英文药名: Lofibra (Fenofibrate Capsules)

中文药名: 非诺贝特胶囊

生产厂家: Solvay Pharma

药品说明
【通用名称】非诺贝特胶囊
【英文名称】Fenofibrate Capsules
【成份】本品主要成份为：非诺贝特
【性状】本品为胶囊剂，内容物为白色或类白色结晶性粉末。
【药理毒理】本品为氯贝丁酸衍生物类血脂调节药，通过抑制极低密度脂蛋白和甘油三酯的生成并同时使其分解代谢增多，降低血低密度脂蛋白、胆固醇和甘油三酯；还使载脂蛋白A1和A11生成增加，从而增高高密度脂蛋白。本品尚有降低正常人及高尿酸血症患者的血尿酸作用。动物实验表明，非诺贝特具有致畸性和致癌性。
【药代动力学】本品口服后，胃肠道吸收良好，与食物同服可使非诺贝特的吸收增加。口服后4－7小时左右血药浓度达峰值。单剂量口服后吸收半衰期与消除半衰期分别为4.9小时与26.6小时，表观分布容积为0.9L/kg；持续治疗后半衰期β为21.7小时。血浆蛋白结合率大约为99%，多剂量给药后未发现蓄积。吸收后在肝、肾、肠道中分布多，其次为肺、心和肾上腺，在睾丸、脾、皮肤内有少量。在肝内和肾组织内代谢，经羧基还原与葡糖醛酸化，代谢产物以葡糖醛酸化产物占大多数，经放射物标记，有大约60%的代谢产物经肾排泄，25%的代谢产物经大便排出。本品的消除半衰期为20小时，因此可以每天一次给药。有研究显示，严重肾功能不全的患者对本品的清除率显著下降，长期用药可造成蓄积。
【适应症】本品用于治疗成人饮食控制疗法效果不理想的高脂血症，其降甘油三酯及混合型高脂血症作用较胆固醇明显。但本品不能完全代替饮食控制疗法，只能用作在控制饮食基础上的辅助治疗。
【用法用量】成人常用量口服，胶囊一次0.1g，每日3次，维持量每次0.1g，每日1－2次。为减少胃部不适，可与饮食同服；肾功不全及老年患者用药应减量；治疗2个月后无效应停药。
【不良反应】发生率约有2%-15%。胃肠道反应包括腹部不适、腹泻、便秘最常见（约5%）；皮疹（2%）；神经系统不良反应包括乏力、头痛、性欲丧失、阳萎、眩晕、失眠（约3%-4%）；本品属氯贝丁酸衍生物，有可能引起肌炎、肌病和横纹肌溶解综合征，导致血肌酸磷酸激酶升高；发生横纹肌溶解，主要表现为肌痛合并血肌酸磷酸激酶升高、肌红蛋白尿、并可导致肾衰，但较罕见；在患有肾病综合征及其它肾损害而导致血白蛋白减少的患者或甲状腺机能亢进的患者，发生肌病的危险性增加。（约1%）；有使胆石增加的趋向，可引起胆囊疾病，乃至需要手术；在治疗初期可引起轻度至中度的血液学改变，如血红蛋白、血细胞比积和白细胞降低等偶有血氨基转移酶增高，包括丙氨酸及门冬氨酸氨基转移酶。
【禁忌】对非诺贝特过敏者禁用；有胆囊疾病史、患胆石症的患者禁用，本品可增加胆固醇向胆汁的排泌，从而引起胆结石。严重肾功能不全、肝功能不全、原发性胆汁性肝硬化或不明原因的肝功能持续异常的患者禁用。
【注意事项】本品对诊断有干扰，服用本品时血小板计数、血尿素氮、氨基转移酶、血钙可能增高；血碱性磷酸酶、γ谷氨酰转肽酶及胆红素可能降低。用药期间应定期检查：
①全血象及血小板计数；
②肝功能试验；
③血胆固醇、甘油三酯或低密度脂蛋白；
④血肌酸磷酸激酶。如果临床有可疑的肌病的症状（如肌痛、触痛、乏力等）或血肌酸磷酸激酶显著升高，则应停药。在治疗高血脂的同时，还需关注和治疗可引起高血脂的各种原发病，如甲状腺机能减退、糖尿病等。某些药物也可引起高血脂，如雌激素、噻嗪类利尿药和β阻滞剂等，停药后，则不再需要相应的抗高血脂治疗。饮食疗法始终是治疗高血脂的首要方法，加上锻炼和减轻体重等方式，都将优于任何形式的药物治疗。
【孕妇及哺乳期妇女用药】孕妇及哺乳期妇女禁用。本品尚无用于人类的实验数据。
【儿童用药】本品用于儿童的疗效和安全性，目前尚无实验研究加以证实，因此本品不能用于儿童。
【老年患者用药】 老年人单剂量口服本品的清除率与成年人相似，但如有肾功能不良时，须适当减少本品用药剂量。
【药物相互作用】 本品应慎与HMG-CoA还原酶抑制剂，如普伐他汀、氟伐他汀、辛伐他汀等合用，可引起肌痛、横纹肌溶解、血肌酸磷酸激酶增高等肌病，严重时应停药。本品与胆汁酸结合树脂，如考来烯胺等合用，则至少应在服用这些药物之前1小时或4－6小时之后再服用非诺贝特。因胆汁酸结合药物还可结合同时服用的其它药物，进而影响其它药的吸收。本品有增强香豆素类抗凝剂疗效的作用，同时使用可使凝血酶原时间延长，故合用时应减少口服抗凝药剂量，以后再按检查结果调整用量。本品主要经肾排泄，在与免疫抑制剂，如环孢素或其它具肾毒性的药物合用时，可能有导致肾功能恶化的危险，应减量或停药。本品与其它高蛋白结合率的药物合用时，可使它们的游离型增加，药效增强，如甲苯磺丁脲及其它磺脲类降糖药、苯妥英、呋塞米等，在降血脂治疗期间服用上述药物，则应调整降糖药及其它药的剂量。
【药物过量】 因非诺贝特与血浆蛋白高度结合，因此当药物过量时，不考虑血液透析，应采取系统性支持疗法。

