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  药店国别: 美国药房
产地国家: 美国
所属类别: 激素内分泌药物->肾上腺皮质激素及促肾上腺皮质激素类药物
处方药:处方药
包装规格: 100毫克/瓶 1瓶
计价单位:
  点击放大  
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
该药品相关信息网址1:
http://www.cortef.com/home/
原产地英文商品名:
SOLU-CORTEF 100mg/vial 1vial (Minimum order qty: 10)
原产地英文药品名:
HYDROCORTISONE SODIUM SUCCINATE/PF
中文参考商品译名:
SOLU-CORTEF 100毫克/瓶 1瓶 (最低订货量:10)
中文参考药品译名:
氢化可的松琥珀酸钠/PF
中文参考化合物名称:
11β,17—二羟基—21—(3—羧基—1—羟丙氧基)孕甾-4-烯-3,20-二酮,—钠盐
原产地国家批准上市年份:
1955/04/27
英文适应病症1:
Adrenal hypofunction and pituitary hypofunction
英文适应病症2:
Anti-inflammatory, anti-allergy, immune suppression
英文适应病症3:
Anti-toxin and anti-shock
临床试验期:
完成
中文适应病症参考翻译1:
肾上腺皮质功能减退症及垂体功能减退症
中文适应病症参考翻译2:
抗炎、抗过敏、免疫抑制
中文适应病症参考翻译3:
抗毒素和抗休克
药品信息:

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 详细处方信息以本药内容附件PDF文件(20104621552034.pdf)的“原文Priscribing Information”为准
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部分中文Solu-Cortef处方资料(仅供参考)

  本品主要成分:氢化可的松琥珀酸钠,其化学名称为:11β,17—二羟基—21—(3—羧基—1—羟丙氧基)孕甾-4-烯-3,20-二酮,—钠盐。
  分子式为:C25H33NaO8
  分子量:484.52
  药品类别: 肾上腺皮质激素类
  适应症: 用于抢救危重病人如中毒性感染、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。
  性状: 本品为白色或几乎白色的疏松块状物。
  药理毒理: 肾上腺皮质激素类药。氢化可的松琥珀酸钠是氢化可的松的盐类化合物。具有抗炎、抗过敏和抑制免疫等多种药理作用。(1)抗炎作用:糖皮质激素减轻和防止组织对炎症的反应,从而减轻炎症的表现。(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:糖皮质激素能对抗细菌内毒素对机体的刺激反应,减轻细胞损伤,发挥保护机体的作用。
  药代动力学: 氢化可的松琥珀酸钠盐为水溶性制剂,可用于静脉注射或作为迅速吸收的肌肉注射剂而迅速发挥作用,其生物T1/2约为100分钟,血中90%以上的氢化可的松与血浆蛋白相结合。本品主要经肝脏代谢,转化为四氢可的松和四氢氢化可的松,大数代谢产物结合成葡糖醛酸酯,极少量以原型经尿排泄。
  用法用量: 临用前,用生理氯化钠注射液或5%葡萄糖注射液稀释后使用。静脉注射 用于治疗成人肾上腺皮质功能减退及垂体前叶功能减退危象,严重过敏反应,哮喘持续状态、休克,每次游离型100mg或氢化可的松琥珀酸钠135mg 静脉滴注,可用至每日300mg至400mg,疗程不超过3-5日。
  不良反应: 糖皮质激素在应用生理剂量替代治疗时无明显不良反应,不良反应多发生在应用药药理剂量时,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、骨质疏松或骨折(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。精神症状由易发生与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。 5.静脉迅速给予大剂量可能发生全身性的过敏反应,包括面部、鼻黏膜、眼睑肿胀,寻麻疹,气短,胸闷,喘鸣
  禁忌症: 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感染如水痘、麻疹、霉菌感染、较重的骨质疏松等。
  注意事项: 1. 诱发感染: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(此时糖皮质激素作用增强)、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,尤以老年人为然。
  孕妇及哺乳期妇女用药:(1)妊娠期用药:糖皮质激素可通过胎盘。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。人类使用药理剂量的糖皮质激素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:由于糖皮质激素可由乳汁中排泄,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。
  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:⑴非甾体消炎镇痛药可加强其致溃疡作用。⑵可增强对乙酰氨基酚的肝毒性。 ⑶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。⑷与蛋白质同化激素合用,可增加水肿的发生率,使痤疮加重。⑸与抗胆碱能药(如阿托品)长期合用,可致眼压增高。⑹三环类抗抑郁药可使其引起的精神症状加重。⑺与降糖药如胰岛素合用时,因可使糖尿病患者血糖升高,应适当调整降糖药剂量。⑻甲状腺激素可使其代谢清除率增加,故甲状腺激素或抗甲状腺药与其合用,应适当调整后者的剂量。⑼与避孕药或雌激素制剂合用,可加强其治疗作用和不良反应。⑽与强心苷合用,可增加洋地黄毒性及心律紊乱的发生。⑾与排钾利尿药合用,可致严重低血钾,并由于水钠潴留而减弱利尿药的排钠利尿效应。⑿与麻黄碱合用,可增强其代谢清除。 ⒀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。 ⒁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。⒂可促进美西律在体内代谢,降低血药浓度。⒃与水杨酸盐合用,可减少血浆水杨酸盐的浓度。⒄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。
  贮藏:密闭,遮光保存。

 

Solu-Cortef Inj Uses
This medication is used to treat various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases. It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. Hydrocortisone is a corticosteroid hormone (glucocorticoid). This injectable form of hydrocortisone is used when a similar drug cannot be taken by mouth or when a very fast treatment is needed, especially in patients with severe medical conditions.

