Cipro

(Ciprofloxacin Hydrochloride)

Check Drug InteractionsCheck known drug interactions.

Cipro Prescribing Information

•
Fluoroquinolones, including CIPRO^®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together
[see Warnings and Precautions ],
including:
- •
  Tendinitis and tendon rupture
  [see Warnings and Precautions (
  5.2 Tendinitis and Tendon Rupture
  Fluoroquinolones, including CIPRO, have been associated with an increased risk of tendinitis and tendon rupture in all ages
  [see Warnings and Precautions and Adverse Reactions ]
  . 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. Discontinue CIPRO immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including CIPRO, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture
  [see Adverse Reactions ].
  )].
- •
  Peripheral neuropathy
  [see Warnings and Precautions (
  5.3 Peripheral Neuropathy
  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
  [see Warnings and Precautions and Adverse Reactions ]
  .
  Discontinue CIPRO immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including CIPRO, in patients who have previously experienced peripheral neuropathy
  [see Adverse Reactions ].
  )].
- •
  Central nervous system effects
  [see Warnings and Precautions (
  5.4 Central Nervous System Effects
  Psychiatric Adverse Reactions
  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. Advise patients receiving CIPRO to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care.
  Central Nervous System Adverse Reactions
  Fluoroquinolones, including CIPRO, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pscudotumor cerebri), dizziness, and tremors. CIPRO, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. As with all fluoroquinolones, use CIPRO with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy, renal dysfunction). If seizures occur, discontinue CIPRO and institute appropriate care
  [see Adverse Reactions and Drug Interactions ].
  )].
Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions
[see Warnings and Precautions ]
.
•
Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis
. [see Warnings and Precautions (
5.5 Exacerbation of Myasthenia Gravis
Fluoroquinolones, including CIPRO, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis
[see Adverse Reactions ].
)].
•
Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions
[see Warnings and Precautions (
5 WARNINGS AND PRECAUTIONS
•Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of CIPRO. Discontinue CIPRO at the first sign of skin rash, jaundice or any sign of hypersensitivity.
•Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur.
•
Clostridioides difficile
-associated diarrhea: Evaluate if colitis occurs.
•QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval.
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects
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
[see Warnings and Precautions ]
.
Discontinue CIPRO immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including CIPRO, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
5.2 Tendinitis and Tendon Rupture
Fluoroquinolones, including CIPRO, have been associated with an increased risk of tendinitis and tendon rupture in all ages
[see Warnings and Precautions and Adverse Reactions ]
. 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. Discontinue CIPRO immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including CIPRO, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture
[see Adverse Reactions ].
5.3 Peripheral Neuropathy
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
[see Warnings and Precautions and Adverse Reactions ]
.
Discontinue CIPRO immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including CIPRO, in patients who have previously experienced peripheral neuropathy
[see Adverse Reactions ].
5.4 Central Nervous System Effects
Psychiatric Adverse Reactions
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. Advise patients receiving CIPRO to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care.
Central Nervous System Adverse Reactions
Fluoroquinolones, including CIPRO, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pscudotumor cerebri), dizziness, and tremors. CIPRO, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. As with all fluoroquinolones, use CIPRO with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy, renal dysfunction). If seizures occur, discontinue CIPRO and institute appropriate care
[see Adverse Reactions and Drug Interactions ].
5.5 Exacerbation of Myasthenia Gravis
Fluoroquinolones, including CIPRO, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis
[see Adverse Reactions ].
5.6 Other Serious and Sometimes Fatal Adverse Reactions
Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including CIPRO. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
•Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens-Johnson syndrome);
•Vasculitis; arthralgia; myalgia; serum sickness;
•Allergic pneumonitis;
•Interstitial nephritis; acute renal insufficiency or failure;
•Hepatitis; jaundice; acute hepatic necrosis or failure;
•Anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
Discontinue CIPRO immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted
[see Adverse Reactions ].
5.7 Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including CIPRO.
