| 简介：
部份中文地高辛处方资料（仅供参考）
商品名：Digoxin Tablets
英文名：Digoxin
中文名：地高辛片
生产商：安斯泰来制药
药品简介
Digoxin（ジゴキシン錠，地高辛）是一种「心脏病药」，其主要作用，心脏强化、心脏收缩能力、心脏强化、心脏收缩、收缩血流量和过度水合引起的心力衰竭。
ジゴキシン錠0.0625「KYO」/ハーフジゴキシンKY錠0.125/ジゴキシンKY錠0.25
药效分类名称
洋地黄苷制剂
批准日期：2015年1月
商標名
Digoxin Tablets 0.0625「KYO」
Halfdigoxin-KY Tablets 0.125
Digoxin-KY Tablets 0.25
一般的名称
ジゴキシン（Digoxin）
化学名
3β-[2,6-Dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyloxy]-12β,14-dihydroxy-5β,14β-card-20(22)-enolide
分子式
C41H64O14
分子量
780.94
性状
地高辛为无色至白色结晶或白色结晶粉末。它易溶于吡啶，微溶于乙醇（95），极微溶于乙酸（100），几乎不溶于水。
化学構造式
药效药理
作用机制
地高辛通过结合和抑制磷酸化的Na+、K+-ATPase α亚基来减少Na+外流并增加细胞内Na+浓度。这成为Na+-Ca2+交换的驱动力，结果细胞内Ca2+增加，心肌收缩力增加。据说它还具有心动过缓和抗心律失常作用。
适应症
・基于以下疾病的充血性心力衰竭（包括肺水肿、心源性哮喘等）
先天性心脏病、瓣膜病、高血压、缺血性心脏病（心肌梗塞、心绞痛等）、肺心病（因肺血栓/栓塞、肺栓塞、肺纤维化等），以及其他心脏病（因肺血栓/栓塞、肺栓塞、肺纤维化等）腹膜炎、心肌病等）、肾病、甲亢和心绞痛等。
・心房颤动/房扑引起的心动过速
・阵发性室上性心动过速
・预防和治疗下列情况下的心力衰竭和各种心动过速
手术、急性发热性疾病、分娩、休克、急性中毒
用法与用量
・通常用于成人作为地高辛
(1)快速饱和疗法（饱和量：1.0-4.0mg）
首次口服0.5～1.0mg，之后每6～8小时口服0.5mg，直至出现充分效果。
(2)可以进行较快的饱和治疗。
(3)可以进行慢饱和疗法。
(4)维持治疗
每天口服0.25至0.5毫克。
・通常用于儿童作为地高辛
(1)快速饱和疗法
2 岁或以下：每天0.06至0.08毫克/公斤，分3至4次口服。
2 岁及以上：每天口服0.04至0.06毫克/公斤，分3至4次服用。
(2)维持治疗
・口服给予饱和剂量的1/5至1/3。
包装
片剂
0.0625 "KYO"
100片[10片(PTP)x10]、100片[瓶、玫瑰]
KY片
0.125
100片[10片(PTP)×10]、100片[瓶、玫瑰]、1000片[10片(PTP)×100]、1400片[14片(PTP)×100]
KY片0.25
100片[10片(PTP)×10]、100片[瓶、玫瑰]、1000片[10片(PTP)×100]
制造商和分销商
京都制药工业株式会社
销售
东亚精洋株式会社
销售
安斯泰来制药公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/2113003F1065_1_15/
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Digoxin tablets 0.0625[KYO]（Digoxin）
Brand name:Digoxin tablets 0.0625 [KYO]
Active ingredient:Digoxin
Dosage form:white to yellowish white tablet(diameter: 6.0mm, thickness: 2.2 mm)
Print on wrapping:(face) KYO270, ジゴキシン「KYO」, 0.0625mg, ジギタリス製剤
(back) ジゴキシン「KYO」, 0.0625mg, ジギタリス製剤
Effects of this medicine
This medicine strengthens myocardial contractile force, slows heart rate, and stabilizes pulse.
It is usually used for the treatment of heart failure and tachycardia.
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: heart disease, renal dysfunction, hypothyroidism, hyperthyroidism, or an electrolyte abnormality
(including potassium, calcium or magnesium, etc).
If you are a hemodialytic patient.
・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>>
・For adults:In general,as maintenance treatment, take 4 to 8 tablets(0.25 to 0.5 mg of the active ingredient) per day.
[For rapid digitalization, for which the saturation dose with digoxin is 1.0 to 4.0 mg, take 0.5 to 1.0mg initially followed by 0.5 mg every 6to 8 hours until a sufficient response is observed]
For children: In general, as maintenance treatment, give one-fifth to one-third of the saturation dose.[For rapiddigitalization, give 0.06 to 0.08 mg/kg per day for a child 2 years old or younger and 0.04 to 0.06 mg/kg per day for a child 2 years old or older in 3 or 4 divided doses]
Each tablet contains 0.0625 mg of the active ingredient.Strictly follow the instructions.
・If you miss a dose, skip the missed dose and take your next dose at the regular time. 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
・Due to the variation in optimal dosage of this medicine among individuals, your doctor may change your dose based on your condition. Therefore, contact your doctor routinely.
・DO NOT take health foods containing hypericum perforatum (St.John's Wort); this may weaken the effect of this
medicine by accelerating its metabolism. Consult with your doctor or pharmacist if you have taken such healthfoods.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash,hives, purpura and edema.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 doctorimmediately.
・loss of appetite, vomiting, visual abnormality, confusion, arrhythmia[digitalistoxicity]
・severe abdominal pain, bloody stools[non-occlusive mesenteric ischemia]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor 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 heat, moisture and light.
・Discard the remainder.Do not store them.Consult with your dispensing pharmacy ormedical institution when you
discard the medicine.
Internal
Published: 01/2015
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. |
