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Although levofloxacin is more soluble than other quinolones, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of a highly concentrated urine.
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced. In patients with impaired renal function (creatinine clearance ≤ 80 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance.
Moderate to severe photo toxicity reactions have been observed in patients exposed to direct sunlight while receiving drugs in this class. Excessive exposure to sunlight should be avoided. However in clinical trials with levofloxacin, photo toxicity has been observed in less than 0.1 % of patients. Therapy should be discontinued if photo toxicity (eg, skin eruption) occurs.
As with other quinolones, levofloxacin should be used with caution in any patient with a known of or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction).
As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycaemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g. glyburide/glibenclamide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycaemic reaction occurs in a patient being treated with levofloxacin, levofloxacin should be discontinued immediately and appropriate therapy should be initiated immediately.
As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic and haematopoietic, is advisable during therapy.
Information for patients: Patients should be advised: To drink fluid liberally.
That antacids containing magnesium, or aluminium, as well as sucralfate, metal cations such as iron, and multi-vitamin preparations with zinc should be taken at least two hours before or two hours after levofloxacin administration.
That levofloxacin can be taken without regard to meals.
That levofloxacin may cause neurologic adverse effects (e.g. dizziness, light- headedness) and that patients should know how they react to levofloxacin before they operate automobile or machinery or engage in other activities requiring mental alertness and coordination.
To discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded.
That levofloxacin may be associated with hypersensitivity reactions, even following the first dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g. swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
To avoid excessive sunlight or artificial ultraviolet light while receiving levofloxacin and to discontinue therapy if phototoxicity (i.e. skin eruption) occurs.
That if they are diabetic and are being treated with insulin or an oral hypoglycaemic agent and hypoglycaemic reaction occurs, they should discontinue levofloxacin and consult a physician.
