CIPROFLOXACIN 
Pronounciation
- (sip-row-FLOX-ah-sin)
Trade Name(s)
- Cipro IV
Baseline studies indicated; see Monitor.
Dose and duration based on severity and nature of the infection, susceptibility of the causative organsim. Usual dose is 200-400 every 8-12 hours.
Used only when alternate therapy cannot be used; see Precautions and Maternal/Child. In all situations, do not exceed an IV dose of 400 mg.
Inhalation anthrax (postexposure):
10 mg/kg every 12 hours IV. Do not exceed 400 mg/dose IV. Begin administration as soon as possible after suspected or confirmed exposure. May transfer to oral therapy when appropriate with a dose of 15 mg/kg PO every 12 hours. Do not exceed a 500-mg dose PO. Administer for 60 days.
Complicated UTIs or pyelonephritis in patients from 1 to 17 years of age:
Dosing and initial route (IV or PO) should be determined by severity of infection. 6 to 10 mg/kg IV every 8 hours. Do not exceed 400 mg/dose IV. May transfer to oral therapy with a dose of 10 to 20 mg/kg PO every 12 hours at discretion of physician. Do not exceed a 750-mg dose PO. Total duration of treatment is 10 to 21 days.
10 mg/kg every 8 to 12 hours IV. Do not exceed 400 mg/dose IV. Begin administration as soon as possible after suspected or confirmed exposure. May transfer to oral therapy when appropriate with a dose of 15 mg/kg PO every 8 to 12 hours. Do not exceed a 500-mg dose PO. Administer for 10 to 21 days.
Pulmonary exacerbations of cystic fibrosis in patients from 5 to 17 years of age (unlabeled):
10 mg/kg/dose IV every 8 hours. Do not exceed 400 mg/dose. May transfer to oral therapy when appropriate at a dose of 20 mg/kg/dose PO every 12 hours; see Monitor.
Increase interval between doses (200 to 400 mg every 18 to 24 hours) if CrCl is less than 30 mL/min (see literature for additional information). ■ Information on dosing adjustments for pediatric patients with renal insufficiency is not available. ■ Dose reduction not required based on age; see Elderly. ■ See Drug/Lab Interactions.
Available prediluted in D5W in latex-free plastic infusion containers ready for use. A clear, colorless to slightly yellow solution. Do not hang plastic containers in series; may cause air embolism. Also available in 20- and 40-mL vials containing 10 mg/mL (1% solution), which must be diluted with NS, D5W, SWFI, D10W, D5/¼NS, D5/½NS, or LR to a final concentration of 1 to 2 mg/mL.
No recommendations available from manufacturer.
Store vials between 5° and 30° C (41° and 86° F). Store flexible containers and vials between 5° and 25° C (41° and 77° F); protect from light, excessive heat, and freezing. Vials diluted in recommended solutions are stable for up to 14 days refrigerated or at room temperature if the final diluted concentration is between 0.5 and 2 mg/mL.
Manufacturer recommends temporarily discontinuing other solutions infusing at the same site during intermittent infusion through a Y-site or volume control and that ciprofloxacin be administered separately and the IV line be flushed before and after administration of any other drug.
Other sources suggest specific compatibilities dependent on concentration and manufacturer; consult a pharmacist.
A single dose must be equally distributed over 60 minutes as an infusion. Too-rapid administration and/or the use of a small vein may increase incidence of local site inflammation and other side effects. May be given through a Y-tube or three-way stopcock of infusion set. Temporarily discontinue other solutions infusing at the same site.
A synthetic, broad-spectrum antimicrobial agent, a fluoroquinolone. Bactericidal to a wide range of aerobic gram-negative and gram-positive organisms through interference with the enzymes needed for bacterial DNA replication, transcription, repair, and recombination. Onset of action is prompt, and serum levels are dose related. Half-life averages 5 to 6 hours. Readily distributed to body fluids (saliva, nasal and bronchial secretions, sputum, skin blister fluid, lymph, peritoneal fluid, bile and prostatic secretions). Found in lung, skin, fat, muscle, cartilage, and bone. Levels in cerebrospinal fluid and eye fluids are lower than plasma levels. Limited metabolism. Excreted primarily as unchanged drug in the urine, usually within 24 hours. A small amount is excreted in the bile and feces. Crosses placental barrier. Secreted in breast milk.
