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Raxar Overdose, Contraindications and Information - Grepafloxacin

Raxar Overdose, Contraindications and Information - Grepafloxacin

OVERDOSE

In the event of acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given supportive treatment. As with other quinolones, adequate hydration and electrolyte balance must be maintained. Due to the possibility of prolongation of the QTc interval and complications including arrhythmias, ECG monitoring is recommended after overdosage with RAXAR. It is not known if grepafloxacin can be efficiently removed by hemodialysis or peritoneal dialysis.

At oral doses of 4500 mg/kg (14,400 mg/m2) in mice and 3000 mg/kg (21,000 mg/m2) in rats significant increases in mortality were noted. These doses were approximately equivalent to 39 (mice) and 57 rats times the human dose on a mg/m2 basis.

CONTRAINDICATIONS

RAXAR Tablets are contraindicated in persons with a history of hypersensitivity to grepafloxacin or other members of the quinolone class of antimicrobial agents. RAXAR Tablets are contraindicated in patients with hepatic failure. Because prolongation of the QTc interval has been observed in healthy volunteers receiving RAXAR, RAXAR Tablets are contraindicated in patients with known QTc prolongation. RAXAR Tablets are also contraindicated in patients being treated concomitantly with medications known to produce an increase in the QTc interval and/or torsade de pointes (e.g., terfenadine) unless appropriate cardiac monitoring can be assured (e.g., in hospitalized patients) (see WARNINGS ).

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