Some reactions were accompanied by cardiovascular collapse, acute myocardial ischemia with or without myocardial infarction, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.
Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated
[see Adverse Reactions ].
5.8 Hepatotoxicity
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. The pattern of injury can be hepatocellular, cholestatic, or mixed. Most patients with fatal outcomes were older than 55 years old. In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), discontinue treatment immediately.
There can be a temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients with previous liver damage, who are treated with CIPRO
[see Adverse Reactions ].
5.9 Risk of Aortic Aneurysm and Dissection
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.
5.10 Serious Adverse Reactions with Concomitant Theophylline
Serious and fatal reactions have been reported in patients receiving concurrent administration of CIPRO and theophylline. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Instances of nausea, vomiting, tremor, irritability, or palpitation have also occurred.
Although similar serious adverse reactions have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by CIPRO cannot be eliminated. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate
[see Drug Interactions ].
5.11
Clostridioides difficile
-Associated Diarrhea
Clostridioides 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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of
C. difficile.
C. difficile
produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing isolates of
C. difficile
cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against
C. difficile
may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of
C. difficile
, and institute surgical evaluation as clinically indicated
[see Adverse Reactions ].
5.12 Prolongation of the QT Interval
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.
Avoid CIPRO in patients with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. Elderly patients may also be more susceptible to drug-associated effects on the QT interval
[see Adverse Reactions , Use in Specific Populations ].
5.13 Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals
CIPRO is indicated in pediatric patients (less than 18 years of age) only for cUTI, prevention of inhalational anthrax (post exposure), and plague
[see Indications and Usage ]
. An increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues, has been observed
[see Adverse Reactions ]
.
In pre-clinical studies, oral administration of CIPRO caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species
[see Use in Specific Populations and Nonclinical Toxicology ].
5.14 Photosensitivity/Phototoxicity
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. Therefore, avoid excessive exposure to these sources of light. Discontinue CIPRO if phototoxicity occurs
[see Adverse Reactions ].
5.15 Development of Drug Resistant Bacteria
Prescribing CIPRO Tablets and CIPRO Oral Suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
5.16 Potential Risks with Concomitant Use of Drugs Metabolized by Cytochrome P450 1A2 Enzymes
CIPRO is an inhibitor of the hepatic CYP1A2 enzyme pathway. 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
[see Drug Interactions and Clinical Pharmacology ].
5.17 Interference with Timely Diagnosis of Syphilis
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.
5.18 Crystalluria
Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline
[see Nonclinical Toxicology ].
Crystalluria related to CIPRO has been reported only rarely in humans because human urine is usually acidic. Avoid alkalinity of the urine in patients receiving CIPRO. Hydrate patients well to prevent the formation of highly concentrated urine
[see Dosage and Administration ]
.
5.19 Blood Glucose Disturbances
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. If a hypoglycemic reaction occurs in a patient being treated with CIPRO, discontinue CIPRO and initiate appropriate therapy immediately
[see Adverse Reactions , Drug Interactions ].
)]
, reserve CIPRO for use in patients who have no alternative treatment options for the following indications:
- •
  Acute exacerbation of chronic bronchitis
  [see Indications and Usage (
  1.10 Lower Respiratory Tract Infections
  CIPRO is indicated in 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
  [see Warnings and Precautions ]
  and for some patients AECB is self-limiting, reserve CIPRO for treatment of AECB in patients who have no alternative treatment options
  .
  )].
- •
  Acute uncomplicated cystitis
  [see Indications and Usage (
  1.11 Urinary Tract Infections
  Urinary Tract Infections in Adults
  CIPRO is indicated in 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
  CIPRO is indicated in 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 [see Warnings and Precautions ]
  .
  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
  [see Warnings and Precautions , Adverse Reactions , Use in Specific Populations and Nonclinical Toxicology ].
  )].
- •
  Acute sinusitis
  [see Indications and Usage (
  1.12 Acute Sinusitis
  CIPRO is indicated in 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
  [see Warnings and Precautions ]
  and for some patients acute sinusitis is self-limiting, reserve CIPRO for treatment of acute sinusitis in patients who have no alternative treatment options
  .
  )].

CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:

•Skin and Skin Structure Infections
•Bone and Joint Infections (
1.2 Bone and Joint Infections
CIPRO is indicated in adult patients for treatment of bone and joint infections caused by
Enterobacter cloacae, Serratia marcescens,
or
Pseudomonas aeruginosa.
)
•Complicated Intra-Abdominal Infections (
1.3 Complicated Intra-Abdominal Infections
CIPRO is indicated in 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 (
1.4 Infectious Diarrhea
CIPRO is indicated in 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) (
1.5 Typhoid Fever (Enteric Fever)
CIPRO is indicated in 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 (
1.6 Uncomplicated Cervical and Urethral Gonorrhea
CIPRO is indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to
Neisseria gonorrhoeae [see Warnings and Precautions ].
)
•Inhalational Anthrax post-exposure in adult and pediatric patients (
1.7 Inhalational Anthrax (Post-Exposure)
CIPRO is indicated in 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.¹Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001
[see Clinical Studies ].
•Plague in adult and pediatric patients (
1.8 Plague
CIPRO is indicated for 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
[see Clinical Studies ]
.
)
•Chronic Bacterial Prostatitis (
1.9 Chronic Bacterial Prostatitis
CIPRO is indicated in adult patients for treatment of chronic bacterial prostatitis caused by
Escherichia coli
or
Proteus mirabilis.
)
•Lower Respiratory Tract Infections (
1.10 Lower Respiratory Tract Infections
CIPRO is indicated in 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
[see Warnings and Precautions ]
and for some patients AECB is self-limiting, reserve CIPRO for treatment of AECB in patients who have no alternative treatment options
.
)
- •Acute Exacerbation of Chronic Bronchitis
•Urinary Tract Infections (
1.11 Urinary Tract Infections
Urinary Tract Infections in Adults
CIPRO is indicated in 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
CIPRO is indicated in 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 [see Warnings and Precautions ]
.
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
[see Warnings and Precautions , Adverse Reactions , Use in Specific Populations and Nonclinical Toxicology ].
)
- •Urinary Tract Infections (UTI)
- •Acute Uncomplicated Cystitis
- •Complicated UTI and Pyelonephritis in Pediatric Patients
•Acute Sinusitis (
1.12 Acute Sinusitis
CIPRO is indicated in 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
[see Warnings and Precautions ]
and for some patients acute sinusitis is self-limiting, reserve CIPRO for treatment of acute sinusitis in patients who have no alternative treatment options
.
)

Usage

1.13 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO and other antibacterial drugs, CIPRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with CIPRO may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.

As with other drugs, some isolates of

Pseudomonas aeruginosa

may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

)

•Tablets: 250 mg, functionally scored and 500 mg, functionally scored (
3 DOSAGE FORMS AND STRENGTHS
•Tablets: 250 mg, functionally scored and 500 mg, functionally scored
•Oral Suspension: 5% (250 mg/5 mL), 10% (500 mg/5 mL) (3)
3.1 Tablets
•250 mg, slightly yellowish, film-coated, round, functionally scored, imprinted with “BAYER” on one side and “CIP 250” on the other
•500 mg, slightly yellowish, film-coated, capsule shaped, functionally scored, imprinted with “BAYER” on one side and “CIP 500” on the other
3.2 Oral Suspension
•5% Oral Suspension: 250 mg ciprofloxacin per 5 mL after reconstitution
•10% Oral Suspension: 500 mg ciprofloxacin per 5 mL after reconstitution
)
•Oral Suspension: 5% (250 mg/5 mL), 10% (500 mg/5 mL)
3 DOSAGE FORMS AND STRENGTHS
•Tablets: 250 mg, functionally scored and 500 mg, functionally scored
•Oral Suspension: 5% (250 mg/5 mL), 10% (500 mg/5 mL) (3)
3.1 Tablets
•250 mg, slightly yellowish, film-coated, round, functionally scored, imprinted with “BAYER” on one side and “CIP 250” on the other
•500 mg, slightly yellowish, film-coated, capsule shaped, functionally scored, imprinted with “BAYER” on one side and “CIP 500” on the other
3.2 Oral Suspension
•5% Oral Suspension: 250 mg ciprofloxacin per 5 mL after reconstitution
•10% Oral Suspension: 500 mg ciprofloxacin per 5 mL after reconstitution
)

