Version May 2024
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue ofloxacin immediately and avoid the use of fluoroquinolones in patients who experience any of these serious adverse reactions. Because fluoroquinolones have been associated with serious adverse reactions, reserve ofloxacin for use in patients who have no alternative treatment options for the following indications: acute exacerbation of chronic bronchitis and acute uncomplicated cystitis.
Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ofloxacin in patients with a known history of myasthenia gravis.
Epididymitis, acute (off-label use):
Likely caused by enteric organisms: Oral: 200 mg twice daily for 14 days (Ref).
Likely caused by sexually transmitted chlamydia and gonorrhea, and enteric organisms (patients who practice insertive anal sex): Oral: 200 mg twice daily for 10 days in combination with ceftriaxone (Ref).
Plague (Y. pestis), (alternative agent) (off-label use):
Note: Consult public health officials for event-specific recommendations.
Postexposure prophylaxis: Oral: 400 mg every 12 hours for 7 days (Ref).
Treatment, excluding meningitis: Oral: 400 mg every 12 hours for 7 to 14 days and for at least a few days after clinical resolution (Ref).
Prostatitis: Oral: 300 mg every 12 hours for 6 weeks.
Sexually transmitted infections:
Cervicitis/urethritis due to Chlamydia trachomatis: Oral: 300 mg every 12 hours for 7 days.
Pelvic inflammatory disease, outpatient therapy, mild to moderate disease (alternative agent):
Note: Reserve fluoroquinolones for patients who cannot use first-line options and are at low risk for fluoroquinolone-resistant Neisseria gonorrhoeae (eg, prevalence is <5% in the location where the infection was acquired) (Ref).
Oral: 400 mg every 12 hours for 10 to 14 days. Guidelines recommend use of a fluoroquinolone in combination with metronidazole (Ref).
Urinary tract infection:
Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder without signs/symptoms of upper tract, prostate, or systemic infection) (alternative agent):
Note: Use is discouraged due to safety concerns and increasing resistance; reserve for those who have no alternative treatment options (Ref). However, for men who have severe symptoms or there is concern for early prostate involvement, some experts prefer fluoroquinolones (Ref).
Oral: 200 mg every 12 hours for 3 days (females) or 5 days (males) (Ref).
Urinary tract infection, complicated (including pyelonephritis):
Note: If the prevalence of fluoroquinolone resistance is >10%, an initial dose of a long-acting parenteral antimicrobial (eg, ceftriaxone) followed by oral therapy is recommended for outpatients (Ref).
Oral: 200 mg every 12 hours for 5 to 7 days (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Oral: After a normal initial dose, adjust as follows:
CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl 20 to 50 mL/minute: Administer usual recommended dose every 24 hours.
CrCl <20 mL/minute: Administer half the usual recommended dose every 24 hours.
Intermittent hemodialysis (IHD): 100 to 200 mg after dialysis (Ref).
Peritoneal dialysis: 200 mg every 24 hours (Ref).
Continuous renal replacement therapy (CRRT): 300 mg every 24 hours (Ref).
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
Severe impairment (eg, cirrhosis with or without ascites): Maximum dose: 400 mg/day
Refer to adult dosing.
(For additional information see "Ofloxacin (systemic): Pediatric drug information")
General dosing, susceptible infection: Limited data available: Children: Oral: 15 mg/kg/day divided every 12 hours (Ref); usual adult dose: 200 to 400 mg every 12 hours (Ref).
Chlamydia trachomatis anogenital tract infection: Limited data available: Children weighing ≥45 kg and Adolescents: Oral: 300 mg twice daily for 7 days (Ref).
Epididymitis: Likely caused by enteric organisms (eg, Escherichia coli) in males who practice insertive anal sex: Children weighing ≥45 kg and Adolescents: Limited data available: Oral: 300 mg every 12 hours for 10 days in combination with ceftriaxone (Ref).
Pelvic inflammatory disease (alternative therapy): Children weighing ≥45 kg and Adolescents: Limited data available: Oral: 400 mg every 12 hours for 10 to 14 days in combination with metronidazole (Ref). Note: The CDC recommends use only if standard cephalosporin therapy is not feasible (patients with severe cephalosporin allergy) and community prevalence of quinolone-resistant gonococcal organisms is low. Culture and susceptibility must be confirmed, and patient follow-up should be ensured (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no pediatric-specific recommendations; based on experience in adult patients, dosage adjustment is suggested.
There are no pediatric-specific recommendations. Based on experience in adult patients, dosage adjustment is suggested in patients with severe impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reactions listed may be based on reports for other agents in this same pharmacologic class (quinolones) and may not be specifically reported for ofloxacin.
