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Ofloxacin

Oral
Ophthalmic
Otic
Class
Antibiotics
Subclass
Fluoroquinolones
Substance name
Ofloxacin
Brand names
Ocuflox®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment
Acute cystitis • Uncomplicated, caused by E. coli or K. pneumoniae
•
200 mg PO BID for 3 days
Acute cystitis • Uncomplicated, caused by Citrobacter diversus, Enterobacter aerogenes, P. aeruginosa, or P. mirabilis
•
200 mg PO BID for 7 days
Cervicitis • Caused by C. trachomatis
•
300 mg PO BID for 7 days
Cervicitis • Mixed infection caused by C. trachomatis and N. gonorrhoeae
•
300 mg PO BID for 7 days
Community-acquired pneumonia
•
400 mg PO BID for 10 days
COPD • Acute exacerbation
•
400 mg PO BID for 10 days
Non-gonococcal urethritis • Caused by C. trachomatis
•
300 mg PO BID for 7 days
Pelvic inflammatory disease
•
400 mg PO BID for 10-14 days
Prostatitis • Caused by E. coli
•
300 mg PO BID for 6 weeks
SSTIs • Uncomplicated
•
400 mg PO BID for 10 days
Urethritis • Mixed infection caused by C. trachomatis and N. gonorrhoeae
•
300 mg PO BID for 7 days
UTIs • Pyelonephritis or complicated UTI
•
200 mg PO BID for 10 days
Acute epididymitis • Off-label
•
200 mg PO BID for 14 days
Alternative
•
500 mg PO daily for 10 days
Enteric fever • Off-label
•
10 mg/kg PO BID for 7 days
Leprosy • Off-label
•
400 mg PO daily for 6-24 months
Administered in combination with clofazimine plus minocycline or clarithromycin.
Plague • Off-label
•
400 mg PO BID for 10-14 days
Traveler's diarrhea • Off-label
•
300 mg PO daily for 3 days or as a single dose
Prevention
Plague • Post-exposure prophylaxis • Off-label
•
400 mg PO BID for 7 days
Plague • Pre-exposure prophylaxis • Off-label
•
400 mg PO BID until 48 hours after the last perceived exposure
Indications for use
Labeled indications
Adults
•
Treatment of acute cystitis (uncomplicated, caused by Citrobacter diversus, Enterobacter aerogenes, P. aeruginosa, or P. mirabilis)
•
Treatment of acute cystitis (uncomplicated, caused by E. coli or K. pneumoniae)
•
Treatment of cervicitis (caused by C. trachomatis)
•
Treatment of cervicitis (mixed infection caused by C. trachomatis and N. gonorrhoeae)
•
Treatment of COPD (acute exacerbation)
•
Treatment of community-acquired pneumonia
•
Treatment of non-gonococcal urethritis (caused by C. trachomatis)
•
Treatment of pelvic inflammatory disease
•
Treatment of prostatitis (caused by E. coli)
•
Treatment of SSTIs (uncomplicated)
•
Treatment of urethritis (mixed infection caused by C. trachomatis and N. gonorrhoeae)
•
Treatment of UTIs (pyelonephritis or complicated UTI)
Off-label indications
Adults
•
Treatment of acute epididymitis
•
Treatment of enteric fever
•
Treatment of leprosy
•
Treatment of plague
•
Treatment of traveler's diarrhea
•
Prevention of plague (post-exposure prophylaxis)
•
Prevention of plague (pre-exposure prophylaxis)
Safety risks
Boxed warnings
Exacerbation of myasthenia gravis
•
Avoid using ofloxacin in patients with myasthenia gravis.
Tendinitis, tendon rupture, peripheral neuropathy, CNS adverse events
•
Maintain a high level of suspicion, as fluoroquinolones, including ofloxacin, have been associated with an increased risk of disabling and potentially irreversible serious adverse reactions that can occur together, including tendinitis and tendon rupture (most commonly affecting the Achilles tendon), peripheral neuropathy, and CNS effects (including convulsions, increased ICP, and psychosis). Reserve moxifloxacin for acute exacerbation of COPD and uncomplicated cystitis only when no alternative treatment options are available. Discontinue ofloxacin immediately and avoid the use of fluoroquinolones in patients who experience any of these serious adverse reactions.
Contraindications
Hypersensitivity to ofloxacin or its components or to other quinolones
QT prolongation
Uncorrected hypokalemia
Warnings and precautions
Antimicrobial resistance
•
Maintain a high level of suspicion, as the use of ofloxacin in the absence of a proven or strongly suspected bacterial infection increases the risk of developing drug-resistant bacteria.
