Dosing and uses of Floxin (ofloxacin)
Adult dosage forms and strengths
tablet
- 200mg
- 300mg
- 400mg
Bronchitis Exacerbation
400 mg PO q12hr for 10 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis
Community Acquired Pneumonia
400 mg PO q12hr for 10 days
Skin & Skin Structure Infections
400 mg PO q12hr for 10 days
Acute, Uncomplicated Urethral and Cervical Gonorrhea
No longer recommended for gonorrhea due to widespread resistance in the Us
400 mg PO single dose
Nongonococcal Cervicitis/Urethritis or Mixed Infection of Cervix/Urethra
300 mg PO q12hr for 7 days
Acute Pelvic Inflammatory Disease
400 mg PO q12hr for 10-14 days
Uncomplicated Cystitis
Due to E. coli or K. pneumoniae: 200 mg PO q12hr for 3 days
Due to other approved pathogens: 200 mg PO q12hr for 7 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections
Complicated UTIs
200 mg PO q12hr for 10 days
Prostatitis Due to E. Coli
300 mg PO q12hr for 6 weeks
Traveler's Diarrhea (Off-label)
300 mg PO q12hr for 1-3 days
Dosage modifications
Renal impairment
- CrCl 20-50 mL/min: Give q24hr
- CrCl <20 mL/min: Give one-half usual dose q24hr
Other Indications and Uses
Mild to moderate infection due to susceptible strains of designated microorganisms
Chlamydia trachomatis, Citrobacter spp, Enterobacter spp, E. coli, Klebsiella pneumoniae, N. gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, S. aureus, S. pneumoniae
Culture and susceptibility tests needed to isolate and identify organisms
Pediatric dosage forms and strengths
Not indicated
Floxin (ofloxacin) adverse (side) effects
1-10%
Nausea (3-10%)
Headache (1-9%)
Insomnia (3-7%)
Dizziness (1-5%)
Vaginitis (1-5%)
Diarrhea (1-4%)
Vomiting (1-4%)
Appetite decreased (1-3%)
Abdominal cramps (1-3%)
Abnormal taste (1-3%)
Chest pain (1-3%)
External genital pruritis in women (1-3%)
Fatigue (1-3%)
Flatulence (1-3%)
GI distress (1-3%)
Nervousness (1-3%)
Pharyngitis (1-3%)
Pyrexia (1-3%)
Rash/pruritis (1-3%)
Sleep disorders (1-3%)
Visual disturbances (1-3%)
Xerostomia (1-3%)
<1%
Prolonged QT intervaL
Torsades de pointes
Syncope
Vasculitis
Edema
HTn
Palpitations
Vasodilation
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Agranulocytosis
Aplastic anemia
Pancytopenia
Thrombocytopenia
Thrombocytopenic purpura
Acute hepatitis
Hepatic failure
Hepatic necrosis
Immune hypersensitivity reaction
Rupture of tendon, Tendinitis
Peripheral neuropathy
Seizure
Acute renal failure
Interstitial nephritis
Renal impairment
Tourette's syndrome
Decr hearing acuity
Tinnitus
Warnings
Black box warnings
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 the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions
May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis
Serious adverse effects and limitations-of-use
- Both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system
- These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
- Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options
- For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option
Contraindications
Documented hypersensitivity
Cautions
May produce false-positive urine opiate screening
No longer recommended for gonorrhea due to widespread resistance in the Us
In prolonged therapy, perform periodic evaluations of organ system functions (eg, renal, hepatic, hematopoietic); adjust dose in renal function impairment; superinfections may occur with prolonged or repeated antibiotic therapy
Not drug of first choice in pediatrics due to increased incidence of adverse events compared to controls, including arthropathy; no data exist for dose for pediatric patients with renal impairment (ie, CrCl <50 mL/min)
Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis reported with fluoroquinolones
Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190
Peripheral neuropathy
- Peripheral neuropathy may occur rapidly after initiating therapy and may potentially become permanent
- Development of peripheral neuropathy appears to be unrelated to the duration of therapy or the age of the patient
- If peripheral neuropathy develops, discontinue the fluoroquinolone and treat with an alternative non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk
Pregnancy and lactation
Pregnancy category: C
Lactation: excreted in breast milk, discontinue drug or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Floxin (ofloxacin)
Mechanism of action
Inhibits bacterial DNA gyrase, which in turn inhibits DNA replication and transcription, DNA repair, recombination and transposicion, causing bacterial cell death.
Absorption
Well absorbed; food causes only minor alterations
Bioavailability: 98%
Distribution
Protein Bound: 32%
Vd: 2.4-3.5 L/kg
Elimination
Half-Life: 4-5 hr
Excretion: Urine (up to 80% unchanged; <5% metabolites); feces 4-8%
Administration
Oral Administration
Do not take with antacids or dairy products
