美国FDA批准其组合药物Consensi（amlodipine/celecoxib）复方口服片上市，用于治疗骨关节炎疼痛和高血压。
批准日期：2018年6月 研发公司：Kitov Pharma 
CONSENSI（氨氯地平和塞来昔布 amlodipine and celecoxib）片剂，用于口服给药。
初始美国批准：2018年
警告：严重的心血管疾病和风险
胃肠道事件
查看完整的盒装警告的完整处方信息。
非甾体类抗炎药（NSAIDs）引起心血管（CV）血栓形成事件增加，包括心肌梗塞和中风，这可能是致命的。这种风险可能在治疗早期发生，并可能随着使用时间的延长而增加。
CONSENSI在冠状动脉旁路移植术（CABG）手术中是禁忌的。
•严重的胃肠道（GI）出血的风险增加的NSAIDs原因adverseevents包括，溃疡和肠stomachor，这可能是致命的穿孔。这些事件可以随时发生，没有警告症状。具有消化性溃疡病和/或胃肠道出血史的老年患者存在严重胃肠道事件的风险。
作用机制
塞来昔布和氨氯地平的组合CONSENSI的作用机制类似于其单个组分塞来昔布和氨氯地平的作用机制，如下所述。
塞来昔布
塞来昔布具有镇痛，抗炎和解热作用。
塞来昔布的作用机制被认为是由于前列腺素合成的抑制，主要是通过抑制COX-2。
塞来昔布是体外前列腺素合成的有效抑制剂。在治疗期间达到的塞来昔布产生了体内效应。前列腺素使传入神经敏感并增强缓激肽在诱导疼痛中的作用
动物模型。前列腺素是炎症的介质。由于塞来昔布是前列腺素合成的抑制剂，其作用方式可能是由于外周组织中前列腺素的减少。
氨氯地平
氨氯地平是二氢吡啶类钙拮抗剂（钙离子拮抗剂或慢通道阻滞剂），可抑制钙离子进入血管平滑肌和心肌的跨膜。实验数据表明氨氯地平与二氢吡啶和非二氢吡啶结合位点结合。心肌和血管平滑肌的收缩过程取决于细胞外钙离子通过特定通道进入这些细胞的运动。氨氯地平抑制钙离子穿过细胞膜，对细胞膜的影响更大
血管平滑肌细胞而非心肌细胞。可以在体外检测负性肌力作用，但是在治疗剂量的完整动物中未观察到。
氨氯地平不影响血清钙浓度。
内的生理pH范围内，是氨氯地平，以离子化化合物（pKa值=），以及其与钙通道受体动力学相互作用通过缔合和解离与受体结合位点的逐渐速率表征，在效果的逐渐发作所得。
氨氯地平是一种外周动脉血管扩张剂，可直接作用于血管平滑肌，从而降低外周血管阻力，降低血压。
适应症和用法
CONSENSI是氨氯地平苯磺酸盐，钙通道阻断剂，和塞来昔布的组合，非类固醇抗炎药（NSAID），适合治疗对他们来说，氨氯地平对hypertensionand塞来昔布用于治疗骨关节炎的治疗是适宜的。降低血压会降低致命和非致死性CV事件的风险，主要是中风和心肌梗塞。
使用限制
CONSENSI的塞来昔布强度为200毫克，每天服用一次。
剂量和用量
使用最低有效剂量的塞来昔布，持续时间最短，与个体治疗目标一致。如果不再需要镇痛治疗，则停止使用CONSENSI并开始接受替代性抗高血压治疗。
开始在（氨氯地平/塞来考昔）5毫克/200毫克（2.5毫克/200毫克小，老人，虚弱或患者或肝损伤）每天一次口服给药。根据需要每日一次滴定至5mg/200mgor10mg/200mg用于血压控制。CONSENSI可以替代其各个组件。
剂量形式和强度
片剂（氨氯地平/塞来昔布）：2.5mg/200mg，5mg/200mg，或10mg/200mg
禁忌症
•已知对氨氯地平，塞来昔布或CONSENSI的任何无活性成分过敏