1% to 10%:
Cardiovascular: Chest pain (1% to 3%)
Dermatologic: Pruritus (1% to 3%), skin rash (1% to 3%)
Gastrointestinal: Abdominal cramps (1% to 3%), abdominal pain (1% to 3%), constipation (1% to 3%), decreased appetite (1% to 3%), diarrhea (1% to 4%), dysgeusia (1% to 3%), flatulence (1% to 3%), gastrointestinal distress (1% to 3%), nausea (3% to 10%), vomiting (1% to 4%), xerostomia (1% to 3%)
Genitourinary: Genital pruritus (female: 1% to 6%), vaginal discharge (1% to 3%), vaginitis (1% to 5%)
Nervous system: Dizziness (1% to 5%), drowsiness (1% to 3%), fatigue (1% to 3%), headache (1% to 9%), insomnia (3% to 7%), nervousness (1% to 3%), sleep disorder (1% to 3%), torso pain (1% to 3%)
Ophthalmic: Visual disturbance (1% to 3%)
Respiratory: Pharyngitis (1% to 3%)
Miscellaneous: Fever (1% to 3%)
<1%:
Cardiovascular: Hypertension, hypotension, palpitations, syncope, vasodilation
Dermatologic: Diaphoresis, urticaria
Endocrine & metabolic: Heavy menstrual bleeding, increased thirst, weight loss
Genitourinary: Dysmenorrhea, dysuria, genital pain (female), genital rash (female), urinary frequency, urinary retention, uterine hemorrhage, vulvovaginal burning, vulvovaginal irritation
Hypersensitivity: Angioedema
Nervous system: Abnormal dreams, anxiety, asthenia, chills, cognitive dysfunction, confusion, depression, euphoria, malaise, pain, seizure, vertigo
Neuromuscular & skeletal: Arthralgia, myalgia
Ophthalmic: Photophobia
Otic: Auditory disturbance, tinnitus
Respiratory: Cough, epistaxis, rhinorrhea
Frequency not defined:
Cardiovascular: Cardiac arrhythmia, prolonged QT interval on ECG
Endocrine & metabolic: Hyperglycemia, hypoglycemia
Genitourinary: Glycosuria, hematuria, proteinuria, pyuria
Hematologic & oncologic: Anemia, eosinophilia, increased erythrocyte sedimentation rate, leukocytosis, leukopenia, lymphocytopenia, lymphocytosis, neutropenia, neutrophilia, thrombocytopenia, thrombocythemia
Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase
Nervous system: Exacerbation of myasthenia gravis, increased intracranial pressure, peripheral neuropathy (including axonal peripheral polyneuropathy, dysesthesia, hypoesthesia, sensorimotor neuropathy, and sensory peripheral polyneuropathy), psychiatric signs and symptoms (including agitation, delirium, disorientation, disturbance in attention, memory impairment, restlessness, and toxic psychosis)
Neuromuscular & skeletal: Rupture of tendon, tendinopathy
Renal: Decreased urine specific gravity, increased blood urea nitrogen, increased serum creatinine, increased urine pH
Postmarketing:
Cardiovascular: Edema (Guay 1992), torsades de pointes, vasculitis (Pace 1989)
Dermatologic: Erythema multiforme (Nettis 2002), maculopapular rash (Guay 1992), Stevens-Johnson syndrome, toxic epidermal necrolysis (Yoon 2010)
Endocrine & metabolic: Diabetes insipidus (Bharani 2001)
Gastrointestinal: Clostridioides difficile-associated diarrhea, dyspepsia (Wilton 1996)
Hematologic & oncologic: Agranulocytosis, aplastic anemia, hemolytic anemia, pancytopenia, thrombotic thrombocytopenic purpura
Hepatic: Hepatic necrosis, hepatitis (Jones 1997), hepatotoxicity (idiosyncratic) (Chalasani 2014), jaundice
Hypersensitivity: Anaphylaxis, hypersensitivity angiitis (Ceyhan 1995), hypersensitivity reaction (Wilton 1996), serum sickness
Nervous system: Hallucination (Wilton 1996), paresthesia (Guay 1992), tremor (Wilton 1996)
Neuromuscular & skeletal: Limb pain (Guay 1992)
Renal: Acute kidney injury, interstitial nephritis, renal insufficiency
Respiratory: Hypersensitivity pneumonitis
Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation
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).
