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Medication Safety Issues
Sound-alike/look-alike issues:
Ciprofloxacin may be confused with cephalexin
Ciloxan® may be confused with cinoxacin, Cytoxan®
Cipro® may be confused with Ceftin®
Pronunciation
(sip roe FLOKS a sin)
U.S. Brand Names
Index Terms
Generic Available
Yes: Excludes ointment, suspension
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use
Children: Complicated urinary tract infections and pyelonephritis due to E. coli. Note: Although effective, ciprofloxacin is not the drug of first choice in children.
Children and Adults: To reduce incidence or progression of disease following exposure to aerolized Bacillus anthracis. Ophthalmologically, for superficial ocular infections (corneal ulcers, conjunctivitis) due to susceptible strains
Adults: Treatment of the following infections when caused by susceptible bacteria: Urinary tract infections; acute uncomplicated cystitis in females; chronic bacterial prostatitis; lower respiratory tract infections (including acute exacerbations of chronic bronchitis); acute sinusitis; skin and skin structure infections; bone and joint infections; complicated intra-abdominal infections (in combination with metronidazole); infectious diarrhea; typhoid fever due to Salmonella typhi (eradication of chronic typhoid carrier state has not been proven); uncomplicated cervical and urethra gonorrhea (due to N. gonorrhoeae); nosocomial pneumonia; empirical therapy for febrile neutropenic patients (in combination with piperacillin)
Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal disease.
Use: Dental
Useful as a single agent or in combination with metronidazole in the treatment of periodontitis associated with the presence of Actinobacillus actinomycetemcomitans (AA), as well as enteric rods/pseudomonads
Use: Unlabeled/Investigational
Acute pulmonary exacerbations in cystic fibrosis (children); cutaneous/gastrointestinal/oropharyngeal anthrax (treatment, children and adults); disseminated gonococcal infection (adults); chancroid (adults); prophylaxis to Neisseria meningitidis following close contact with an infected person; empirical therapy (oral) for febrile neutropenia in low-risk cancer patients; HACEK group endocarditis; infectious diarrhea (children)
Pregnancy Risk Factor
C
Pregnancy Implications
Ciprofloxacin crosses the placenta and concentrates in amniotic fluid; maternal serum levels may be decreased during pregnancy. Reports of arthropathy (observed in immature animals and reported rarely in humans) have limited the use of fluoroquinolones in pregnancy. According to the FDA, the Teratogen Information System concluded that therapeutic doses during pregnancy are unlikely to produce substantial teratogenic risk, but data are insufficient to say that there is no risk. In general, reports of exposure have been limited to short durations of therapy in the first trimester. When considering treatment for life-threatening infection and/or prolonged duration of therapy (such as in anthrax), the potential risk to the fetus must be balanced against the severity of the potential illness.
Lactation
Enters breast milk/not recommended (AAP rates “compatible”)
Breast-Feeding Considerations
Ciprofloxacin is excreted in breast milk; however, the exposure to the infant is considered small and one source suggests that the decision to breast-feed be independent of the need for the antibiotic in the mother. Another source recommends the mother wait 48 hours after the last dose of ciprofloxacin to continue nursing. The manufacturer recommends to discontinue nursing or to discontinue ciprofloxacin.
Contraindications
Hypersensitivity to ciprofloxacin, any component of the formulation, or other quinolones; concurrent administration of tizanidine
Warnings/Precautions
Concerns related to adverse effects:
• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with a history of QTc prolongation, uncorrected hypokalemia, hypomagnesemia, or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).
• CNS stimulation: Tremor, restlessness, confusion, and very rarely hallucinations or seizures may occur; use with caution in patients with known or suspected CNS disorder. Discontinue in patients who experience significant CNS adverse effects (eg, dizziness, hallucinations, suicidal ideations or actions).
• Crystalluria: Rarely, crystalluria has occurred; urine alkalinity may increase the risk. Ensure adequate hydration during therapy.
• Glucose regulation: Fluoroquinolones have been associated with the development of serious, and sometimes fatal, hypoglycemia. These events have occurred most often in elderly patients with diabetes, but have also been reported in patients without a prior history of diabetes. Prompt identification and treatment of hypoglycemia is essential. Individual quinolones may differ in their potential to cause this effect. It was most evident with gatifloxacin (no longer marketed as s systemic formulation). Hyperglycemia has also been associated with the use of fluoroquinolones. Patients should be monitored closely for signs/symptoms of disordered glucose regulation.
• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.
• Peripheral neuropathy: The use of quinolones has been linked to peripheral neuropathy (rare); discontinue if symptoms of sensory or sensorimotor neuropathy occur.
• Phototoxicity: Avoid excessive sunlight; may cause moderate-to-severe phototoxicity reactions.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Tendon inflammation/rupture: There have been reports of tendon inflammation (commonly Achilles, shoulder, or hand tendons) and/or rupture with quinolone antibiotics; risk may be increased with concurrent corticosteroids, particularly in the elderly. Discontinue at first sign of tendon inflammation or pain.
Disease-related concerns:
• Myasthenia gravis: Some quinolones may exacerbate myasthenia gravis, use with caution (rare, potentially life-threatening weakness of respiratory muscles may occur).
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required.
• Seizures: Use with caution in individuals at risk of seizures (CNS disorders or concurrent therapy with medications which may lower seizure threshold). Potential for seizures, although very rare, may be increased with concomitant NSAID therapy.
