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[½»Á÷] FDA˵Ã÷Êé·­Òë

Pregnancy
Pregnancy Category B: Memantine given orally to pregnant rats and pregnant rabbits
during the period of organogenesis was not teratogenic up to the highest doses tested (18
mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively,
the maximum recommended human dose [MRHD] on a mg/m2 basis).
Slight maternal toxicity, decreased pup weights and an increased incidence of nonossified
cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which
rats were given oral memantine beginning pre-mating and continuing through the postpartum
period. Slight maternal toxicity and decreased pup weights were also seen at this
dose in a study in which rats were treated from day 15 of gestation through the postpartum
period. The no-effect dose for these effects was 6 mg/kg, which is 3 times the
MRHD on a mg/m2 basis.

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zqxia2009(½ð±Ò+1): 2010-04-17 08:15
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BÀàÔи¾£º¿Ú·þ¸øÒ©ÓÚÓ¤Ó×¶ùÆ÷¹ÙÐγÉʱÆÚµÄ»³ÔдóÊóºÍÍÃ×ÓµÄ×î¸ßÊÔÑé¼ÁÁ¿ÃÀ½ð¸ÕûÓÐÖ»û×÷Ó㨴óÊó18mg/kg/dayºÍÍÃ×Ó30 mg/kg/day, Õâ·Ö±ðÊÇ»ùÓÚmg/m2µÄ×î´óÈËÌåÍÆ¼ö¼ÁÁ¿[MRHD] µÄ9±¶ºÍ 30 ±¶£©¡£ÔÚ18 mg/kg/day ¿Ú·þ¼ÁÁ¿µÄÒ»ÏîÑо¿ÖУ¬¹Û²ìµ½Çá΢µÄĸÌå¶¾ÐÔ¡¢Ó×áÌÌåÖØ¼õÇáºÍ·Ç½©»¯¾±×µ·¢ÉúÂÊÉÏÉý£¬ÔÚÕâÏîÑо¿ÖУ¬´óÊóÔÚ½»Åäǰ±»¿Ú·þ¸øÒ©ÃÀ½ð¸Õ£¬²¢ÔÚÕû¸ö²úºóÆÚÖгÖÐø¸øÒ©¡£Çá΢µÄĸÌå¶¾ÐÔºÍÓ×áÌÌåÖØ¼õÇáÒ²ÔÚÕâ¸ö¼ÁÁ¿×éµÄÁíÒ»ÏîÑо¿Öб»¹Û²ìµ½£¬ÔÚ±¾ÏîÑо¿ÖУ¬´óÊó´ÓÈÑÉïµÄµÚ15ÌìºÍÕû¸ö²úºóÆÚ±»¸øÒ©´¦Àí¡£¶ÔÓÚÕâЩӰÏìÎÞЧӦ¼ÁÁ¿Îª6 mg/kg, Ï൱ÓÚ»ùÓÚmg/m2µÄ×î´óÈËÌåÍÆ¼ö¼ÁÁ¿[MRHD] µÄ3±¶.
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