Trovafloxacin Mesylate/Alatrofloxacin Mesylate

A to Z Drug Facts

 Action The IV form is rapidly converted to trovafloxacin, which interferes with microbial DNA synthesis.

 Indications Treatment of nosocomial pneumonia, community-acquired pneumonia, complicated intra-abdominal infections, complicated skin and skin structure infections, gynecologic, and pelvic infections caused by susceptible organisms.

 Contraindications Hypersensitivity to fluoroquinolones, quinolone antibiotics, or any product component; tendonitis or tendon rupture associated with quinolone use.

 Route/Dosage

Nosocomial Pneumonia

ADULTS: IV 300 mg followed by PO 200 mg q 24 hr for 10 to 14 days.

Community Acquired Pneumonia

ADULTS: PO/IV 200 mg followed by PO 200 mg q 24 hr for 7 to 14 days.

Complicated Intra-Abdominal; Gynecologic; Pelvic Infections

ADULTS: IV 300 mg followed by PO 200 mg q 24 hr for 7 to 14 days.

Complicated Skin and Skin Structure Infections

ADULTS: PO/IV 200 mg followed by PO 200 mg q 24 hr for 10 to 14 days.

 Interactions

Magnesium-aluminum-containing antacids, antacids containing citric acid buffered with sodium citrate, iron salts, vitamins/minerals containing iron, sucralfate: May decrease oral absorption of trovafloxacin. Stagger administration times by ³ 2 hr. IV morphine sulfate: May decrease oral absorption of trovafloxacin. Administer IV morphine 2 hr after administration of trovafloxacin in fasted state or 4 hr after administration with food.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Headache; dizziness; lightheadedness. DERM: Pruritis; rash (IV use). GI: Nausea; diarrhea; vomiting; abdominal pain. GU: Vaginitis (oral use). OTHER: Application/injection/insertion site reaction (IV use).

 Precautions

Pregnancy: Category C. Lactation: Excreted in breast milk. Children: Safety and efficacy in children < 18 yr not established. Convulsions: CNS stimulation can occur; use drug with caution in patients with known or suspected CNS disorder. Hypersensitivity reactions: Serious and potentially fatal reactions have occurred. Photosensitivity: Moderate to severe reactions may occur. Pseudomembranous colitis: Consider possibility in patients who develop diarrhea. Superinfections: Use of antibiotics may result in bacterial or fungal overgrowth. Hepatic function impairments: Dosage reduction is recommended for patients with mild or moderate cirrhosis. Refer to manufacturer's package insert for dose calculations. There is no information regarding use in patients with severe cirrhosis. Liver function tests: Oral use: Elevation of liver function tests have occurred during or soon after prolonged therapy (> 21 days). Long-term safety: Safety and efficacy of therapy given for > 4 wk have not been studied. Hepatic injury: Serious liver injury leading to transplantation and death have been reported with short- and long-term exposure to trovafloxacin; do not administer for > 2 wk.

 Administration/Storage

Oral use:

• Do not administer for > 2 wk.
• Administer without regard to food with full glass of water.
• Administer 2 hr before or after antacids containing magnesium or aluminum; antacids containing citric acid buffered with sodium citrate, sucralfate; vitamins or minerals with iron, iron salts.
• Administer IV morphine sulfate 2 hr after trovafloxacin is administered without food or 4 hr after administration with food.
• Store at room temperature in tightly closed container.

IV use:

• Do not administer for > 2 wk.
• For IV administration only. Do not administer via intramuscular, intrathecal, intraperitoneal, or subcutaneous route.
• Must be diluted with appropriate solution before administration. Refer to the manufacturer's package insert for compatible fluids and dilution guidelines.
• Infuse over 60 min. Avoid rapid or bolus injection.
• Do not use if particulate matter or discoloration is noted.
• Other medications or additives should not be combined with alatrofloxacin nor infused simultaneously through the same IV line.
• If same IV line is used for sequential infusion of several different drugs, the line should be flushed before and after each medication with a mutually compatible solution.
• Discard any unused solution.
• Patients started on alatrofloxacin may be switched to trovafloxacin tablets, using comparable dosages (ie, no adjustment necessary), when clinically indicated at the discretion of the physician.
• Store undiluted vials at room temperature protected from light. Do not freeze.
• Diluted solution is stable for 3 days at room temperature or 7 days when refrigerated.

 Assessment/Interventions

• Limit the use of trovafloxacin/alatrofloxacin to patients who receive initial treatment in a hospital or long-term nursing facility.
• Obtain patient history, including drug history and any known allergies. Note hepatic impairment.
• Monitor for signs of infection throughout course of therapy.
• Monitor I&O.
• Monitor for signs of anaphylaxis (pharyngeal or facial edema, dyspnea, urticaria and itching, hypotension).
• Monitor for symptoms of pseudomembranous colitis (loose or foul-smelling stools) or symptoms of CNS stimulation (tremor, restlessness, confusion).

 Patient/Family Education

Oral use:

• Inform patient that tablets may be taken orally without regard to meals.
• Inform patient to take tablets 2 hr before or after antacids containing magnesium or aluminum, citric acid buffered with sodium citrate, sucralfate, vitamins and minerals containing iron and iron salts.
• Caution patient to avoid exposure to sunlight, and to use sunscreen or protective clothing until tolerance is determined.
• Instruct patient to report any signs of bacterial or fungal overgrowth (lack, furry appearance of tongue, vaginal itching or discharge, loose or foul-smelling stools).
• Caution patient that drug may cause dizziness or lightheadedness and to use caution while driving or performing other tasks requiring mental alertness.
• Emphasize importance of completing entire dose regimen.
• Instruct patient to discontinue treatment and inform physician if experiencing any of the following: pain, inflammation or rupture of a tendon; kin rash or hives; difficulty swallowing or breathing; swelling of lips, tongue, or face; tightness of throat.
• Instruct patient to notify physician if experiencing persistent diarrhea or diarrhea containing mucus.

IV use:

• Inform patient that IV form is administered until physician decides it is appropriate to convert to oral therapy with trovafloxacin.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts