等待内容更新

【药品名称】

商品名称：欧乃派克
通用名称：碘海醇注射液
英文名称：Iohexol

【成份】

本品主要成份及其化学名称为：N，N'-双(2,3-二羟基丙基)-5-[N-(2,3-二羟基丙基)乙酰胺基]-2,4,6-三碘-1,3-苯二甲酰胺。
分子式：C19H26I3N3O9
分子量：821.14

【 适应症 】

1．血管内应用临床应用本品于成人及儿童的尿路造影和心血管造影，以及成人的大脑血管造影，外周及各种动脉造影、静脉造影、数字减影和CT增强扫描。2．蛛网膜下应用适用于成人及儿童的脊髓造影，以及应用于蛛网膜下注射后进行脑池CT扫描检查。3．体腔内应用适用于各种体腔检查，包括口服。如关节造影；内窥镜逆行胰胆管造影（ERCP）；疝囊造影；尿路造影；子宫输卵管造影；涎管造影以及各种使用口服水溶造影剂进行的胃肠道检查等。

【用法用量】

1  血管内应用剂量参考表 应用项目 浓 度 用 量 注 释 尿道造影 成人 　 儿童＞7kg 　 ＜7kg 　 300mgI/ml 或350mgI/ml 240mgI/ml 或300mgI/ml 240mgI/ml 或300mgI/ml 　 40～80ml 40～80ml 4ml/kg 3ml/kg 3ml/kg 2ml/kg（最高40ml） 　 在大剂量的尿路造影时可用较高浓度的造影剂 动脉造影 主动脉与血管造影 选择性大脑动脉造影 主动脉造影 四肢动脉造影 　 其他动脉造影 静脉造影（四肢） 　 300mgI/ml 300mgI/ml 350mgI/ml 300mgI/ml 或350mgI/ml 300mgI/ml 240mgI/ml 　 每次注射30～40ml 每次注射5～10ml 每次注射40～60ml 　 　 取决于检查的项目 20～100ml（四肢） 心血管造影 成人 左心室主动脉根注射 选择性冠状动脉造影 儿童 或300mgI/ml 　 350mgI/ml 350mgI/ml 300mgI/ml 或350mgI/ml 　 　 每次注射30～60ml 每次注射4～8ml 取决于年龄、体重和病种（最高8ml/kg） 　 数字减影 动脉内注射 　 　 静脉内注射 　 140mgI/ml 或240mgI/ml 或300mgI/ml 300mgI/ml 或350mgI/ml 　 每次注射1～15ml 每次注射1～15ml 每次注射1～15ml 每次注射20～60ml 每次注射20～60ml 　 取决于造影部位。 CT增强扫描 140mgI/ml 或240mgI/ml 或300mgI/ml 或350mgI/ml 100～400ml 100～250ml 100～200ml 100～150ml 总碘量通常为30～60g；低浓度造影剂适宜静脉滴注，高浓度造影剂适宜静脉快速注入，儿童用量酌减。
2  蛛网膜下应用 剂量与浓度视检查的类别、采用的技术及蛛网膜下腔的大小而定。 一般注射方法是腰椎穿刺术，在腰椎第3/4节间穿刺（腰部及胸部脊髓造影），或在颈椎第1/2节间作侧颈穿刺（颈部脊髓造影）。 若采用腰椎穿刺术作颈脊髓造影，把病人倾倒时要非常小心，以免大量的高浓度造影剂进入脑内。 为减少造影剂与脑脊液混合，可采用1至2分钟的注射速度注入，造影剂用量见下表。 造影剂剂量参考表 应用项目 浓 度 用 量 腰及胸脊髓造影 （腰椎穿刺） 颈脊髓造影 （腰椎穿刺） 颈脊髓造影 （颈侧面穿刺） CT脑室造影 （腰椎穿刺） 180mgI/ml 或240mgI/ml 240mgI/ml 或300mgI/ml 240mgI/ml 或300mgI/ml 180mgI/ml 或240mgI/ml 10～15ml 8～12ml 10～12ml 7～10ml 6～10ml 6～8ml 5～15ml 4～12ml 儿科脊髓造影 ＜2岁 2～6岁 ＞6岁 　 180毫克碘/毫升 180毫克碘/毫升 180毫克碘/毫升 　 2～6毫升 4～8毫升 6～12毫升 总含碘量不应超过3g，以减低产生不良反应的可能性。 
3  体腔内应用 造影剂剂量参考表 应用项目 浓 度 用 量 关节造影 240mgI/ml 或300mgI/ml 或350mgI/ml 5～20ml 5～15ml 5～10ml 内窥镜进行胰管/ 胆管及胰管联合造影 240mgI/ml 20～50ml 疝囊造影 240mgI/ml 50ml 子宫输卵管造影 240mgI/ml 或300mgI/ml 15～50ml 15～25ml 涎管造影 240mgI/ml 或300mgI/ml 0.5～2ml 0.5～2ml 胃肠道检查－（口服） 180mgI/ml 或350mgI/ml 10～200ml 10～200ml。

