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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Medication Safety Issues
Sound-alike/look-alike issues:
Cetraxal® may be confused with cefTRIAXone
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, otic solution, suspension
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
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. Auricularly, for acute otitis externa due to susceptible strains of Pseudomonas aeruginosa or Staphylococcus aureus
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 Considerations
Adverse events have been observed in some animal studies; therefore, the manufacturer classifies ciprofloxacin as pregnancy category C. Ciprofloxacin crosses the placenta and produces measurable concentrations in the amniotic fluid and cord serum. An increased risk of teratogenic effects has not been observed in animals or humans following ciprofloxacin use during pregnancy; however, because of concerns of cartilage damage in immature animals, ciprofloxacin should only be used during pregnancy if a safer option is not available. Ciprofloxacin is recommended for prophylaxis and treatment of pregnant women exposed to anthrax. Serum concentrations of ciprofloxacin may be lower during pregnancy than in nonpregnant patients.
Lactation
Enters breast milk/not recommended (AAP rates “compatible”)
Breast-Feeding Considerations
Ciprofloxacin is excreted in breast milk. Breast-feeding is not recommended by the manufacturer. The AAP considers ciprofloxacin to be “usually compatible with breast-feeding.” Due to the low concentrations in human milk, minimal toxicity would be expected in the nursing infant and infant serum levels were undetectable in one report. Nondose-related effects could include modification of bowel flora. There has been a single case report of perforated pseudomembranous colitis in a breast-feeding infant whose mom was taking ciprofloxacin.
Contraindications
Hypersensitivity to ciprofloxacin, any component of the formulation, or other quinolones; concurrent administration of tizanidine
Warnings/Precautions
Boxed Warnings:
• Tendon inflammation/rupture: See “Concerns related to adverse effects” below.
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 and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may cause moderate-to-severe phototoxicity reactions. Discontinue use if photosensitivity occurs.
• 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: [U.S. Boxed Warning]: There have been reports of tendon inflammation and/or rupture with quinolone antibiotics; risk may be increased with concurrent corticosteroids, organ transplant recipients, and in patients >60 years of age. Rupture of the Achilles tendon sometimes requiring surgical repair has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps) have also been reported. Strenuous physical activity may be an independent risk factor for tendonitis. Discontinue at first sign of tendon inflammation or pain. May occur even after discontinuation of therapy.
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. May increase risk of tendon rupture.
• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.
• 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.
• Syphilis: Since ciprofloxacin is ineffective in the treatment of syphilis and may mask symptoms, all patients should be tested for syphilis at the time of gonorrheal diagnosis and 3 months later.
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.
• G6PD deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients with latent or actual G6PD deficiency.
• 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
Systemic:
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 increased, 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
Otic:
1% to 10%:
Central nervous system: Headache (2% to 3%)
Local: Application site pain (2% to 3%), fungal superinfection (2% to 3%), pruritus (2% to 3%)
Metabolism/Transport Effects
Inhibits CYP1A2 (strong), 3A4 (weak)
Drug Interactions
Antacids: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Exceptions: Sodium Bicarbonate. Risk D: Consider therapy modification
Bendamustine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Bendamustine. Concentrations of the active metabolites of bendamustine may be decreased. Risk C: Monitor therapy
Caffeine: Quinolone Antibiotics may decrease the metabolism of Caffeine. Risk C: Monitor therapy
Calcium Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Exceptions: Calcium Chloride. Risk D: Consider therapy modification
Corticosteroids (Systemic): Quinolone Antibiotics may enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk of tendon-related side effects, including tendonitis and rupture, may be enhanced. Risk C: Monitor therapy
CYP1A2 Substrates: CYP1A2 Inhibitors (Strong) may decrease the metabolism of CYP1A2 Substrates. Risk D: Consider therapy modification
Didanosine: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents (excludes enteric coated formulation of didanosine). Risk D: Consider therapy modification
Erlotinib: Ciprofloxacin may increase the serum concentration of Erlotinib. Risk C: Monitor therapy
Insulin: May enhance the hyperglycemic effect of Quinolone Antibiotics. Insulin may enhance the hypoglycemic effect of Quinolone Antibiotics. Risk C: Monitor therapy
Iron Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk D: Consider therapy modification
