Names and pronunciation
(o-flox′a-sin)
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Individual generic drug information
Extracted information for ofloxacin only.
(o-flox′a-sin)
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Func. class.: Antiinfective
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Chem. class.: Fluoroquinolone
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ACTION: Interferes with conversion of intermediate DNA fragments into high- O molecular-weight DNA in bacteria; inhib- its DNA gyrase
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USES: Treatment of lower respiratory tract infections (pneumonia, bronchitis), genitourinary infections (prostatitis, UTIs) caused by Escherichia coli, Kleb- siella pneumoniae, Chlamydia tra- chomatis, skin and skin-structure infec- tions; otitis media, PID
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Unlabeled uses: Spontaneous bacterial peritonitis
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Extracted information for ofloxacin only.
CONTRAINDICATIONS: Hyper- sensitivity to quinolones Precautions: Pregnancy, breastfeeding, children, geriatric patients, renal disease, seizure disorders, excessive sunlight, hypokalemia, colitis, QT prolongation
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Black Box Warning: Tendon pain/rupture, tendinitis, myasthenia gravis, psychiatric event, peripheral neuropathy, neurotoxic- ity, acute bacterial exacerbations of UTIs/ bronchitis Black Box Warning: Increase: tendon rupture/tendinitis—corticosteroids • May alter blood glucose levels: antidia- betics Possible theophylline toxicity: theophyl- line Increase: QT prolongation—class IA/III antidysrhythmics, some phenothiazines, β-agonists, local anesthetics, tricyclics, haloperidol, methadone, chloroquine, cla- rithromycin, droperidol, erythromycin, pentamidine Increase: CNS stimulation, seizures— NSAIDs Increase: anticoagulation—warfarin Decrease: ofloxacin—sevelamer Decrease: absorption—antacids with aluminum, magnesium, iron products, sucralfate, zinc products; separate by 2 hr Drug/Lab Test Increase: INR Black Box Warning: Tendon rupture/ tendinitis: more common in lung, heart, kidney transplants or geriatric patients; assess for pain or inflammation; product should be discontinued; steroids may in- crease risk • Blood studies: BUN, creatinine, AST, ALT, CBC, blood glucose, INR (warfarin use); hypoglycemia is more common in diabetes in those >60 yr • CNS symptoms: insomnia, vertigo, headache, agitation, confusion; seizures, pseudotumor cerebri; if serious CNS re- actions occur, stop drug Black Box Warning: Myasthenia gravis: product may increase weakness; avoid use in patients with myasthenia gravis Black Box Warning: Peripheral neu- ropathy: stop drug immediately if this occurs, may be more common with fluoroquinolones Black Box Warning: CDAD: assess for diarrhea during and for a few months after discontinuing drug, if CDAD is suspected, discontinue • For overgrowth of infection in long- term treatment • Anaphylaxis, Stevens-Johnson syn- drome, toxic epidermal necrolysis: rash, flushing, urticaria, pruritus, peripheral neu- ropathy; may be fatal; may occur even af- ter first dose; have emergency equipment nearby
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SIDE EFFECTS CNS: Dizziness, headache, fatigue, somnolence, depression, insomnia, leth- argy, malaise, seizures, vertigo CV: QT prolongation, dysrhythmias, chest pain EENT: Visual disturbances, pharyngitis GI: Diarrhea, nausea, vomiting, anorexia, flatulence, heartburn, dry mouth, increased AST, ALT, abdominal pain, constipation, CDAD, abnormal taste, xerostomia HEMA: Blood dyscrasias INTEG: Rash, pruritus, photosensitivity MS: Tendinitis, tendon rupture, rhabdo- myolysis SYST: Anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis
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INTERACTIONS
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Extracted information for ofloxacin only.
DOSAGE AND ROUTES Cervicitis/urethritis (acute) Adult: PO Nongonococcal (due to Chla- mydia trachomatis): 300 mg q12hr × 7 days; 400 mg as a single dose (gonorrhea) Chronic bronchitis (acute exacer bation), community-acquired pneu- monia, skin and skin structure infec- tions (uncomplicated) Adult: PO 400 mg q12hr × 10 days Pelvic inflammatory disease (acute) Adult: PO: 400 mg q12hr × 10-14 days, use with metronidazole Prostatitis Adult: PO 300 mg q12hr × 6 wk UTI Adult: PO Uncomplicated: 200 mg q12hr × 3-7 days; complicated: 200 mg q12hr × 10 days Spontaneous bacterial peritonitis (unlabeled) Adult: PO 400 mg q12h × 5-7 days Renal dose • Adult: PO CCr 20-50 mL/min, give q24hr; CCr <20 mL/min, give 50% of dose q24hr Hepatic dose • Adult (Child-Pugh class C): PO max 400 mg/day
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Available forms: Tabs 200, 300, 400 mg
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Administer: PO route • 2 hr before or 2 hr after antacids, calcium, iron, zinc products, without re- gard to food, maintain hydration • Store at room temperature, protect from light
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Extracted information for ofloxacin only.
Assess:
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Evaluate: • Therapeutic response: culture nega- tive, absence of symptoms of infection
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To ambulate, perform activities using assistance if dizziness or light-headedness occurs • To complete full course of therapy; to take with plenty of fluids • That those with diabetes are more prone to hypoglycemia • To avoid iron- or mineral-containing supplements within 2 hr before or after dose; to take without regard to meals • Anaphylaxis, Stevens-Johnson syn- drome, toxic epidermal necroly- sis: that allergic reactions usually occur after first dose but may occur later; to stop product; to report to prescriber rash, fever • To report bloody diarrhea immediately • To avoid sun exposure; photosensitivity can occur • To avoid use with other products un- less approved by prescriber • To notify prescriber immediately if tin- gling, pain in extremities occurs; muscle/ tendon pain, numbness in extremities See Appendix B
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Extracted information for ofloxacin only.
PHARMACOKINETICS PO: Peak 1-2 hr; half-life 4-8 hr; steady- state 2 days; excreted in urine as active product, metabolites; 90%-95% bioavailability
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Filter the extracted dose blocks for this individual drug.
(unlabeled) Adult: PO 400 mg q12h × 5-7 days Renal dose
• Adult: PO CCr 20-50 mL/min, give q24hr; CCr <20 mL/min, give 50% of dose q24hr Hepatic dose
Candidate age grouping · source page 974
(unlabeled) Adult: PO 400 mg q12h × 5-7 days Renal dose
• Adult (Child-Pugh class C): PO max 400 mg/day
Candidate age grouping · source page 974