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英文药名：Starasid Cap(Cytarabine Ocfosphate Hydrate)
中文药名：阿糖胞苷磷酸盐水合物
生产厂家：日本化药
药品简介
Cytarabine Ocfosfate是一种口服有效的阿糖胞苷硬脂酸盐衍生物，由Yamasa Corporation和Nippon Kayaku共同开发。1992年该药在日本以商品名Starasid上市，用于治疗骨髓发育不良综合征（MDS）和白血病。
スタラシドカプセル５０／スタラシドカプセル１００
治疗类别名称
抗肿瘤药
欧文商標名
Starasid Cap
一般名：
シタラビン オクホスファート水和物(Cytarabine Ocfosphate Hydrate)
化学名：
4-amino-1-β-D-arabinofuranosyl-2(1H )-pyrimidinone 5'-(sodium octadecyl phosphate)monohydrate
分子式：
C27H49N3NaO8P・H2O
分子量：
615.67
構造式：
性状：
阿糖胞苷Okuhosufato水合物是一种白色结晶性或结晶性粉末。
易溶于水或甲醇，乙醇，微溶于（95），并在乙醚中几乎不溶。
药效药理
1. 抗肿瘤作用
本剂是在口服给药时，显示出在各种小鼠肿瘤生存益处，包括L1210白血病。这种效果是依赖于总剂量上不依赖于施用的时间安排。
此外，它表现出阿霉素，道诺霉素，丝裂霉素C，与在小鼠P388白血病顺铂或长春新碱两种药物同时结合一个显著协同效应。
2. 作用机序
本剂代谢到阿糖胞苷在体内的活性代谢物的后面，表示阿糖胞苷，前药，ARA-CTP在肿瘤细胞下，通过抑制DNA聚合酶的抗肿瘤效果。
适应病症
●成人急性非淋巴细胞白血病（该优先级给予该疗法的患者强大化疗成为主体。）
●骨髓增生异常综合征（骨髓增生异常综合征）
用法用量
●成人急性非淋巴细胞白血病
每天100〜300毫克2〜3周连续口服给药，随后停药两至三个星期。这是重复的。应当指出的是，剂量根据病情，症状等进行调整。这种药物和饭后给药的定时，考虑分成每天一至三次。
●骨髓增生异常综合征（骨髓增生异常综合征）
每天100〜200毫克2〜3周连续口服给药，随后停药两至三个星期。这是重复的。应当指出的是，剂量根据病情，症状等进行调整。这种药物和饭后给药的定时，考虑分成每天一至三次。
注意事项
仔细管理
（以下的患者，应谨慎对待）
1.患者骨髓抑制
可能加重骨髓抑制。
2.患者伴感染
骨髓抑制，感染可能会加剧。
3.患者的药物过敏史
4.患者肝功能损害
由于代谢功能[和下降，可能会出现强烈的副作用。
重要注意事项
1.两种药代动力学和临床试验结果表明，注射 - 从要表达的，每天给药3周的效果，病人受到密集化疗诱导治疗和药物管理局的这一进行优先的基础上，以避免诱导治疗。
2.注意表达或从这种药物由于骨髓抑制出血加剧。
3.加重出血可能发生的原因，由于与此药品监督管理局骨髓衰竭基础疾病确认出血，血液测试的存在，做好临床观察。
4.因为它可能会导致骨髓抑制等严重的副作用，常见的（血液检查，肝功能检查，肾功能检查等），临床检查，而且要很好地观察病人的病情。如果观察到异常消瘦，撤销，应采取适当措施停止。出现的副作用强，时间跨度长的使用，因为它仍然延长，治疗应慎重考虑。
5.注意表达或感染加重。
6.如果你需要进行管理与生育年龄的患者，考虑到对性腺的影响。
副作用
不良反应的发生率
共有708例（163例批准时，茂功研究使用545案件）和实验室异常的不良反应发生率55.7％，主要的有19.1％，血小板减少，白细胞减少18.2％，18.2％厌食，恶心，呕吐14.1％，12.4％的血红蛋白下降，红细胞下降12.3％，发热9.5％和AST（GOT）的上升9.0％，谷丙转氨酶（GPT）的上升9.0％，8.5％疲劳，LDH和增加8.5％ 。
储存
储存在室温下
包装规格
胶囊剂
50毫克：40粒 100粒
100毫克：40粒
制造厂商:日本化药有限公司
 
完整说明书附件：http://www.info.pmda.go.jp/go/pack/4224001M1020_1_11/
Starasid Cap(Cytarabine Ocfosphate Hydrate，阿糖胞苷磷酸盐水合物/阿糖胞苷十八烷基磷酸盐硬胶囊)
Starasid Cap. 50（スタラシドカプセル50）
Brand name : Starasid Cap. 50
Active ingredient: Cytarabine ocfosfate
Dosage form: magenta/white capsule (size 3 capsule)
Print on wrapping: スタラシドカプセル50, スタラシド,50mg,NK7025 ,Staraside Cap
Effects of this medicine
This medicine inhibits DNA (deoxyribonucleic acid) synthesis of cancer cells to suppress their growth.
It is used to treat adult acute non-lymphatic leukemia or myelodysplastic syndrome.
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 are a patient with marrow depression, infection, liver 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>>
•For adult acute non-lymphatic leukemia: In general, for adults, take 2-6 capsules (100-300mg of the active ingredient anhydride) in 1-3 divided doses a day after meal.
For myelodysplastic syndrome: In general, for adults, take 2-4 capsules (100-200mg of the active ingredient anhydride) in 1-3 divided doses a day after meal, for 2 to 3 weeks every day, then discontinue the medication for 2-3 weeks and repeat this schedule. The dosage may be adjusted according to your disease or symptoms.Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as possible. 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, nausea/vomiting, fever, malaise and rash. 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.
•anemia, fever, bleeding tendency (nasal bleeding, bleeding gums, bleeding under the skin), malaise [marrow depression include pancytopenia]
•fever, dry cough, breathing difficulty [interstitial pneumonia]
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 moisture.
•Discard the remainder. Do not store them. Ask your pharmacist how to discard.
NIPPON KAYAKUInternal
Published: 3/2008
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.
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