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羟基脲胶囊Hydrea(Hydroxyurea Capsules)

2011-01-15 13:59:17  作者:新特药房  来源:中国新特药网天津分站  浏览次数:291  文字大小:【】【】【
简介: 药品名称 药品名称:羟基脲 英文名:Hydroxycarbamide 中文别名:氨基甲酰基羟胺、氨甲酰基胺、羟基脲素、羟脲 英文别名:Hudura、Hydrea、Hydroxicarbamidum、Hydroxyurea、Idroxicarbamidum 别名:氨 ...

药品名称

药品名称:羟基脲
英文名:Hydroxycarbamide
中文别名:氨基甲酰基羟胺、氨甲酰基胺、羟基脲素、羟脲
英文别名:Hudura、Hydrea、Hydroxicarbamidum、Hydroxyurea、Idroxicarbamidum
别名:氨基甲酰基羟胺、氨甲酰基胺、羟基脲素、羟脲、Hudura、Hydrea、Hydroxicarbamidum、Hydroxyurea、Idroxicarbamidum
性状:本品为白色结晶性粉末;无臭,味微涩。本品在水中易溶,在乙醇中微溶,在乙醚中不溶。
熔点: 本品的熔点为138~145℃,熔融时同时分解。
 
药物动力学
本品口服吸收较快,2小时后血清浓度已达高峰,6小时后消失,T1/2为3~4小时,可透过血脑屏障。主要在肝内代谢,由尿中排泄,4小时内能排出60%,12小时内80%。
适应症
主要用于治疗慢性粒细胞白血病(慢粒)、慢粒的加速期和急变期、真性红细胞增多症,另对头颈部原发性鳞癌、复发性转移性卵巢癌等亦有一定疗效; 与放射治疗同时应用或作为放射增敏剂,可增加治疗头颈部肿瘤的疗效。
用法用量
1.成人常用量
①慢粒,可根据患者用药前病情及白细胞数高低而决定剂量,一般开始剂量为每日按体重20—30mg/kg,1次或分2次口服,当白细胞下降至10×109/L以下时减量至约为每日20mg/kg,口服维持或改间歇服用。
②头颈癌、卵巢癌等,剂量为每次按体重60—80mg/kg或按体表面积2000—3000mg/平方米,每3日口服1次,单独服用或与放疗合用;亦可每日按体重20—30mg/kg,每日1次口服给药。
2. 小儿常用量尚未确定。
(1)对饮食牛奶、乳糖或对酒石黄(tartrazine)不能忍受者,对服用以乳糖或酒石黄作为赋形剂的本品胶囊亦可能不能忍受。
(2)患者避免接受死(或活)病毒疫苗的免疫接种,由于服用本品会使患者的免疫机制受抑制,对接种疫苗后产生抗体的反应亦减弱,且要经3个月后才能恢复,因而要停用本品3个月到1年后才可以考虑接种疫苗。本品与活病毒同时合用时,会增强病毒的增殖能力与毒性,因而白血病患者在获完全缓解后离最后一次化疗日3个月以上才能考虑活病毒疫苗接种。与患者密切接触的家属成员等亦应延缓口服脊髓灰质炎疫苗。
(3)服用本品时应适量增加液体的摄入量,以增加尿量及尿酸的排出。
(4)治疗前后及治疗期要严密定期随访血常规、血小板计数、血尿素氮、尿酸、肌酐浓度。
(5)本品的使用剂量必须根据患者对治疗的反应、耐受性等而调节。
(6)若服用本品已达6周仍未见效,应考虑停服本品而改换其他药物治疗。
(7)在服用本品过程中,若出现显著的粒细胞或血小板减低,例如白细胞下降至2.5×109/L或血小板下降至100×109/L以下,应暂停服用本品,并予相应的处理。
(8)与放疗合用时,应在放疗前7日开始给药,并严密观察血象,若出现严重的放疗不良反险亦应考虑减少或暂停服用本品。
任何疑问,请遵医嘱!
不良反应
(1)造血系统:较常见的有白细胞减少、贫血或红细胞形态的异常。白细胞减低通常在治疗开始约10日后发生,少数可合并感染,红细胞可出现巨幼红改变,形态类似恶性贫血,但其发生与维生素Bl2或叶酸缺乏无关。患者的血清铁清除率迟缓、红细胞对铁利用率减少。较少的有血小板减少。
(2)消化系统:较常见的有胃纳减退、恶心、呕吐,较少见的有便秘,长期服用本品可发生口腔粘膜炎、口腔溃疡等。
(3)其它:皮疹、红斑、瘙痒等皮肤反应及脱发较为少见,可偶然发生由于大量白细胞迅速崩溃而引起的血尿酸增高或尿酸性肾病,偶然可见到头痛、倦睡、头晕、幻觉、惊厥等神经毒性表现。骨髓抑制,白细胞及血小板减少.药热,胃肠道反应.有报道可引起睾丸缩小及致畸胎作用。其他还有色素沉着、超敏反应、局部损伤及对射线过敏等等。
禁忌
(1)由于本品有诱变、致畸胎、致癌的潜在可能,故应避免在妊娠初期的3个月内或哺乳期内服用。
(2)老年患者对本品较敏感,且肾功能可能较差,故服用本品时应适当减少剂量。
(3)下列情况禁用:水痘、带状疱疹及各种严重感染。下列情况应慎用:严重贫血未纠正前、骨髓抑制、肾功能不全、痛风、尿酸盐结石史等。有报道可引起睾丸缩小及致畸胎作用。
药物相互作用
(1)由于本品有可能提高服用者血尿酸的浓度,因此与别嘌醇、秋水仙碱、丙磺舒等合用治疗痛风时,必须调节上述抗痛风药物剂量,以控制痛风病变及血尿酸的浓度。本品与别嘌醇合用时能预防并逆转本品所致的高尿酸血症。
(2)与能引起白细胞或血小板减低的药物或放射疗法联合应用时,应严密观察患者的血象,并根据血白细胞及血小板数适当调节羟基脲的用量。(3)本品与烷化剂和放射线无交叉耐药性。
规格
羟基脲片500mg
(1).抗癌:一日40-60mg/kg,一周2次,一疗程6周.可大剂量间歇给药,每8小时1次,剂量60mg/kg,或6小时1次,剂量100mg/kg,24小时一疗程,间歇4-7天.
(2).顽固和脓疱性银屑病:日0.5-1.5g,4-8周一疗程.

