药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201112121333222.PDF,201112121332728.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文依他停处方资料(仅供参考)
药品名称: 商品名称:依他停 通用名称:醋酸去氨加压素鼻喷雾剂 英文名称:Octostim (desmopressin acetate nasal spray)
成份: 醋酸去氨加压素
适应症: 1.主要用于治疗中枢性尿崩症以及颅外伤或手术所致暂时性尿崩症。 2.用于尿崩症的诊断和鉴别诊断。 3.治疗夜间遗尿症(6岁或6岁以上的患者)。 4.用于肾脏浓缩功能试验。 5.治疗血友病A(FⅧ:C缺乏症)、血管性血友病(vWD)。 6.用于血小板减少症(国外资料)。
规格: 醋酸去氨加压素鼻喷雾剂 2.5ml:250μg(每喷10μg)。
用法用量: 成人 经鼻给药 常规剂量 1.中枢性尿崩症:(1)鼻喷雾剂:开始时10μg,睡前喷鼻,以后根据尿量每晚递增2.5μg,直至获得良好睡眠。若全天尿量仍较大,可于早晨再加10μg喷鼻,并根据尿量调整用量,直至获得满意疗效。维持用药,一日10-40μg,1次或分2-3次喷鼻。 2.夜间遗尿症:开始时睡前每侧一次10μg,一日总量20μg。维持用药,根据患者反应调整用量,通常一日总量10-40μg。 3.血友病A:剂量同“静脉给药”。 4.血管性血友病:用于轻度出血者,剂量同“静脉给药”。 5.肾脏浓缩功能试验:40μg。
不良反应: 1.常见头痛、恶心、胃痛。还可见鼻充血、鼻出血、鼻炎、子宫绞痛、低血钾、过敏反应。 2.偶见血压升高、紫绀、心肌缺血、面部潮红、皮肤红斑、肿胀、烧灼感等,极少数患者可引起脑血管或冠状血管血栓形成、血小板减少等。 3.大剂量可见疲劳、短暂的血压降低、反射性心跳加快及眩晕。 4.此外,注射给药时,可致注射部位疼痛、肿胀。
注意事项: 1.禁忌症 (1)对本药过敏者(国外资料)。(2)对防腐剂过敏者。(3)2B型血管性血友病患者。(4)习惯性或精神性烦渴症患者。(5)心功能不全者。(6)不稳定性心绞痛患者。(7)因其它疾病需服利尿药的患者。 2.慎用 (1)体液及(或)电解质紊乱的患者。(2)颅内压易升高的患者。(3)高血压性心血管病者(国外资料)。(4)冠状动脉疾病者(国外资料)。(5)婴儿。(6)老年患者。 3.药物对妊娠的影响 本药致畸仅有个案报道,但孕妇应慎用。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为B级。 4.药物对哺乳的影响 经鼻给予高剂量(300μg)后,测试母乳中本药含量,发现母乳中药物的含量远低于能影响利尿所需的剂量。 5.用药前后及用药时应当检查或监测 (1)用药期间需监测患者的尿量、渗透压和体重,必要时需监测血浆渗透压。(2)用于治疗或控制出血时,需密切观察患者的血压。
FDA妊娠药物分级: 尚未进行孕妇研究,但在动物繁殖性研究中,未见到对胎儿的影响,并且孕妇使用该药品的治疗获益可能胜于其潜在危害。或者,该药品尚未进行动物试验,也没有对孕妇进行充分严格的对照研究。
儿童用药: 常规剂量 经鼻给药 1.中枢性尿崩症:(1)3个月以下婴儿的用药剂量目前尚无完整资料。(2)3个月至12岁:开始时5μg,睡前喷鼻,以后根据尿量每晚递增2.5μg,直至获得良好睡眠。
药物相互作用: 药物-药物相互作用 1.辛伐他汀、吲哚美辛增强患者对本药的反应,但不影响本药作用持续时间。 2.与利尿药、三环类抗抑郁药、氯丙嗪、氯磺丙脲、氯贝丁酯和卡马西平等合用可增加水潴留或抗利尿作用,应避免合用。必需合用时,本药的剂量要从较小剂量开始,逐渐调整至最适剂量。 3.格列本脲可抑制本药效应。
药理作用: 本药为去氨加压素的醋酸盐,是血管升压素的衍生物。去氨加压素具有较强的抗利尿作用及较弱的加压作用,其抗利尿作用/加压作用比是加压素的2000至3000倍,作用维持时间也较加压素长(可达6-24小时)。
药代动力学: 本药经鼻、舌下、口腔或口服给药均能迅速吸收,皮下或肌内注射吸收迅速而完全。本药经鼻给药1小时、或口服给药1-2小时产生抗利尿作用,口服4-7小时达最大效应。血药浓度达峰时间分别为:口服54-90分钟。
化学成份: 化学名称为:1-去氨基-8-D精氨酸加压素醋酸盐 分子式:C46H64N14O12S2 分子量:1069.2
贮藏: 2-8℃冷藏。
生产企业: 辉凌制药有限公司
药物分类:脑垂体激素和相关药物
Octostim (desmopressin nasal solution)
How does Octostim work? What will it do for me? Desmopressin nasal solution belongs to 2 classes of medications: antidiuretics and antihemorrhagics. It can be used to treat central diabetes insipidus, a condition where the kidneys are unable to conserve water due to a lack of antidiuretic hormone (ADH). This condition causes frequent urination and thirst. It is also used to treat temporary increased thirst and urination that can occur after a head injury or certain types of brain surgery. For these uses, desmopressin nasal solution works by helping to reduce the amount of urine produced by the kidneys.
Desmopressin nasal solution may also be used to prevent bleeding for people with mild hemophilia A and mild von Willebrand's disease type I. Desmopressin nasal solution works by increasing certain components involved in blood clotting.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.