This drug may also be used with other medications as a replacement for certain hormones.

How to use Solu-Cortef Inj
This medication is given by slow injection into a vein or directly into a muscle by a health care professional as directed by your doctor. Follow your doctor's directions carefully. Dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often than prescribed without consulting your doctor. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid.

If you have been using this medication for a long time, do not suddenly stop using it without your doctor's approval. Your dose may need to be gradually decreased to reduce symptoms such as weakness, weight loss, nausea, or extreme tiredness.

If you are giving yourself injections at home, learn how to prepare and inject this medication properly. Ask your doctor, pharmacist, or nurse any questions you may have about how to give yourself hydrocortisone.

Learn how to store and discard needles, medical supplies, and any unused medication safely. Consult your pharmacist. Never reuse needles or syringes.

Tell your doctor if your condition persists or worsens.

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Solu-Cortef Inj Side Effects
Stomach upset, headache, dizziness, menstrual period changes, trouble sleeping, increased appetite, weight gain, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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: bone/joint pain, easy bruising/bleeding, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, increased thirst/urination, fast/slow/pounding/irregular heartbeat, shortness of breath, swelling of the ankles/feet, tendon pain, persistent weight gain, puffy face, unusual hair growth, thinning skin, slow wound healing, signs of infection (e.g., persistent fever/cough/sore throat, painful urination, eye pain/discharge), muscle weakness/pain, mental/mood changes (e.g., mood swings, depression, agitation), vision changes, seizures, unusual skin growths.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

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Solu-Cortef Inj Precautions
Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current fungal infections.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other infections (e.g., tuberculosis, threadworm), bleeding problems, blood clots, brittle bones (osteoporosis), high blood pressure, certain heart problems (e.g., congestive heart failure, recent heart attack), diabetes, certain eye diseases (e.g., cataracts, herpes infection, glaucoma), kidney disease, severe liver disease (cirrhosis), mental/mood conditions (e.g., psychosis, anxiety, depression), seizures, stomach/intestinal problems (e.g., diverticulitis, ulcer, ulcerative colitis), underactive thyroid gland (hypothyroidism), untreated mineral problems (e.g., low potassium or calcium).

This drug may make you dizzy. Use caution while driving, using machinery, or doing any activity that requires alertness.

This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report to your doctor any injuries or signs of infection (e.g., persistent sore throat/cough/fever, pain during urination, muscle aches) that occur while using this medication or within 12 months after stopping it.

If you have been using this medication for a long time, your body may not be able to make enough natural steroids while you are under stress due to infection, surgery, or injury. Your dose may need to be adjusted. If you have stopped using this drug within the past 12 months, you may need to start using it again if your body is under severe stress. Consult your doctor for more details. Tell your doctor immediately if any of these side effects occur: unusual weakness, sudden weight loss, dizziness.

Do not have immunizations, vaccinations, or skin tests unless specifically directed by your doctor. Live vaccines may cause serious problems (e.g., infection) if given while you are using this medication. Avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
Avoid contact with people who have chickenpox or measles unless you have previously had these diseases (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.

If you have a history of ulcers, or if you take large doses of aspirin or other arthritis medication, limit alcoholic beverages while using this medication to decrease the risk of stomach/intestinal bleeding.

Consult your doctor or pharmacist for more details.

Before having surgery, tell your doctor or dentist that you are using this medication or have used it within the last 12 months.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially osteoporosis. Talk with your doctor about ways to prevent bone loss.

Caution is advised when using this drug for a long time in children. This medication may temporarily slow down a child's rate of growth, but it will probably not affect final adult height. Monitor your child's height periodically.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to an unborn baby when corticosteroids are used during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Although there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

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Solu-Cortef Inj Interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aldesleukin, large doses of aspirin and aspirin-like drugs (salicylates such as salsalate), birth control pills/patch/ring, "blood thinners" (e.g., warfarin), bupropion, drugs for diabetes, drugs that cause potassium loss (e.g., amphotericin B, diuretics such as hydrochlorothiazide, furosemide), estrogens, mifepristone, natalizumab, nonsteroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ibuprofen), quinolone antibiotics (e.g., levofloxacin), drugs affecting liver enzymes that remove hydrocortisone from your body (e.g., aprepitant, azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, rifamycins such as rifampin, certain anti-seizure medications such as phenytoin and phenobarbital), herbal products (e.g., licorice).

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that may increase the risk of stomach bleeding from this drug. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Consult your doctor or pharmacist for more details.

This medication may interfere with certain laboratory tests (including skin tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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Solu-Cortef Inj Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES:
Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood counts, blood glucose/mineral levels, blood pressure, bone density tests, height/weight measurements, eye examinations, X-rays) should be performed periodically to monitor your progress or check for side effects during long-term treatment. Consult your doctor for more details.

Lifestyle changes that help reduce the risk of bone loss (osteoporosis) during long-term treatment include doing weight-bearing exercise, getting adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Talk with your doctor about lifestyle changes that might benefit you.
If you use this medication for prolonged periods, you should wear or carry identification stating that you are using it.

MISSED DOSE:
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture.

Do not store in the bathroom. Keep all medicines away from children and pets.

After mixing and dilution in correct IV fluids, the drug may be kept at room temperature for up to 72 hours if protected from light Consult your pharmacist for details. Discard any unused liquid.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

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 详细处方信息以本药内容附件PDF文件(20104621552034.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-11-06
附件:
 
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