Trovafloxacin Pregnancy and Breastfeeding Warnings
Trovafloxacin is also known as: Trovan
Trovafloxacin Pregnancy Warnings
Of 549 cases reported by the European Network of Teratology Information Services involving exposure to other fluoroquinolones, congenital malformations were reported in 4.8%; however, this was not higher than the background rate.
Trovafloxacin has been assigned to pregnancy category C by the FDA. Some animal studies failed to reveal evidence of fetal harm. However, studies using high doses demonstrated fetotoxicity and teratogenicity (increased perinatal mortality, decreased body weight and cartilage damage and arthropathies that have suggested abnormal fetal bone formation). There are no controlled data from human pregnancy studies. Because safer alternatives are available, some experts consider fluoroquinolones contraindicated during pregnancy, especially during the first trimester. The manufacturer recommends that trovafloxacin should only be given during pregnancy when benefit outweighs risk.
Trovafloxacin Breastfeeding Warnings
Trovafloxacin is excreted into human milk. Quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Trovafloxacin was detectable in the breast milk of three lactating women. The average breast milk concentration was 0.8 mcg/mL (range 0.3 to 2.1 mcg/mL) after single intravenous alatrofloxacin 300 mg and repeated oral trovafloxacin 200 mg doses.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.