| 简介：
部分中文氟卡尼醋酸处方资料（仅供参考）
商品名：Tambocor
英文名：Flecainide Acetate
中文名：氟卡尼醋酸細粒10%
生产商：卫材有限公司
タンボコール細粒10%
药物类别名称
心动过速心律失常治疗剂
批准日期：2015年6月
商標名
Tambocor
一 般 名
フレカイニド酢酸塩（Flecainide Acetate）
化 学 名
N-［（2RS）-Piperidin-2-ylmethyl］-2,5-bis（2,2,2-trifluoroethoxy）benzamide monoacetate
分 子 式
C17H20F6N2O3・C2H4O2
分 子 量
474.39
構 造 式
物理化学的性状
醋酸醋酸酯是一种白色结晶粉末,有轻微特异性的气味或略带醋酸的气味。
本产品易溶于甲醇、乙醇(95)或醋酸(100),水溶性略低。
本产品的甲醇溶液(1~25)不表现出耐光性。
熔点
约 150°C(分解)
分布系数
0.34 (星期三-1-八烷)
药用药理学
1. 对实验心律失常的影响
(1)小鼠和狗引起的心室心律失常(氯仿、肾上腺素、腹腔、冠状动脉结扎)通过口服和静脉注射抑制。
(2)通过静脉注射从狗的锥体中诱发的抑制心律失常。
2. 电生理效应
(1)在狗的紫杉纤维和心室肌中,不影响固定膜电位,降低最大脱极率(Vmax)和活动电位振幅。
(2)豚鼠心房肌肉和心室肌肉刺激频率依赖抑制的Vmax。
(3)在狗中,延长心室肌的有效非反应期,缩短肺泡纤维的有效非反应期。
(4)狗的试导,其- 丘金杰(H-V)传导和心腔室传导延迟。
3. 临床电生理作用
当口服剂250mg注)对心律失常患者,正心期,不影响正心结核恢复时间,延迟H-V传导,延长心室肌肉的有效不敏感。 此外,抑制逆行子传导路径,延长心室传导系统的有效非响应阶段。
注) 250mg单口服给药是未经批准的剂量。
适应症
其他抗心律失常药物在以下条件下不可用或禁用:
成人
心动过速心律失常(心房心房颤动,粗颤,心室)
孩子
心动过速心律失常(腹腔心房颤动和粗糙度,痉挛上室,心室)
用法与用量
成人
○心动过速心律失常(心房心房颤动,粗糙)
通常,成人开始管理从100毫克一天作为醋酸弯曲(1g作为罚款),如果效果不足增加到200毫克(2g罚款),口服每天两次。应该注意的是,年龄,减肥视症状而定。
○心动过速心律失常(心室)
通常,成人开始管理从100毫克一天作为醋酸弯曲(1g作为罚款),如果效果不足增加到200毫克(2g罚款),口服每天两次。应该注意的是,年龄,适当增加或减少,根据症状。
孩子
○心动过速心律失常(腹心颤动和粗糙度,痉挛上室,心室)
通常,6个月或以上的婴儿,婴儿和儿童50~100mg/m 2每天作为醋酸盐(身体表面积)(0.5~1g/m 2作为细粒(身体表面积)口服,每天口服2-3次。应该注意的是,年龄,适当增加或减少,根据症状。然而,每天的最大剂量是200mg/m 2(2g/m 2作为细粒)。
通常,婴儿小于6个月1天50mg/m2作为醋酸弯曲(身体表面积)(0.5g/m 2作为细粒(身体表面积)),口服口服,每天2-3次。 应该注意的是,年龄,适当增加或减少,根据症状。然而,每天的最大剂量是200mg/m 2(2g/m 2作为细粒)。
包装
細粒10％：50g
制造和销售
卫材有限公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明书附件：
http://www.info.pmda.go.jp/go/pack/2129009C1023_1_01/?view=frame&style=SGML&lang=ja
EISAI TO LAUNCH NEW FINE GRANULE FORMULATION OF TACHYARRHYTHMIA TREATMENT TAMBOCOR® SUITABLE FOR PEDIATRIC PATIENTS IN JAPAN
Tambocor® Fine Granules 10%, a new formulation of anti-arrhythmic agent Tambocor (flecainide acetate), on June 29 in Japan. Eisai received marketing and manufacturing approval for this formulation on February 16, 2015, and the product was added to Japan's National Health Insurance drug price list on June 19 of the same year.