【不良反应】

1 少数病人可能会产生一些轻微的反应，例如：短暂的温感、微痛、脸红、恶心/呕吐、轻微胸口作痛、皮肤瘙痒及风疹等。 2 头痛、恶心及呕吐都是脊髓造影中最常见的不良反应。持续数天的剧烈头痛，可能间断发生。迄今发现的其他轻微不良反应有短暂的头晕、背痛、颈痛或四肢痛楚以及各种感觉异常现象。也曾发生脑电图记录显示不明确的短暂变化（慢波）。用水溶性造影剂作脊髓造影后曾发现无菌性脑膜炎。使用本品作脊髓造影也曾报道过类似情况，但十分轻微且持续时间短暂。 3 有的病人在造影后数小时至数日内出现迟发性不良反应的报道也

【禁忌】

1 有明显的甲状腺病症患者。 2 对碘海醇注射液有严重反应既往史者。 3 有癫痫病史的人，不宜在蛛网膜下腔使用碘海醇。 4 有严重的局部感染或全身感染，而可能形成菌血症的患者，禁忌腰椎穿刺术。 5 鉴于怀孕期间应尽量避免接触放射线，故需权衡X线检查的利弊关系。除非医生认为必要，否则孕妇应禁用。 6 由于剂量限制，对造影时失败者，也不宜即时进行重复造影。

【注意事项】

1 含碘造影剂可能会引起过敏性反应或其他过敏现象。虽然碘海醇引起剧烈反应的风险甚微，但仍应事先制定紧急救治程序，以便发生严重的反应时能马上进行治疗。有过敏症或气喘病史，或是曾对含碘造影剂有不良反应的病人，使用此造影剂时需要特别小心。必需造影时，可考虑在造影前使用皮质类固醇及抗组胺剂。2 一旦发现有大量造影剂流入病人脑内的迹象，可考虑使用巴比妥酸盐进行抗惊厥治疗。（1） 术前护理及术前用药：倘若病人需要镇静剂，可使用苯甲二氮卓。病人若感觉到强烈的痛楚，可服用止痛药。需确保病人在进行检查前有充足的水分。（2） 术后护理及术后用药：病人接受脊髓造影后，须仰卧病床，头部保持高抬至少6小时，并在24小时内不得自行移动。若怀疑病人的癫痫发病阈有所降低，需密切监护。倘若癫痫发作，须马上给予抗癫痫治疗，例如把10mg苯甲二氮卓缓慢的注射入静脉。要防止复发，可在停止发病20～30分钟后，在肌肉内注射200mg苯巴比妥。鼓励病人进食流质食品和可以接受的固体食物。若发生持续性恶心或呕吐现象，应立即考虑进行静脉输液，以更换体液。必要时，可给予止吐剂。（3） 后备术后护理：在脊髓造影后，病人挺身端坐在轮椅上，可能会减少发生不良反应。这种挺身端坐姿势，可能有助于延迟造影剂向上身散播，并加强腰部蛛网膜的吸收能力。要告诫病人切记在术后24小时内不可弯身下俯。同时要指导病人，应尽量避免移动身体，以减少脑脊液泄漏。3 体外试验表明非离子型造影剂对止血（即血凝固机理）的抑制作用比浓度相似的离子型造影剂为低。因此，血管造影应按标准步骤进行。血管造影导管应经常冲洗并避免血液和造影剂在注射器及导管中长时间接触。4 对高危病人如患有严重肝脏或肾脏机能不全，甲状腺病及骨髓白血病的病人，使用时应特别小心，给予特别监护，且应避免脱水。必要时术后进行透析治疗。5 碘造影剂可加重重症肌无力的症状。嗜铬细胞瘤患者进行静脉注射时，应预防性地给予α－受体阻断剂，以避免出现高血压危象。血清内肌酸酐浓度超过500μmol/L的糖尿病患者，应避免用此造影剂（除非检查为病人带来的益处明显超过冒险成分）。6 确保病人在接受造影剂前后有良好的水电解质平衡。7 所有含碘质造影剂均可能妨碍甲状腺功能的检查。甲状腺组织的碘结合能力可能会受造影剂影响而降低，并且需要数日甚至两星期才能完全恢复。8 孕妇及哺乳期妇女应尽量避免使用。虽然动物实验并未显示碘海醇会损害生育能力或导致畸形婴儿，但怀孕期间应尽量减少使用，直至在病人中进行严格控制的研究有明确的结论为止。此造影剂被排入母乳的程度，虽然估计是相当轻微，但实际情况尚未确定。9 造影剂也不应与其它药物混合，应使用专用的注射针和针筒。10 每瓶碘海醇只应供一名病人使用，剩余的部分应弃掉。11 造影前2小时应禁食。12 本品如有变色、沉淀则不能使用。