Treatment of infections caused by susceptible isolates of designated organisms in the conditions and patient populations listed below. ■ Treatment of skin and skin structure infections in adults. ■ Treatment of bone and joint infections in adults. ■ Treatment of complicated intra-abdominal infections in adults (used in combination with metronidazole). ■ Treatment of nosocomial pneumonia in adults. ■ Empiric treatment of febrile neutropenia in adults (used in combination with piperacillin sodium). ■ Treatment of inhalational anthrax (postexposure) to reduce the incidence or progression of disease in adults or pediatric patients following exposure to aerosolized Bacillus anthracis (Anthrax). ■ Treatment of plague (including pneumonic and septicemic plague) due to Yersinia pestis, and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. ■ Treatment of chronic bacterial prostatitis in adults. ■ Treatment of lower respiratory infections in adults (not the drug of first choice in treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae). ■ Treatment of acute exacerbations of chronic bronchitis (AECB) in adults. Because ciprofloxacin has been associated with serious adverse reactions and because for some patients AECB is self-limiting, reserve ciprofloxacin for treatment of AECB in patients who have no alternative treatment options.■ Treatment of urinary tract infections in adults. ■ Treatment of complicated UTI and pyelonephritis due to Escherichia coli in pediatric patients 1 to 17 years of age. Although effective, ciprofloxacin is not the drug of first choice because of an increased incidence of adverse reactions compared with controls; see Maternal/Child. ■ Treatment of acute sinusitis in adults. Because ciprofloxacin has been associated with serious adverse reactions and because for some patients acute sinusitis is self-limiting, reserve ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options.■ Oral route of administration indicated for treatment of other infections (e.g., infectious diarrhea, typhoid fever, urethral and cervical gonococcal infections).
Cystic fibrosis. ■ Infective endocarditis. ■ Surgical prophylaxis. ■ Tularemia.
Known hypersensitivity to ciprofloxacin or any other quinolone antimicrobial agent (e.g., levofloxacin) or any of the product components. ■ Concomitant administration with tizanidine is contraindicated.
To reduce the development of drug-resistant bacteria and maintain its effectiveness, ciprofloxacin should be used to treat or prevent only those infections proven or strongly suspected to be caused by bacteria. ■ Specific culture and sensitivity studies indicated to determine susceptibility of the causative organism to ciprofloxacin. ■ The emergence of bacterial resistance to fluoroquinolones and the occurrence of cross-resistance with other fluoroquinolones have been observed and are of concern. Proper use of fluoroquinolones and other classes of antibiotics is encouraged to avoid the emergence of resistant bacteria from overuse. ■ Pseudomonas aeruginosa may develop resistance during treatment. Ongoing culture and sensitivity studies indicated. ■ If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. ■ Prolonged use may cause superinfection because of overgrowth of nonsusceptible organisms. Monitor carefully. ■ Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together in the same patient. Commonly seen adverse reactions include tendinitis and tendon rupture, arthralgia, myalgia, peripheral neuropathy, changes in blood glucose levels, and CNS effects (e.g., anxiety, confusion, depression, hallucinations, insomnia, severe headaches). These reactions can occur within hours to weeks after starting ciprofloxacin and have been seen in patients of any age and in patients without any pre-existing risk factors. Discontinue ciprofloxacin immediately and avoid the use of fluoroquinolones, including ciprofloxacin, in patients who experience any of these serious adverse reactions.■ Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), dizziness, and tremors. May trigger seizures or lower the seizure threshold. Use caution in patients with epilepsy or known or suspected CNS disorders that may predispose them to seizures or lower the seizure threshold (e.g., 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 them to seizures (e.g., drugs that may lower the seizure threshold, renal dysfunction). ■ Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of psychiatric adverse reactions that include 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; and memory impairment. These reactions may occur following the first dose. ■ Tendinitis and tendon rupture that required surgical repair or resulted in prolonged disability have been reported in patients of all ages receiving quinolones. Most frequently involves the Achilles tendon but has also been reported with the shoulder, hand, biceps, thumb, and other tendon sites. ■ Inflammation and tendon rupture may occur during or up to months after fluoroquinolone therapy and may occur bilaterally. Risk may be increased in patients over 60 years of age; in patients taking corticosteroids; in patients with heart, kidney, or lung transplants; with strenuous physical activity; and in patients with renal failure or previous tendon disorders such as rheumatoid arthritis. Avoid ciprofloxacin in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture. Discontinue ciprofloxacin immediately if patient experiences pain, swelling, inflammation, or rupture of a tendon. ■ Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Serious adverse events, including requirement for ventilatory support and deaths, have been reported in patients with myasthenia gravis. Avoid use in patients with a known history of myasthenia gravis.■ Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias (impairment of sensitivity or touch), or weakness have been reported. Symptoms may occur soon after initiation of therapy and may be irreversible. Avoid ciprofloxacin in patients who have previously experienced peripheral neuropathy. ■ Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported. ■ Prolongation of the QT interval on ECG and infrequent cases of arrhythmia (including torsades de pointes) have been reported with the use of some fluoroquinolones, including ciprofloxacin. Avoid ciprofloxacin in patients with known prolongation of the QT interval, in patients with risk factors for QT prolongation or torsades de pointes (e.g., congenital long QT syndrome, uncorrected electrolyte imbalances [e.g., hypokalemia, hypomagnesemia], and cardiac disease [e.g., heart failure, MI, and significant bradycardia]), and in patients receiving concurrent treatment with Class 1A antiarrhythmic agents (e.g., quinidine, procainamide), Class III antiarrhythmic agents (e.g., amiodarone, sotalol), tricyclic antidepressants, macrolides, or antipsychotics. ■ Other serious events (sometimes fatal) due to hypersensitivity or uncertain etiology have been reported with fluoroquinolones, including ciprofloxacin. Manifestations may include allergic pneumonitis, renal or hepatic impairment/failure, hematologic toxicity, and dermatologic toxicity; see Side Effects, Post-Marketing. These reactions usually occur following administration of multiple doses. Discontinue ciprofloxacin at the first appearance of a skin rash, jaundice, or other signs of hypersensitivity. Cases of severe hepatic toxicity, including necrosis, life-threatening hepatic failure, and fatal events have been reported. Acute liver injury is rapid in onset (range 1 to 39 days) and is often associated with hypersensitivity. Temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients with previous liver damage, has also been reported. ■ Epidemiologic studies report an increased rate of aortic aneurysm and dissection within 2 months after use of fluoroquinolones, particularly in elderly patients. In patients with a known aortic aneurysm or in patients who are at greater risk for aortic aneurysms, ciprofloxacin use should be limited to cases in which no alternative antibacterial treatments are available. ■ Clostridium difficile–associated diarrhea (CDAD) has been reported. May range from mild diarrhea to fatal colitis. Consider in patients who present with diarrhea during or after treatment with ciprofloxacin. ■ Moderate to severe photosensitivity/phototoxicity reactions have been reported in patients receiving quinolones; see Patient Education. ■ Fluroquinolones, including ciprofloxacin, 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 (e.g., 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. Ciprofloxacin and other quinolones should be reserved for cases in which no other drugs are available.
Monitor for S/S of hypersensitivity reaction (e.g., cardiovascular collapse, dyspnea, itching, loss of consciousness, pharyngeal or facial edema, tingling, urticaria). May cause anaphylaxis with the first or succeeding doses, even in patients without known hypersensitivity. Emergency equipment must always be available. ■ Monitor for S/S of peripheral neuropathy. Discontinue ciprofloxacin at the first symptoms of neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) or if patient is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength. ■ Monitor for CNS adverse effects, including altered mental status, seizures, and changes in mood or behavior. ■ Monitor for S/S of tendinitis or tendon rupture. ■ ECG monitoring for QT prolongation may be indicated in selected patients. ■ Maintain adequate hydration and acidity of urine throughout treatment. Can form crystals in concentrated alkaline urine. ■ Monitor hematopoietic, hepatic, and renal systems during prolonged treatment. Patients with severe infections and severe renal impairment and hepatic insufficiency require careful monitoring. ■ Monitor blood glucose, especially in diabetic patients. ■ Use of large veins recommended to reduce incidence of local irritation. Symptoms of local irritation do not preclude further administration of ciprofloxacin unless they recur or worsen. Generally resolve when infusion complete. ■ Concomitant use with theophylline may cause serious and fatal reactions, including cardiac arrest, respiratory failure, seizures, and/or status epilepticus. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dose as indicated. ■ Doses will increase slightly with transfer to oral ciprofloxacin (e.g., 200 mg IV every 12 hours equals 250 mg PO every 12 hours; 400 mg IV every 12 hours equals 500 mg PO every 12 hours; 400 mg IV every 8 hours equals 750 mg PO every 12 hours). ■ See Drug/Lab Interactions.
