"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
(Generic versions may still be available.)
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.
RAXAR (grepafloxacin) Tablets are contraindicated in persons with a history of hypersensitivity to grepafloxacin or other members of the quinolone class of antimicrobial agents. RAXAR (grepafloxacin) Tablets are contraindicated in patients with hepatic failure. Because prolongation of the QTc interval has been observed in healthy volunteers receiving RAXAR (grepafloxacin) , RAXAR (grepafloxacin) Tablets are contraindicated in patients with known QTc prolongation. RAXAR (grepafloxacin) 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 ).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Raxar Information
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