Magnesium Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Risk D: Consider therapy modification
Methotrexate: Ciprofloxacin may increase the serum concentration of Methotrexate. Risk C: Monitor therapy
Mycophenolate: Quinolone Antibiotics may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolone Antibiotics. Risk C: Monitor therapy
Pentoxifylline: Ciprofloxacin may enhance the adverse/toxic effect of Pentoxifylline. Risk C: Monitor therapy
P-Glycoprotein Inducers: May decrease the serum concentration of P-Glycoprotein Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy
P-Glycoprotein Inhibitors: May increase the serum concentration of P-Glycoprotein Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy
Phenytoin: Ciprofloxacin may decrease the serum concentration of Phenytoin. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Quinolone Antibiotics. Risk C: Monitor therapy
QTc-Prolonging Agents: Ciprofloxacin may enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Quinapril: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
Ropinirole: Ciprofloxacin may decrease the metabolism of Ropinirole. Risk C: Monitor therapy
Ropivacaine: Ciprofloxacin may decrease the metabolism of Ropivacaine. Risk C: Monitor therapy
Sevelamer: May decrease the absorption of Quinolone Antibiotics. Risk D: Consider therapy modification
Sucralfate: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
Sulfonylureas: Quinolone Antibiotics may enhance the hypoglycemic effect of Sulfonylureas. This appears to be particularly concerning early in the course of combination therapy. Quinolone Antibiotics may diminish the hypoglycemic effect of Sulfonylureas. With longer-term combination, there is a greater risk of hyperglycemia. Risk C: Monitor therapy
Theophylline Derivatives: Quinolone Antibiotics may decrease the metabolism of Theophylline Derivatives. Ciprofloxacin and enoxacin are of greatest concern. Theophylline/quinolone therapy might augment the seizure-producing potential of each of the individual agents. Exceptions: Dyphylline. Risk D: Consider therapy modification
TiZANidine: Ciprofloxacin may decrease the metabolism of TiZANidine. Risk X: Avoid combination
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Quinolone Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Zinc Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Risk D: Consider therapy modification
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 2°C to 25°C (36°F to 77°F). Protect from light.
Otic solution: Store at 15°C to 25°C (59°F to 77°F). Protect from light. Store unused single-dose containers in foil overwrap pouch until immediately prior to use.
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)
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:
Acute otitis externa: Children ?1 year: Refer to adult dosing
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:
Acute otitis externa: Otic solution: Instill 0.25 mL (contents of 1 single-dose container) into affected ear twice daily for 7 days
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: Other
Ophthalmic ointment/solution: For topical ophthalmic use only; avoid touching tip of applicator to eye or other surfaces.
Otic solution: For otic use only. Prior to use, warm solution by holding container in hands for at least 1 minute. Patient should lie down with affected ear upward and medication instilled. Patients should remain in the position for at least 1 minute to allow penetration of solution.
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
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; and sudden itching or skin rash. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.
Oral: Take exactly according to specific directions (eg, timing with meals, dairy products, antacids or 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 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) or increased sensitivity to sunlight (use sunscreen, wear protective clothing and dark glasses, and avoid direct exposure to sunlight or tanning salons). If tendon inflammation or pain occurs or you experience signs of an allergic reaction (eg, itching, skin rash, 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); 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 or occurs 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
See Warnings/Precautions regarding tendon rupture in patients >60 years of age. 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® I.V.: 200 mg (100 mL); 400 mg (200 mL)
Injection, solution [concentrate]: 10 mg/mL (20 mL, 40 mL, 120 mL)
Cipro® I.V.: 10 mg/mL (20 mL, 40 mL [DSC])
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) [equivalent to ciprofloxacin base 0.3%]
Solution, ophthalmic, as hydrochloride: 3.5 mg/mL (2.5 mL, 5mL, 10 mL) [equivalent to ciprofloxacin base 0.3%]
Ciloxan®: 3.5 mg/mL (5 mL) [0.3% base; contains benzalkonium chloride]
Solution, otic, as hydrochloride [preservative free]:
Cetraxal®: 0.5 mg/0.25 mL (14s) [equivalent to ciprofloxacin base 0.2%]
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) [strength expressed as base]
Pricing: U.S. (www.drugstore.com)
Solution (Ciloxan)
0.3% (5): $65.07
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): $16.99
500 mg (100): $39.96
750 mg (30): $135.99
750 mg (100): $429.99
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International Brand Names
Lexi-Comp.com
Last full review/revision July 2009
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