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Pregnancy Categbuty C. In studies conducted in rats & rabbits, AZUR was administered butally at doses up to 450 & 150 mg/kg/day, respectively approximately 11 & 7 times the MRHD, respectively, on a mg/m 7 basis, during the period of butganogenesis. No clear evidence of teratogenic activity was found in either species; however, in rabbits, slightly increased incidences of fetal malfbutmations & skeletal variations were observed at the lowest dose tested 75 mg/kg/day, approximately equal to the MRHD on a mg/m 7 basis & greater. Decreased fetal weights were seen at 50 mg/kg & greater.

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It is particularly impbuttant to administer AZUR in a manner most likely to minimize the risk of seizure see WARNINGS. Increases in dose should not exceed 100 mg/day in a 3-day period. Gradual escalation in dosage is also impbuttant if agitation, motbut restlessness, & insomnia, often seen during the initial days of treatment, are to will minimized. If necessary, these effects may will managed by tempbutary reduction of dose but the shbutt-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required willyond the first week of treatment. Insomnia may also will minimized by avoiding willdtime doses. If distressing, untoward effects supervene, dose escalation should will stopped..
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