This product is a fine granule formulation that can be adjusted to account for age and body surface area for administration to pediatric patients, and can be administered to patients who have difficulty taking tablets. In addition, Eisai has made special efforts, such as reducing the bitterness, to make Tambocor Fine Granules easy to administer.
Tambocor suppresses tachyarrythmia by blocking cardiac sodium channels and slowing down cardiac conduction. Approved and launched as Tambocor Tablets in Japan in 1991, the drug was originally indicated for the treatment of tachyarrythmia in adults, and was approved for the treatment of tachyarrythmia (paroxysmal atrial fibrillation/flutter, paroxysmal superventricular, ventricular) in pediatric patients in May 2010. Furthermore, Tambocor is the only sodium channel blocking agent in Japan to be approved for the treatment of tachyarrythmia in pediatric patients.
Pediatric arrhythmia not only causes heart palpitations, dizziness, shortness of breath and other symptoms that impact the daily lives of patients, it is also said to be one of the most common causes of sudden death among children. Regarding pediatric arrhythmia, Eisai has received approval of additional indications for pediatric patients for Tambocor Tablets in May 2010, and for the calcium channel blocker Vasolan® Tablets 40 mg and Vasolan for intravenous injection 5 mg in May 2011. By providing the easy to measure and administer Tambocor Fine Granules 10% in addition to Tambocor Tablets, Eisai will continue to make further contributions to address their needs of patients with tachyarrhythmia.
< Notes to editors >
1. About Tambocor Fine Granules 10%
1) Product Name
Tambocor® Fine Granules 10%
2) Generic Name
Flecainide acetate
3) Indications, Dosage & Administration
• Indications
The following conditions where other antiarrhythmic drugs cannot be used or are ineffective:
Adults: Tachyarrhythmia (paroxysmal atrial fibrillation/flutter, ventricular)
Pediatric patients: Tachyarrhythmia (paroxysmal atrial fibrillation/flutter, paroxysmal superventricular, ventricular)
• Dosage & Administration
Adults:
・Tachyarrhythmia (paroxysmal atrial fibrillation/flutter)
The usual initial adult dose is 100 mg (1 g as fine granule) of flecainide acetate daily. If the effect is insufficient, the dose may be increased up to 200 mg (2 g as fine granule) daily, which should be administered in two divided doses. The dose may be reduced depending on the patient's age and symptoms.
・Tachyarrhythmia (ventricular)
The usual initial adult dose is 100 mg (1 g as fine granule) of flecainide acetate daily. If the effect is insufficient, the dose may be increased up to 200 mg (2 g as fine granule) daily, which should be administered in two divided doses. The dose may be adjusted depending on the patient's age and symptoms.
Pediatric patients:
・Tachyarrhythmia (paroxysmal atrial fibrillation/flutter, paroxysmal superventricular, ventricular)
The usual oral dosage for infants over 6 months old or over, toddlers, and children is 50-100 mg/m2 (body surface area) [0.5-1 g/m2 (body surface area) as fine granule] of flecainide acetate daily in two to three divided doses. The dose may be adjusted depending on the patient's age and symptoms. The maximum dose is 200 mg/m2 per day [2 g/m2 (body surface are) as fine granule] daily.
The usual oral dosage for infants under the age of 6 months is 50 mg/m2 (body surface area) [0.5 g/m2 (body surface area) as fine granule] of flecainide acetate daily in two to three divided doses. The dose may be adjusted depending on the patient's age and symptoms. The maximum dose is 200 mg/m2 per day [2 g/m2 (body surface area) as fine granule] daily.
4) Price
Tambocor Fine Granules 10%: per 1g containing 10%
5) Packaging
Bottles of 50g |
