氢化可的松琥珀酸钠粉剂(SOLU-CORTEF POWDER)说明书

产地国家:美国 处 方 药:所属类别:100毫克/瓶 10瓶/盒 包装规格:100毫克/瓶 10瓶/盒 计价单位:生产厂家中文参考译名:法马西亚和普强 生产厂家英文名:PHARMACIA AND UPJOHN 原产地英文商品名:SOLU-CORTEF POWDER 100mg/vial 10vials/box 原产地英文药品名:HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION 中文参考商品译名:SOLU-CORTEF粉剂 100毫克/瓶 10瓶/盒 中文参考药品译名:氢化可的松琥珀酸钠

简介

部分中文Solu-Cortef处方资料(仅供参考) 药品名称:氢化可的松琥珀酸钠注射液 属激素类药物,风湿类风湿保健网专家提醒大家慎用激素药物,一定要在医生指导下食用该药不可自行使用。治疗慢性病一定以中西医结合治疗 有效期: 2年 产品剂型: 注射剂 【药效作用】用于抢救危重病人如中毒性感染(结核性脑膜炎、胸膜炎、关节炎、腱鞘炎、急慢性捩伤、肌腱劳损)、过敏性休克、严重的肾上腺皮质功能减退症、结缔组织病、严重的支气管哮喘等过敏性疾病,并可用于预防和治疗移植物急性排斥反应。 【药品名称】 通用名:氢化可的松注射液 【性状】 本品为微细颗粒的混悬液,静置后微细颗粒下沉,振摇后成均匀的乳白色混悬液。 【药理毒理】 本品为糖皮质激素,具有抗炎、免疫抑制、抗毒素和抗休克作用。 (1)抗炎作用:对除病毒外的各种病因引起的炎症均有作用,糖皮质激素减轻和防止组织对炎症的反应,从而减轻炎症的症状,亦可抑制炎症后期组织的修复,减少后遗症。 (2)免疫抑制作用:防止或抑制细胞中介的免疫反应,延迟性的过敏反应,并减轻原发免疫反应的扩展。(3)抗毒、抗休克作用:糖皮质激素能提高机体的耐受能力,减轻细胞损伤,发挥保护机体的作用。还有扩张血管,增强心肌收缩力,改善微循环作用。 【药代动力学】 半衰期(t1/2)1.3~1.9小时,蛋白结合率75%~96%,总清除率(CL)21~30L/小时。在肝脏中代谢灭活,只有少量皮质醇从尿中排出,其他代谢产物以葡萄糖醛酸结合或硫酸酯形式从肾脏排出。 【适应症】 肾上腺皮质功能减退症及垂体功能减退症,也用于过敏性和炎症性疾病,抢救危重中毒性感染。 【用法用量】 肌内注射 一日20~40mg,静脉滴注一次100mg,一日1次。临用前加25倍的氯化钠注射液或5%葡萄糖注射液500ml稀释后静脉滴注,同时加用维生素C 0.5~1g。 【不良反应】 本品在应用生理剂量替代治疗时一般无明显不良反应。不良反应多发生在应用药理剂量时,而且与疗程、剂量、用药种类、用法及给药途径等有密切关系。 常见不良反应有以下几类: 1.长程使用可引起以下副作用:医源性库欣综合征面容和体态、体重增加、下肢浮肿、紫纹、易出血倾向、创口愈合不良、痤疮、月经紊乱、肱或股骨头缺血性坏死、骨质疏松及骨折(包括脊椎压缩性骨折、长骨病理性骨折)、肌无力、肌萎缩、低血钾综合征、胃肠道刺激(恶心、呕吐)、胰腺炎、消化性溃疡或穿孔,儿童生长受到抑制、青光眼、白内障、良性颅内压升高综合征、糖耐量减退和糖尿病加重。 2.患者可出现精神症状:欣快感、激动、谵妄、不安、定向力障碍,也可表现为抑制。精神症状尤易发生于患慢性消耗性疾病的人及以往有过精神不正常者。 3.并发感染为肾上腺皮质激素的主要不良反应。以真菌、结核菌、葡萄球菌、变形杆菌、绿脓杆菌和各种疱疹病毒为主。 4.糖皮质激素停药综合征:有时患者在停药后出现头晕、昏厥倾向、腹痛或背痛、低热、食欲减退、恶心、呕吐、肌肉或关节疼痛、头疼、乏力、软弱,经仔细检查如能排除肾上腺皮质功能减退和原来疾病的复燃,则可考虑为对糖皮质激素的依赖综合征。 【禁忌】 对本品及其它甾体激素过敏者禁用。下列疾病患者一般不宜使用,特殊情况应权衡利弊使用,但应注意病情恶化可能:严重的精神病(过去或现在)和癫痫,活动性消化性溃疡病,新近胃肠吻合手术,骨折,创伤修复期,角膜溃疡,肾上腺皮质机能亢进症,高血压,糖尿病,孕妇,抗菌药物不能控制的霉菌感染、水痘、麻疹,较重的骨质疏松症等。 【注意事项】 1.发感染:在激素作用下,原来已被控制的感染可活动起来,最常见者为结核感染复发。在某些感染时应用激素可减轻组织的破坏、减少渗出、减轻感染中毒症状,但必须同时用有效的抗生素治疗、密切观察病情变化,在短期用本药后,即应迅速减量、停药。 2.对诊断的干扰: (1)糖皮质激素可使血糖、血胆固醇和血脂肪酸、血钠水平升高、使血钙、血钾下降。 (2)对外周血象的影响为淋巴细胞、真核细胞及嗜酸、嗜碱细胞数下降,多核白细胞和血小板增加,后者也可下降。 (3)长期大剂量服用糖皮质激素可使皮肤试验结果呈假阴性,如结核菌素试验、组织胞浆菌素试验和过敏反应皮试等。 (4)还可使甲状腺131I摄取率下降,减弱促甲状腺激素(TSH)对TSH释放素(TRH)刺激的反应,使TRH兴奋实验结果呈假阳性。干扰促黄体生成素释放素(LHRH)兴奋试验的结果。 (5)使同位素脑和骨显象减弱或稀疏。 3.下列情况应慎用: 心脏病或急性心力衰竭、糖尿病、憩室炎、情绪不稳定和有精神病倾向、全身性真菌感染、青光眼、肝功能损害、眼单纯性疱疹、高脂蛋白血症、高血压、甲减(此时糖皮质激素反应增强)、重症肌无力、骨质疏松、胃溃疡、胃炎或食管炎、肾功能损害或结石、结核病等。 4.随访检查:长期应用糖皮质激素者,应定期检查以下项目: (1)血糖、尿糖或糖耐量试验,尤其是糖尿病或糖尿病倾向者。 (2)小儿应定期检测生长和发育情况。 (3)眼科检查,注意白内障、青光眼或眼部感染的发生。 (4)血清电解质和大便隐血。 (5)高血压和骨质疏松的检查,尤其注意老年人。 (6)用药过程中减量宜缓慢,不可突然停药。 【孕妇及哺乳期妇女用药】 (1)妊娠期用药:本品可通过胎盘。动物实验研究证实孕期给药可增加胚胎腭裂,胎盘功能不全、自发性流产和子宫内生长发育迟缓的发生率。可增加胎盘功能不全、新生儿体重减少或死胎的发生率。 (2)哺乳期用药:由于本品可由乳汁中排泄,对婴儿造成不良影响,如生长受抑制、肾上腺皮质功能抑制等。孕妇及哺乳期妇女在权衡利弊情况下,尽可能避免使用。 【儿童用药】 小儿如长期使用肾上腺皮质激素,须十分慎重。肾上腺皮质功能低下症及先天性肾上腺皮质增生症例外。  【老年患者用药】 老年患者用糖皮质激素易发生高血压及糖尿病。老年患者尤其是更年期后的女性应用糖皮质激素易加重骨质疏松。 【药物相互作用】 1.非甾体消炎镇痛药可加强本品致消化道溃疡作用。 2.