Ciprofloxacin

(Ciprofloxacin Hydrochloride)

Check Drug InteractionsCheck known drug interactions.

Ciprofloxacin Prescribing Information

Fluoroquinolones, including
ciprofloxacin
, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together
[see
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects
Fluoroquinolones, 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 (5.2, 5.3, 5.4)]
.

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
  5.2 Tendinitis and Tendon Rupture
  Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages
  [see Warnings and Precautions (5.1)and Adverse Reactions (6.2)]
  . 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 (6.2)]
  .
  ]
- Peripheral neuropathy
  [see
  5.3 Peripheral Neuropathy
  Fluoroquinolones, 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 (5.1)and Adverse Reactions (6.1, 6.2)].
  
  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 (6.1, 6.2)]
  .
  ]
- Central nervous system effects
  [see
  5.4 Central Nervous System Effects
  Psychiatric Adverse Reactions
  
  Fluoroquinolones, 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 Reactions
  
  Fluoroquinolones, 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 (6.1)and Drug Interactions (7)].
  ]
Discontinue
ciprofloxacin
immediately and avoid the use of fluoroquinolones, including
ciprofloxacin
, in patients who experience any of these serious adverse reactions
[see
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects
Fluoroquinolones, 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 (5.2, 5.3, 5.4)]
.

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
, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid
ciprofloxacin
in patients with known history of myasthenia gravis
[see
5.5 Exacerbation of Myasthenia Gravis
Fluoroquinolones, 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 (6.2)]
.
].
Because fluoroquinolones, including
ciprofloxacin
, have been associated with serious adverse reactions
[see
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects
Fluoroquinolones, 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 (5.2, 5.3, 5.4)]
.

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.
to
5.16 Potential Risks with Concomitant Use of Drugs Metabolized by Cytochrome P450 1A2 Enzymes
Ciprofloxacin 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 (7)and Clinical Pharmacology (12.3)]
.
)]
, reserve
ciprofloxacin
for use in patients who have no alternative treatment options for the following indications:
- Acute exacerbation of chronic bronchitis
  [see
  1.10 Lower Respiratory Tract Infections
  Ciprofloxacin 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 tablets, have been associated with serious adverse reactions
  [see Warnings and Precautions (5.1to 5.16)]
  and for some patients AECB is self-limiting, reserve ciprofloxacin tablets for treatment of AECB in patients who have no alternative treatment options.
  ]
- Acute uncomplicated cystitis
  [see
  1.11 Urinary Tract Infections
  Urinary Tract Infections in Adults
  
  Ciprofloxacin 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-susceptible
  Staphylococcus epidermidis, Staphylococcus saprophyticus,
  or
  Enterococcus faecalis.
  Acute Uncomplicated Cystitis
  
  Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by
  Escherichia coli
  or
  Staphylococcus saprophyticus.
  
  Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions
  [see Warnings and Precautions (5.1to 5.16)]
  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 Patients
  
  Ciprofloxacin 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 (8.4)].
  
  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, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals
  [see Warnings and Precautions (5.13), Adverse Reactions (6.1), Use in Specific Populations (8.4)and Nonclinical Toxicology (13.2)]
  .
  ]
- Acute sinusitis
  [see
  1.12 Acute Sinusitis
  Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by
  Haemophilus influenzae, Streptococcus pneumoniae,
  or
  Moraxella catarrhalis
  .
  
  Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions
  [see Warnings and Precautions (5.1to 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.
  