•服用阿司匹林或其他NSAID后哮喘，荨麻疹或其他过敏反应的病史
•在CABG手术的环境中
•表现出对磺胺类药物的过敏反应
警告和注意事项
•肝毒性和肝功能衰竭患者：告知患者肝毒性症状和体征。如果异常测试持续或恶化或肝病的临床症状和体征发展，则停止使用。
•高血压：服用抗高血压药物的患者在服用NSAID时可能对这些疗法的反应受损。监测血压。
•低血压：症状性低血压是可能的，特别是在严重主动脉瓣狭窄的患者中。
•增加心绞痛或心肌梗塞：心绞痛恶化急性心肌和心肌梗塞，尤其是重症患者obstructivecoronary动脉疾病。
•心力衰竭和水肿：避免在心力衰竭患者中使用CONSENSI。
•肾毒性：监测肾脏或肝脏损害，心力衰竭，脱水或血容量不足患者的肾功能。避免在患有晚期肾病的患者中使用CONSENSI。
•过敏反应：如果发生过敏反应，请寻求紧急帮助。
•与阿司匹林敏感性相关的哮喘恶化：对阿司匹林敏感性哮喘患者禁用CONSENSI。监测患有既往哮喘的患者（不含阿司匹林敏感性）。
•严重皮肤反应：首次出现皮疹或其他过敏症状时，停用CONSENSI。
•胎儿动脉导管过早闭合：避免在怀孕30周开始使用孕妇。
•血液学毒性：监测患有贫血症状或症状的患者的血红蛋白或血细胞比容。
不良反应
在关节炎试验塞来昔布最常见的不良反应（> 2％和>安慰剂）：腹痛，腹泻，消化不良，肠胃气胀，外周性水肿，意外伤害，头晕，咽炎，鼻炎，鼻窦炎，上呼吸道感染，皮疹。
对氨氯地平的最常见的不良反应是水肿，其以adose关系方式发生。腹痛，恶心，腹痛和嗜睡。
报告可疑的不良反应，请联系Kitov PharmaLtd在1-800-651-6606或FDA电话：1-800-FDA-1088 orwww.fda.gov/medwatch。
药物相互作用
•药物并用止血干扰（如华法林，阿司匹林，SSRIs类药物/的SNRI）：监测患者的出血谁与药物并用hemostasis.Concomitant使用CONSENSI镇痛剂量的阿司匹林的干扰concomitantlytaking CONSENSI是notgenerally建议。
•ACE抑制剂，血管紧张素受体阻断剂（ARB），或β受体阻滞剂：与CONSENSI伴随使用可能会降低的合成药物的antihypertensiveeffect。监测血压。
•ACE抑制剂和ARB：伴随CONSENSI在老年人，体积减少或肾功能不全患者中的使用。在这样的高风险患者中，监测肾功能恶化的情况。
•利尿剂：NSAIDs可降低呋塞米和噻嗪类利尿剂的利尿作用。监测患者以确保利尿剂的疗效，包括抗癫痫
如何提供/存储和处理
CONSENSI片剂为白色和双凸面，无涂层，无刻痕，片剂强度在一侧凹陷，可作为
如下：
                                Bottle of100tablets Bottle of 500tablets 
2.5mg/200mg     Elongated oval   64239-201-01         64239-201-02
5mg/200mg       Caplet           64239-202-01         64239-202-02
10mg/200mg      Round            64239-203-01         64239-203-02 
存储
在室温20°C至25°C（68°F至77°F）下储存; [见USP受控室温]。 分配紧，轻
耐药容器（USP）。

