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Special Alerts
Fluroquinolones: New Boxed Warning Required for Tendonitis and Tendon Rupture - July 2008
The Food and Drug Administration (FDA) is notifying the manufacturers of all systemic fluoroquinolone antibiotics that a boxed warning must now be included in the prescribing information describing the increased risk of tendonitis and tendon rupture associated with the use of these agents. In addition, the manufacturers must also develop a Medication Guide to be distributed with outpatient prescriptions. Otic and ophthalmic agents are not included in this mandate.
Fluoroquinolone-associated tendonitis and tendon rupture most frequently involve the Achilles tendon (~90%; Khaliq, 2003). Risk factors that may further increase the risk include age >60 years, kidney, heart, or lung transplantation, and/or concomitant corticosteroid use. Tendonitis or tendon rupture may occur during or after completion of therapy; cases have been reported several months after discontinuation of therapy (Szarfman, 1995). Physicians should advise patients to discontinue fluoroquinolone therapy, avoid exercise and use of the affected area, and contact their healthcare provider immediately at the first sign of tendon pain, swelling, or inflammation.
Additional information may be found at http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone
References:
Khaliq Y and Zhanel GG, “Fluoroquinolone-Associated Tendinopathy: A Critical Review of the Literature,” Clin Infect Dis, 2003, 36(11):1404-10.
Szarfman A, Chen M, and Blum MD, “More on Fluoroquinolone Antibiotics and Tendon Rupture,” N Engl J Med, 1995, 332(3):193.
Medication Safety Issues
Sound-alike/look-alike issues:
Floxin® may be confused with Flexeril®
Ocuflox® may be confused with Occlusal®-HP, Ocufen®
International issues:
Floxin® may be confused with Flogen® which is a brand name for naproxen in Mexico
Floxin® may be confused with Fluoxin® which is a brand name for fluoxetine in the Czech Republic and Romania
Floxin® may be confused with Flexin® which is a brand name for orphenadrine in Israel and indomethacin in Great Britain
Pronunciation
(oh FLOKS a sin)
U.S. Brand Names
Index Terms
Generic Available
Yes
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Quinolone antibiotic for the treatment of acute exacerbations of chronic bronchitis, community-acquired pneumonia, skin and skin structure infections (uncomplicated), urethral and cervical gonorrhea (acute, uncomplicated), urethritis and cervicitis (nongonococcal), mixed infections of the urethra and cervix, pelvic inflammatory disease (acute), cystitis (uncomplicated), urinary tract infections (complicated), prostatitis
Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal disease.
Ophthalmic: Treatment of superficial ocular infections involving the conjunctiva or cornea due to strains of susceptible organisms
Otic: Otitis externa, chronic suppurative otitis media, acute otitis media
Use: Unlabeled/Investigational
Epididymitis (nongonococcal), leprosy, Traveler's diarrhea
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in some animal studies; therefore, the manufacturer classifies ofloxacin as pregnancy category C. Ofloxacin crosses the placenta and produces measurable concentrations in the amniotic fluid. An increased risk of teratogenic effects has not been observed in animals or humans following ofloxacin use during pregnancy; however, because of concerns of cartilage damage in immature animals, ofloxacin should only be used during pregnancy if a safer option is not available. Serum concentrations of ofloxacin may be lower during pregnancy than in nonpregnant patients.
Lactation
Enters breast milk/not recommended (AAP rates “compatible”)
Breast-Feeding Considerations
Ofloxacin is excreted in breast milk. Breast-feeding is not recommended by the manufacturer. The AAP considers ofloxacin to be “usually compatible with breast-feeding.” Due to the low concentrations in human milk, minimal toxicity would be expected in the nursing infant. Nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to ofloxacin or other members of the quinolone group, such as nalidixic acid, oxolinic acid, cinoxacin, norfloxacin, and ciprofloxacin; hypersensitivity to any component of the formulation
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).
• 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 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:
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• 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.
• 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.
Special populations:
• Elderly: Adverse effects (eg, tendon rupture, QT changes) may be increased in the elderly.
• Pediatrics: Safety and efficacy have not been established in children.