Concurrent drug therapy issues:
• CYP1A2 substrates: Ciprofloxacin is a potent inhibitor of CYP1A2. Coadministration of drugs which depend on this pathway may lead to substantial increases in serum concentrations and adverse effects.
Special populations:
• Elderly: Adverse effects (eg, tendon rupture, QT changes) may be increased in the elderly.
• Pediatrics: Adverse effects, including those related to joints and/or surrounding tissues, are increased in pediatric patients and therefore, ciprofloxacin should not be considered as drug of choice in children (exception is anthrax treatment).
Adverse Reactions
1% to 10%:
Central nervous system: Neurologic events (children 2%, includes dizziness, insomnia, nervousness, somnolence); fever (children 2%); headache (I.V. administration); restlessness (I.V. administration)
Dermatologic: Rash (children 2%, adults 1%)
Gastrointestinal: Nausea (children/adults 3%); diarrhea (children 5%, adults 2%); vomiting (children 5%, adults 1%); abdominal pain (children 3%, adults <1%); dyspepsia (children 3%)
Hepatic: ALT/AST increased (adults 1%)
Local: Injection site reactions (I.V. administration)
Respiratory: Rhinitis (children 3%)
<1%: Abnormal gait, acute renal failure, agitation, allergic reactions, anaphylaxis, anemia, angina pectoris, angioedema, anorexia, arthralgia, ataxia, atrial flutter, breast pain, bronchospasm, candidiasis, cardiopulmonary arrest, cerebral thrombosis, chills, cholestatic jaundice, confusion, chromatopsia, crystalluria (particularly in alkaline urine), cylindruria, depersonalization, depression, dizziness, drowsiness, dyspnea, edema, eosinophilia, erythema nodosum, fever (adults), gastrointestinal bleeding, hallucinations, headache (oral), hematuria, hyperpigmentation, hyper-/hypotension, insomnia, interstitial nephritis, intestinal perforation, irritability, joint pain, laryngeal edema, lightheadedness, lymphadenopathy, malaise, manic reaction, migraine, MI, nephritis, nightmares, palpitation, paranoia, paresthesia, peripheral neuropathy, petechia, photosensitivity, pulmonary edema, seizure, syncope, tachycardia, thrombophlebitis, tinnitus, tremor, urethral bleeding, vaginitis, ventricular ectopy, visual disturbance, weakness
Postmarketing and/or case reports: Agranulocytosis, albuminuria, anaphylactic shock, anosmia, bone marrow depression (life-threatening), candiduria, constipation, delirium, dyspepsia (adults), dysphagia, erythema multiforme, exfoliative dermatitis, fixed eruption, flatulence, hemolytic anemia, hepatic failure (some fatal), hepatic necrosis, hyperesthesia, hyperglycemia, hypertonia, jaundice, methemoglobinemia, moniliasis, myalgia, myasthenia gravis, myoclonus, nystagmus, orthostatic hypotension, pancreatitis, pancytopenia (life-threatening or fatal), pneumonitis, prolongation of PT/INR, pseudomembranous colitis, psychosis, renal calculi, serum cholesterol increased, serum glucose increased, serum sickness-like reactions, serum triglycerides increased, Stevens-Johnson syndrome, taste loss, tendon rupture, tendonitis, toxic epidermal necrolysis (Lyell's syndrome), torsade de pointes, twitching, vaginal candidiasis, vasculitis
Drug Interactions
Inhibits CYP1A2 (strong), 3A4 (weak)
Caffeine: Ciprofloxacin may decrease the metabolism of caffeine.
Corticosteroids: Concurrent use may increase the risk of tendon rupture, particularly in elderly patients (overall incidence rare).
CYP1A2 substrates: Ciprofloxacin may increase the levels/effects of CYP1A2 substrates. Example substrates include aminophylline, fluvoxamine, mexiletine, mirtazapine, ropinirole, tizanidine, and trifluoperazine.
Foscarnet: Concomitant use with ciprofloxacin has been associated with an increased risk of seizures.
Glyburide: Quinolones may increase the effect of glyburide; monitor.
Metal cations (aluminum, calcium, iron, magnesium, and zinc) bind quinolones in the gastrointestinal tract and inhibit absorption. Concurrent administration of most antacids, oral electrolyte supplements, quinapril, sucralfate, some didanosine formulations (pediatric powder for oral suspension), and other highly-buffered oral drugs, should be avoided. Ciprofloxacin should be administered 2 hours before or 6 hours after these agents.
Methotrexate: Ciprofloxacin may decrease renal secretion of methotrexate; monitor.
NSAIDs: Risk of seizures may be increased with concomitant NSAID use. Risk is considered quite low and may only be a factor with high serum levels of either agent and/or in patients with additional predisposing factors (eg, renal dysfunction, history of seizure or other neurological disorder).
Pentoxifylline: Monitor for headache during concomitant therapy.
Phenytoin: Ciprofloxacin may decrease phenytoin levels; monitor.
Probenecid: May decrease renal secretion of quinolones.
QTc-prolonging agents: Ciprofloxacin may enhance the QT-prolonging effects of known QTc-prolonging agents; information based on rare case reports.
Ropivacaine: Ciprofloxacin may decrease the metabolism of ropivacaine.
Sevelamer: May decrease absorption of oral ciprofloxacin.
Theophylline: Serum levels may be increased by ciprofloxacin; in addition, CNS stimulation/seizures may occur at lower theophylline serum levels due to additive CNS effects.
Tizanidine: Ciprofloxacin may increase serum levels of tizanidine. Concurrent administration is contraindicated.