C. difficile infection
•
Maintain a high level of suspicion, as nearly all antibiotics, including ofloxacin, are associated with an increased risk of C. difficile-associated diarrhea.
Decreased blood glucose
•
Use caution in patients taking oral hypoglycemic drugs, such as glyburide, or insulin.
Mask symptoms of syphilis
•
Maintain a high level of suspicion, as ofloxacin used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Obtain serologic testing for syphilis in all patients with gonorrhea at the time of diagnosis and 3 months after treatment.
Photosensitivity of skin
•
Maintain a high level of suspicion, as quinolones, including ofloxacin, have been associated with an increased risk of photosensitivity reactions. Advise avoiding excessive sun exposure.
Seizure
•
Use caution in patients with a known or suspected CNS disorder or at risk of seizures.
Specific populations
Renal impairment
CrCl > 50 mL/min
•
Use acceptable. No dose adjustment required.
CrCl 20-50 mL/min
•
Use with caution. Do not exceed frequency of once daily.
CrCl < 20 mL/min
•
Use with caution. Reduce dose by 50%. Do not exceed frequency of once daily.
Renal replacement therapy
Continuous renal replacement
•
No guidance available.
Intermittent hemodialysis
•
Use with caution. Dose as in eGFR < 20 mL/min/1.73 m².
Peritoneal dialysis
•
Use with caution. Dose as in eGFR < 20 mL/min/1.73 m².
Hepatic impairment
Any severity
•
Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals.
Breastfeeding
Do not use during breastfeeding.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Common 1-10%
•
Anemia, ↓ WBC count, ↑ WBC count, ↓ blood neutrophil count, ↑ blood neutrophil count, ↓ blood lymphocyte count, ↑ blood lymphocyte count, ↑ blood eosinophil count, ↑ platelet count, ↓ platelet count, ↑ ESR, ↑ serum ALP, ↑ serum AST, ↑ serum ALT, ↑ serum creatinine, ↑ blood glucose, ↓ blood glucose, ↑ urine glucose, ↑ BUN, hematuria, pyuria, ↑ urine protein, chest pain, abdominal pain, abdominal cramps, dry mouth, loss of appetite, dysgeusia, fatigue, flatulence, nervousness, pharyngitis, itching, fever, sleeping disorder, somnolence, skin rash, vaginal discharge, visual disturbances, constipation, diarrhea, vomiting, dizziness, headache, insomnia, nausea, vaginal itching, vaginitis
Uncommon < 1%
•
Cardiac arrest, vasculitis, asthenia, chills, malaise, pain in extremity, nosebleed, hypertension, edema, hypotension, palpitations, skin flushing, dyspepsia, genital burning sensation, dysmenorrhea, menorrhagia, arthralgia, myalgia, seizure, anxiety, depression, cognitive impairment, nightmares, hallucinations, euphoria, paresthesia, syncope, vertigo, tremor, confusion, ↑ thirst, weight loss, cough, respiratory arrest, angioedema, diaphoresis, rhinorrhea, urticaria, hearing loss, tinnitus, photophobia, dysuria, urinary frequency, urinary retention
Unknown frequency
•
Stroke, pulmonary edema, torsades de pointes, hepatic necrosis, hepatitis, acute liver failure, Clostridioides difficile infection, vulvovaginal candidiasis, hemolytic anemia, aplastic anemia, thrombotic thrombocytopenic purpura, tendinitis, tendon rupture, rhabdomyolysis, anaphylaxis, serum sickness, hypersensitivity pneumonitis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis, nephrolithiasis, renal failure, interstitial nephritis, tachycardia, jaundice, intestinal perforation, gastrointestinal bleeding, pancytopenia, agranulocytosis, petechiae, ecchymosis, muscle weakness, suicidal ideation, paranoid ideation, disorientation, psychosis, agitation, restlessness, hostility, emotional lability, mania, peripheral neuropathy, ataxia, lightheadedness, dysphasia, dyspnea, bronchospasm, stridor, erythema nodosum, hyperpigmentation, conjunctivitis, photosensitivity of skin, diplopia, nystagmus, blurred vision, change in smell, polyuria, ↑PT, ↑ serum triglycerides, ↑ serum cholesterol, ↑ serum potassium, ↑ serum TBIL, ↑ serum LDH, ↑ serum gamma-glutamyltransferase
Interactions
Drug(s)
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