The clinical relevance of these findings to humans is unknown. Use caution in patients with known or suspected CNS disorders. Treatment with all antibiotics, including trovafloxacin, has been associated with the development of pseudomembranous colitis, so the diagnosis should be considered in patients who present with diarrhea after or during antibiotic use. Although not seen in clinical trials with trovafloxacin, other members of the quinolone class have been associated with ruptures of the shoulder, hand, and achilles tendon. Trovafloxacin should be discontinued if patient reports pain, inflammation, or rupture of a tendon.
Tendon rupture can occur during or after therapy with a quinolone agent.
Trovafloxacin is contraindicated in persons with a history of hypersensitivity to trovafloxacin, alatrofloxacin, quinolone antimicrobials or any other components of these products. There are no adequate and well-controlled studies in pregnant women. Trovafloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fetotoxicity and fetal skeletal malformations have also been associated with other quinolones. There are no data for patients with severe cirrhosis.