Typhoid vaccine: Antibiotics may decrease the therapeutic effect of live, attenuated Ty21a vaccine; delay vaccination for >24 hours after administration of antibacterial agents.
Warfarin: The hypoprothrombinemic effect of warfarin may be enhanced by ciprofloxacin; monitor INR.
Ethanol/Nutrition/Herb Interactions
Food: Food decreases rate, but not extent, of absorption. Ciprofloxacin serum levels may be decreased if taken with dairy products or calcium-fortified juices. Ciprofloxacin may increase serum caffeine levels if taken with caffeine.
Enteral feedings may decrease plasma concentrations of ciprofloxacin probably by >30% inhibition of absorption. Ciprofloxacin should not be administered with enteral feedings. The feeding would need to be discontinued for 1-2 hours prior to and after ciprofloxacin administration. Nasogastric administration produces a greater loss of ciprofloxacin bioavailability than does nasoduodenal administration.
Herb/Nutraceutical: Avoid dong quai, St John's wort (may also cause photosensitization).
Storage
Injection:
Premixed infusion: Store between 5°C to 25°C (41°F to 77°F); avoid freezing. Protect from light.
Vial: Store between 5°C to 30°C (41°F to 86°F); avoid freezing. Protect from light. Diluted solutions of 0.5-2 mg/mL are stable for up to 14 days refrigerated or at room temperature.
Ophthalmic solution/ointment: Store at 36°F to 77°F (2°C to 25°C). Protect from light.
Microcapsules for oral suspension: Prior to reconstitution, store below 25°C (77°F). Protect from freezing. Following reconstitution, store below 30°C (86°F) for up to 14 days. Protect from freezing.
Tablet:
Immediate release: Store below 30°C (86°F).
Extended release: Store at room temperature of 15°C to 30°C (59°F to 86°F).
Reconstitution
Injection, vial: May be diluted with NS, D5W, SWFI, D10W, D51/4NS, D51/2NS, LR.
Compatibility
Stable in D51/4NS, D51/2NS, D5W, D10W, LR, NS; variable stability (consult detailed reference) in peritoneal dialysis solution.
Y-site administration: Compatible: Amifostine, amino acids (dextrose), aztreonam, calcium gluconate, ceftazidime, cisatracurium, clarithromycin, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dopamine, doxorubicin liposome, etoposide phosphate, gemcitabine, gentamicin, granisetron, hydroxyzine, lidocaine, linezolid, lorazepam, metoclopramide, midazolam, midodrine, piperacillin, potassium acetate, potassium chloride, potassium phosphates, promethazine, ranitidine, remifentanil, Ringer's injection (lactated), sodium chloride, tacrolimus, teniposide, thiotepa, tobramycin, verapamil. Incompatible: Aminophylline, ampicillin/sulbactam, cefepime, dexamethasone sodium phosphate, furosemide, heparin, hydrocortisone sodium succinate, methylprednisolone sodium succinate, phenytoin, propofol, sodium phosphates, warfarin. Variable (consult detailed reference): Magnesium sulfate, sodium bicarbonate, teicoplanin, TPN.
Compatibility when admixed: Compatible: Amikacin, aztreonam, ceftazidime, cyclosporine, gentamicin, metronidazole, netilmicin, piperacillin, potassium chloride, ranitidine, tobramycin, vitamin B complex. Incompatible: Aminophylline, clindamycin, floxacillin, heparin.
Mechanism of Action
Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA
Pharmacodynamics/Kinetics
Absorption: Oral: Immediate release tablet: Rapid (?50% to 85%)
Distribution: Vd: 2.1-2.7 L/kg; tissue concentrations often exceed serum concentrations especially in kidneys, gallbladder, liver, lungs, gynecological tissue, and prostatic tissue; CSF concentrations: 10% of serum concentrations (noninflamed meninges), 14% to 37% (inflamed meninges); crosses placenta; enters breast milk
Protein binding: 20% to 40%
Metabolism: Partially hepatic; forms 4 metabolites (limited activity)
Half-life elimination: Children: 2.5 hours; Adults: Normal renal function: 3-5 hours
Time to peak: Oral:
Immediate release tablet: 0.5-2 hours
Extended release tablet: Cipro® XR: 1-2.5 hours, Proquin® XR: 3.5-8.7 hours
Excretion: Urine (30% to 50% as unchanged drug); feces (15% to 43%)
Dosage
Note: Extended release tablets and immediate release formulations are not interchangeable. Unless otherwise specified, oral dosing reflects the use of immediate release formulations.
Usual dosage ranges:
Children (see Warnings/Precautions):
Oral: 20-30 mg/kg/day in 2 divided doses; maximum dose: 1.5 g/day
I.V.: 20-30 mg/kg/day divided every 12 hours; maximum dose: 800 mg/day
Adults:
Oral: 250-750 mg every 12 hours
I.V.: 200-400 mg every 12 hours
Indication-specific dosing:
Children:
Anthrax:
Inhalational (postexposure prophylaxis):
Oral: 15 mg/kg/dose every 12 hours for 60 days; maximum: 500 mg/dose
I.V.: 10 mg/kg/dose every 12 hours for 60 days; do not exceed 400 mg/dose (800 mg/day)
Cutaneous (treatment, CDC guidelines): Oral: 10-15 mg/kg every 12 hours for 60 days (maximum: 1 g/day); amoxicillin 80 mg/kg/day divided every 8 hours is an option for completion of treatment after clinical improvement. Note: In the presence of systemic involvement, extensive edema, lesions on head/neck, refer to I.V. dosing for treatment of inhalational/gastrointestinal/oropharyngeal anthrax.