A patient medication guide is available from the manufacturer. ■ Discontinue ciprofloxacin and promptly report the development of any severe adverse reaction. ■ Capable of numerous drug interactions. Review all prescription and nonprescription medications with your health care provider. ■ Inform physician of any history of myasthenia gravis. Patients with a history of myasthenia gravis should avoid using ciprofloxacin. ■ Photosensitivity has been reported. Avoid excessive sunlight or artificial ultraviolet light. May cause severe sunburn; wear protective clothing, use sunscreen, and wear dark glasses outdoors. Report a sunburn-like reaction or skin eruption promptly. ■ Effects of caffeine- or theophylline-containing preparations may be increased; promptly report difficulty breathing, palpitations, and/or seizures. Limit or eliminate concurrent use. Monitor if concurrent use is necessary. ■ Promptly report tendon pain or inflammation, weakness, or the inability to use a joint; rest and refrain from exercise. Symptoms may be irreversible. ■ Promptly report skin rash or any other hypersensitivity reaction. ■ Promptly report pain, burning, tingling, numbness, and/or weakness. Nerve damage can be permanent. ■ Promptly report development of any CNS side effects (e.g., convulsions, dizziness, light-headedness, change in mood or behavior). ■ Inform physician of any history of seizures. ■ Request assistance with ambulation; may cause dizziness and light-headedness. Use caution in tasks that require alertness. ■ Parents should inform physician of any history of joint-related problems and should promptly report any joint-related problems that develop during or after therapy. ■ Promptly report diarrhea or bloody stools that occur during treatment or up to several months after an antibiotic has been discontinued; may indicate CDAD and require treatment. ■ Promptly report any S/S of hepatic toxicity (e.g., dark-colored urine, fever, itching, light-colored bowel movement, loss of appetite, nausea, right upper quadrant tenderness, tiredness, weakness, yellowing of skin). ■ May prolong QT interval. Review medications and medical history. ■ Drink fluids liberally to avoid formation of highly concentrated urine and crystal formation. ■ Seek emergency medical care if sudden chest, stomach, or back pain is experienced. ■ Diabetic patients taking oral hypoglycemic agents or insulin should discontinue ciprofloxacin and contact their provider if they experience a hypoglycemic reaction.
Category C: use during pregnancy only if benefits justify potential risk to fetus and mother. ■ Discontinue breast-feeding. ■ May erode cartilage of weight-bearing joints or cause other signs of arthropathy (arthralgia, arthritis) in infants and children. Indicated for treatment of complicated UTIs or pyelonephritis. Although effective, it is not the drug of first choice for this indication due to adverse reactions. Also indicated for inhalation anthrax (postexposure) and for treatment of and prophylaxis for the plague. The risk-benefit assessment indicates that administration of ciprofloxacin for these indications is appropriate. ■ Has been used in infants and children to treat serious infections unresponsive to other antibiotic regimens.
Safety and effectiveness similar to younger adults. ■ May be at increased risk of experiencing side effects (e.g., aortic aneurysm and dissection, CNS effects, drug-associated effects on the QT interval, tendinitis, tendon rupture); see Precautions. Half-life may be slightly extended because of age-related renal impairment; see Dose Adjustments. Monitoring of renal function may be useful.
