部份中文左卡尼汀处方资料（仅供参考）
商品名：L-Cartin FF
英文名：Levocarnitine
中文名：左卡尼汀口服溶液
生产商：大冢制药
エルカルチンFF内用液10％／ ※エルカルチンFF内用液10％分包5mL／ ※エルカルチンFF内用液10％分包10mL
药用类别名称
左旋肉碱制剂
批准日期：2013年2月
商標名
L-Cartin FF oral solution
一般名
レボカルニチン〔Levocarnitine（JAN）〕
化学名
(R)-3-Hydroxy-4-trimethylammoniobutanoate
構造式
分子式
C7H15NO3
分子量
161.20
性状
它是一种白色结晶性粉末。 它非常溶于水, 微溶于乙醇 (99.5)。 它是吸湿的。 水溶液 (1→20) 的 ph 值为6.5 到8.5。
熔点
约 200°c (分解)
操作注意事项
请放在儿童接触不到的地方。
药用药理学
1. 纠正组织内的 "慢性肉碱缺乏症" 状况。
2. 组织中多余的有害 "丙基基" 作为丙基肉碱在体外 (尿液) 排泄。
3. 保护线粒体功能不受有害的 "丙基基" 和激活其代谢。
利用大鼠肝线粒体, 将左旋肉碱氯化物(l-体)与d-肉碱氯化物进行了比较, dl-肉碱氯化物是一种光学异构体。因此, l-体对线粒体呼吸活性无明显抑制作用, 对丙酸抑制线粒体呼吸能力的作用有显著的恢复作用。
适应症
肉碱缺乏
用法与用量
通常情况下, 成人, 作为左旋替尼, 1天1.5至3g(15 ~ 30ml) 口服分为三次。另外, 它是适当的增加或减少取决于病人的情况。
通常情况下, 孩子, 作为左旋肉碱, 分为三次口服每天重量1公斤 25~100毫克(0.25~1kg)。另外 它是适当的增加或减少取决于病人的情况。
临床结果
由于我们没有使用这种药物进行临床试验, 已发表论文的结果如下(外国国民的结果)。
原发性肉碱缺乏症
在原发性 (全身) 肉碱缺乏症患者中, 每天口服三次左旋肉碱 1 1g1, 减少肌肉萎缩, 观察到肌肉力量增强。
继发性肉碱缺乏与先天性代谢紊乱
卡尼林-阿基基霉素转移酶(cact)每天口服两次 (30mgggg day) 给有缺陷的儿童, 没有表达低血糖和严重氨血症等症状, 观察到正常生长。
-左旋卡尼汀25mg/kg/day 在丙酸血患者中, 经口服左旋肉碱 100mg/kg·天为甲基丙二酸血, 血浆游离肉碱、短链和长链共济并培养了乙酰卡尼宁的浓度。无尿肉碱和乙酰肉碱浓度增加。
给予左旋肉碱60 ~ 100mgg/kg日, 以异维酸血液, 总肉碱在血浆中, 游离肉碱增加到一个重要的参考值, 在治疗期间保持。在管理开始后的30个月, 运动发展几乎恢复正常, 增长和发展恢复正常。
透析患者的继发性肉碱缺乏症
在透析患者继发性肉碱缺乏症患者中, 通过左旋肉碱2天口服, 肌肉恢复, 肌肉疼痛, 改善临床症状, 如肌肉痉挛。
药物次生肉碱缺乏症
在二次肉碱缺乏症患者中, 观察到左旋卡尼汀50mg/kg·日间口服, 在高蛋白摄入过程中血浆氨浓度增加。
包装
※ 溶液 10%:
100ml x1瓶
※ 溶液10%
最少5毫升: 5毫升x10胶囊
*内部溶液
10ml:10毫升x10胶囊
制造和销售
大冢制药
注：以上中文资料不够完整，使用者以原处方资料为准。
完整说明附件：http://www.info.pmda.go.jp/go/pack/3999033S1024_1_07/
L-Cartin FF oral solution（Levocarnitine）エルカルチンFF内用液10％
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name : L-CARTIN FF Oral Solution 10%
　Active ingredient: Levocarnitine
　Dosage form: colorless to slightly yellow, clear solution
　Print on wrapping:
Effects of this medicine
This medicine activates mitochondrial function by improving a carnitine deficient state, and improves symptoms such as convulsive attack and hypotonia.
It is usually used for the treatment of carnitine deficiency.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have renal disorder.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take 15 to 30 mL (1.5 to 3 g of active ingredient) daily, in 3 divided doses. For children, take 0.25 to 1 mL (25 to 100 mg of active ingredient)/kg of body weight daily, in 3 divided doses. The dosage may be adjusted according to your symptoms. This preparation contains 10 mL (1 g of active ingredient) per bottle. Strictly follow the instructions of your doctor and pharmacist.
•If you miss a dose, take the dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include loss of appetite, diarrhea, loose stools, enlarged feeling of abdomen, facial edema, hematuria, and anemia. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and humidity.
•If there is a remainder, this is to be discarded. Do not store it.
Otsuka Pharmaceutical Co., Ltd.Internal
Published: 3/2013
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.