Inhalational/gastrointestinal/oropharyngeal (treatment, CDC guidelines): I.V.: Initial: 10-15 mg/kg every 12 hours for 60 days (maximum: 500 mg/dose); switch to oral therapy when clinically appropriate; refer to adult dosing for notes on combined therapy and duration
Bacterial conjunctivitis: See adult dosing
Corneal ulcer: See adult dosing
Cystic fibrosis (unlabeled use):
Oral: 40 mg/kg/day divided every 12 hours administered following 1 week of I.V. therapy has been reported in a clinical trial; total duration of therapy: 10-21 days
I.V.: 30 mg/kg/day divided every 8 hours for 1 week, followed by oral therapy, has been reported in a clinical trial
Urinary tract infection (complicated) or pyelonephritis:
Oral: 20-30 mg/kg/day in 2 divided doses (every 12 hours) for 10-21 days; maximum: 1.5 g/day
I.V.: 6-10 mg/kg every 8 hours for 10-21 days (maximum: 400 mg/dose)
Adults:
Anthrax:
Inhalational (postexposure prophylaxis):
Oral: 500 mg every 12 hours for 60 days
I.V.: 400 mg every 12 hours for 60 days
Cutaneous (treatment, CDC guidelines): Oral: Immediate release formulation: 500 mg every 12 hours for 60 days. Note: In the presence of systemic involvement, extensive edema, lesions on head/neck, refer to I.V. dosing for treatment of inhalational/gastrointestinal/oropharyngeal anthrax
Inhalational/gastrointestinal/oropharyngeal (treatment, CDC guidelines): I.V.: 400 mg every 12 hours. Note: Initial treatment should include two or more agents predicted to be effective (per CDC recommendations). Continue combined therapy for 60 days.
Bacterial conjunctivitis:
Ophthalmic solution: Instill 1-2 drops in eye(s) every 2 hours while awake for 2 days and 1-2 drops every 4 hours while awake for the next 5 days
Ophthalmic ointment: Apply a 1/2” ribbon into the conjunctival sac 3 times/day for the first 2 days, followed by a 1/2” ribbon applied twice daily for the next 5 days
Bone/joint infections:
Oral: 500-750 mg twice daily for 4-6 weeks
I.V.: Mild to moderate: 400 mg every 12 hours for 4-6 weeks; Severe/complicated: 400 mg every 8 hours for 4-6 weeks
Chancroid (CDC guidelines): Oral: 500 mg twice daily for 3 days
Corneal ulcer: Ophthalmic solution: Instill 2 drops into affected eye every 15 minutes for the first 6 hours, then 2 drops into the affected eye every 30 minutes for the remainder of the first day. On day 2, instill 2 drops into the affected eye hourly. On days 3-14, instill 2 drops into affected eye every 4 hours. Treatment may continue after day 14 if re-epithelialization has not occurred.
Endocarditis due to HACEK organisms (AHA guidelines, unlabeled use): Note: Not first-line option; use only if intolerant of beta-lactam therapy:
Oral: 500 mg every 12 hours for 4 weeks
I.V.: 400 mg every 12 hours for 4 weeks
Febrile neutropenia*: I.V.: 400 mg every 8 hours for 7-14 days
Gonococcal infections:
Urethral/cervical gonococcal infections: Oral: 250-500 mg as a single dose (CDC recommends concomitant doxycycline or azithromycin due to possible coinfection with Chlamydia; Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of uncomplicated gonococcal disease.
Disseminated gonococcal infection (CDC guidelines): Oral: 500 mg twice daily to complete 7 days of therapy (initial treatment with ceftriaxone 1 g I.M./I.V. daily for 24-48 hours after improvement begins); Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of more serious gonococcal disease, unless no other options exist and susceptibility can be confirmed via culture.
Infectious diarrhea: Oral:
Salmonella: 500 mg twice daily for 5-7 days
Shigella: 500 mg twice daily for 3 days
Traveler's diarrhea: Mild: 750 mg for one dose; Severe: 500 mg twice daily for 3 days
Vibrio cholerae: 1 g for one dose
Intra-abdominal*:
Oral: 500 mg every 12 hours for 7-14 days
I.V.: 400 mg every 12 hours for 7-14 days
Lower respiratory tract, skin/skin structure infections:
Oral: 500-750 mg twice daily for 7-14 days
I.V.: Mild to moderate: 400 mg every 12 hours for 7-14 days; Severe/complicated: 400 mg every 8 hours for 7-14 days
Nosocomial pneumonia: I.V.: 400 mg every 8 hours for 10-14 days
Prostatitis (chronic, bacterial): Oral: 500 mg every 12 hours for 28 days
Sinusitis (acute): Oral: 500 mg every 12 hours for 10 days
Typhoid fever: Oral: 500 mg every 12 hours for 10 days
Urinary tract infection:
Acute uncomplicated, cystitis:
Oral:
Immediate release formulation: 250 mg every 12 hours for 3 days
Extended release formulation (Cipro® XR, Proquin® XR): 500 mg every 24 hours for 3 days
I.V.: 200 mg every 12 hours for 7-14 days
Complicated (including pyelonephritis):
Oral:
Immediate release formulation: 500 mg every 12 hours for 7-14 days
Extended release formulation (Cipro® XR): 1000 mg every 24 hours for 7-14 days
I.V.: 400 mg every 12 hours for 7-14 days
*Combination therapy generally recommended.
