Ciprofloxacin Prescribing Information
- Fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together[see Warnings and Precautions ()]
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System EffectsFluoroquinolones, including ciprofloxacin, 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 ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions
[see Warnings and Precautions ].Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
including:- Tendinitis and tendon rupture[see Warnings and Precautions ()]
5.2 Tendinitis and Tendon RuptureFluoroquinolones, including ciprofloxacin, 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 ciprofloxacin, 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 ciprofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including ciprofloxacin, 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 NeuropathyFluoroquinolones, including ciprofloxacin, 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 ciprofloxacin. Symptoms may occur soon after initiation of ciprofloxacin and may be irreversible in some patients
[see Warnings and Precautions and Adverse Reactions ].Discontinue ciprofloxacin 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 ciprofloxacin, in patients who have previously experienced peripheral neuropathy
[see Adverse Reactions ]. - Central nervous system effects[see Warnings and Precautions ()]
5.4 Central Nervous System EffectsPsychiatric Adverse ReactionsFluoroquinolones, including ciprofloxacin, 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 ciprofloxacin to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care
[see Adverse Reactions ].Central Nervous System Adverse ReactionsFluoroquinolones, including ciprofloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), dizziness, and tremors. Ciprofloxacin, 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 ciprofloxacin 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 ciprofloxacin, and institute appropriate care
[see Adverse Reactions and Drug Interactions ].
Discontinue Ciprofloxacin Injection (in 5% Dextrose Injection) immediately and avoid the use of fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), in patients who experience any of these serious adverse reactions[see Warnings and Precautions ()]5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System EffectsFluoroquinolones, including ciprofloxacin, 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 ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions
[see Warnings and Precautions ].Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
. - Fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Ciprofloxacin Injection in patients with known history of myasthenia gravis[see Warnings and Precautions ()]
5.5 Exacerbation of Myasthenia GravisFluoroquinolones, including ciprofloxacin, 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 ciprofloxacin in patients with known history of myasthenia gravis
[see Adverse Reactions ].. - Because fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), have been associated with serious adverse reactions[see Warnings and Precautions (to
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System EffectsFluoroquinolones, including ciprofloxacin, 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 ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions
[see Warnings and Precautions ].Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
)]5.16 Potential Risks with Concomitant Use of Drugs Metabolized by Cytochrome P450 1A2 EnzymesCiprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Co-administration of ciprofloxacin 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 ]., reserve Ciprofloxacin Injection (in 5% Dextrose Injection) for use in patients who have no alternative treatment options for the following indications:- Acute exacerbation of chronic bronchitis[see Indications and Usage ()]
1.9 Lower Respiratory Tract InfectionsCiprofloxacin Injection 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,orStreptococcus pneumoniae. Ciprofloxacin Injection is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary toStreptococcus pneumonia.Ciprofloxacin Injection is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by
Moraxella catarrhalis.Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions
[see Warnings and Precautions ]and for some patients AECB is self-limiting, reserve Ciprofloxacin Injection for treatment of AECB in patients who have no alternative treatment options. - Acute Sinusitis[see Indications and Usage ()]
1.11 Acute SinusitisCiprofloxacin Injection is indicated in adult patients for treatment of acute sinusitis caused by
Haemophilus influenzae,Streptococcus pneumoniae, orMoraxella catarrhalis.Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions
[see Warnings and Precautions ]and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options.