• Aortic aneurysm and dissection: Fluoroquinolones have been associated with aortic aneurysm ruptures or dissection within 2 months following use, particularly in elderly patients. Fluoroquinolones should not be used in patients with a known history of aortic aneurysm or those at increased risk, including patients with peripheral atherosclerotic vascular diseases, hypertension, genetic disorders involving blood vessel changes (eg, Marfan syndrome, Ehlers-Danlos syndrome), and elderly patients, unless no other treatment options are available. Longer treatment duration (eg, >14 days) may increase risk (Lee 2018).
• CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects including seizures, increased intracranial pressure (including pseudotumor cerebri), dizziness, lightheadedness, and tremors. Use with caution in patients with known or suspected CNS disorders (eg, severe cerebral arteriosclerosis, epilepsy) or other risk factors that may predispose to seizures or lower the seizure threshold.
• Glucose regulation: Fluoroquinolones have been associated with disturbances in glucose regulation, including hyperglycemia and hypoglycemia. These events have occurred most often in patients receiving concomitant oral hypoglycemic agents or insulin. Severe cases of hypoglycemia, including coma and death, have been reported. Diabetic patients should be monitored closely for signs/symptoms of disordered glucose regulation. Discontinue if a hypoglycemic reaction occurs and immediately initiate appropriate therapy.
• Hypersensitivity reactions: Severe, sometimes fatal, 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: Peripheral neuropathy has been reported (rare); may occur soon after initiation of therapy and may be irreversible; 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.
• Psychiatric reactions: Fluoroquinolones have been associated with an increased risk of psychiatric reactions, including toxic psychosis or hallucinations; may also cause nervousness, agitation, confusion, disorientation, delirium, attention disturbances, and memory impairment. Use with caution in patients with a history of or risk factor for depression; discontinue if reaction occurs and institute appropriate therapy.
• 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.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• 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 ofloxacin 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. Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of uncomplicated gonococcal disease.
Special populations:
• Older adult: Adverse effects (eg, tendon rupture, QT changes) may be increased in the elderly.
• G6PD deficiency: Hemolytic reactions may (rarely) occur with fluoroquinolone use in patients with G6PD deficiency (Luzzatto 2020).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Generic: 300 mg, 400 mg
Yes
Tablets (Ofloxacin Oral)
300 mg (per each): $14.76
400 mg (per each): $19.68
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Generic: 200 mg, 300 mg, 400 mg
Administer with or without food. Do not take within 2 hours of sucralfate, didanosine, iron, zinc, or antacids containing magnesium, calcium, or aluminum.
Oral: May administer with or without food.
An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088599.pdf, must be dispensed with this medication.
Treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, skin and soft tissue infections (uncomplicated), urethritis and cervicitis (nongonococcal) due to Chlamydia trachomatis infection, pelvic inflammatory disease (acute), cystitis (uncomplicated), urinary tract infections (complicated), prostatitis.
Limitations of use: Because fluoroquinolones, including ofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinopathy and tendon rupture, peripheral neuropathy, CNS effects), reserve ofloxacin for use in patients who have no alternative treatment options for uncomplicated urinary tract infection and for acute exacerbations of chronic bronchitis when treatment is necessary (FDA 2016).
Epididymitis, acute; Plague (Yersinia pestis); Typhoid and paratyphoid fever (Salmonella typhi or S. parathyphi infection), uncomplicated, treatment
Substrate of OAT1/3
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Blood Glucose Lowering Effects: Quinolones may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Amphetamines: May enhance the cardiotoxic effect of Quinolones. Risk C: Monitor therapy
Antacids: May decrease the absorption of Quinolones. Of concern only with oral administration of quinolones. Management: Avoid concurrent administration of quinolones and antacids to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone; see full monograph for details. Risk D: Consider therapy modification
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Calcium Salts: May decrease the absorption of Quinolones. Of concern only with oral administration of both agents. Management: Consider administering an oral quinolone at least 2 hours before or 6 hours after the dose of oral calcium to minimize this interaction. Monitor for decreased therapeutic effects of quinolones during coadministration. Risk D: Consider therapy modification
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy
Delamanid: Quinolones may enhance the QTc-prolonging effect of Delamanid. Management: Avoid concomitant use if possible. If coadministration is unavoidable, frequent monitoring of electrocardiograms (ECGs) throughout the full delamanid treatment period should occur. Risk D: Consider therapy modification
Didanosine: Quinolones may decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. Risk D: Consider therapy modification
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Iron Preparations: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, oflox-, peflox, or nalidixic acid) oral iron. Risk D: Consider therapy modification