Review of patient medication profile required. ■ Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Coadministration with other drugs metabolized by this route, such as clozapine, methylxanthines (e.g., theophylline), olanzapine, ropinirole, tizanidine, or zolpidem, results in increased plasma concentrations of these drugs, which may cause significant toxicity. ■ Concomitant administration with tizanidine is contraindicated (hypotensive and sedative effects potentiated). ■ Concurrent use with zolpidem is not recommended. ■ May cause serious or fatal reactions with theophylline (e.g., cardiac arrhythmias or arrest, respiratory failure, or seizures). If must be used concomitantly, monitor serum levels of theophylline and decrease dose as appropriate. Observe closely with caffeine intake; has caused similar problems. Elevated serum levels of other xanthine derivatives (e.g., pentoxifylline-containing products) have also been seen with concurrent use. ■ Use with cyclosporine may cause an increase in SCr and nephrotoxic effects. Monitor SCr if concurrent use required. ■ May potentiate oral anticoagulants (e.g., warfarin); monitor PT/INR. ■ Potentiated by probenecid. Use with caution and monitor for possible ciprofloxacin toxicity. ■ Severe hypoglycemia has been reported with concomitant use of oral antidiabetic agents (e.g., glyburide, glimepiride); monitor serum glucose levels. ■ May increase or decrease serum phenytoin levels; monitor phenytoin levels with concomitant use and repeat phenytoin levels shortly after completion of ciprofloxacin therapy. ■ Risk of CNS stimulation and seizures may be increased with concurrent use of NSAIDs with high doses of quinolones. ■ Concurrent use with methotrexate requires close monitoring. May inhibit renal tubular transport of methotrexate, thereby increasing methotrexate serum levels and the risk of toxicity. ■ Coadministration with drugs that prolong the QT interval such as Class IA or III antiarrhythmic agents (e.g., amiodarone, disopyramide, procainamide, quinidine), tricyclic antidepressants, macrolide antibiotics, and antipsychotics may increase the risk of QT prolongation and life-threatening arrhythmias. Concurrent use is not recommended. ■ Fivefold increase in duloxetine exposure with concurrent use. Avoid use if possible. If must be given concurrently, monitor for duloxetine toxicity. ■ Twofold increase in sildenafil exposure. Use with caution. ■ May cause a false-positive when testing urine for opiates; more specific testing methods may be indicated. ■ See Side Effects.
Central nervous system disturbances, diarrhea, eosinophilia, headache, hepatic enzyme abnormalities (elevation of alkaline phosphatase, AST, ALT, LDH, serum bilirubin), local IV site reactions, nausea and vomiting, rash, and restlessness are reported most frequently. Other less frequent reactions include abdominal pain; allergic reactions (e.g., anaphylaxis, cardiovascular collapse, death, dyspnea, edema [facial, pharyngeal, or pulmonary], fever, itching, loss of consciousness, urticaria); cardiovascular effects (e.g., cardiac arrest, QT interval prolongation, tachycardia, torsades de pointes, vasodilation); CDAD; CNS effects (e.g., confusion, depression, hallucinations, light-headedness, seizures, tingling, toxic psychosis, tremors); crystalluria; elevated platelet counts, BUN, serum amylase, serum creatinine, serum creatine phosphokinase, serum potassium, uric acid, and triglycerides; hyperglycemia; hypoglycemia; increased intracranial pressure; peripheral neuropathy (e.g., pain, burning, tingling, numbness and/or weakness [see Precautions, Monitor]); photosensitivity/phototoxicity and vision changes; respiratory arrest; status epilepticus; tendinitis; and tendon rupture. Capable of numerous other reactions in fewer than 1% of patients.
Acute generalized exanthematous pustulosis (AGEP), allergic pneumonitis, arthralgia, exacerbation of myasthenia gravis, hematologic abnormalities (agranulocytosis, anemia [hemolytic and aplastic], leukopenia, pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura), increased INR in patients treated with vitamin K antagonists, interstitial nephritis, liver abnormalities (e.g., acute hepatic necrosis or failure, hepatitis, jaundice), myalgia, polyneuropathy, serum sickness, severe dermatologic reactions (e.g., toxic epidermal necrolysis [Lyell’s syndrome], Stevens-Johnson syndrome), vasculitis.
Keep physician informed of all side effects. Many will require symptomatic treatment; monitor closely. Death may result from some of these side effects. Discontinue ciprofloxacin at the first appearance of a skin rash or major side effect (hypersensitivity, CDAD, CNS symptoms, dermatologic reactions, hepatoxicity, hypoglycemia, peripheral neuropathy, phototoxicity, or tendinitis or tendon rupture). Treat hypersensitivity reactions with epinephrine, airway management, oxygen, IV fluids, antihistamines (diphenhydramine), corticosteroids (hydrocortisone sodium succinate), and pressor amines (dopamine) as indicated. Treat CNS symptoms as indicated. Mild cases of CDAD may respond to discontinuation of ciprofloxacin. Treat CDAD with fluids, electrolytes, protein supplements, and appropriate antibiotics (e.g., oral vancomycin) as indicated. In severe cases, surgical evaluation may be indicated. In overdose, observe carefully, provide supportive treatment, maintain hydration, and monitor renal function and urinary pH and acidify, if required, to prevent crystalluria. No specific antidote; up to 10% may be removed by hemodialysis or peritoneal dialysis. Maintain patient until drug excreted.