可增强对乙酰氨基酚的肝毒性。 3.与两性霉素B或碳酸酐酶抑制剂合用,可加重低钾血症,长期与碳酸酐酶抑制剂合用,易发生低血钙和骨质疏松。 4.与蛋白质同化激素合用,可增加水肿的发生率,使痤疮加重。 5.与抗胆碱能药(如阿托品)长期合用,可致眼压增高。 6.三环类抗抑郁药可使本品引起的精神症状加重。 7.与降糖药如胰岛素合用时,因本品可使糖尿病患者血糖升高,应适当调整降糖药剂量。 8.甲状腺激素可使本品代谢清除率增加,故与甲状腺激素或抗甲状腺药合用,应适当调整后者的剂量。 9.与避孕药或雌激素制剂合用,可加强本品治疗作用和不良反应。 10.与强心苷合用,可增加洋地黄毒性及心律失常的发生。 11.与排钾利尿药合用,可致严重低血钾症,并由于水钠潴留而减弱利尿药的排钠利尿效应。 12.与麻黄碱合用,可增强其代谢清除。 13.与免疫抑制剂合用,可增加感染的危险性,并可能诱发淋巴瘤或其他淋巴细胞增生性疾病。 14.可增加异烟肼在肝脏代谢和排泄,降低异烟肼的血药浓度和疗效。 15.可促进美西律在体内代谢,降低血药浓度。 16.与水杨酸盐合用,可减少血浆水杨酸盐的浓度。 17.与生长激素合用,可抑制后者的促生长作用。 【药物过量】 可引起类肾上腺皮质功能亢进综合症。如及时发觉并停药症状可自行消退,症状严重者可行相应对症治疗。 【贮藏】 遮光,密闭保存。

英文版说明书

Solu-Cortef solutionPronunciation Generic Name: hydrocortisone (hye-droe-KOR-ti-sone) Brand Name: Solu-Cortef Solu-Cortef solution is used for: Treating certain conditions caused by allergies, adrenal gland problems, rheumatoid arthritis, skin problems, eye problems, bowel inflammation, breathing or blood problems, multiple sclerosis, or certain cancers. It may also be used for other conditions as determined by your doctor. Solu-Cortef solution is a corticosteroid. It works by modifying the body's immune response to various conditions and decreasing inflammation. Do NOT use Solu-Cortef solution if: •you are allergic to any ingredient in Solu-Cortef solution •you are taking mifepristone •the patient is a premature infant •you have a systemic fungal infection •you are scheduled to have a smallpox vaccine Contact your doctor or health care provider right away if any of these apply to you. Before using Solu-Cortef solution: Some medical conditions may interact with Solu-Cortef solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you: •if you are pregnant, planning to become pregnant, or are breast-feeding •if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement •if you have allergies to medicines, foods, or other substances •if you have a history of bleeding problems, heart problems (eg, congestive heart failure), heart attack, high blood pressure, kidney problems, liver problems, diabetes, seizures, an underactive thyroid, adrenal gland problems, any mental or mood problems, low blood potassium levels, or high blood sodium levels •if you have or have recently had a fungal, bacterial, viral, or other type of infection; herpes infection of the eye; chickenpox; measles; or shingles •if you have HIV infection or tuberculosis (TB), or if you have ever had a positive TB skin test •if you have any stomach problems (eg, ulcers), intestinal problems (eg, blockage, perforation, infection, unexplained diarrhea, diverticulitis, ulcerative colitis), recent intestinal surgery, or inflammation of the esophagus •if you have weak bones (eg, osteoporosis) or muscle problems (eg, myasthenia gravis) •if you have had any recent vaccinations (eg, smallpox) Some MEDICINES MAY INTERACT with