Ciprofloxacin - Ciprofolxacin tablet Prescribing Information
• Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together[see Warnings and Precautions (including:)]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.
o 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 ].o 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 ].o 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.
Central Nervous System Adverse ReactionsFluoroquinolones, including ciprofloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pscudotumor 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 immediately and avoid the use of fluoroquinolones, including ciprofloxacin, in patients who experience any of these serious adverse reactions[see Warnings and Precautions (. Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis)]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.
[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, have been associated with serious adverse reactions[see Warnings and Precautions (, reserve ciprofloxacin for use in patients who have no alternative treatment options for the following indications:–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 ].o Acute exacerbation of chronic bronchitis[see Indications and Usage ()]1.10 Lower Respiratory Tract InfectionsCiprofloxacin tablets are 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.Ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to
Streptococcus pneumoniae.Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by
Moraxella catarrhalis.Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions
[see Warnings and Precautions ]and for some patients AECB is self-limiting, reserve ciprofloxacin tablets for treatment of AECB in patients who have no alternative treatment options.o Acute uncomplicated cystitis[see Indications and Usage ()]1.11 Urinary Tract InfectionsUrinary Tract Infections in AdultsCiprofloxacin tablets are 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.Acute Uncomplicated CystitisCiprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by
Escherichia coliorStaphylococcus saprophyticus.Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions
[see Warnings and Precautions ]and for some patients acute uncomplicated cystitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.Complicated Urinary Tract Infection and Pyelonephritis in Pediatric PatientsCiprofloxacin tablets are indicated in pediatric patients aged 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 tablets are 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 tablets, like other fluoroquinolones, are 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 ].o Acute sinusitis[see Indications and Usage ()]1.12 Acute SinusitisCiprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by
Haemophilus influenzae, Streptococcus pneumoniae,orMoraxella catarrhalis.Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions
[see Warnings and Precautions (5.1- 5.16)]and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute sinusitis in patients who have no alternative treatment options.
Warnings and Precautions, Hypersensitivity Reactions (
Serious 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, 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
Ciprofloxacin 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 ()1.1 Skin and Skin Structure InfectionsCiprofloxacin tablets are 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 tablets are 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 tablets are 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.• Infectious Diarrhea ()1.4 Infectious DiarrheaCiprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by
Escherichia coli(enterotoxigenic isolates),Campylobacter jejuni, Shigella boydii†,Shigella dysenteriae, Shigella flexneriorShigella 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)Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever)
caused bySalmonella 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 GonorrheaCiprofloxacin tablets are 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)Ciprofloxacin tablets are 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 PlagueCiprofloxacin tablets are 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 ProstatitisCiprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by
Escherichia coliorProteus mirabilis.• Lower Respiratory Tract Infections ()1.10 Lower Respiratory Tract InfectionsCiprofloxacin tablets are 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.Ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to
Streptococcus pneumoniae.Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by
Moraxella catarrhalis.Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions
[see Warnings and Precautions ]and for some patients AECB is self-limiting, reserve ciprofloxacin tablets for treatment of AECB in patients who have no alternative treatment options.o Acute Exacerbation of Chronic Bronchitis• Urinary Tract Infections ()1.11 Urinary Tract InfectionsUrinary Tract Infections in AdultsCiprofloxacin tablets are 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.Acute Uncomplicated CystitisCiprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by
Escherichia coliorStaphylococcus saprophyticus.Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions
[see Warnings and Precautions ]and for some patients acute uncomplicated cystitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.Complicated Urinary Tract Infection and Pyelonephritis in Pediatric PatientsCiprofloxacin tablets are indicated in pediatric patients aged 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 tablets are 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 tablets, like other fluoroquinolones, are 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 ].o Urinary Tract Infections (UTI)o Acute Uncomplicated Cystitiso Complicated UTI and Pyelonephritis in Pediatric Patients• Acute Sinusitis ()1.12 Acute SinusitisCiprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by
Haemophilus influenzae, Streptococcus pneumoniae,orMoraxella catarrhalis.Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions
[see Warnings and Precautions (5.1- 5.16)]and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets 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 and other antibacterial drugs, ciprofloxacin 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 tablets and other antibacterial drugs, ciprofloxacin tablets 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 tablets 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 tablets should be administered orally as described in the appropriate Dosage Guidelines tables.
• Ciprofloxacin Tablets, USP 250 mg, white, round shaped tablets, plain on one side, and “Y101” with no breakline on the other side.• Ciprofloxacin Tablets, USP 500 mg, white, oval shaped tablets, plain on one side, and “Y102” with no breakline on the other side.
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