【特殊人群用药】

儿童注意事项：
 

妊娠与哺乳期注意事项：
请参见禁忌症和注意事项。

老人注意事项：
 

【药物相互作用】

1  使用造影剂可能会导致短暂性肾功能不全，这可使服用降糖药（二甲双胍）的糖尿病人发生乳酸性中毒。作为预防，在使用造影剂前48小时应停服双胍类降糖药，只有在肾功能稳定后再恢复用药。 
2  两周内用白介素－2治疗的病人其延迟反应的危险性会增加（感冒样症状和皮肤反应）。
3  所有含碘质造影剂均可能妨碍甲状腺功能的检查。甲状腺组织的碘结合能力可能会受造影剂影响而降低，并且需要数日甚至两星期才能完全恢复。
4  血清和尿中高浓度的造影剂会影响胆红素、蛋白或无机物（如铁、铜、钙和磷）的实验室测定结果。在使用造影剂的当天不应做这些检查。

【药理作用】

药理学本品为X光及CT检查常用的造影剂，可供血管内、椎管内和体腔内使用。动物试验结果表明本品对犬肝脏、腹主动脉、CT扫描影像有增强效应。毒理学犬肾动脉造影时有蛋白尿发生的现象。

【贮藏】

遮光，密闭保存。

 

Omnipaque 300

Generic Name: iohexol (Injection route, Oral route, Rectal route)

eye-oh-HEX-ol

 

 Commonly used brand name(s)

In the U.S.

Omnipaque 140 Omnipaque 180 Omnipaque 240 Omnipaque 300 Omnipaque 350 Omnipaque Flexipak

Available Dosage Forms:

 Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

 Uses For Omnipaque 300

Iohexol injection is used to help diagnose or find problems in the brain, back, heart, head, blood vessels, and other parts of the body. It is an iodinated contrast agent. Contrast agents are used to create a clear picture of the different parts of the body during certain medical procedures such as CT scans and angiography.

Iohexol may also be given orally or rectally to help diagnose or find problems in the joints, stomach or intestines, pancreas, and other parts of the body.

This medicine is to be given only by or under the supervision of a doctor.

 Before Using Omnipaque 300

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

 Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

 Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of iohexol in children. Some pediatric patients with certain medical conditions may have more unwanted side effects which may require caution in patients receiving iohexol.

 Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iohexol in the elderly. However, elderly patients are more likely to have unwanted side effects which may require caution in patients receiving iohexol.

 Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

 Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

 Metformin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

 AmiodaroneInteractions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

 Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

 Alcohol abuse or Heart or blood vessel disease or Multiple sclerosis or Seizures or epilepsy, history of—Iohexol injection should be used with caution in these patients. Allergies or hypersensitivities, or Allergic rhinitis (hay fever) or Allergy to a contrast agent, history of or Allergy to food or Allergy to iodine or Asthma—Use with caution. May increase risk of having allergic reactions. Anuria (not able to pass urine) or Blood vessel disease, severe or Congestive heart failure or Dehydration or Diabetes or Diabetic nephropathy or Kidney disease or Multiple myeloma (cancer of plasma cells) or Paraproteinemia (high amount of paraprotein in the blood)—May increase risk of having kidney failure. Blood clotting problems (eg, thrombosis) or Heart or blood vessel disease (eg, arteriosclerosis) or Hypertension (high blood pressure) or Hyperthyroidism (overactive thyroid) or Kidney disease, severe or Liver disease or Pheochromocytoma (adrenal problem) or Sickle cell anemia (inherited blood disorder)—Use with caution. May make these conditions worse. Homocystinuria (genetic disease)—Patients with this condition should avoid undergoing angiography because of the increased risk of having blood clotting problems. Infection—Iohexol injection should not be given for myelography in patients with this condition. Proper Use of iohexol

