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MAXAQUIN (LOMEFLOXACIN HYDROCHLORIDE) TABLETS: WARNINGS
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Maxaquin (Lomefloxacin HCl) pills and other antibacterial drugs, Maxaquin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Moderate to severe phototoxic reactions have occurred in patients exposed to direct or indirect sunlight or to artificial ultraviolet light (eg, sunlamps) during or following treatment with lomefloxacin. These reactions have also occurred in patients exposed to shaded or diffuse light, including exposure through glass. Patients should be advised to discontinue lomefloxacin therapy at the first signs or symptoms of a phototoxicity reaction such as a sensation of skin burning, redness, swelling, blisters, rash, itching, or dermatitis.
These phototoxic reactions have occurred with and without the use of sunscreens or sunblocks. Single doses of lomefloxacin have been associated with these types of reactions. In a few cases, recovery was prolonged for several weeks. As with some other types of phototoxicity, there is the potential for exacerbation of the reaction on re-exposure to sunlight or artificial ultraviolet light prior to complete recovery from the reaction. In rare cases, reactions have recurred up to several weeks after stopping lomefloxacin therapy.
Exposure to direct or indirect sunlight (even when using sunscreens or sunblocks) should be avoided while taking lomefloxacin and for several days following therapy. Lomefloxacin therapy should be discontinued immediately at the first signs or symptoms of phototoxicity. Risk of phototoxicity may be reduced by taking lomefloxacin in the evening.
The safety and efficacy of lomefloxacin in pediatric patients and adolescents (under the age of 18 years), pregnant women, and lactating women have not been established. The oral administration of multiple doses of lomefloxacin to juvenile dogs at 0.3 times and to rats at 5.4 times the recommended adult human dose based on mg/m2 (0.6 and 34 times the recommended adult human dose based on mg/kg, respectively) caused arthropathy and lameness. Histopathologic examination of the weight-bearing joints of these animals revealed permanent lesions of the cartilage. Other quinolones also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in juvenile animals of various species.
Convulsions have been reported in patients receiving lomefloxacin. Whether the convulsions were directly related to lomefloxacin administration has not yet been established. However, convulsions, increased intracranial pressure, and toxic psychoses have been reported in patients receiving other quinolones. Nevertheless, lomefloxacin has been associated with a possible increased risk of seizures compared to
other quinolones. Some of these may occur with a relative absence of predisposing factors. Quinolones may also cause central nervous system (CNS) stimulation, which may lead to tremors, restlessness, lightheadedness, confusion, and hallucinations. If any of these reactions occurs in patients receiving lomefloxacin, the drug should be discontinued and appropriate measures instituted. However, until more information becomes available, lomefloxacin, like all other quinolones, should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, or other factors that predispose to seizures. Psychiatric disturbances, agitation, anxiety, and sleep disorders may be more common with lomefloxacin than other products in the quinolone class.
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