Pharmacologic class: Fluoroquinolone
Therapeutic class: Anti-infective
Pregnancy risk category C
FDA Box Warning
• Fluoroquinolones for systemic use are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in patients usually over age 60, with concomitant use of corticosteroids, and in kidney, heart, and lung transplant recipients.
Inhibits bacterial DNA synthesis by inhibiting DNA gyrase in susceptible gram-negative and gram-positive organisms
Injection: 200 mg/20 ml, 400 mg/40 ml, 200 mg/100 ml premixed in dextrose 5% in water (D5W), 400 mg/200 ml premixed in D5W, 1,200 mg/120-ml bulk package
Ophthalmic ointment: 3.5-g tube
Ophthalmic solution: 2.5-ml and 5-ml plastic dispensers
Otic solution: 0.2% (0.5 mg in 0.25 ml) in single-use container
Tablets: 250 mg, 500 mg, 750 mg
Indications and dosages
➣ Acute sinusitis
Adults: 500 mg P.O. q 12 hours or 400 mg I.V. q 12 hours for 10 days
Adults: 500 mg P.O. q 12 hours or 400 mg I.V. q 12 hours for 28 days
➣ Intra-abdominal infections
Adults: 500 mg P.O. q 12 hours or 400 mg I.V. q 12 hours for 7 to 14 days
➣ Febrile neutropenic patients
Adults: 400 mg I.V. q 8 hours for 7 to 14 days
Adults: 500 mg P.O. as a single dose
➣ Infectious diarrhea
Adults: 500 mg P.O. q 12 hours for 5 to 7 days
➣ Inhalation anthrax (postexposure)
Adults: 500 mg P.O. q 12 hours for 60 days or 400 mg I.V. q 12 hours for 60 days
Children: 15 mg/kg P.O. q 12 hours for 60 days (not to exceed 500 mg/dose), or 10 mg/kg I.V. q 12 hours for 60 days, not to exceed 400 mg/dose
➣ Infections of lower respiratory tract, skin and skin structures, bones, and joints
Adults: 500 to 750 mg P.O. q 12 hours or 400 mg I.V. q 8 hours for 7 to 14 days. Severe bone and joint infections may necessitate up to 6 weeks of therapy.
➣ Nosocomial pneumonia
Adults: 400 mg I.V. q 8 hours for 10 to 14 days
➣ Typhoid fever
Adults: 500 mg P.O. q 12 hours for 10 days
➣ Urinary tract infections
Adults: 250 to 500 mg P.O. q 12 hours or 200 to 400 mg I.V. q 12 hours for 3 days in acute uncomplicated infection or for 7 to 14 days in acute complicated infection
➣ Complicated urinary tract infections or pyelonephritis
Children ages 1 to 17: 6 to 10 mg/kg I.V. q 8 hours for 10 to 21 days (maximum, 400 mg/dose; not to be exceeded, even in patients weighing more than 51 kg [112 lb]). Or, 10 to 20 mg/kg P.O. q 12 hours for 10 to 21 days (maximum, 750 mg/dose; not to be exceeded, even in patients weighing more than 51 kg).
➣ Acute otitis externa
Adults: Instill contents of one single-use otic solution container (0.5 mg) into affected ear b.i.d. (approximately 12 hours apart) for 7 days
➣ Bacterial conjunctivitis caused by susceptible organisms
Adults: 0.5″ ribbon of ophthalmic ointment applied to conjunctival sac t.i.d. on first 2 days, then 0.5" ribbon b.i.d. for 5 days. Or one to two drops of ophthalmic solution applied to conjunctival sac q 2 hours while awake for 2 days, then one or two drops q 4 hours while awake for 5 days.
➣ Corneal ulcers caused by susceptible organisms
Adults: Two drops of ophthalmic solution instilled into affected eye q 15 minutes for first 6 hours, then two drops into affected eye q 30 minutes for remainder of first day. On second day, two drops of ophthalmic solution hourly; on days 3 through 14, two drops q 4 hours.
