Names and pronunciation
(dela-flox′-a-sin) Baxdela
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Drug reference
(dela-flox′-a-sin) Baxdela
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Func. class.: Antiinfective
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Chem. class.: Fluoroquinolone
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ACTION: Inhibits bacterial DNA gyrase
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USES: For the treatment of acute bac- terial skin and skin structure infections
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CONTRAINDICATIONS Hypersensitivity to this product or fluoroqui- nolones, tendon rupture, aortic aneurysm, renal failure, myasthenia gravis, children Precautions: Pregnancy, breastfeeding, renal disease, CDAD, elderly, transplants, RA, psychiatric disorders Administer PO route • Take without regard to meals, give ≥2 hr prior to or 6 hr after any antacid, multivi- tamin, or other medication that contains divalent or trivalent cations • If a dose is missed, take it as soon as possible up to 8 hr prior to the next sched- uled dose. If less than 8 hr before next dose, wait until the next scheduled dose IV route • Reconstitute the 300-mg vial/10.5 mL of 5% dextrose for injection or 0.9% sodium chloride for injection 300 mg/12 mL (25 mg/mL) • Shake vigorously until dissolved • The reconstituted vial must be further diluted • Storage: Reconstituted vials refriger- ated at 36°F to 46°F (2°C to 8°C) or at room temperature of 68°F to 77°F (20°C to 25°C) for up to 24 hr. Do not freeze • Withdraw the needed volume of reconsti- tuted solution per dose, 12 mL for a 300- mg dose and 8 mL for a 200-mg dose • Dilute the reconstituted solution to a total volume of 250 mL using either 5% dextrose for injection or 0.9% sodium chloride for injection to achieve a con- centration of 1.2 mg/mL • Storage: Diluted solutions may be kept refrigerated at 36°F to 46°F (2°C to 8°C) or at room temperature of 68°F to 77°F (20°C to 25°C) for up to 24 hr. Do not freeze Intermittent IV infusion • Infuse over 60 min • Do not administer with any solution containing multivalent cations through the same IV line • Do not admix with other medications. Flush lines with 5% dextrose for injection or 0.9% sodium chloride for injection prior to and after each infusion if using common IV line
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SIDE EFFECTS CNS: Headache, dizziness, insomnia, anxiety, paresthesia, unusual dreams CV: Palpitations, sinus tachycardia, hyper/hypotension, flushing, bradycardia GI: Nausea, vomiting, anorexia, abdomi- nal pain, CDAD GU: Vaginal candidiasis, renal dysfunc- tion, renal failure EENT: Blurred vision, tinnitus, oral candidiasis META: Hypo/hyperglycemia MS: Myalgia INTEG: Infusion site reactions MISC: Hypersensitivity, fungal infections
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INTERACTIONS Increase: Infection risk—corticosteroids Decrease: Delafloxacin level—antacids, didanosine Drug/Lab: Increase: LFTs, CK, alkaline phosphatase, blood glucose Decrease: Blood glucose
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Black Box Warning: Myasthenia gra- vis: avoid use in these patients, muscle weakness Black Box Warning: Tendonitis, rup- ture: monitor for tenderness, weakness, inflammation of tendons, muscles, dis- continue at first signs, increased in those >60 yr or taking corticosteroids Black Box Warning: Peripheral neu- ropathy: monitor for tingling, burning, pain of extremities • CDAD: Monitor for diarrhea with blood, mucus, abdominal pain, stop product immediately • Hypersensitivity: Assess for rash, pruritus, discontinue immediately • Psychiatric disorders: Assess for hallucinations, psychosis, paranoia, delusions, suicidal thought/behaviors • CNS symptoms: Headache, dizziness, fatigue, insomnia • Monitor renal, hepatic studies: LFTs, BUN, creatinine Black Box Warning: To report muscle tenderness, weakness, inflammation to stop immediately HIGH ALERT
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DOSAGE AND ROUTES • Adult: PO 450 mg q12hr × 5-14 days • Adult: IV 300 mg q12hr × 5-14 days Renal dose: Adult (eGFR 15-29 mL/ D min/1.73 m2) no change: PO 200 mg q12hr IV then switch to 450 mg PO
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Available forms: Injection 300 mg in single-dose vials; tablets 450 mg
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Assess: • C&S prior to starting treatment, may be- gin treatment before results are received • Infection: monitor WBC, temperature, vital signs, baseline and periodically
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Evaluate: • Therapeutic response • C&S negative, decreasing signs or symptoms of infection
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Teach the patient continuing follow-ups and lab work will be needed • To report diarrhea with blood or mu- cous, abdominal pain, fever, stop prod- uct immediately • To report if pregnancy is planned or suspected or if breastfeeding • To report rash, itching, headache, diz- ziness, fatigue, insomnia • To report injection site pain, redness, burning
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PHARMACOKINETICS PO: Onset unknown, peak 1 hr, duration unknown IV: Onset unknown, peak 1 hr, duration unknown Half-life PO 4-8½ hr, IV 3.7 hr
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• Adult: PO 450 mg q12hr × 5-14 days
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• Adult: IV 300 mg q12hr × 5-14 days Renal dose: Adult (eGFR 15-29 mL/ D min/1.73 m2) no change: PO 200 mg q12hr IV then switch to 450 mg PO
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