Elderly: No adjustment needed in patients with normal renal function
Dosing adjustment in renal impairment: Adults:
Clcr 30-50 mL/minute: Oral: 250-500 mg every 12 hours
Clcr <30 mL/minute: Acute uncomplicated pyelonephritis or complicated UTI: Oral: Extended release formulation: 500 mg every 24 hours
Clcr 5-29 mL/minute:
Oral: 250-500 mg every 18 hours
I.V.: 200-400 mg every 18-24 hours
Dialysis: Only small amounts of ciprofloxacin are removed by hemo- or peritoneal dialysis (<10%); usual dose: Oral: 250-500 mg every 24 hours following dialysis
Continuous renal replacement therapy (CRRT): I.V.:
CVVH: 200 mg every 12 hours
CVVHD or CVVHDF: 200-400 mg every 12 hours
Dental Usual Dosing
Treatment of periodontitis: Adults: Oral: 500 mg every 12 hours for 8-10 days
Administration: Oral
May administer with food to minimize GI upset; avoid antacid use; maintain proper hydration and urine output. Administer immediate release ciprofloxacin and Cipro® XR at least 2 hours before or 6 hours after, and Proquin® XR at least 4 hours before or 6 hours after antacids or other products containing calcium, iron, or zinc (including dairy products or calcium-fortified juices). Separate oral administration from drugs which may impair absorption (see Drug Interactions).
Oral suspension: Should not be administered through feeding tubes (suspension is oil-based and adheres to the feeding tube). Patients should avoid chewing on the microcapsules.
Nasogastric/orogastric tube: Crush immediate-release tablet and mix with water. Flush feeding tube before and after administration. Hold tube feedings at least 1 hour before and 2 hours after administration.
Tablet, extended release: Do not crush, split, or chew. May be administered with meals containing dairy products (calcium content <800 mg), but not with dairy products alone. Proquin® XR should be administered with a main meal of the day; evening meal is preferred.
Administration: I.V.
Administer by slow I.V. infusion over 60 minutes into a large vein.
Administration: I.V. Detail
Administer slowly to reduce the risk of venous irritation (burning, pain, erythema, and swelling).
pH: 3.3-3.9 (vials); 3.5-4.6 (PVC bags)
Monitoring Parameters
Patients receiving concurrent ciprofloxacin, theophylline, or cyclosporine should have serum levels monitored; CBC, renal and hepatic function during prolonged therapy
Reference Range
Therapeutic: 2.6-3 mcg/mL; Toxic: >5 mcg/mL
Test Interactions
Some quinolones may produce a false-positive urine screening result for opiates using commercially-available immunoassay kits. This has been demonstrated most consistently for levofloxacin and ofloxacin, but other quinolones have shown cross-reactivity in certain assay kits. Confirmation of positive opiate screens by more specific methods should be considered.
Dietary Considerations
Food: Drug may cause GI upset; take without regard to meals (manufacturer prefers that immediate release tablet is taken 2 hours after meals). Extended release tablet may be taken with meals that contain dairy products (calcium content <800 mg), but not with dairy products alone.
Dairy products, calcium-fortified juices, oral multivitamins, and mineral supplements: Absorption of ciprofloxacin is decreased by divalent and trivalent cations. The manufacturer states that the usual dietary intake of calcium (including meals which include dairy products) has not been shown to interfere with ciprofloxacin absorption. Immediate release ciprofloxacin and Cipro® XR may be taken 2 hours before or 6 hours after, and Proquin® XR may be taken 4 hours before or 6 hours after, any of these products.
Caffeine: Patients consuming regular large quantities of caffeinated beverages may need to restrict caffeine intake if excessive cardiac or CNS stimulation occurs.
Patient Education
Do not take any new prescription or OTC medications or herbal products during therapy without consulting prescriber. If administered by infusion: Report immediately any redness, swelling, or pain at infusion site; any swelling of mouth, lips, tongue, or throat; chest pain or tightness; respiratory difficulty; back pain; itching; skin rash; tingling; tendon pain; dizziness; abnormal thinking; or anxiety. May cause dizziness, lightheadedness, or confusion (use caution to avoid falls or injury); nausea or vomiting (request antiemetic from prescriber). Report any tendon pain, chest pain or palpitations, or other adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.
Oral: Take according to specific directions (eg, timing with meals, dairy products, antacids [products containing calcium, iron, or zinc differs with each formulation]). Take all of prescribed medication even if feeling better. Do not crush, split, or chew extended release tablets or chew on microcapsules in oral suspension. Maintain adequate hydration (2-3 L/day) unless instructed to restrict fluid intake. Consult prescriber before having any vaccinations. You may experience nausea, vomiting, or anorexia (small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); increased sensitivity to sunlight (use sunscreen, wear protective clothing and dark glasses, and avoid direct exposure to sunlight or tanning salons). If inflammation or tendon pain occurs or you experience signs of an allergic reaction (eg, itching, urticaria, respiratory difficulty, facial edema or difficulty swallowing, loss of consciousness, tingling, chest pain, palpitations) discontinue use and contact prescriber immediately. Report persistent GI disturbances; CNS changes (eg, excessive sleepiness, agitation, tremors); skin rash; vision changes; respiratory difficulty; signs of opportunistic infection (eg, sore throat, chills, fever, burning, itching on urination, vaginal discharge, white plaques in mouth); persistent diarrhea (especially if it lasts after completing prescription), or worsening of condition.