• Renal impairment or insufficiency
• Cystic fibrosis
• Pseudomembranous colitis caused by anti-infectives
• Hypersensitivity to drug or other fluoroquinolones
• Comcomitant administration of tizanidine
Use cautiously in:
• cirrhosis, renal impairment, underlying CNS disease
• concurrent use of theophylline (risk of serious or fatal reactions, such as cardiac arrest, seizures, status epilepticus, and respiratory failure)
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 18 (except for complicated urinary tract infection, pyelonephritis, and postexposure inhalation antrax only).
• Administer oral drug with or without food but not with dairy products or calcium-fortified juices alone; however, drug may be taken with a meal that contains these products.
• Infuse I.V. dose over at least 1 hour, using pump to ensure 1-hour duration.
☞ Know that too-rapid I.V. infusion increases risk of anaphylaxis and other adverse reactions.
☞ Know that treatment with ophthalmic solution may be continued after 14 days if corneal re-epithelialization hasn't occurred.
CNS: agitation, headache, restlessness, confusion, delirium, peripheral neuropathy, toxic psychosis
CV: orthostatic hypotension, vasculitis
EENT: nystagmus; with ophthalmic use-blurred vision; burning, stinging, irritation, itching, tearing, and redness of eyes; eyelid itching, swelling, or crusting; sensitivity to light
GI: nausea, vomiting, diarrhea, constipation, abdominal pain or discomfort, dyspepsia, dysphagia, flatulence, pancreatitis, pseudomembranous colitis
GU: albuminuria, candiduria, renal calculi
Hematologic: methemoglobinemia, agranulocytosis, hemolytic anemia
Hepatic: jaundice, hepatic necrosis
Metabolic: hyperglycemia, hyperkalemia
Musculoskeletal: myalgia, myoclonus, tendinitis, tendon rupture
Skin: rash, exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme photosensitivity
Other: injection-site reaction, altered taste, anosmia, exacerbation of myasthenia gravis, overgrowth of nonsusceptible organisms, hypersensitivity reactions including anaphylaxis and Stevens-Johnson syndrome
Drug-drug. Antacids, bismuth subsalicylate, iron salts, sucralfate, zinc salts: decreased ciprofloxacin absorption
Cyclosporine: transient creatinine increase
Hormonal contraceptives: reduced contraceptive efficacy
Oral anticoagulants: increased anticoagulant effects
Phenytoin: increased or decreased phenytoin blood level
Probenecid: decreased renal elimination of ciprofloxacin, causing increased blood level
Theophylline: increased theophylline blood level, greater risk of toxicity
Tizanidine: significantly elevated tizanidine plasma level
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, cholesterol, glucose, lactate dehydrogenase, potassium, triglycerides: increased levels Prothrombin time: prolonged
Drug-food. Caffeine: interference with caffeine clearance
Concurrent tube feedings, milk or yogurt (when consumed alone with ciprofloxacin): impaired drug absorption
Drug-herbs. Fennel: decreased drug absorption
• In patients with renal insufficiency, assess creatinine level before giving first dose and at least once a week during prolonged therapy. Monitor drug blood level closely.
☞ Watch for signs and symptoms of serious adverse reactions, including GI problems, jaundice, tendon problems, and hypersensitivity reactions.
• Tell patient to take drug with or without food at the same time each day.
• Advise patient not to take drug with dairy products or calcium-fortified juices alone or with caffeinated beverages.
• Advise patient to drink 8 oz of water every hour while awake to ensure adequate hydration.
☞ Instruct patient to stop taking drug and notify prescriber at first sign of burning, numbness, or tingling in hands or feet; yellow eyes or skin; unusual tiredness; persistent diarrhea; rash; or tendon pain, swelling, or inflammation.
• Advise patient to avoid excessive exposure to sun or ultraviolet light and to discontinue drug and notify prescriber if phototoxicity (burning, erythema, exudation, vesicles, blistering, edema) occurs.
• Advise patient taking hormonal contraceptives to use supplemental birth control method, such as condoms, because drug reduces contraceptive efficacy.
• Inform breastfeeding patient that drug is excreted in breast milk and can affect infant's bone growth. Advise her to consult prescriber before using drug.
• Teach patient how to use eye ointment or solution and tell patient not to touch eye dropper tip to any surface, to avoid contamination.
• Instruct patient how to use ear solution and to lie with affected ear upward for at least 1 minute after instilling solution.
• Caution patient with bacterial conjunctivitis not to wear contact lenses.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.