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当前位置:药品说明书与价格首页 >> 心血管系统 >> 药品目录 >> 调血脂和抗动脉粥样硬化药类 >> 他汀类 >> 氨氯地平阿伐他汀片|Caduet (Amlodipine/Atorvastatin)

氨氯地平阿伐他汀片|Caduet (Amlodipine/Atorvastatin)

2009-12-08 18:42:21  作者:新特药房  来源:中国新特药网  浏览次数:754  文字大小:【】【】【
简介: 12月2日,辉瑞和Astellas两家公司将在日本合作推出用于治疗高血压症和血胆脂醇过多的复方制剂Caduet,该药为片剂,含有苯磺酸氨氯地平和阿伐他汀钙两种成分。 辉瑞抗高血压药Norvasc的主要成分即为苯 ...

12月2日,辉瑞和Astellas两家公司将在日本合作推出用于治疗高血压症和血胆脂醇过多的复方制剂Caduet,该药为片剂。该药为治疗高血压症和血胆脂醇过多的复方制剂Caduet,该药为片剂,含有苯磺酸氨氯地平和阿伐他汀钙两种成分。
辉瑞抗高血压药Norvasc的主要成分即为苯磺酸氨氯地平,而其用于治疗血胆脂醇过多症治疗药Lipitor的主要成分即为阿伐他汀钙。
Caduet囊括了上述极为常用的两种药物成分,可同时用于治疗这两种病症,从而有望增强患者对药物的依从度。
开发阶段:2004年1月获得批准(美国,适应症包括高血压、慢性稳定性心绞痛、血管痉挛性心绞痛(或称变异性心绞痛)、各种家族性或非家族性血脂异常)
简介:CADUET® (苯磺酸氨氯地平+阿托伐他汀钙) 包含长效钙通道阻断剂苯磺酸氨氯地平和合成的降血脂药物阿托伐他汀钙。苯磺酸氨氯地平的化学名为3-Ethyl-5-methyl(±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate;阿托伐他汀钙的化学名为:[R-(R*,R*)] -2-(4-fluorophenyl)-ß,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate。
CADUET片除了包含上述两种活性成分外,还含有碳酸钙、croscarmellose sodium、微晶纤维素、pregelatinized starch、聚山梨醇酯80、hydroxypropyl cellulose、纯水、二氧化硅胶、硬脂酸镁等辅料。CADUET片有多种规格,包括5mg/10mg、5mg/20mg、5mg/40mg、5mg/80mg、10mg/10mg、10mg/20mg、10mg/40mg、10mg/80mg(前为氨氯地平,后为阿托伐他汀)8个规格。
口服CADUET后,血浆氨氯地平的峰值在服药后6-12小时出现,阿托伐他汀的峰值在1-2小时后出现。服用CADUET后两种活性成分的生物利用度和这两种成分分开服用并没有显著的差异。CADUET 中氨氯地平的生物利用度并不受进食的影响。进食可以降低CADUET 中的阿托伐他汀的吸收率和吸收程度(分别降低32%和11%),但和阿托伐他汀单独服用的降低程度是一样的。另外,进食与否对LDL-C 的降低并没有影响。
 在一项双盲、安慰剂对照试验中,总共有1660名合并高血压和高血脂患者随机接受了氨氯地平/阿托伐他汀联合治疗(共有8个剂量组:5/10、10/10、5/20、10/20、5/40、10/40、5/80、10/80mg)、氨氯地平单独治疗(5mg或10mg)、阿托伐他汀单独治疗(10 mg、20 mg、40 mg或80 mg)或安慰剂治疗。除了合并有高血压和高血脂,15%的病人还有糖尿病,22%的患者吸烟,14%的患者有心血管病家族史。在治疗8周后,8个剂量的联合治疗组患者都出现了显著的、剂量依赖性的收缩压、舒张压和LDL-C 的降低。和两种活性成分单独服用时对上述参数的影响没有显著的差异。

Caduet
Generic Name: amlodipine and atorvastatin (am LOE di peen and a TORE va sta tin)
Brand Names: Caduet

What is Caduet?
Caduet contains a combination of atorvastatin and amlodipine. Atorvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Atorvastatin blocks the production of cholesterol (a type of fat) in the body.

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes the blood vessels, improving blood flow and making it easier for the heart to pump.

Caduet is used to treat high blood pressure (hypertension) or chest pain (angina) that occurs with high cholesterol or triglyceride levels.

Caduet may also be used for other purposes not listed in this medication guide.