Ophthalmic: Use exactly as directed. Wash hands prior to instilling eye medication. Do not touch dropper to eye or any other surface. Do not wear contact lenses while using this medication (check with prescriber before using again). Tilt head back, look upward, and pull lower eyelid down to make a pouch. Drop prescribed number of drops directly into eye. Close eye, place one finger at corner of eye near nose, and apply gentle pressure. Do not blink or rub eye. If also using ointment, use drops before ointment. Use for exact time as prescribed; do not discontinue, even if symptoms disappear. May cause temporary stinging or burning. Report persistent eye discomfort, itching, redness, unusual tearing, feeling as if something is in your eye, blurred vision, eye pain, worsening vision, a bad taste in your mouth, sensitivity to light, skin rash, difficulty breathing, or worsening of symptoms.
Geriatric Considerations
Ciprofloxacin should not be used as first-line therapy unless the culture and sensitivity findings show resistance to usual therapy. The interactions with caffeine and theophylline can result in serious toxicity in the elderly. Adjust dose for renal function.
Additional Information
Although the systemic use of ciprofloxacin is only FDA approved in children for the treatment of complicated UTI and postexposure treatment of inhalation anthrax, use of the fluoroquinolones in pediatric patients is increasing. Current recommendations by the American Academy of Pediatrics note that the systemic use of these agents in children should be restricted to infections caused by multidrug resistant pathogens with no safe or effective alternative, and when parenteral therapy is not feasible or other oral agents are not available.
Cardiovascular Considerations
Ciprofloxacin has been weakly associated with torsade de pointes and/or QT prolongation, but is unlikely to be a risk for torsade de pointes when used in the usual recommended dosages and in patients without other risk factors (eg, concomitant QT-prolonging drugs, bradycardia, electrolyte disturbances, congenital long QT syndrome, concomitant drugs that inhibit metabolism). Ciprofloxacin should not be used in patients with congenital prolonged QT syndrome.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Convulsions and toxic psychosis have been reported with quinolones. May cause dizziness, confusion, hallucinations, depression, and rarely suicidal ideation and attempts. These reactions may occur after the first dose. Discontinue drug and institute safety measures. Ciprofloxacin may also cause nervousness, agitation, insomnia, anxiety, nightmares or paranoia, phobia, depersonalization, manic reaction, ataxia, irritability, and drowsiness.
Mental Health: Effects on Psychiatric Treatment
Inhibits CYP1A2 isoenzyme; use caution with clozapine; monitor for adverse effects. May rarely cause agranulocytosis; monitor with clozapine and carbamazepine. Use caution in patients with CNS disorders that may predispose them to seizures (epilepsy, alcohol/sedative hypnotic withdrawal).
Nursing: Physical Assessment/Monitoring
Assess results of culture and sensitivity tests prior to beginning therapy. Use caution in patients with known or suspected CNS disorder, current or potential for QT prolongation, renal or hepatic impairment, or diabetes. Assess other pharmacological or herbal products patient may be taking for potential interactions. I.V.: See Administration specifics. Evaluate results of laboratory tests, therapeutic effectiveness (according to purpose for use), and adverse effects (eg, hypersensitivity reactions [severe reactions, including anaphylaxis, have occurred with quinolone therapy]; C. difficile-associated colitis [can occur up to 2 months post treatment]; changes in CNS) regularly during prolonged therapy. Teach patient proper use (appropriate for formulation), possible side effects/appropriate interventions, and adverse symptoms to report.
Oncology: Emetic Potential
Very low (<10%)
Oncology: Vesicant
No
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Infusion [premixed in D5W]: 200 mg (100 mL); 400 mg (200 mL)
Cipro®: 200 mg (100 mL); 400 mg (200 mL)
Injection, solution [concentrate]: 10 mg/mL (20 mL, 40 mL, 120 mL)
Cipro®: 10 mg/mL (20 mL, 40 mL)
Microcapsules for suspension, oral:
Cipro®: 250 mg/5 mL (100 mL); 500 mg/5 mL (100 mL) [strawberry flavor]
Ointment, ophthalmic, as hydrochloride:
Ciloxan®: 3.33 mg/g (3.5 g) [0.3% base]
Solution, ophthalmic, as hydrochloride: 3.5 mg/mL (2.5 mL, 5mL, 10 mL) [0.3% base]
Ciloxan®: 3.5 mg/mL (5 mL) [0.3% base; contains benzalkonium chloride]
Tablet, as hydrochloride: 100 mg [strength expressed as base], 250 mg [strength expressed as base], 500 mg [strength expressed as base], 750 mg [strength expressed as base]
Cipro®: 250 mg [strength expressed as base], 500 mg [strength expressed as base], 750 mg [strength expressed as base]
Tablet, extended release, as base and hydrochloride: 500 mg [strength expressed as base], 1000 mg [strength expressed as base]
Cipro® XR: 500 mg [strength expressed as base], 1000 mg [strength expressed as base]
Tablet, extended release, as hydrochloride:
Proquin® XR: 500 mg [strength expressed as base]
Tablet, extended release, as hydrochloride [dose pack]:
Proquin® XR: 500 mg (3s)
Pricing: U.S. (www.drugstore.com)
Solution (Ciloxan)
0.3% (5): $61.99
Solution (Cipro)
400 mg (40): $259.99
Solution (Ciprofloxacin HCl)
0.3% (2.5): $19.99
0.3% (5): $29.99
0.3% (10): $59.99
Tablet, 24-hour (Cipro XR)
500 mg (20): $187.54
Tablet, 24-hour (Ciprofloxacin-Ciproflox HCl)
500 mg (50): $394.99
Tablet, 24-hour (ProQuin XR)
500 mg (3): $39.99
500 mg (50): $499.99
Tablets (Cipro)
500 mg (30): $177.10
Tablets (Ciprofloxacin HCl)
250 mg (30): $117.99
500 mg (100): $39.99
750 mg (30): $135.99
750 mg (100): $429.99
References
Abramowicz M, “Antimicrobial Prophylaxis in Surgery,” Medical Letter on Drugs and Therapeutics, Handbook of Antimicrobial Therapy, 16th ed, New York, NY: Medical Letter, 2002.