Ciprofloxacin Injection is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:
- Skin and Skin Structure Infections ()
1.1 Skin and Skin Structure InfectionsCiprofloxacin Injection (in 5% Dextrose Injection) is indicated in 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-susceptibleStaphylococcus aureus,methicillin-susceptibleStaphylococcus epidermidis,orStreptococcus pyogenes. - Bone and Joint Infections ()
1.2 Bone and Joint InfectionsCiprofloxacin Injection is indicated in adult patients for treatment of bone and joint infections caused by
Enterobacter cloacae, Serratia marcescens,orPseudomonas aeruginosa. - Complicated Intra-Abdominal Infections ()
1.3 Complicated Intra-Abdominal InfectionsCiprofloxacin Injection 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,orBacteroides fragilis. - Nosocomial Pneumonia ()
1.4 Nosocomial PneumoniaCiprofloxacin Injection is indicated in adult patients for treatment of nosocomial pneumonia caused by
Haemophilus influenzae or Klebsiella pneumoniae. - Empirical Therapy for Febrile Neutropenic Patients ()
1.5 Empirical Therapy for Febrile Neutropenic PatientsCiprofloxacin Injection is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium
[see Clinical Studies ]. - Inhalational Anthrax Post-Exposure in Adult and Pediatric Patients ()
1.6 Inhalational Anthrax (Post-Exposure)Ciprofloxacin Injection is indicated in adults and pediatric patients from birth to 17 years of age for treatment of 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 ()
1.7 PlagueCiprofloxacin Injection 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 ()
1.8 Chronic Bacterial ProstatitisCiprofloxacin Injection is indicated in adult patients for treatment of chronic bacterial prostatitis caused by
Escherichia coliorProteus mirabilis. - Lower Respiratory Tract Infections ()
1.9 Lower Respiratory Tract InfectionsCiprofloxacin Injection 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,orStreptococcus pneumoniae. Ciprofloxacin Injection is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary toStreptococcus pneumonia.Ciprofloxacin Injection is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by
Moraxella catarrhalis.Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions
[see Warnings and Precautions ]and for some patients AECB is self-limiting, reserve Ciprofloxacin Injection for treatment of AECB in patients who have no alternative treatment options.- Acute Exacerbation of Chronic Bronchitis
- Urinary Tract Infections ()
1.10 Urinary Tract InfectionsUrinary Tract Infection in AdultsCiprofloxacin Injection 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-susceptibleStaphylococcus epidermidis,Staphylococcus saprophyticus, orEnterococcus faecalis.Complicated Urinary Tract Infections and Pyelonephritis in Pediatric PatientsCiprofloxacin Injection is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to
Escherichia coli [see Use in Specific Populations ].Although effective in clinical trials, Ciprofloxacin Injection 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. Ciprofloxacin Injection, 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)
- Complicated UTI and Pyelonephritis in Pediatric Patients
- Acute Sinusitis ()
1.11 Acute SinusitisCiprofloxacin Injection is indicated in adult patients for treatment of acute sinusitis caused by
Haemophilus influenzae,Streptococcus pneumoniae, orMoraxella catarrhalis.Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions
[see Warnings and Precautions ]and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection and other antibacterial drugs, Ciprofloxacin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection and other antibacterial drugs, Ciprofloxacin Injection 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 Ciprofloxacin Injection 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
Ciprofloxacin injection should be administered intravenously at dosages described in the appropriate Dosage Guidelines tables.
Ciprofloxacin Injection, USP (in 5% Dextrose) is a sterile, ready-for-use solution for intravenous infusion, available as:
- 200 mg per 100 mL (in 5% Dextrose) in Flexible Containers
- 400 mg per 200 mL (in 5% Dextrose) in Flexible Containers
See full prescribing information for pediatric patients (
Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Quinolones, including ciprofloxacin, cause arthropathy (arthralgia, arthritis), in juvenile animals
Ciprofloxacin is indicated for the treatment of cUTI and pyelonephritis due to
Ciprofloxacin 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
Ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ciprofloxacin. 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 ciprofloxacin to elderly patients especially those on corticosteroids. Patients should be informed of this potential adverse reaction and advised to discontinue ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur
Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients
In a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin 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
In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using ciprofloxacin 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)
- Known hypersensitivity to ciprofloxacin injection or other quinolones (,
4.1 HypersensitivityCiprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components
[see Warnings and Precautions ].)5.7 Hypersensitivity ReactionsSerious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including ciprofloxacin. Some reactions were accompanied by cardiovascular collapse, 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 ]. - Concomitant administration with tizanidine ()
4.2 TizanidineConcomitant administration with tizanidine is contraindicated
[see Drug Interactions ].