藥品新增

<13A077>Aripiprazole (Abilify Maintena®) (300mg).針

新藥介紹

<13A077>Aripiprazole (Abilify Maintena®) (300mg).針

藥理作用/作用機轉

Aripiprazole is a quinolinone antipsychotic which exhibits high affinity for D2, D3, 5-HT1A, and 5-HT2A receptors; moderate affinity for D4, 5-HT2C, 5-HT7, alpha1 adrenergic, and H1 receptors. It also possesses moderate affinity for the serotonin reuptake transporter; has no affinity for muscarinic (cholinergic) receptors. Aripiprazole functions as a partial agonist at the D2 and 5-HT1A receptors, and as an antagonist at the 5-HT2A receptor.

適應症/

劑量

IM

【Adult】投與雙劑400毫克劑量發生不良反應,考慮減低其維持劑量至每個月300毫克。

　●Bipolar I disorder; Schizophrenia: Note: Establish tolerability by oral aripiprazole prior to initiation of ER injection; due to the prolonged half-life of oral ariaripiprazole, it may take up to 2 weeks to fully assess tolerability.

　　*Single injection start: 400 mg once monthly (be separated by ≧26 days). Continue (overlap) oral aripiprazole or other oral antipsychotic for 14 days during initiation of the ER injection.

　　*Double injection start: Initial: Administer a single oral aripiprazole 20 mg dose, plus two 400 mg injections in separate injection sites (eg, right deltoid and left gluteal muscle). Maintenance: 400 mg once monthly (be separated by ≧ 26 days).

【Pediatric】Safety and efficacy not established in pediatric patients.

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

No dosage adjustment necessary

『Hepatic Impairment: Adult』

No dosage adjustment necessary

使用禁忌

Hypersensitivity to aripiprazole.

警告/預防

Orthostatic hypotension

不良反應

【>10%】Headache, EPS, drowsiness, akathisia, fatigue, sedation; Weight gain, increased cholesterol, TG, glucose, LDL; decreased HDL; Nausea, constipation.

【1% to 10%】Dizziness, drooling, restlessness, pain, dystonia, ataxia, hypersomnia,

fatigue, insomnia, anxiety; Tachycardia, peripheral edema, orthostatic hypotension; Skin rash; Weight loss; Vomiting, sialorrhea, increased appetite, xerostomia, toothache, diarrhea, gastric distress, stomach discomfort, abdominal distress, anorexia; dysmenorrheal; Neutropenia ; Injection site reaction; Arthralgia, back pain, limb pain, myalgia, stiffness, musculoskeletal pain, cramps, rigidity, spasm; weakness, dyskinesia; URI.

【<1%】Not referred here, please see package insert or other reference.

懷孕用藥分級(FDA)

C /避免使用，除非有治療必要

健保規範

  • 藥品說明：比照13A069

(1)記載理由或診斷(2)超過下列日劑量時,須記載理由:Risperidone 6mg、Quetiapine 600mg、Amisulpride 800mg、Ziprasidone 120mg、Aripiprazole 15mg、Paliperidone 12mg、Lurasidone 120mg (3)雙極性疾患之鬱症發作不得使用

  • 藥品理由：

01)每個月接種一次劑型

其他

會升高患有失智症相關精神病之老年病人的死亡率.

從未使用過aripiprazole的患者，在開始使用前先確立其對口服aripiprazole之耐受性。

至少2 週的時間，全面評估aripiprazole的耐受性。

在第一個劑量注射後，須接受連續14 天的口服aripiprazole (10~20mg)， 以確保在初始治療期間可達到治療濃度。若患者已以其他的口服抗精神病藥物穩定治療(且已知可耐受aripiprazole)，在第一個劑量注射後，繼續接受連續14天的口服抗精神病藥物，以確保在初始治療期間維持抗精神病藥物的治療濃度。

 

核對用法: IM 注射部位:三角肌.臀部

配製後於30分鐘內使用

不要揉注射部位

依注射部位與體重決定注射針頭