比卡鲁胺片BICALUTAMIDE(Casodex Table 50mg)

产地国家美国

处方药

所属类别 50毫克/片 30片/盒

包装规格 50毫克/片 30片/盒

计价单位

生产厂家英文名AstraZeneca

原产地英文商品名Casodex -50mg/Tablet 30Tablets

原产地英文药品名BICALUTAMIDE

中文参考商品译名Casodex -50毫克/片 30片/盒

中文参考药品译名比卡鲁胺

简介:

【治疗分类】内分泌治疗

【主要成份】比卡鲁胺生产厂家: AstraZeneca(阿斯利康)

【适应症】与促黄体生成素释放激素(LHRH)类似物或外科睾丸切除术联合应用于晚期前列腺癌的治疗。

【用量用法】成人:成年男性包括老年人:一片(50mg),一天一次,用康士得治疗应与LHRH类似物或外科睾丸切除术治疗同时开始。儿童:本品禁用于儿童。肾损害:对于肾损害的病人无需调整剂量。肝损害:对于轻度肝损害的病人无需调整剂量,中重度肝损伤的病人可能发生药物蓄积(见注意事项)。如果您有任何疑问,请遵医嘱。

【不良反应】本品一般来说有良好的耐受性,少有因不良反应而停药的情况。本品的药理作用可以引起某些预期的反应,包括面色潮红、搔痒、另外乳房触痛和男性乳房女性化,它可随睾丸切除术减轻。本品也可能引起腹泻、恶心、呕吐、乏力和皮肤干燥。肝功改变(转氨酶水平升高,黄疸)已经在本品的临床试验中被观察到,但少见严重变化,这种改变常常是短暂的。无论是继续治疗还是随即中止治疗均可逐渐消退或改善。接受本品治疗的患者极少出现肝功能衰竭,且其因果关系尚未确立。应考虑定期查肝功能。(见注意事项)。在使用本品与LHRH类似物伍用进行临床研究期间还观察到下列副作用(临床试验者认为可能与药物相关且发生率大于1%)。这些副作用与药物的使用没有因果关系,有些是老年人日常固有的。心血管系统:心衰消化系统:厌食、口干、消化不良、便秘、胃肠胀气。中枢神经系统:头晕、失眠、嗜睡、性欲减低。呼吸系统:呼吸困难。泌尿生殖系统:阳痿、夜尿增多。 血液学:贫血。皮肤及其附件:脱发、皮疹、出汗、多毛。代谢及营养:糖尿病、高血糖、周围性水肿、体得增加、体重减轻。躯干:腹痛、胸痛、头痛、骨盆痛、寒战。禁忌症康士得禁用于妇女和儿童。康士得不能用于对本品过敏的病人。本品不可与特非那定,阿司咪唑或西沙比利联合使用。

【注意事项】本品广泛在肝脏代谢。数据表明严重肝损害的病人药物清除可能会减慢,由此可能导致蓄积。所以本品对有中、重度肝损伤的病人应慎用。由于可能出现肝脏改变,应考虑定期进行肝功能检测。主要的改变一般在本品治疗的最初6个月内出现。严重的肝功能改变很少见于本品的治疗(见不良反应)。如果出现严重改变应停止本品治疗。本品显示抑制细胞色素P450(CYP3A4)活性,因此当与主要由CYP3A4代谢的药物联合应用时应谨慎。妊娠和哺乳本品禁用于女性,更不能用于妊娠妇女或正哺乳的母亲。对驾驶和操作机器能力的影响:本品不会影响病人驾驶及操作机器的能力。

【贮 藏】低于30度保存。

英文版说明书:

GENERIC NAME: BICALUTAMIDE – ORALBRAND NAME(S): CasodexUSES:Bicalutamide is used to treat prostate cancer that has spread to other areas of the body. It is used in combination with hormone treatment. This medication works by blocking the action of male hormones in the prostate, slowing growth of the tumors.This medication should not be used in women or children.HOW TO USE:Take this medication by mouth, usually once a day in the morning or evening, with or without food, or as directed by your doctor.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. The dosage is based on your medical condition and response to therapy.Do not increase your dose or take this medication more often without your doctor’s approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.SIDE EFFECTS:Flushing and sweating (hot flashes), body aches and pains, breast swelling/tenderness/pain, headache, dizziness, drowsiness, trouble sleeping, weakness, hair loss, weight changes, constipation, diarrhea, stomach upset, gas, nausea, vomiting, and loss of appetite may occur.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual ability/desire, vision changes, numbness/tingling of the hands or feet, swelling of the arms/legs, unusual or easy bleeding/bruising, change in the amount of urine, painful urination, signs of infection (e.g., fever, chills, persistent sore throat), trouble breathing, persistent cough, mental/mood changes (e.g., anxiety, depression).Seek immediate medical attention if any of these very serious side effects occur: chest pain, jaw/left arm pain.Rarely, bicalutamide may cause growth of other types of tumors. Consult your doctor immediately if new lumps or growths occur.This medication may rarely cause serious (possibly fatal) liver disease. Seek immediate medical attention if any of these side effects occur: dark urine, yellowing of the eyes/skin, unusual tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs.Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects.If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at

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