Adverse Reactions
Systemic:
1% to 10%:
Cardiovascular: Chest pain (1% to 3%)
Central nervous system: Headache (1% to 9%), insomnia (3% to 7%), dizziness (1% to 5%), fatigue (1% to 3%), somnolence (1% to 3%), sleep disorders (1% to 3%), nervousness (1% to 3%), pyrexia (1% to 3%)
Dermatologic: Rash/pruritus (1% to 3%)
Gastrointestinal: Diarrhea (1% to 4%), vomiting (1% to 4%), GI distress (1% to 3%), abdominal cramps (1% to 3%), flatulence (1% to 3%), abnormal taste (1% to 3%), xerostomia (1% to 3%), appetite decreased (1% to 3%), nausea (3% to 10%), constipation (1% to 3%)
Genitourinary: Vaginitis (1% to 5%), external genital pruritus in women (1% to 3%)
Ocular: Visual disturbances (1% to 3%)
Respiratory: Pharyngitis (1% to 3%)
Miscellaneous: Trunk pain
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Anaphylaxis reactions, anxiety, blurred vision, chills, cognitive change, cough, depression, dream abnormality, ecchymosis, edema, erythema nodosum, euphoria, extremity pain, hallucinations, hearing acuity decreased, hepatic dysfunction, hepatic failure (some fatal), hepatitis, hyper-/hypoglycemia, hypertension, interstitial nephritis, lightheadedness, malaise, myasthenia gravis exacerbation, palpitation, paresthesia, peripheral neuropathy, photophobia, photosensitivity, pneumonitis, psychotic reactions, rhabdomyolysis, seizure, Stevens-Johnson syndrome, syncope, tendonitis and tendon rupture, thirst, tinnitus, torsade de pointes, Tourette's syndrome, toxic epidermal necrolysis, vasculitis, vasodilation, vertigo, weakness, weight loss
Ophthalmic: Frequency not defined:
Central nervous system: Dizziness
Gastrointestinal: Nausea
Ocular: Blurred vision, burning, chemical conjunctivitis/keratitis, discomfort, dryness, edema, eye pain, foreign body sensation, itching, photophobia, redness, stinging, tearing
Otic:
>10%: Local: Application site reaction (<1% to 17%)
1% to 10%:
Central nervous system: Dizziness (?1%), vertigo (?1%)
Dermatologic: Pruritus (1% to 4%), rash (1%)
Gastrointestinal: Taste perversion (7%)
Neuromuscular & skeletal: Paresthesia (1%)
<1% (Limited to important or life-threatening): Diarrhea, fever, headache, hearing loss (transient), hypertension, nausea, otorrhagia, tinnitus, tremor, vomiting, xerostomia
Postmarketing and/case reports: Transient neuropsychiatric disturbances
Metabolism/Transport Effects
Inhibits CYP1A2 (strong)
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
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
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; 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
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
Quinapril: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
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 hyperglycemic effect of Sulfonylureas. Quinolone Antibiotics may enhance the hypoglycemic effect of Sulfonylureas. 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
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: Ofloxacin average peak serum concentrations may be decreased by 20% if taken with food.
Herb/Nutraceutical: Avoid dong quai, St John's wort (may also cause photosensitization).
Storage
Ophthalmic and otic solution: Store between 15°C to 25°C (59°F to 77°F).
Otic Singles™: Store between 15°C to 30°C (59°F to 86°F). Store in pouch to protect from light.
Tablet: Store below 30°C (86°F).
Mechanism of Action
Ofloxacin is a DNA gyrase inhibitor. DNA gyrase is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; bactericidal
Pharmacodynamics/Kinetics
Absorption: Well absorbed; food causes only minor alterations
Distribution: Vd: 2.4-3.5 L/kg
Protein binding: 32%
Bioavailability: Oral: 98%
Half-life elimination: Biphasic: 4-5 hours and 20-25 hours (accounts for <5%); prolonged with renal impairment
Excretion: Primarily urine (as unchanged drug)
Dosage
Usual dosage range:
Children ?6 months: Otic: 5 drops daily
Children >1 year: Ophthalmic: 1-2 drops every 30 minutes to 4 hours initially, decreasing to every 4-6 hours
Children >12 years: Otic: 10 drops once or twice daily
Adults:
Ophthalmic: 1-2 drops every 30 minutes to 4 hours initially, decreasing to every 4-6 hours
Oral: 200-400 mg every 12 hours
Otic: 10 drops once or twice daily
Indication-specific dosing:
Children 6 months to 13 years: Otic:
Otitis externa: Instill 5 drops (or the contents of 1 single-dose container) into affected ear(s) once daily for 7 days
Children 1-12 years: Otic:
Acute otitis media with tympanostomy tubes: Instill 5 drops (or the contents of 1 single-dose container) into affected ear(s) twice daily for 10 days
Children >1 year and Adults: Ophthalmic:
Conjunctivitis: Instill 1-2 drops in affected eye(s) every 2-4 hours for the first 2 days, then use 4 times/day for an additional 5 days
Corneal ulcer: Instill 1-2 drops every 30 minutes while awake and every 4-6 hours after retiring for the first 2 days; beginning on day 3, instill 1-2 drops every hour while awake for 4-6 additional days; thereafter, 1-2 drops 4 times/day until clinical cure.
