FLOXIN IN DEXTROSE 5%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLOXIN IN DEXTROSE 5% (FLOXIN IN DEXTROSE 5%).
Inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, preventing DNA replication and transcription.
| Metabolism | Hepatic metabolism via CYP1A2 and possibly other CYP enzymes; renal excretion of unchanged drug and metabolites. |
| Excretion | Primarily renal (approximately 70-90% unchanged drug), with 5-10% biliary/fecal elimination. |
| Half-life | Terminal elimination half-life: 6-8 hours (prolonged in renal impairment, up to 20-30 hours in severe impairment). |
| Protein binding | 20-32% (primarily to albumin). |
| Volume of Distribution | 2.0-3.0 L/kg (indicates extensive tissue penetration, including lung, prostate, and bone). |
| Bioavailability | Not applicable (IV administration only); oral floxin has bioavailability ~70-80%, but FLOXIN IN DEXTROSE 5% is IV. |
| Onset of Action | Intravenous: immediate (minutes); peak concentrations achieved by end of infusion. |
| Duration of Action | Approximately 12 hours (supports twice-daily dosing). |
| Molecular Weight | 361.37 |
400 mg intravenously every 12 hours.
| Dosage form | INJECTABLE |
| Renal impairment | If CrCl 20-50 mL/min: 400 mg IV every 24 hours; if CrCl <20 mL/min or hemodialysis: 400 mg IV every 48 hours. |
| Liver impairment | No dosage adjustment required for mild to moderate hepatic impairment (Child-Pugh A/B). Not studied in severe impairment (Child-Pugh C). |
| Pediatric use | Not recommended for children under 18 years due to risk of musculoskeletal adverse events. |
| Geriatric use | Use with caution; reduce dose based on renal function. Monitor for tendonitis and QT prolongation. |
| 1st trimester | Contraindicated due to risk of arthropathy and cartilage damage in animal studies. |
| 2nd trimester | Contraindicated due to potential fetal toxicity. |
| 3rd trimester | Contraindicated due to risk of neonatal arthropathy and CNS effects. |
Clinical note
Comprehensive clinical and safety monograph for FLOXIN IN DEXTROSE 5% (FLOXIN IN DEXTROSE 5%).
| Placental transfer | Crosses placenta; documented in human studies. |
| Breastfeeding | Excreted in breast milk; avoid breastfeeding due to potential adverse effects on infant joints and cartilage. |
| Lactation Rating | L5 - Contraindicated |
■ FDA Black Box Warning
Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture, especially in patients over 60 years, those taking corticosteroids, and those with kidney, heart, or lung transplants. May exacerbate muscle weakness in myasthenia gravis.
| Serious Effects |
Hypersensitivity to floxin or any quinoloneHistory of tendon disorders related to fluoroquinolonesAge less than 18 years (for systemic use)Pregnancy and breastfeeding
| Precautions | Avoid use in patients with known aortic aneurysm or dissection; increased risk of peripheral neuropathy, CNS effects including seizures and increased intracranial pressure; photosensitivity; QT prolongation; hypoglycemia; and tendon disorders. |
| Food/Dietary | No specific food interactions; however, avoid excessive caffeine as ofloxacin may increase caffeine effects. Take oral forms on an empty stomach (1 hour before or 2 hours after meals) if using oral formulation; IV not affected. |
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| Teratogenic Risk | FLOXIN (ofloxacin) is contraindicated in pregnancy. Fluoroquinolones cause arthropathy in juvenile animals and may damage fetal cartilage. Use is not recommended in any trimester. There is no safe trimester for use. |
| Fetal Monitoring | If inadvertent exposure occurs, monitor fetal growth and joint development (ultrasound). For the mother, monitor for tendon pain, CNS effects, and gastrointestinal disturbances. No specific fetal monitoring is routinely indicated because use is avoided. |
| Fertility Effects | Fluoroquinolones have not been associated with impaired fertility in animal studies. However, ofloxacin may cause sperm DNA damage in vitro; clinical significance in humans is unknown. No specific fertility effects are documented. |
| Clinical Pearls | Floxin (ofloxacin) in D5W is a fluoroquinolone antibiotic. Administer IV slowly over at least 60 minutes to avoid hypotension. Avoid concurrent NSAIDs due to increased CNS stimulation risk. Monitor for QT prolongation, especially in elderly or those on antiarrhythmics. Adjust dose in renal impairment (CrCl <50 mL/min). |
| Patient Advice | Report any tendon pain, swelling, or rupture, especially in Achilles tendon; discontinue and rest if symptoms occur. · Avoid driving or operating machinery if you experience dizziness, drowsiness, or vision changes. · Stay well hydrated during treatment to prevent crystalluria. · Complete full course even if feeling better; do not stop early. · Use sun protection as risk of photosensitivity; avoid excessive sun or tanning beds. · Inform your doctor if you have a history of seizures, myasthenia gravis, or QT prolongation. |