Երկիր: Թայվան
Լեզու: չինարեն
Աղբյուրը: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ENALAPRIL MALEATE
美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)
C09AA02
錠劑
ENALAPRIL MALEATE (2408004010) 5MG
盒裝
製 劑
須由醫師處方使用
MERCK SHARP & DOHME LTD. SHOTTON LANE, CRAMLINGTON, NORTHUMBERLAND, NE23 3JU, UNITED KINDOMHERTFORD ROAD HODDESDON HERFFORDSHIRE EN11 9BU UNITED KINGDOM GB
enalapril
高血壓、充血性心臟衰竭。
註銷日期: 2015/09/22; 註銷理由: 自請註銷; 有效日期: 2017/03/26; 英文品名: RENITEC TABLETS 5MG
已註銷
1997-03-26
trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated. ACE inhibitors can cause fetal and neonatal morbidity and mortality when administered to pregnant women during the second and third trimesters. Use of ACE inhibitors during this period has been associated with fetal and neonatal injury including hypotension, renal failure, hyperkalemia, and/or skull hypoplasia in the newborn. Maternal oligohydramnios, presumably representing decreased fetal renal function, has occurred and may result in limb contractures, craniofacial deformations and hypoplastic lung development. If RENITEC is used, the patient should be apprised of the potential hazard to the fetus. These adverse effects to the embryo and fetus do not appear to have resulted from intrauterine ACE-inhibitor exposure limited to the first trimester. In those rare cases where ACE inhibitor use during pregnancy is deemed essential, serial ultrasound examinations should be performed to assess the intraamniotic environment. If oligohydramnios is detected, RENITEC should be discontinued unless it is considered life-saving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Infants whose mothers have taken RENITEC should be closely observed for hypotension, oliguria and hyperkalemia. Enalapril, which crosses the placenta, has been removed from the neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion. NURSING MOTHERS Enalapril and enalaprilat are secreted in human milk in trace amounts. Caution should be exercised if RENITEC is given to a nursing mother. PEDIATRIC USE The safety and effectiveness of RENITEC have been established in hypertensive pediatric patients age 1 month to 16 years. Use of RENITEC in these age groups is supported by evidence from adequate and well-controlled studies of RENIT Կարդացեք ամբողջական փաստաթուղթը