Generic Name: amlodipine and celecoxib
Dosage Form: Tablets
Date of Approval: May 31, 2018
Company: Kitov Pharma Ltd.

Treatment for: Hypertension and Osteoarthritis Pain

The U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine besylate and celecoxib), an antihypertensive calcium channel blocker and a non-steroidal anti-inflammatory drug (NSAID) combination for the treatment of hypertension and osteoarthritis pain.

Read this Patient Information carefully before you start treatment. This information does not take the place of talking with your doctor about your medical condition or your treatment

Consensi contains celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious side effects, including:

· Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

o with increasing doses of NSAIDs

o with longer use of NSAIDs

Do not take Consensi right before or after a heart surgery called a “coronary artery bypass graft” (CABG).

Avoid taking Consensi after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

· Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines:

o anytime during use

o without warning symptoms

o that may cause death

The risk of getting an ulcer or bleeding increases with:

o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs

o taking medicines called “corticosteroids”, “anticoagulants”, “selective serotonin reuptake inhibitors (SSRIs)”, or “serotonin norepinephrine reuptake inhibitors (SNRIs)”

o increasing doses of NSAIDs

o longer use of NSAIDs

o smoking

o drinking alcohol

o older age

o poor health

o advanced liver disease

o bleeding problems

You should not take other medicines that contain NSAIDs or salicylates during treatment with Consensi because of increased risk of stomach problems. Taking other medicines that contain NSAIDs or salicylates during treatment with Consensi will not provide increased relief of symptoms of osteoarthritis.

Consensi should only be used:

· exactly as prescribed

· at the lowest dose possible for your treatment

· for the shortest time needed

Consensi is a prescription medicine used in adults who need treatment:

· with amlodipine for high blood pressure (hypertension), to lower blood pressure, and

· with celecoxib for the management of the signs and symptoms of osteoarthritis.

It is not known if this medicine is safe and effective in children.

Do not take Consensi:

· if you are allergic to amlodipine, celecoxib or any of the inactive ingredients in Consensi. See the end of this Medication Guide for a complete list of ingredients.

· if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.

· right before or after heart bypass surgery

· if you have had an allergic reaction to sulfonamides.

Before taking Consensi, tell your healthcare provider about all your medical conditions, including if you:

· have heart problems.

· have liver or kidney problems.

· have asthma.

· are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking Consensi during pregnancy. You should not take Consensi after 29 weeks of pregnancy.

· are breastfeeding or plan to breastfeed. Consensi can pass into your breast milk. It is not known if Consensi will harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Consensi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Consensi and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

· Take Consensi exactly as your healthcare provider tells you to.

· Take one tablet orally each day.

· If your pain stops, do not stop taking Consensi until your healthcare provider prescribes a different medicine to treat your blood pressure. Your healthcare provider will monitor your blood pressure when changing to the new medicine.

· If you take too much or overdose, call your healthcare provider or get medical help right away.

Consensi can cause serious side effects, including:

See Important information.

· liver problems, including liver failure

· worsening chest pain (angina) or heart attack, particularly in people with severe obstructive coronary artery disease

· heart failure

· swelling of your arms, legs, hands and feet (peripheral edema) is common with Consensi but can sometimes be serious.

· kidney problems, including kidney failure

· increased potassium levels (hyperkalemia)

· life-threatening allergic reactions

· life-threatening skin reactions

· low red blood cells (anemia)

Your healthcare provider will monitor your blood pressure and do blood tests to check you for side effects during treatment.

Consensi may cause fertility problems in females that is reversible when treatment is stopped. Talk to your healthcare provider if this is a concern for you.

The most common side effects include:

· swelling of the arms, legs, hands, and feet

· joint swelling

· dizziness

· stomach pain

· diarrhea

· heartburn

· headache

· frequent urination

· hot or warm feeling in your face (flushing)

· gas

· tiredness

· extreme sleepiness

Get emergency help right away if you get any of the following symptoms:

· shortness of breath or trouble breathing

· chest pain

· weakness in one part or side of your body

· slurred speech

· swelling of the face or throat

Stop treatment and call your healthcare provider right away if you get any of the following symptoms:

· nausea

· more tired or weaker than usual

· diarrhea

· itching

· your skin or eyes look yellow

· indigestion or stomach pain

· flu-like symptoms

· vomit blood

· there is blood in your bowel movement or it is black and sticky like tar

· unusual weight gain

· skin rash or blisters with fever

· swelling of the arms, legs, hands and feet

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

· Store the tablets at room temperature between 68° and 77°F (20°C to 25°C).

Keep all medicines out of the reach of children.

· Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

· Some NSAIDs are sold in lower doses without a prescription (over-the- counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

Active ingredients: amlodipine and celecoxib

Inactive ingredients: mannitol DC 200, croscarmellose sodium, povidone K-30, sodium lauryl sulfate, magnesium stearate, and colloidal silicon dioxide.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.