American Academy of Pediatrics Committee on Drugs, “The Transfer of Drugs and Other Chemicals Into Human Milk,” Pediatrics, 2001, 108(3):776-89.
American Thoracic Society and Infectious Diseases Society of America, “Guidelines for the Management of Adults With Hospital-Acquired, Ventilator-Associated, and Healthcare-Associated Pneumonia,” Am J Respir Crit Care Med, 2005, 171(4):388-416.
Baddour LM, Wilson WR, Bayer AS, et al, “Infective Endocarditis. Diagnosis, Antimicrobial Therapy, and Management of Complications. A Statement for Healthcare Professionals from the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease in the Young, and the Councils on Clinical Cardiology, Stroke, and Cardiovascular Surgery and Anesthesia, American Heart Association,” Circulation, 2005, 111(23):e394-434.
Bayer A, Gajewska A, Stephens M, et al, “Pharmacokinetics of Ciprofloxacin in the Elderly,” Respiration, 1987, 51(4):292-5.
Centers for Disease Control and Prevention, “Update to CDC's Sexually Transmitted Diseases Treatment Guidelines, 2006: Fluoroquinolones No Longer Recommended for Treatment of Gonococcal Infections,” MMWR Recomm Rep, 2007, 56(14):332-6.
Centers for Disease Control and Prevention, “Prevention and Control of Meningococcal Disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP),” MMWR Recomm Rep, 2000, 49(RR-7):1-10. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4907a1.htm. Accessed May 5, 2004.
Centers for Disease Control and Prevention, “Update: Investigation of Bioterrorism-Related Anthrax and Interim Guidelines for Exposure Management and Antimicrobial Therapy, October 2001,” MMWR, October 26, 2001, 50(42):909-19. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5042a1.htm. Accessed October 26, 2001.
Chung AM, Reed MD, and Blumer JL, “Antibiotics and Breast-Feeding: A Critical Review of the Literature,” Paediatr Drugs, 2002, 4(12):817-37.
Cohen H and Francisco DH, “Twelve Gram Overdose of Ciprofloxacin With Mild Symptomatology,” Ann Pharmacother, 1994, 28(6):805-6.
Committee on Infectious Diseases, “The Use of Systemic Fluoroquinolones,” Pediatrics, 2006, 118(3):1287-92.
Davies SP, Azadian BS, Kox WJ, et al, “Pharmacokinetics of Ciprofloxacin and Vancomycin in Patients With Acute Renal Failure Treated by Continuous Haemodialysis,” Nephrol Dial Transplant, 1992, 7(8):848-54.
Food and Drug Administration (FDA), “CIPRO (Ciprofloxacin) Use by Pregnant and Lactating Women.” Available at http://www.fda.gov/cder/drug/infopage/cipro/cipropreg.htm. Last accessed August 9, 2004.
Friedrich LV and Dougherty R, “Fatal Hypoglycemia Associated With Levofloxacin,” Pharmacotherapy, 2004, 24(12):1807-12.
Frothingham R, “Glucose Homeostasis Abnormalities Associated With Use of Gatifloxacin,” Clin Infect Dis, 2005, 41(9):1269-76.
Gamboa F, Rivera JM, Gomez Mateos JM, et al, “Ciprofloxacin-Induced Henoch-Schönlein Purpura,” Ann Pharmacother, 1995, 29(1):84.
Gavin JR 3rd, Kubin R, Choudhri S, et al, “Moxifloxacin and Glucose Homeostasis: A Pooled-Analysis of the Evidence From Clinical and Postmarketing Studies,” Drug Saf, 2004, 27(9):671-86.
Giamarellou H, Kolokythas E, Petrikkos G, et al, “Pharmacokinetics of Three Newer Quinolones in Pregnant and Lactating Women,” Am J Med, 1989, 87(Suppl 5A):49-51.
Graumlich JF, Habis S, Avelino RR, et al, “Hypoglycemia in Inpatients After Gatifloxacin or Levofloxacin Therapy: Nested Case-Control Study,” Pharmacotherapy, 2005, 25(10):1296-302.
Guay DRP, Awni WM, Peterson PK, et al, “Single and Multiple Dose Pharmacokinetics of Oral Ciprofloxacin in Elderly Patients,” Int J Clin Pharmacol Ther Toxicol, 1988, 26(6):279-84.
Guharoy SR, “Serum Sickness Secondary to Ciprofloxacin Use,” Vet Hum Toxicol, 1994, 36(6):540-1.
Hughes WT, Armstrong D, Bodey GP, et al, “2002 Guidelines for the Use of Antimicrobial Agents in Neutropenic Patients With Cancer,” Clin Infect Dis, 2002, 15;34(6):730-51.
Kapila K, Chysky V, Hullman R, et al, “Worldwide Clinical Experience on Safety of Ciprofloxacin in Children on Compassionate Use Basis,” Proceedings of Third International Symposium on New Quinolones, Vancouver, Canada, 1990, 9.