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Lanthanum: May decrease the serum concentration of Quinolones. Management: Administer oral quinolone antibiotics at least one hour before or four hours after lanthanum. Risk D: Consider therapy modification
Levoketoconazole: QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of Levoketoconazole. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Magnesium Salts: May decrease the serum concentration of Quinolones. Management: Administer oral quinolones several hours before (4 h for moxi/pe/spar/enox-, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome/pe/enox-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Risk D: Consider therapy modification
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Methylphenidate: May enhance the cardiotoxic effect of Quinolones. Risk C: Monitor therapy
Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Quinolones. Specifically, polyvalent cations in multivitamin products may decrease the absorption of orally administered quinolone antibiotics. Management: Administer oral quinolones at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (ie, calcium, iron, magnesium, selenium, zinc). Monitor for decreased quinolone efficacy. Risk D: Consider therapy modification
Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Quinolones. Specifically, minerals in the multivitamin/mineral product may impair absorption of quinolone antibiotics. Management: Administer oral quinolones at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (ie, calcium, iron, magnesium, selenium, zinc). Monitor for decreased therapeutic effects of quinolones. Risk D: Consider therapy modification
Mycophenolate: Quinolones may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate. Risk C: Monitor therapy
Nadifloxacin: May enhance the adverse/toxic effect of Quinolones. Risk X: Avoid combination
Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Risk C: Monitor therapy
Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Quinolones. Management: Give oral quinolones at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Probenecid: May decrease the excretion of Quinolones. Specifically, probenecid may decreased the renal excretion of quinolone antibiotics. Probenecid may increase the serum concentration of Quinolones. Risk C: Monitor therapy
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Strontium Ranelate: May decrease the serum concentration of Quinolones. Management: In order to minimize any potential impact of strontium ranelate on quinolone antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during quinolone therapy. Risk X: Avoid combination
Sucralfate: May decrease the serum concentration of Quinolones. Management: Avoid concurrent administration of quinolones and sucralfate to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Quinolones may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Zinc Salts: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, pe- or ofloxacin or nalidixic acid) oral zinc salts. Risk D: Consider therapy modification
Ofloxacin crosses the placenta and produces measurable concentrations in the amniotic fluid.
Based on available data, an increased risk of teratogenic effects has not been observed following ofloxacin use during pregnancy (Padberg 2014).
Serum concentrations of ofloxacin may be lower during pregnancy than in nonpregnant patients (Giamarellou 1989).
Ofloxacin is used in the management of plague (Y. pestis). Untreated infections in pregnant patients may result in hemorrhage (including postpartum hemorrhage), maternal and fetal death, preterm birth, and stillbirth. Limited data suggest maternal-fetal transmission of Y. pestis can occur if not treated. Pregnant patients should be treated for Y. pestis; parenteral antibiotics are preferred for initial treatment when otherwise appropriate. Ofloxacin is an alternative fluroquinolone recommended for use (in combination with an aminoglycoside) for treating pregnant patients with bubonic, pharyngeal, pneumonic, or septicemic plague. Ofloxacin may also be used as an alternative antibiotic for pre- and postexposure prophylaxis in pregnant patients exposed to Y. pestis (CDC [Nelson 2021]).
Ofloxacin is present in breast milk.
Following administration of ofloxacin 200 mg as a single oral dose, breast milk concentrations were similar to those in the maternal plasma.
Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
Ofloxacin is used in the management of plague (Y. pestis). The risk for transmission of Y. pestis via breast milk is considered low. Patients with pneumonic plague can breastfeed if both the mother and infant are receiving antibiotic treatment or the infant is receiving postexposure prophylaxis, considering the risk of exposure to the drug via breast milk. If the infant is not being treated, breast milk should be expressed for at least 48 hours of maternal antibiotic therapy to limit person-to-person contact with the infant. The expressed breast milk may be given to the infant. Once maternal clinical improvement is observed, direct breastfeeding may resume. Patients taking ofloxacin for the treatment of plague can decrease infant exposure via breast milk by feeding 4 to 6 hours after the dose (CDC [Nelson 2021]).
Monitor CBC, renal and hepatic function periodically if therapy is prolonged; signs and symptoms of disordered glucose regulation.
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.
Absorption: Well absorbed.
Distribution: Widely distributed into body tissues and fluids, including blister fluid, cervix, lung, ovary, prostatic tissue, skin, and sputum ; Vd: 2.4 to 3.5 L/kg.
Protein binding: 32%.
Bioavailability: 98%.
Half-life elimination: ~9 hours (biphasic: 4 to 5 hours [6.4 to 7.4 hours in elderly patients] and 20 to 25 hours [accounts for <5%]); prolonged with renal impairment.
Time to peak, serum: 1 to 2 hours.
Excretion: Urine: 65% to 80% (as unchanged drug); feces: 4% to 8%; <10% is metabolized.
Altered kidney function: Clearance is reduced in patients with CrCl <50 mL/minute.
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