Important information about Caduet
Caduet can harm an unborn baby or cause birth defects. Do not use this medication if you are pregnant. You should not use Caduet if you are allergic to amlodipine (Norvasc) or atorvastatin (Lipitor), if you have liver disease, or if you are pregnant or breast-feeding.

Before taking Caduet, tell your doctor if you have liver problems, heart disease, congestive heart failure, a serious illness or infection, or if you are taking other heart or blood pressure medications.

In rare cases, atorvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Caduet is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Avoid drinking alcohol. It may increase your risk of liver damage. Alcohol can also further lower blood pressure and can increase some of the side effects of amlodipine and atorvastatin. Caduet may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Before taking Caduet
You should not use Caduet if you are allergic to amlodipine (Norvasc) or atorvastatin (Lipitor), if you have liver disease, or if you are pregnant.

If you have any of these other conditions, your doctor may need to adjust the dose of Caduet or order special tests:
liver problems;
heart disease, congestive heart failure, or recent stroke;
a serious illness or infection; or
if you take other heart or blood pressure medications.

FDA pregnancy category X. Caduet can cause birth defects. Do not use Caduet if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether amlodipine and atorvastatin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Caduet

How should I take Caduet?
Take Caduet exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Caduet is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You may take this medication with or without food. Caduet is usually taken once a day. Try to take your dose at the same time each day. Follow your doctor's instructions.

To be sure Caduet is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

You may need to stop using the medication if you have an injury, serious infection or illness, seizures, metabolic disorders, or any type of surgery. Tell any doctor or other healthcare provider who treats you that you are taking Caduet.

If you are being treated for high blood pressure, keep using Caduet even if you feel fine. High blood pressure often has no symptoms.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fast heart rate, feeling light-headed, fainting, and warmth, redness, or tingling under your skin.

What should I avoid while taking Caduet?
Avoid eating foods that are high in fat or cholesterol. This medication will not be as effective in treating your condition if you do not follow the diet plan recommended by your doctor.

Avoid drinking alcohol. It may increase your risk of liver damage. Alcohol can also further lower blood pressure and can increase some of the side effects of amlodipine and atorvastatin. Caduet may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Grapefruit and grapefruit juice may interact with Caduet. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Caduet side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Caduet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. In rare cases, atorvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine. Stop using Caduet and call your doctor at once if you have any of these serious side effects:
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
slow, fast, uneven, or pounding heartbeats;
feeling light-headed, fainting; or
swelling of your hands or feet.

Less serious Caduet side effects may include:
headache, dizziness;
warmth or tingly feeling;
mild stomach pain, diarrhea, gas, upset stomach;
decreased sex drive, impotence, or difficulty having an orgasm;
mild itching or skin rash; or
drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Caduet side effects in more detail

What other drugs will affect Caduet?
Many drugs can interact with Caduet. Below is just a partial list. Tell your doctor if you are using:
spironolactone (Aldomet, Aldactazide);
cimetidine (Tagamet);
antacids;
gemfibrozil (Lopid) or fenofibrate (Antara, Lipofen, Lofibra, Tricor, Triglide);
niacin (Niacor, Nicolar, Nicobid, Niaspan);
cholestyramine (Questran) or colestipol (Colestid);
hormonal birth control (pills, patches, or implants);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or rifampin (Rifater, Rifadin, Rifamate);
antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
HIV medications such as efavirenz (Sustiva), lopinavir (Kaletra), ritonavir (Norvir), or saquinavir (Invirase) especially if used together;
drugs that weaken your immune system such as cancer medicine or steroids, cyclosporine (Neoral, Sandimmune, Gengraf), sirolimus (Rapamune), tacrolimus (Prograf), and others; or

other cholesterol-lowering medicines such as lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), fluvastatin (Lescol), or atorvastatin (Lipitor).

This list is not complete and other drugs may interact with Caduet. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about Caduet.

What does my medication look like?
Amlodipine and atorvastatin is available with a prescription under the brand name Caduet. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medicine, especially if it is new to you.

Caduet 5 mg - amlodipine/40 mg atorvastatin-white tablets
Caduet 5 mg - amlodipine/80 mg atorvastatin-white tablets
Caduet 10 mg - amlodipine/40 mg atorvastatin-blue tablets
Caduet 10 mg - amlodipine/80 mg atorvastatin-blue tablets
Caduet 5 mg - amlodipine/10 mg atorvastatin-white tablets
Caduet 5 mg - amlodipine/20 mg atorvastatin-white tablets
Caduet 10 mg - amlodipine/10 mg atorvastatin-blue tablets
Caduet 10 mg - amlodipine/20 mg atorvastatin-blue tablets

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist



 

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