Treatment of nosocomial pneumonia, community-acquired pneumonia, complicated intra-abdominal infections, gynecologic/pelvic infections, complicated skin and skin structure infections

Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. If an allergic reaction occurs (itching, urticaria, dyspnea, facial edema, loss of consciousness, tingling, cardiovascular collapse), discontinue drug immediately. Prolonged use may result in superinfection; pseudomembranous colitis may occur and should be considered in all patients who present with diarrhea. Quinolones may exacerbate myasthenia gravis, use with caution (rare, potentially life-threatening weakness of respiratory muscles may occur).

1% to 10% (range reported in clinical trials):

Central nervous system: Dizziness (2% to 11%), lightheadedness (<1% to 4%), headache (1% to 5%)

Dermatologic: Rash (<1% to 2%), pruritus (<1% to 2%)

Gastrointestinal: Nausea (4% to 8%), abdominal pain (<1% to 1%), vomiting, diarrhea

Genitourinary: Vaginitis (<1% to 1%)

Hepatic: Increased LFTs

Local: Injection site reaction, pain, or inflammation

<1%: Phototoxicity, convulsions, dyskinesia, pseudomembranous colitis, allergic/anaphylactoid reaction, tendonitis, bronchospasm, interstitial nephritis, anaphylaxis, hepatic necrosis, pancreatitis, Stevens-Johnson syndrome; quinolones have been associated with tendon rupture

Corticosteroids: Concurrent use may increase the risk of tendon rupture, particularly in elderly patients (overall incidence rare).

Glyburide: Quinolones may increase the effect of glyburide; monitor.

Metal cations (aluminum, calcium, iron, magnesium, and zinc) bind quinolones in the gastrointestinal tract and inhibit absorption. Concurrent administration of most antacids, oral electrolyte supplements, quinapril, sucralfate, and some didanosine formulations (chewable/buffered tablets and pediatric powder for oral suspension) should be avoided. Trovafloxacin should be administered 2 hours before or 2 hours after these agents.

Probenecid: May decrease renal secretion of trovafloxacin.

Warfarin: The hypoprothrombinemic effect of warfarin may be enhanced by some quinolone antibiotics; monitor INR.

Food: Dairy products such as milk or yogurt may reduce absorption of oral trovafloxacin; avoid concurrent use. Enteral feedings may also limit absorption.

Herb/Nutraceutical: Avoid dong quai, St John's wort (may also cause photosensitization).

Dilute to a concentration of 0.5-2 mg/mL in dextrose 5% in water, 0.45% sodium chloride, dextrose 5% in water and 0.45% sodium chloride, dextrose 5% in water and 0.2% sodium chloride, or lactated Ringer's in dextrose 5% in water.

Alatrofloxacin: Stable in D5W, D5LR, D5¹/4NS, D5¹/2NS, ¹/2NS; incompatible with NS, LR

Y-site administration: Compatible: Amikacin, cyclosporine, dopamine, droperidol, fentanyl, gentamicin, ketorolac, lorazepam, LR, midazolam, nitroglycerin, ondansetron, potassium chloride, sodium bicarbonate, ¹/2NS, tobramycin, vancomycin. Incompatible: Aztreonam, ceftazidime, ceftriaxone, dobutamine, famotidine, furosemide, heparin, insulin (regular), magnesium sulfate, morphine, piperacillin/tazobactam, ticarcillin/clavulanate

Dilute to a concentration of 0.5-2 mg/mL in dextrose 5% in water, 0.45% sodium chloride, dextrose 5% in water and 0.45% sodium chloride, dextrose 5% in water and 0.2% sodium chloride, or lactated Ringer's in dextrose 5% in water; should not be diluted with 0.9% sodium chloride or lactated Ringer's

Distribution: Concentration in most tissues greater than plasma or serum

Protein binding: 76%

Metabolism: Hepatic conjugation; glucuronidation 13%, acetylation 9%

Bioavailability: 88%

Half-life elimination: 9-12 hours

Time to peak, serum: Oral: Within 2 hours

Excretion: Feces (43% as unchanged drug); urine (6% as unchanged drug)

Nosocomial pneumonia: I.V.: 300 mg single dose followed by 200 mg/day orally for a total duration of 10-14 days

Community-acquired pneumonia: Oral, I.V.: 200 mg/day for 7-14 days

Complicated intra-abdominal infections, including postsurgical infections/gynecologic and pelvic infections: I.V.: 300 mg as a single dose followed by 200 mg/day orally for a total duration of 7-14 days

Skin and skin structure infections, complicated, including diabetic foot infections: Oral, I.V.: 200 mg/day for 10-14 days

Dosage adjustment in renal impairment: No adjustment is necessary

Dosage adjustment for hemodialysis: None required; trovafloxacin not sufficiently removed by hemodialysis

Dosage adjustment in hepatic impairment:

Mild to moderate cirrhosis:

Initial dose for normal hepatic function: 300 mg I.V.; 200 mg I.V. or oral; 100 mg oral

Reduced dose: 200 mg I.V.; 100 mg I.V. or oral; 100 mg oral

Severe cirrhosis: No data available

Oral: Administer without regard to meals.

I.V.: Not for I.M. or SubQ; administer IVPB over 60 minutes

Injection, solution, as mesylate [alatrofloxacin]: 5 mg/mL (40 mL, 60 mL)

Tablet, as mesylate [trovafloxacin]: 100 mg, 200 mg

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