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【中文通用名】恩曲他滨
【别 名】Emtriva，FTC
【英文TNN名】EmtricItabine
【药品性质】处方药
【药品分类】国外最新药品 -> 抗微生物新药
【药理毒理】本品是一种新型核苷类逆转录酶抑制剂，对Hiv-1HIv-2及HBV均有抗病毒活性。本品口服后被磷酸化为具有细胞活性的5´-三磷酸盐，5´-三磷酸盐通过进入病毒DNA主链，与主链结合，导致链终止，从而抑制HIV-1逆转录酶及HBV DNA聚合酶活性。
【药代动力学】给雄性小鼠口服和静注单剂量本品100mg/kg100mg／kg或600mg／kg，结果显示，本品吸收好，清除快，且在研究所使用的剂量范围内其药代动力学呈剂量依赖性，总清除速率快接近于肾血流量。对HIV感染者单独给予本品100～1200mg，Tmax为1．25～1．61h。HIV感染者接受本品一日200mg，其血浆半衰期7．5～8h，本品三磷酸盐的细胞内半衰期大约为39h。
【适应症】与其他抗逆转录病毒药物联合用于成人Hiv感染的治疗。
【剂 型】恩曲他滨胶囊；200mg/粒。
【用法用量】18岁以上成人口服用药，每次200㎎，每日1次。空腹服用，也可与食物同服。肾功能不良者应调整剂量，改为200mg，隔日1次或每3天1次。
【不良反应】
1．全身腹痛、无力、头痛。
2．消化系统腹泻、消化不良、恶心、呕吐。
3.骨骼肌肉: 关节痛、肌痛。
4.神经系统: 睡梦异常、抑郁、头晕 、失眠、神经痛、外周神经炎、感觉异常。
5．呼吸系统: 咳嗽加重、鼻炎。
6. 皮肤疹。
【禁 忌】
1.已知对本品或其中任一组分过敏者禁用。
2.禁用于晚期肾病及肝功能不全者。
【慎用】
1.孕妇服用本品可能对胎儿和新生儿有不利影响。本品可通过乳脲分泌也可影响受乳婴儿，一般不推荐孕妇和哺乳期妇女使用本品。
2.老年人选择剂量时应慎重，可根据其肝、肾、心功能的衰退、伴发疾病以及其他药物治疗的影响，酌情减量服用。
【注意事项】
1.本品主要经肾排泄，故肾功能不全患者服用本品应减量。
2.儿童尚未建立安全有效的依据，故儿童不推荐使用。
3.尚无特效解救药，药物过量采用支持治疗。
【药物相互作用】本品不影响肝微粒体酶P 450酶系统，不产生由此介导的相互作用，与替诺氟韦、茚地那韦、泛昔洛韦、司坦夫定合用，药代动力学几乎无影响。
Medication name
Generic name: Emtricitabine - Oral
Brand name(s): Emtriva
Warning
Rarely, emtricitabine has caused a severe (sometimes fatal) liver and blood problem (lactic acidosis). Tell your doctor immediately if you develop symptoms of liver problems (persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (rapid breathing, drowsiness, muscle aches).This medication is not approved for the treatment of hepatitis B virus infection. If you have hepatitis B infection in addition to HIV, your hepatitis symptoms may get worse or become very serious if you stop taking emtricitabine. Talk with your doctor before stopping this medication. Your doctor will perform liver function tests for several months after you stop emtricitabine. Tell your doctor immediately if you develop symptoms of worsening liver problems.
Uses
Emtricitabine is used with other medications to help control your HIV infection, thereby improving your quality of life. It may also lower your risk of complications from HIV (such as new infections, cancers). Emtricitabine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors-NRTI.Emtricitabine is not a cure for HIV and it does not prevent the spread of HIV to others through sexual contact or blood contamination (such as sharing used needles).
Other uses
This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used to prevent HIV infection after contact with the virus.
How to use
Read the Patient Information Leaflet provided by your pharmacist before you start taking emtricitabine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth, usually once daily with or without food or as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.Dosage is based on your medical condition, dosage form (capsule or liquid), and response to treatment. Do not switch between the capsule and liquid forms.This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at the same time each day.It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Refill your medication before you run out.Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.Tell your doctor if your condition persists or worsens.
Precautions
Before taking emtricitabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis, cirrhosis), alcohol use.Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug.During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Emtricitabine may be part of that treatment. Discuss the risks and benefits with your doctor.It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
Drug interactions
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Lamivudine is similar to emtricitabine and should not be taken with this medication. Check the labels on all your HIV medicines because they may contain the same ingredients as found in this product. Taking too much of these drugs will not necessarily improve your condition, and may cause more side effects.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.
Side effects
See also Warning section.Headache, nausea, diarrhea, trouble sleeping, or darkening skin color on palms of hands and soles of feet may occur. If any of these effects persist or worsen, notify 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.Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression).Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.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.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Missed dose
If you miss a dose, take 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.
Overdose
If overdose is suspected, contact a 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 (such as liver tests, viral load, T-cell counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Keep all medical and laboratory appointments.
Medical alert
Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (US) or 1-800-668-1507 (Canada).
Storage
Store emtricitabine capsules at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Store emtricitabine oral solution in the refrigerator at 36-46 degrees F (2-8 degrees C). Do not freeze. Emtricitabine solution may also be stored at room temperature at 77 degrees F (25 degrees C) with brief storage between 59-86 degrees F (15-30 degrees C), but in this case it must be used within 3 months. Keep all medicines away from children and pets.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.
Photos by medication strength
Click the "Photos" link to see sample photographs for a specific medication strength.
Common strengths
Emtriva 10 mg/mL Oral Soln
Emtriva 200 mg Cap
*The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.
Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Information last revised January 2012 Copyright(c) 2012 First DataBank, Inc.
Oral
Capsule
emtricitabine|
Human Immunodeficiency Virus Disease|Human Immunodeficiency Virus Infection|Human Immunodeficiency Virus Post Exposure Prophylaxis|HIV Contact Prophylaxis|
HIV|Prevention of HIV Infection after Exposure|
AIDS Virus Infection|
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First DataBank, Inc., 2012. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.
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产地国家：美国
所属类别：抗病毒药物 ->抗艾滋病药物
原产地英文药品名：
EMTRICITABINE
中文参考药品译名：
恩曲他滨 原产地英文商品名：
EMTRIVA ORAL SOLUTION 10MG/ML 170MLS/BOTTLE
中文参考商品译名：
EMTRIVA口服溶液 10毫克/毫
生产厂家英文名：
GILEAD
生产厂家中文参考译名：
GILEAD
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产地国家：美国
所属类别：抗病毒药物 ->抗艾滋病药物
原产地英文药品名：
EMTRICITABINE
中文参考药品译名：
恩曲他滨 原产地英文商品名：
EMTRIVA CAPSULE 200MG/CAP 30CAPS/BOTTLE
中文参考商品译名：
EMTRIVA胶囊剂 200毫克/胶
生产厂家英文名：
GILEAD
生产厂家中文参考译名：
GILEAD
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