Fenofibrate

Fenofibrate is used for:
 Cholesterol
 
Why it's so important to manage your cholesterol levels.
Controlling high cholesterol and triglyceride levels in the blood. It is used in combination with a diet that is low in cholesterol and saturated fat.

Fenofibrate is a lipid-lowering agent. It works by lowering elevated blood triglyceride levels by making the liver produce fewer triglycerides and increasing the elimination of triglycerides from the blood stream.

Do NOT use Fenofibrate if:
you are allergic to any ingredient in Fenofibrate
you have gallbladder problems, liver problems (including cirrhosis, hepatitis), or severe kidney problems (eg, kidney failure)
you are breast-feeding or pregnant
Contact your doctor or health care provider right away if any of these apply to you.

Before using Fenofibrate:
Some medical conditions may interact with Fenofibrate. 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 diabetes, an underactive thyroid, heart blood vessel problems, gallstones, kidney problems, or certain muscle problems (myopathy)
if you have a history of pancreatitis or blood clots in your veins (deep vein thrombosis or pulmonary embolism)
if you are very overweight, have an inactive lifestyle, or you drink large amounts of alcohol
if you are taking a beta-blocker (eg, propranolol), estrogen, or thiazide diuretic (eg, hydrochlorothiazide)
Some MEDICINES MAY INTERACT with Fenofibrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

HMG-CoA reductase inhibitors (eg, simvastatin) because the risk of serious muscle problems leading to kidney failure may be increased
Immunosuppressants (eg, cyclosporine) or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because they may decrease Fenofibrate's excretion and increase the risk of its side effects
Anticoagulants (eg, warfarin) or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Fenofibrate
This may not be a complete list of all interactions that may occur. Ask your health care provider if Fenofibrate 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 Fenofibrate:
Use Fenofibrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Fenofibrate by mouth with or without food.
Swallow Fenofibrate whole. Do not break, crush, or chew before swallowing. Do not take chipped or broken tablets.
Take Fenofibrate with a full glass of water (8 oz/240 mL).
If you also take a bile acid-binding resin (eg, cholestyramine), do not take it within 4 to 6 hours before or 1 hour after taking Fenofibrate. Check with your doctor if you have any questions.
Take Fenofibrate on a regular schedule to get the most benefit from it.
If you miss a dose of Fenofibrate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Fenofibrate.

Important safety information:
Fenofibrate may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Fenofibrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Avoid drinking alcohol while you are using Fenofibrate.
Do NOT take more than the recommended dose without checking with your doctor.
Follow the diet, exercise, and weight reduction program given to you by your health care provider.
Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.
Lab tests, including liver function, kidney function, blood cholesterol, and other blood tests, may be performed while you use Fenofibrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Fenofibrate with caution in the ELDERLY; they may be more sensitive to its effects.
Fenofibrate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fenofibrate while you are pregnant. It is not known if Fenofibrate is found in breast milk. Do not breast-feed while taking Fenofibrate.
Possible side effects of Fenofibrate:
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:

Headache; nausea.

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); calf pain; chest pain; confusion; dark urine; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased coughing or coughing up blood; muscle pain, tenderness, or weakness (with or without fever and fatigue); pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or lightheadedness; severe or persistent nausea, stomach pain, or vomiting; severe pain or swelling in the ankles, feet, or legs; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

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
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 Fenofibrate:
Store Fenofibrate between 68 and 77 degrees F (20 and 25 degrees C) in a moisture-protective container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fenofibrate out of the reach of children and away from pets.

General information:
If you have any questions about Fenofibrate, please talk with your doctor, pharmacist, or other health care provider.
Fenofibrate 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 is a summary only. It does not contain all information about Fenofibrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider