendon rupture, risk increases in patients over 60, in patients taking corticosteroid drugs and in patients with kidney, heart or lung transplants. GoToSource

Hearing loss and tinnitus. GoToSource

Peripheral neuropathy (including headache, dizziness, drowsiness, agitation, psychosis and convulsions). GoToSource

Anxiety, depression and suicidal ideation and behavior. GoToSource

Anaphylaxis and pulmonary edema. GoToSource

Muscle weakness and death in patients with myasthenia gravis. GoToSource

Retinal detachment. GoToSource

Pseudomembranous enterocolitis (inflammation of the colon). GoToSource

Choreoathetosis (abnormal body movements). GoToSource

QT prolongation. GoToSource

Kounis syndrome (acute coronary syndrome). GoToSource

Urticaria (hives). GoToSource 

Clostridium difficile-associated diarrhea. GoToSource

Seizures, hallucinations and psychosis. GoToSource

Severe hepatotoxicity (including hepatic necrosis and liver failure). GoToSource

Acute generalized exanthematous pustulosis (skin eruption). GoToSource

Increased intracranial pressure (including pseudotumor cerebri). GoToSource

Hypersensitivity reactions. GoToSource

Bone marrow depression. GoToSource

Lawsuits filed for ruptured tendons and hearing loss.