 

This section provides information on the proper use of a number of products that contain iohexol. It may not be specific to Omnipaque 300. Please read with care.

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in an artery or a vein, or into your spinal cord. It may also be given by mouth or through your rectum.

Your doctor may also give you medicines (eg, antihistamines, steroids) to prevent allergic reactions.

Drink extra fluids so you will pass more urine while you are receiving this medicine. This may help prevent kidney problems.

 Precautions While Using Omnipaque 300

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Tell your doctor if you are pregnant.

This medicine may cause heart attack, stroke, and blood clotting problems during angiographic procedures. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness, coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, or problems with vision, speech, or walking after receiving this medicine.

Severe kidney problems may occur after receiving this medicine. Tell your doctor right away if you have the following symptoms after receiving the medicine: agitation, confusion, decreased urine output, dizziness, headache, muscle twitching, rapid weight gain, or swelling of the face, ankles, or hands.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a skin rash, itching, shortness of breath, sweating, swelling of the face, tongue, and throat, or tightness in the chest after you receive this medicine.

Make sure your doctor knows if you have had an allergic reaction to any dye or medicine given during a test or procedure.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

Make sure any doctor or dentist who treats you knows that you are using iohexol injection. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. You should not receive iohexol injection together with a steroid medicine into your spinal cord.

 Omnipaque 300 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common—Oral or rectal route

 Swelling or pain

Less common—Intravascular route

 Arm, back, or jaw pain chest pain or discomfort chest tightness or heaviness difficulty breathing Dizziness Fainting fast, slow, or irregular heartbeat Nausea shortness of breath Sweating swelling in the throat 

Less common—Oral or rectal route

Blurred vision Confusion Dizziness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position Headache Nervousness pounding in the ears slow or fast heartbeat Sweating unusual tiredness or weakness 

Rare—Intrathecal route

 Blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings Confusion dizziness or lightheadedness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position feeling of constant movement of self or surroundings Headache Nervousness pounding in the ears Seizures slow or fast heartbeat Sweating unusual tiredness or weakness 

Rare—Intravascular route

 Blurred vision Confusion dilated neck veins dizziness or lightheadedness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position extreme fatigue fast, pounding, or irregular heartbeat or pulse feeling cold feeling of constant movement of self or surroundings Fever irregular breathing pale skin Seizures sensation of spinning swelling of the face, fingers, feet, or lower legs troubled breathing with exertion unusual bleeding or bruising unusual tiredness or weakness weight gain 

Rare—Oral or rectal route

 Muscle weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common—Intrathecal route

 Nausea pain in the neck, back, or nerve 

More common—Oral or rectal route

 Abdominal or stomach pain bloated or full feeling Diarrhea excess air or gas in the stomach or intestines Nausea passing gas Vomiting 

Less common—Intrathecal route

 Vomiting 

Less common—Intravascular route

 Bad, unusual, or unpleasant (after) taste change in taste Headache 

Less common—Oral or rectal route

 Hives or welts, itching, or skin rash redness of the skin sleepiness or unusual drowsiness 

Rare—Intrathecal route

 Change in color vision continuing ringing or buzzing or other unexplained noise in the ears difficulty seeing at night Drowsiness hearing loss increased sensitivity of the eyes to sunlight loss of appetite sensation of spinning 

Rare—Intravascular route

 Acid or sour stomach Anxiety Belching Chills cold sweats Coma cool, pale skin Cough Depression Diarrhea dry mouth Heartburn hives or welts, itching, or rash increased hunger Indigestion Nightmares redness of the skin runny nose Shakiness sleepiness or unusual drowsiness slurred speech Sneezing stomach discomfort, upset, or pain stuffy nose uncontrolled eye movements vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.