Solu-Cortef solution. Tell your health care provider if you are taking any other medicines, especially any of the following: •Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), lithium, or rifampin because they may decrease Solu-Cortef solution's effectiveness •Aprepitant, clarithromycin, cyclosporine, diltiazem, erythromycin, hormonal contraceptives (eg, birth control pills), itraconazole, ketoconazole, or troleandomycin because side effects, such as adrenal gland or nervous system problems (eg, seizures), may occur •Aspirin, mifepristone, or ritodrine because their actions and the risk of their side effects may be increased by Solu-Cortef solution •Live vaccines because their effectiveness may be decreased by Solu-Cortef solution This may not be a complete list of all interactions that may occur. Ask your health care provider if Solu-Cortef solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. How to use Solu-Cortef solution: Use Solu-Cortef solution as directed by your doctor. Check the label on the medicine for exact dosing instructions. •Solu-Cortef solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Solu-Cortef solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Solu-Cortef solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. •Do not use Solu-Cortef solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. •Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. •If you miss a dose of Solu-Cortef solution, contact your doctor right away. Ask your health care provider any questions you may have about how to use Solu-Cortef solution. Important safety information: •Solu-Cortef solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills within 12 months after stopping Solu-Cortef solution. •If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. If you do have contact with anyone who has chickenpox or measles, contact your doctor immediately. •Tell your doctor or dentist that you take Solu-Cortef solution before you receive any medical or dental care, emergency care, or surgery. •Check with your doctor before having vaccinations while you are using Solu-Cortef solution. •It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to begin taking additional corticosteroids. •Serious health problems have happened when corticosteroids, including Solu-Cortef solution, have been given into the spine (epidural). These include paralysis, blindness, stroke, and sometimes death. Safety and effectiveness of corticosteroids given into the spine have not been confirmed. Corticosteroids are not approved for this use. Discuss any questions or concerns with your doctor. •Diabetes patients - Solu-Cortef solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. •Lab tests, including adrenal function tests or blood pressure monitoring, may