Lactation:
Breastfeeding is not recommended during treatment, but a lactating

woman may pump and discard breastmilk during treatment and an additional 2 days after the last dose. In patients treated for inhalational anthrax (post exposure), consider the risks and benefits of continuing breastfeeding.
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8.2 Lactation
Risk Summary
Published literature reports that ciprofloxacin is present in human milk following intravenous and oral administration
.
There is no information regarding effects of CIPRO on milk production or the breastfed infant. Because of the potential risk of serious adverse reactions in breastfed infants, including arthropathy shown in juvenile animal studies
[see Use in Specific Populations (8.4), (Clinical Considerations)],
for most indications a lactating woman may consider pumping and discarding breast milk during treatment with CIPRO and an additional two days (five half-lives) after the last dose. Alternatively, advise a woman that breastfeeding is not recommended during treatment with CIPRO and for an additional two days (five half-lives) after the last dose.
However, for inhalation anthrax (post exposure), during an incident resulting in exposure to anthrax, the risk-benefit assessment of continuing breastfeeding while the mother (and potentially the infant) is (are) on CIPRO may be acceptable
[see Dosage and Administration , Pediatric Use , and Clinical Studies ].
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CIPRO and any potential adverse effects on the breastfed child from CIPRO or from the underlying maternal condition.
Clinical Considerations
Ciprofloxacin may cause intestinal flora alteration of the breastfeeding infant. Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash).
)
See full prescribing information
for use in pediatric and geriatric patients (
8.4 Pediatric Use
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. Quinolones, including CIPRO, cause arthropathy (arthralgia, arthritis), in juvenile animals
[see Warnings and Precautions and Nonclinical Toxicology ]
.
Complicated Urinary Tract Infection and Pyelonephritis
CIPRO is indicated for the treatment of cUTI and pyelonephritis due to
Escherichia coli
in pediatric patients 1 to 17 years of age
.
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 the controls, including events related to joints and/or surrounding tissues
[see Adverse Reactions and Clinical Studies ].
Inhalational Anthrax (Post-Exposure)
CIPRO is indicated in pediatric patients from birth to 17 years of age, for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate
[see Dosage and Administration and Clinical Studies ].
Plague
CIPRO is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to
Yersinia pestis (Y. pestis)
and prophylaxis for plague. Efficacy studies of CIPRO could not be conducted in humans with pneumonic plague for feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals. The risk-benefit assessment indicates that administration of CIPRO to pediatric patients is appropriate
[see Indications and Usage , Dosage and Administration and Clinical Studies ].
,
8.5 Geriatric Use
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as CIPRO. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing CIPRO to elderly patients especially those on corticosteroids. Patients should be informed of this potential adverse reaction and advised to discontinue CIPRO and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur
. [see Boxed Warning, Warnings and Precautions , and Adverse Reactions ].
Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients
[see Warnings and Precautions ].
In a retrospective analysis of 23 multiple-dose controlled clinical trials of CIPRO encompassing over 3500 ciprofloxacin-treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients
[see Dosage and Administration and Clinical Pharmacology ].
In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using CIPRO with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia)
[see Warnings and Precautions ].
)

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