Khaliq Y and Zhanel GG, “Fluoroquinolone-Associated Tendinopathy: A Critical Review of the Literature,” Clin Infect Dis, 2003, 36(11):1404-10.
Lawrence KR, Adra M, and Keir C, “Hypoglycemia-Induced Anoxic Brain Injury Possibly Associated With Levofloxacin,” J Infect, 2006, 52(6):e177-80.
Loebstein R, Addis A, Ho E, et al, “Pregnancy Outcome Following Gestational Exposure to Fluoroquinolones: A Multicenter, Prospective Controlled Study,” Antimicrob Agents Chemother, 1998, 42(6):1336-9.
Lomaestro BM and Bailie GR, “Quinolone-Cation Interactions: A Review,” DICP, 1991, 25(11):1249-58.
Mackay AD and Mehta A, “Autoimmune Haemolytic Anemia Associated With Ciprofloxacin,” Clin Lab Haematol, 1995, 17(1):97-8.
Malone RS, Fish DN, Abraham E, et al, “Pharmacokinetics of Levofloxacin and Ciprofloxacin During Continuous Renal Replacement Therapy in Critically Ill Patients,” Antimicrob Agents Chemother, 2001, 45(10):2949-54.
Mohr JF, McKinnon PS, Peymann PJ, et al, “A Retrospective, Comparative Evaluation of Dysglycemias in Hospitalized Patients Receiving Gatifloxacin, Levofloxacin, Ciprofloxacin, or Ceftriaxone,” Pharmacotherapy, 2005, 25(10):1303-9.
Mulhall JP and Bergmann LS, “Ciprofloxacin-Induced Acute Psychosis,” Urology, 1995, 46(1):102-3.
Mullen CA, “Ciprofloxacin in Treatment of Fever and Neutropenia in Pediatric Cancer Patients,”Pediatr Infect Dis J, 2003, 22(12):1138-42.
Nilsson-Ehle I and Ljungberg B, “Quinolone Disposition in the Elderly: Practical Implications,” Drugs Aging, 1991, 1(4):279-88.
Park-Wyllie LY, Juurlink DN, Kopp A, et al, “Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults,” N Engl J Med, 2006, 354(13):1352-61.
Paul J and Brown NM, “Tinnitus and Ciprofloxacin,” BMJ, 1995, 311(6999):232.
Rams TE and Slots J, “Antibiotics in Periodontal Therapy: An Update,” Compendium, 1992, 13(12):1130, 1132, 1134.
Rfidah EI, Findlay CA, and Beattie TJ, “Reversible Encephalopathy After Intravenous Ciprofloxacin Therapy,” Pediatr Nephrol, 1995, 9(2):250-1.
Rodriguez WJ, and Wiedermann BL, “The Role of Newer Oral Cephalosporins, Fluoroquinolones, and Macrolides in the Treatment of Pediatric Infections,” Adv Pediatr Infect Dis, 1994, 9:125-59.
Rubio TT, Miles MV, Lettieri JT, et al, “Pharmacokinetic Disposition of Sequential Intravenous/Oral Ciprofloxacin in Pediatric Cystic Fibrosis Patients With Acute Pulmonary Exacerbation,” Pediatr Infect Dis J, 1997, 16:112-7
Schaad UB, abdus Salam M, Aujard Y, et al, “Use of Fluoroquinolones in Pediatrics: Consensus Report of an International Society of Chemotherapy Commission,” Pediatr Infect Dis J, 1995, 14(1):1-9.
Sudip RG, “Serum Sickness Secondary to Ciprofloxacin Use,” Vet Hum Toxicol, 36(6):540-1, 1994.
Szarfman A, Chen M, and Blum MD, “More on Fluoroquinolone Antibiotics and Tendon Rupture,” N Engl J Med, 1995, 332(3):193.
Trotman RL, Williamson JC, Shoemaker DM, et al, “Antibiotic Dosing in Critically Ill Adult Patients Receiving Continuous Renal Replacement Therapy,” Clin Infect Dis, 2005, 41(8):1159-66.
Villenueve JP, Davies C, and Cote J, “Suspected Ciprofloxacin-Induced Hepatotoxicity,” Ann Pharmacother, 1995, 29(3):257-9.
Walker RC and Wright AJ, “The Fluoroquinolones,” Mayo Clin Proc, 1991, 66(12):1249-59.
Wang S and Rizvi AA, “Levofloxacin-Induced Hypoglycemia in a Nondiabetic Patient,” Am J Med Sci, 2006, 331(6):334-5.
Workowski KA and Berman SM, "Centers for Disease Control and Prevention: Sexually Transmitted Diseases Treatment Guidelines," MMWR, 2006, 55(RR-11):1-94.
Yew WW, Chau CH, Wong PC, et al, “Ciprofloxacin-Induced Renal Dysfunction in Patients With Mycobacterial Lung Infections,” Tuber Lung Dis, 1995, 76(2):173-5.
Zacher JL and Givone DM, “False-Positive Urine Opiate Screening Associated With Fluoroquinolone Use,” Ann Pharmacother, 2004, 38:1525-28.
Zimbabwe, Bangladesh, South Africa (Zimbasa) Dysentery Study Group, “Multicenter, Randomized, Double Blind Clinical Trial of Short Course Versus Standard Course Oral Ciprofloxacin for Shigella dysenteriae Type 1 Dysentery in Children,” Pediatr Infect Dis J, 2002, 21(12):1136-41.
International Brand Names
Lexi-Comp.com
Last full review/revision May 2008
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