  ]

Ciprofloxacin tablet 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 Infections
Ciprofloxacin 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-susceptible
Staphylococcus aureus,
methicillin-susceptible
Staphylococcus epidermidis,
or
Streptococcus pyogenes.
)
Bone and Joint Infections (
1.2 Bone and Joint Infections
Ciprofloxacin tablets are 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
Ciprofloxacin 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,
or
Bacteroides fragilis.
)
Infectious Diarrhea (
1.4 Infectious Diarrhea
Ciprofloxacin tablets are 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)
Ciprofloxacin tablets are 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
Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to
Neisseria gonorrhoeae
[see Warnings and Precautions (5.17)]
.
)
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 (14.2)]
.
)
Plague in adult and pediatric patients (
1.8 Plague
Ciprofloxacin 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 (14.3)]
.
)
Chronic Bacterial Prostatitis (
1.9 Chronic Bacterial Prostatitis
Ciprofloxacin tablets are 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
Ciprofloxacin 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 tablets, have been associated with serious adverse reactions
[see Warnings and Precautions (5.1to 5.16)]
and for some patients AECB is self-limiting, reserve ciprofloxacin tablets 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

Ciprofloxacin 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-susceptible
Staphylococcus epidermidis, Staphylococcus saprophyticus,
or
Enterococcus faecalis.
Acute Uncomplicated Cystitis

Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by
Escherichia coli
or
Staphylococcus saprophyticus.

Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions
[see Warnings and Precautions (5.1to 5.16)]
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 Patients

Ciprofloxacin 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 (8.4)].

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, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals
[see Warnings and Precautions (5.13), Adverse Reactions (6.1), Use in Specific Populations (8.4)and Nonclinical Toxicology (13.2)]
.
)
- Urinary Tract Infections (UTI)
- Acute Uncomplicated Cystitis
- Complicated UTI and Pyelonephritis in Pediatric Patients
Acute Sinusitis (
1.12 Acute Sinusitis
Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by
Haemophilus influenzae, Streptococcus pneumoniae,
or
Moraxella catarrhalis
.

Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions
[see Warnings and Precautions (5.1to 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.

)

Usage

1.13 Usage

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

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, 500 mg and 750 mg (
3 DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg, 500 mg and 750 mg
3.1 Tablets
250 mg
are white to off-white, round shaped film coated tablets debossed with ‘C’ on one side and ‘95’ on the other side.
500 mg
are white to off-white, capsule shaped film coated tablets debossed with ‘C’ on one side and ‘94’ on the other side.
750 mg
are white to off-white, capsule shaped film coated tablets debossed with ‘C’ on one side and ‘93’ on the other side.
)

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. (

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 ciprofloxacin 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 ciprofloxacin and an additional two days (five half-lives) after the last dose. Alternatively, advise a woman that breastfeeding is not recommended during treatment with ciprofloxacin 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 ciprofloxacin may be acceptable

[see Dosage and Administration (2.2), Pediatric Use (8.4), and Clinical Studies (14.2)]

. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ciprofloxacin and any potential adverse effects on the breastfed child from ciprofloxacin 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, 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

[see Warnings and Precautions (5.13)and Nonclinical Toxicology (13.2)]

Complicated Urinary Tract Infection and Pyelonephritis

Ciprofloxacin 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, ciprofloxacin 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 (6.1)and Clinical Studies (14.1)].

Inhalational Anthrax (Post-Exposure)

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

[see Dosage and Administration (2.2)and Clinical Studies (14.2)].

Plague

Ciprofloxacin 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 ciprofloxacin 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 ciprofloxacin to pediatric patients is appropriate

[see Indications and Usage (1.8), Dosage and Administration (2.2)and Clinical Studies (14.3)].

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 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

[see

Boxed Warning

Warnings and Precautions (5.2)

, and

Adverse Reactions (6.2)

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 (5.9)

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

[see

Dosage and Administration (2.3)

and

Clinical Pharmacology (12.3)

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)

[see

Warnings and Precautions (5.12)

)

Known hypersensitivity to ciprofloxacin tablets or other quinolones (
4.1 Hypersensitivity
Ciprofloxacin tablets are 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)].
,
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 ciprofloxacin. 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 ciprofloxacin immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted
[see Adverse Reactions (6.1, 6.2)]
.
,
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 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 (6.1)]
.
)
Concomitant administration with tizanidine (
4.2 Tizanidine
Concomitant administration with tizanidine is contraindicated
[see Drug Interactions (7)].
)

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