Children >12 years and Adults: Otic:
Otitis media, chronic suppurative with perforated tympanic membranes: Instill 10 drops (or the contents of 2 single-dose containers) into affected ear twice daily for 14 days
Children ?13 years and Adults: Otic:
Otitis externa: Instill 10 drops (or the contents of 2 single-dose containers) into affected ear(s) once daily for 7 days
Adults: Oral:
Cervicitis/urethritis:
Nongonococcal: 300 mg every 12 hours for 7 days
Gonococcal (acute, uncomplicated): 400 mg as a single dose; Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of uncomplicated gonococcal disease.
Chronic bronchitis (acute exacerbation), community-acquired pneumonia, skin and skin structure infections (uncomplicated): 400 mg every 12 hours for 10 days
Epididymitis, nongonococcal (unlabeled use): 300 mg twice daily for 10 days
Leprosy (unlabeled use): 400 mg once daily
Pelvic inflammatory disease (acute): 400 mg every 12 hours for 10-14 days with or without metronidazole; Note: The CDC recommends use only if standard cephalosporin therapy is not feasible and community prevalence of quinolone-resistant gonococcal organisms is low. Culture sensitivity must be confirmed.
Prostatitis:
Acute: 400 mg for 1 dose, then 300 mg twice daily for 10 days
Chronic: 200 mg every 12 hours for 6 weeks
Traveler's diarrhea (unlabeled use): 300 mg twice daily for 3 days
UTI:
Uncomplicated: 200 mg every 12 hours for 3-7 days
Complicated: 200 mg every 12 hours for 10 days
Dosing adjustment/interval in renal impairment: Adults: Oral: After a normal initial dose, adjust as follows:
Clcr 20-50 mL/minute: Administer usual dose every 24 hours
Clcr <20 mL/minute: Administer half the usual dose every 24 hours
Continuous arteriovenous or venovenous hemodiafiltration effects: Administer 300 mg every 24 hours
Dosing adjustment in hepatic impairment: Severe impairment: Maximum dose: 400 mg/day
Administration: Oral
Do not take within 2 hours of food or any antacids which contain zinc, magnesium, or aluminum.
Administration: Other
Ophthalmic: For ophthalmic use only; avoid touching tip of applicator to eye or other surfaces.
Otic: Prior to use, warm solution by holding container in hands for 1-2 minutes. Patient should lie down with affected ear upward and medication instilled. Pump tragus 4 times to ensure penetration of medication. Patient should remain in this position for 5 minutes.
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.
Patient Education
Do not take any new prescription or OTC medications or herbal products during therapy without consulting prescriber. Take oral tablets as directed on an empty stomach (2 hours before or 2 hours after meals, dairy products, antacids, or other medication). Complete full course of therapy, even if symptoms resolve. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Consult prescriber before having any vaccination. May cause dizziness, lightheadedness, or headache (use caution when driving or engaging in tasks that require alertness until response to drug is known); nausea, vomiting, or taste perversion (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help). 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 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. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.
Ophthalmic: Wash hands before instilling solution. Sit or lie down to instill. Open eye, look at ceiling, and instill prescribed amount of solution as directed. Close eye, roll eye in all directions, and apply gentle pressure to inner corner of eye. Do not touch tip of applicator or let tip of applicator touch eye (may cause eye infection, eye damage, or vision loss). Do not wear contact lenses during therapy. Temporary stinging, blurred vision, dry eyes, or a bad taste in your mouth may occur after installation. Report persistent pain, burning, excessive tearing, decreased visual acuity, swelling, itching, or worsening of condition.
Otic: Wash hands before and after applying drops. Warm solution by holding container in hands for a few minutes. Lie with affected ear up and instill prescribed number of drops into ear. Remain on side with ear up for 5 minutes.
Geriatric Considerations
Dosage must be carefully adjusted to renal function. The half-life of ofloxacin may be prolonged and serum concentrations are elevated in elderly patients even in the absence of overt renal impairment. The risk of torsade de pointes and tendon inflammation and/or rupture associated with the concomitant use of corticosteroids and quinolones is increased in the elderly population.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation) and abnormal taste.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause drowsiness, dizziness, nervousness, or insomnia; quinolones reported to cause restlessness, hallucinations, euphoria, depression, panic, and paranoia
Mental Health: Effects on Psychiatric Treatment
Inhibits CYP1A2 isoenzyme; use caution with clozapine and other psychotropics; monitor for adverse effects
Nursing: Physical Assessment/Monitoring
Assess results of culture and sensitivity tests and patient's allergy history before initiating therapy. Use caution with known or suspected CNS disorders; current or potential for QT prolongation; renal impairment; or diabetes. Assess potential for interactions with other pharmacological or herbal agents patient may be taking. See administration specifics for different formulations (otic, ophthalmic, oral). Patient should be monitored closely; if an allergic reaction occurs (itching, urticaria, dyspnea or facial edema, loss of consciousness, tingling, cardiovascular collapse), drug should be discontinued immediately and prescriber notified. Evaluate results of laboratory tests, therapeutic effectiveness (resolution of infection), and adverse reactions (eg, hypersensitivity reactions [severe reactions, including anaphylaxis, have occurred with quinolone therapy], opportunistic infection, tendon rupture, persistent diarrhea [C. difficile-associated colitis can occur up to 2 months post treatment]) regularly during prolonged therapy. Teach patient proper use (according to 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.