英文药名: Hydrea (Hydroxyurea Capsules)

中文药名: 羟基脲胶囊

生产厂家: Bristol Meyers Squibb((百时美施贵宝)

Product Description

This page contains drug information on Hydrea.
The information provided includes the following:
what is Hydrea
the possible side effects of Hydrea
what happens if you miss a dose of Hydrea
what happens if you overdose with Hydrea
the most important information about Hydrea
how to use Hydrea
other drugs that may affect Hydrea
what to avoid while using Hydrea
 
Generic Name: hydroxyurea (high drox ee you REE ah)
Brand Names: Droxia, Hydrea
 
What is the most important information I should know about hydrea?
 •  Notify your doctor immediately if you develop fever, chills, a sore throat, nausea, vomiting, loss of appetite, diarrhea, sore in the mouth or on the lips, or unusual bleeding or bruising. These may be early signs of dangerous side effects.
 •  If you have difficulty swallowing the capsules and your doctor has directed you to empty the contents of the hydrea capsules into water, do not inhale the powder or let it come in contact with your skin. If the contents of a capsule are spilled, wipe it up with a damp cloth and throw it away in a sealed container (e.g., a plastic bag). Keep all medicine and empty capsule shells out of the reach of children and pets.

What is hydrea?
 •  hydrea affects certain cells in the body (e.g., cancer cells, sickled red blood cells). The exact way that hydrea works is not known.
 •  hydrea is used to treat melanoma (a type of skin cancer), chronic myelocytic leukemia (CML), cancer of the ovary, and primary squamous cell (skin) cancer of the head and neck. hydrea is also used in the treatment of sickle cell anemia.
 •  hydrea may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking hydrea?
 •  Before taking this medication, tell your doctor if you have
      · poor bone marrow function
      · liver disease
      · kidney disease, or
      · had radiation therapy.
 •  You may not be able to take hydrea, or you may require a dosage adjustment or special monitoring during therapy if you have any of the conditions listed above.
 •  hydrea is in the FDA pregnancy category D. This means that hydrea is known to be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. Use of effective contraception is recommended during treatment with hydrea for the prevention of pregnancy.
 •  hydrea passes into breast milk and may affect a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding.

How should I take hydrea?
 •  Take hydrea exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.
 •  Take each dose with a full glass of water.
 •  hydrea can be taken with or without food.
 •  If you have difficulty swallowing the capsules and your doctor has directed you to empty the contents of the hydrea capsules into water, do not inhale the powder or let it come in contact with your skin. If the contents of a capsule are spilled, wipe it up with a damp cloth and throw it away in a sealed container (e.g., a plastic bag). Keep all medicine and empty capsule shells out of the reach of children and pets.
 •  If vomiting occurs shortly after taking a dose of hydrea, contact your doctor. You may need to take another dose or you may be instructed to wait until the next scheduled dose.
 •  Your doctor may want you to have blood tests or other medical evaluations during treatment with hydrea to monitor progress and side effects.
 •  Do not stop taking this medication without first talking to your doctor. It is important to take hydrea regularly to get the most benefit.
 •  Store hydrea at room temperature away from moisture and heat.

What happens if I miss a dose?
 •  Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?
 •  Seek emergency medical attention if an overdose is suspected.
 •  Symptoms of a hydrea overdose are not known.

What should I avoid while taking hydrea?
 •  Individuals not taking hydrea should avoid contact with the medication. If the contents of a capsule are spilled, wipe it up with a damp cloth and throw it away in a sealed container (e.g., a plastic bag). Keep all medicine and empty capsule shells out of the reach of children and pets.
 •  hydrea can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

What are the possible side effects of hydrea?
 •  If you experience any of the following serious side effects, stop taking hydrea, and seek emergency medical attention or notify your doctor immediately:
      · an allergic reaction (difficulty breathing closing of the throat swelling of the lips, tongue, or face or hives) or
      · fever, chills, or sore throat
      · nausea or vomiting
      · loss of appetite
      · diarrhea 
      · sores in the mouth or on the lips or
      · unusual bleeding or bruising.
 •  Other less serious side effects may be more likely to occur. Continue to take hydrea and talk to your doctor if you experience
      · constipation
      · skin rash
      · itching
      · leg sores
      · redness of the face
      · hair loss
      · drowsiness
      · headache or
      · dizziness.
 •  Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect hydrea?
 •  Do not receive "live" vaccines during treatment with hydrea without first talking to your doctor. Your immune system may not be strong enough to receive a live vaccine while taking this medication.
 •  Other medications, especially those that affect the immune system, may interact with hydrea. Do not take any other prescription or over-the-counter medications, including vitamins, minerals, and herbal products, without first talking to your doctor.

责任编辑:admin


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