be performed while you use Solu-Cortef solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. •Solu-Cortef solution has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects. •Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Solu-Cortef solution. •Caution is advised when using Solu-Cortef solution in CHILDREN; they may be more sensitive to its effects. •PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Solu-Cortef solution while you are pregnant. It is not known if Solu-Cortef solution is found in breast milk. If you are or will be breast-feeding while you use Solu-Cortef solution, check with your doctor. Discuss any possible risks to your baby. If you suddenly stop taking Solu-Cortef solution, you may experience WITHDRAWAL symptoms, including unbalanced hormones (in both men and women). Possible side effects of Solu-Cortef solution: All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Acne; clumsiness; dizziness; facial flushing; feeling of whirling motion; general body discomfort; headache; increased appetite; increased sweating; nausea; nervousness; pain, swelling, or redness at the injection site; sleeplessness; upset stomach. Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual periods; changes in skin color; chest pain; easy bruising or bleeding; mental or mood changes (eg, depression); muscle pain, weakness, or wasting; swelling of feet or legs; seizures; severe nausea or vomiting; sudden severe dizziness or headache; symptoms of infection (eg, fever, chills, sore throat); tendon or bone pain; thinning of the skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA. If OVERDOSE is suspected: Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Proper storage of Solu-Cortef solution: Solu-Cortef solution is usually handled and stored by a health care provider. If you are using Solu-Cortef solution at home, store Solu-Cortef solution as directed by your pharmacist or health care provider. Keep Solu-Cortef solution out of the reach of children and away from pets. General information: •If you have any questions about Solu-Cortef solution, please talk with your doctor, pharmacist, or other health care provider. •Solu-Cortef solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. •If your symptoms do not improve or if they become worse, check with your doctor. •Check with your pharmacist about how to dispose of unused medicine. This information should not be used to decide whether or not to take Solu-Cortef solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Solu-Cortef solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Solu-Cortef solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Solu-Cortef solution.
用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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