Pronunciation:

(sip roe FLOKS a sin)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

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)

Use - Dental:

Use - Unlabeled/Investigational:

Pregnancy Risk Factor:

Pregnancy Implications:

Lactation:

Contraindications:

Warnings/Precautions:

Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. Quinolones may exacerbate myasthenia gravis, use with caution (rare, potentially life-threatening weakness of respiratory muscles may occur). Use caution in renal impairment. Avoid excessive sunlight; may cause moderate-to-severe phototoxicity reactions.

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, anosmia, bone marrow depression (life-threatening), candiduria, constipation, delirium, dyspepsia (adults), dysphagia, erythema multiforme, exfoliative dermatitis, fixed eruption, flatulence, hemolytic anemia, hepatic failure, hepatic necrosis, hyperesthesia, hyperglycemia, hypertonia, jaundice, methemoglobinemia, moniliasis, myalgia, myasthenia gravis, myoclonus, nystagmus, orthostatic hypotension, pancreatitis, pancytopenia (life-threatening or fatal), 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, torsade de pointes, twitching, vaginal candidiasis, vasculitis

Overdosage/Toxicology:

Drug Interactions:

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, 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, and some didanosine formulations (chewable/buffered tablets and pediatric powder for oral suspension) 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.

Phenytoin: Ciprofloxacin may decrease phenytoin levels; monitor.

Probenecid: May decrease renal secretion of quinolones.

Ropivacaine: Ciprofloxacin may decrease the metabolism of ropivacaine.

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.

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).

Stability:

Injection:

Premixed infusion: Store between 5°C to 25°C (41°F to 77°F); protect from light; avoid freezing.

Vial: Store between 5°C to 30°C (41°F to 86°F); protect from light; avoid freezing. May be diluted with NS, D5W, SWFI, D10W, D5¹/4NS, D5¹/2NS, LR. 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).

Compatibility:

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:

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: 1-2.5 hours

Excretion: Urine (30% to 50% as unchanged drug); feces (15% to 40%)

Dosage:

Children (see Warnings/Precautions):

Oral:

Complicated urinary tract infection or pyelonephritis: Children 1-17 years: 20-30 mg/kg/day in 2 divided doses (every 12 hours) for 10-21 days; maximum: 1.5 g/day

Cystic fibrosis (unlabeled use): Children 5-17 years: 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

Anthrax:

Inhalational (postexposure prophylaxis): 15 mg/kg/dose every 12 hours for 60 days; maximum: 500 mg/dose

Cutaneous (treatment, CDC guidelines): 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

I.V.:

Complicated urinary tract infection or pyelonephritis: Children 1-17 years: 6-10 mg/kg every 8 hours for 10-21 days (maximum: 400 mg/dose)

Cystic fibrosis (unlabeled use): Children 5-17 years: 30 mg/kg/day divided every 8 hours for 1 week, followed by oral therapy, has been reported in a clinical trial

Anthrax:

Inhalational (postexposure prophylaxis): 10 mg/kg/dose every 12 hours for 60 days; do not exceed 400 mg/dose (800 mg/day)

Inhalational/gastrointestinal/oropharyngeal (treatment, CDC guidelines): Initial: 10-15 mg/kg every 12 hours for 60 days (maximum: 500 mg/dose); switch to oral therapy when clinically appropriate; refer to Adults dosing for notes on combined therapy and duration

Adults: Oral:

Urinary tract infection:

Acute uncomplicated: Immediate release formulation: 100 mg or 250 mg every 12 hours for 3 days

Acute uncomplicated pyelonephritis: Extended release formulation: 1000 mg every 24 hours for 7-14 days

Uncomplicated/acute cystitis: Extended release formulation: 500 mg every 24 hours for 3 days

Mild/moderate: Immediate release formulation: 250 mg every 12 hours for 7-14 days

Severe/complicated:

Immediate release formulation: 500 mg every 12 hours for 7-14 days

Extended release formulation: 1000 mg every 24 hours for 7-14 days

Lower respiratory tract, skin/skin structure infections: 500-750 mg twice daily for 7-14 days depending on severity and susceptibility

Bone/joint infections: 500-750 mg twice daily for 4-6 weeks, depending on severity and susceptibility

Infectious diarrhea: 500 mg every 12 hours for 5-7 days

Intra-abdominal (in combination with metronidazole): 500 mg every 12 hours for 7-14 days

Typhoid fever: 500 mg every 12 hours for 10 days

Urethral/cervical gonococcal infections: 250-500 mg as a single dose (CDC recommends concomitant doxycycline or azithromycin due to developing resistance; avoid use in Asian or Western Pacific travelers)

Disseminated gonococcal infection (CDC guidelines): 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)

Chancroid (CDC guidelines): 500 mg twice daily for 3 days

Sinusitis (acute): 500 mg every 12 hours for 10 days

Chronic bacterial prostatitis: 500 mg every 12 hours for 28 days

Anthrax:

Inhalational (postexposure prophylaxis): 500 mg every 12 hours for 60 days

Cutaneous (treatment, CDC guidelines): 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

Adults: I.V.:

Bone/joint infections:

Mild to moderate: 400 mg every 12 hours for 4-6 weeks

Severe or complicated: 400 mg every 8 hours for 4-6 weeks

Lower respiratory tract, skin/skin structure infections:

Mild to moderate: 400 mg every 12 hours for 7-14 days

Severe or complicated: 400 mg every 8 hours for 7-14 days

Nosocomial pneumonia (mild to moderate to severe): 400 mg every 8 hours for 10-14 days

Prostatitis (chronic, bacterial): 400 mg every 12 hours for 28 days

Sinusitis (acute): 400 mg every 12 hours for 10 days

Urinary tract infection:

Mild to moderate: 200 mg every 12 hours for 7-14 days

Severe or complicated: 400 mg every 12 hours for 7-14 days

Febrile neutropenia (with piperacillin): 400 mg every 8 hours for 7-14 days

Intra-abdominal infection (with metronidazole): 400 mg every 12 hours for 7-14 days

Anthrax:

Inhalational (postexposure prophylaxis): 400 mg every 12 hours for 60 days

Inhalational/gastrointestinal/oropharyngeal (treatment, CDC guidelines): 400 mg every 12 hours. Note: Initial treatment should include two or more agents predicted to be effective (per CDC recommendations). Agents suggested for use in conjunction with ciprofloxacin or doxycycline include rifampin, vancomycin, imipenem, penicillin, ampicillin, chloramphenicol, clindamycin, and clarithromycin. May switch to oral antimicrobial therapy when clinically appropriate. Continue combined therapy for 60 days.

Elderly: No adjustment needed in patients with normal renal function

Ophthalmic:

Solution: Children >1 year and Adults:

Bacterial conjunctivitis: 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

Corneal ulcer: 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.

Ointment: Children >2 years and Adults: Bacterial conjunctivitis: 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

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 arteriovenous or venovenous hemodiafiltration effects: Administer 200-400 mg I.V. every 12 hours

Administration:

Oral: May administer with food to minimize GI upset; avoid antacid use; maintain proper hydration and urine output. Administer at least 2 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.

Parenteral: Administer by slow I.V. infusion over 60 minutes to reduce the risk of venous irritation (burning, pain, erythema, and swelling); final concentration for administration should not exceed 2 mg/mL

Monitoring Parameters:

Reference Range:

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. Ciprofloxacin may be taken 2 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:

Anesthesia and Critical Care Concerns/Other Considerations:

Cardiovascular Considerations:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Oncology: Emetic Potential:

Oncology: Vesicant:

Dosage Forms:

Infusion, [premixed in D5W] (Cipro®): 200 mg (100 mL); 400 mg (200 mL) [latex free]

Injection, solution (Cipro®): 10 mg/mL (20 mL, 40 mL, 120 mL)

Microcapsules for oral suspension (Cipro®): 250 mg/5 mL (100 mL); 500 mg/5 mL (100 mL) [strawberry flavor]

Ointment, ophthalmic, as hydrochloride (Ciloxan®): 3.33 mg/g [0.3% base] (3.5 g)

Solution, ophthalmic, as hydrochloride (Ciloxan®): 3.5 mg/mL [0.3% base] (2.5 mL, 5 mL, 10 mL) [contains benzalkonium chloride]

Tablet [film coated]: 250 mg, 500 mg, 750 mg

Cipro®: 100 mg, 250 mg, 500 mg, 750 mg

Tablet, extended release [film coated] (Cipro® XR): 500 mg [equivalent to ciprofloxacin hydrochloride 287.5 mg and ciprofloxacin base 212.6 mg]; 1000 mg [equivalent to ciprofloxacin hydrochloride 574.9 mg and ciprofloxacin base 425.2 mg]

International Brand Names: