# E% a% i1 l% O5.39.217.77:8898 基於前述症候群與其他可能風險，需發展一套風險評估與緩解策略，以使緩釋型olanzapine僅限醫療專業人士與納入計畫的病患。 9 j4 q) k. X. b6 G/ _% V) G j8 B/ L- N9 I% k5 H; N, @
Olanzapine緩釋型肌肉注射劑由Zypadhera行銷，之前獲得歐盟核准使用。 tvb now,tvbnow,bttvb: M+ F% Y* F& F
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FDA Approves Long-Acting Olanzapine Injection $ f8 K x) g5 v" |
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By Yael Waknine # ~. Y5 q; J9 [2 E1 Wtvb now,tvbnow,bttvbMedscape Medical News tvb now,tvbnow,bttvb" F- c& w+ t% H( |" F+ s/ l
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December 15, 2009 — The US Food and Drug Administration (FDA) has approved olanzapine extended-release intramuscular injection (Zyprexa Relprevv, Eli Lilly Company) for the treatment of schizophrenia in adults. / r! {3 L. _' H& Z5.39.217.77:8898 ( t3 H- o3 e) s+ L/ g/ qThe product, which provides therapeutic levels of olanzapine for 2 to 4 weeks, is intended to promote medication adherence and thereby break the "revolving door" cycle often associated with schizophrenic relapse. " V3 {% K( c8 r, A8 Z公仔箱論壇 * r- V K E" Z* N* @. I& f1 o9 i$ i5.39.217.77:8898"There is a growing recognition among psychiatrists in the United States that non-adherence to medication is an even greater barrier to care for patients with schizophrenia than was previously understood, and that long-acting treatments can play a beneficial role in helping patients maintain a stable treatment regimen," said John Hayes, MD, vice president of Lilly Research Laboratories, in a company news release. "Zyprexa Relprevv provides a new mechanism for helping appropriate patients benefit from the well-characterized efficacy of olanzapine."公仔箱論壇5 _4 W+ R5 `/ V8 F6 U9 i/ V
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Approval of the long-lasting formulation was based on data from clinical trials of 2054 patients, showing that its use effectively controlled schizophrenic symptoms such as hallucinations, delusions, apathy, and social withdrawal for up to 4 weeks. 3 z: w. L) Y/ a/ e9 N公仔箱論壇 2 a- w5 Y2 @0 j7 F, aThe formulation's safety profile was similar to that of oral olanzapine, with the exception of injection-related events that included postinjection delirium/sedation syndrome. This syndrome was reported in less than 0.1% of injections and about 2% of patients, most frequently occurring within the first 3 hours of drug administration and resolving within 72 hours. / z, J# z0 X! w& |1 \; C9 F" ^5.39.217.77:8898公仔箱論壇 A# w5 H: j J0 j F" ^
Because of these and other potential risks, a risk evaluation and mitigation strategy has been developed to restrict distribution of extended-release olanzapine to medical professionals or patients enrolled in the program. 1 {" R& X: x4 g5 O1 v0 m+ Q. _' y1 |TVBNOW 含有熱門話題，最新最快電視，軟體，遊戲，電影，動漫及日常生活及興趣交流等資訊。' U' E( G7 E/ c/ \; i0 @
Olanzapine extended-release intramuscular injection, marketed as Zypadhera, previously was approved for use in the European Union.