Solution, ophthalmic [drops]: 0.3% (5 mL, 10 mL)
Ocuflox®: 0.3% (5 mL) [contains benzalkonium chloride]
Solution, otic [drops]: 0.3% (5 mL, 10 mL)
Floxin®: 0.3% (5 mL, 10 mL) [contains benzalkonium chloride]
Floxin® Otic Singles™: 0.3% (0.25 mL) [contains benzalkonium chloride; packaged as 2 single-dose containers per pouch, 10 pouches per carton, total net volume 5 mL]
Tablet: 200 mg, 300 mg, 400 mg
Pricing: U.S. (www.drugstore.com)
Solution (Floxin Otic)
0.3% (5): $75.99
0.3% (10): $136.04
Solution (Ocuflox)
0.3% (5): $52.99
0.3% (10): $91.61
Solution (Ofloxacin)
0.3% (5): $17.99
0.3% (5): $59.99
0.3% (10): $40.00
0.3% (10): $92.99
Tablets (Ofloxacin)
200 mg (14): $53.99
300 mg (14): $65.99
400 mg (30): $125.00
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.
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, "Sexually Transmitted Diseases Treatment Guidelines, 2006," MMWR, 2006, 55(RR-11): 1-94.
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.
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.
Hoogkamp-Korstanje JA, “In vitro Activities of Ciprofloxacin, Levofloxacin, Lomefloxacin, Ofloxacin, Pefloxacin, Sparfloxacin, and Trovafloxacin Against Gram-Positive and Gram-Negative Pathogens From Respiratory Tract Infections,” J Antimicrob Chemother, 1997, 40(3):427-31.
Hooper DC and Wolfson JS, “Fluoroquinolone Antimicrobial Agents,” N Engl J Med, 1991, 324(6):384-94.
Jacobs MR, Felmingham D, Appelbaum PC, et al, “The Alexander Project 1998-2000: Susceptibility of Pathogens Isolated From Community-Acquired Respiratory Tract Infection to Commonly Used Antimicrobial Agents,” J Antimicrob Chemother, 2003, 52(2):229-46.
Khaliq Y and Zhanel GG, “Fluoroquinolone-Associated Tendinopathy: A Critical Review of the Literature,” Clin Infect Dis, 2003, 36(11):1404-10.
Kohler RB, Arkins N, and Tack KJ, “Accidental Overdose of Intravenous Ofloxacin With Benign Outcome,” Antimicrob Agents Chemother, 1991, 35(6):1239-40.
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.
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.
Monk JP and Campoli-Richards DM, “Ofloxacin. A Review of Its Antibacterial Activity, Pharmacokinetic Properties, and Therapeutic Use,” Drugs, 1987, 33(4):346-91.
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.
Peled Y, Friedman S, Hod M, et al, “Ofloxacin During the Second Trimester of Pregnancy,” DICP, 1991, 25(11):1181-2.
Stein GE, “The 4-Quinolone Antibiotics: Past, Present, and Future,” Pharmacotherapy, 1988, 8(6):301-14.
Szarfman A, Chen M, and Blum MD, “More on Fluoroquinolone Antibiotics and Tendon Rupture,” N Engl J Med, 1995, 332(3):193.
Thalhammer F, Kletzmayr J, El Menyawi I, et al, “Ofloxacin Clearance During Hemodialysis: A Comparison of Polysulfone and Cellulose Acetate Hemodialyzers,” Am J Kidney Dis, 1998, 32(4):642-5.
Thomas RJ and Reagan DR, “Association of a Tourette-Like Syndrome With Ofloxacin,” Ann Pharmacother, 1996, 30(2):138-41.
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.
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.
Zacher JL and Givone DM, “False-Positive Urine Opiate Screening Associated With Fluoroquinolone Use,” Ann Pharmacother, 2004, 38:1525-28.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
Content last modified August 2008
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