How should I use Octostim? For diabetes insipidus: The usual recommended dose for adults is 10 μg to 40 μg daily. The usual recommended dose for children 3 months to 12 years of age is 5 μg to 30 μg daily. The dose may be given as a single dose or divided into 2 or 3 doses. The lowest effective dosage should be used. Do not drink any fluids for at least 1 hour before taking desmopressin and for 8 hours after using desmopressin.
For preventing bleeding: The usual recommended dose is one 150 μg spray in each nostril, or one 150 μg spray in one nostril for people who weigh less than 50 kg (110 lbs). If it is being used to prevent bleeding related to surgery, it is given 2 hours before surgery.
Follow the instructions in the package insert on how to use medication. This medication should not be sniffed or inhaled; it works by being absorbed through the nose. To ensure the best absorption of the medication, place a finger on the outside of the nostril you just sprayed to close it for 10 seconds. During this time, breathe through the unsprayed nostril or through your mouth. If you are unsure of how to administer the medication, talk to your pharmacist.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, administer it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
This medication comes in 2 forms: the spray and the rhinyle solution. Store the spray in an upright position at room temperature, protect it from light, and kept it out of the reach of children. Store the rhinyle solution in the refrigerator at 2°C to 8°C and keep it out of the reach of children.
This medication is available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms listed here. The forms available for the specific brand you have searched are listed under "What form(s) does this medication come in?"
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
What form(s) does Octostim come in? Each mL contains desmopressin acetate 1.5 mg. Nonmedicinal ingredients: benzalkonium chloride (preservative), citric acid monohydrate, disodium phosphate dihydrate, purified water, and sodium chloride. Glass bottles of 2.5 mL furnished with a pre-compression pump with applicator and protective cap.
Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.
Who should NOT take Octostim? Desmopressin nasal solution should not be used by anyone who: •is allergic to desmopressin or to any of the ingredients of the medication •is known to have decreased levels of sodium in their blood •has habitual or psychogenic polydipsia (drinking excessive amounts water) •has medical conditions that require treatment with diuretics (e.g., heart failure, high blood pressure) •has moderately or severely reduced kidney function •has primary nocturnal enuresis (bedwetting) •has type IIB or platelet type (pseudo) von Willebrand's disease
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201112121333222.PDF,201112121332728.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- |