部分中文单硝酸异山梨酯处方资料（仅供参考）

【药品名称】
通用名：单硝酸异山梨酯
商品名：依姆多/Imdur
英文名：Isosorbide Mononitrate
本品主要成份及其化学名称为：本品主要成份为单硝酸异山梨酯，其化学名称为1,4；3,6-二脱水-D-山梨醇-5-硝酸酯。
其结构式为：
分子式：C6H9NO6
分子量：191.16

【性状】
本品为薄膜衣片，30mg为粉红色，60mg为黄色，除去包衣后显白色或类白色。

【药理毒理】
单硝酸异山梨酯为硝酸异山梨酯的主要活性代谢产物。可通过扩张外周血管，特別是增加靜脉血容量，减少回流量，降低心脏前后负荷，而减少心肌耗氧量；同时还可通过促进心肌血流重新分布而改善缺血区血流供应，可能通过这两方面发挥抗心肌缺血作用。

【药代动力学】
单硝酸异山梨酯口服吸收迅速，无肝脏首过效应，有效血药浓度稳定，持续时间长，分布心脏、脑组织中含量较高，血浆蛋白结合率为13%，主要经尿中排泄(约为81%)，胆汁中也有部分排泄(约为18%)。在尿中排泄的主要形式为异山梨醇，为48%；其次为5-单硝酸异山梨酯-葡糖醛酸结合物，占27%，以原形排泄仅占6%。胆汁排泄的主要形式也为5-单硝酸异山梨酯-葡糖醛酸结合物，它们随胆汁进入肠腔后被氺解，释放出的5-单硝酸异山梨酯，绝大部分又重新吸收至血液。
本品为单硝酸异山梨酯缓释制剂，释放时间长达10小时，具有白天髙血药浓度和夜间低血药浓度的特点。硝酸酯类药物多次给药达到高而平稳的血药浓度后，机体会对它产生耐受性，本品的这一特性可以避免产生耐受性，且不引起停药后的症状反跳。
有效成份的释放与pH无关，食物对吸收无影响。本品血药浓度的亇体内和个体间差异小，使得药物作用可以预见和重现。
急性心肌梗死时服用依姆多也是安全的，患者的血药浓度类似于健康志愿者，偶尓会有吸收延长，这可能与患者同时服用吗啡有关。
肝肾功能损害对本品的药代动力学没有很大影响。

【适应症】
冠心病的长期治疗、预防血管痉挛型和混合型心绞痛，也适用于心肌梗死后的治疗及慢性心衰的长期治疗。

【用法用量】
口服。一日1次，一次1片，清晨服用；病情严重者，可在毎日清晨服2片，若出现头疼，最初剂量可减至一日半片。整片或半片服用前应保持完整，用半杯水吞服，不可咀嚼或碾碎服用。

【不良反应】
开始治疗时可能有短暂的头痛，偶尔有低血压，伴有晕眩及惡心，但症状在持续用药后往往会消失。偶见呕吐、皮疹、瘙痒、晕厥和心动过速。

【禁忌】
靑光眼、休克、明显低血压、肥厚梗阻性心脏病、严重脑动脉硬化者禁用，对本品过敏者禁用。

【注意事项】
1.急性心肌梗死伴心室充盈压过低时慎用。
2.体位性循环调节障碍时慎用。
3.本品不用于心绞痛急性发作。
对驾驶和操作机器能力的影响：
不影响驾驶和操作机器能力。

【孕妇及哺乳期妇女用药】
孕妇和哺乳期妇女用药的有效性和安全性尚未确立。

【药物相互作用】
同时服用西地那非和本品会加重血管的扩张，有可能引起严重的不良反应，如晕厥和心肌梗死，因此，在服用本品期间，不可服用西地那非。
本品可以和?受体阻滞剂及钙离子拮抗剂合用。

【药物过量】
服药过量时可有搏动性头痛，较严重症狀有兴奋、潮红、出冷汗、恶心、呕吐、眩晕、晕厥、心动过速及血压下降。
服药过量的处理措施：
1. 诱导呕吐
2. 服用活性炭
3. 血压下降者可抬高腿部、仰卧，若需要可静脉补液。

【规格】
(1) 30毫克 (2) 60毫克

【贮藏】
遮光，密封保存。

Imdur Oral Uses
Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart.

This medication will not relieve chest pain once it occurs. It is also not intended to be taken just before physical activities (such as exercise, sexual activity) to prevent chest pain. Other medications may be needed in these situations. Consult your doctor for more details.

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 with other drugs to improve the symptoms of heart failure (such as trouble breathing).

How to use Imdur Oral
Take this medication by mouth, usually once daily when you wake up or as directed by your doctor. Swallow this medication whole with half a glass (4 ounces/120 milliliters) of water. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Use this medication regularly to get the most benefit from it. Do not suddenly stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Although unlikely, when this medication is used for a long time, it may not work as well and may require different dosing. Tell your doctor if this medication stops working well (for example, you have worsening chest pain or it occurs more often).

Imdur Oral Side Effects
Headache, dizziness, lightheadedness, nausea, and flushing may occur as your body adjusts to this medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Headache is often a sign that this medication is working. Your doctor may recommend treating headaches with an over-the-counter pain reliever (such as acetaminophen, aspirin). If the headaches continue or become severe, tell your doctor promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

An empty tablet shell may appear in your stool. This effect is harmless since your body has already absorbed the medication.

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

Imdur Oral Precautions
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as nitroglycerin); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: recent head injury, frequent stomach cramping/watery stools/severe diarrhea (GI hypermotility), lack of proper absorption of nutrients (malabsorption).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, low blood pressure, loss of too much body water (dehydration), other heart problems (such as recent heart attack).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Older adults may be more sensitive to the side effects of this medication, especially dizziness and lightheadedness, which could increase the risk of falls.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk or if it may harm a nursing infant. Consult your doctor before breast-feeding.

Imdur Oral Interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: drugs to treat erectile dysfunction (such as sildenafil, tadalafil, vardenafil).

If you are currently using any of these medications, tell your doctor or pharmacist before starting isosorbide mononitrate.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: rosiglitazone, certain drugs to treat migraine headaches (ergot alkaloids such as ergotamine), drugs that lower blood pressure (including alpha blockers such as tamsulosin).

This medication may interfere with certain laboratory tests (including blood cholesterol levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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.

Imdur Oral Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can contact a provincial poison control center. Symptoms of overdose may include: slow heartbeat, vision changes, severe nausea/vomiting, sweating, cold/clammy skin, bluish fingers/toes/lips.

NOTES:
Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure monitoring) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Lifestyle changes such as dietary changes, exercise, and stopping smoking may help this drug work better. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

MISSED DOSE:
If you miss a dose, take it as soon as you remember. If it is within 6 hours of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
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产地国家: 美国
原产地英文商品名:
ISOSORBIDE MN(IMDUR GENERIC) 10mg/tab 100tabs/box
原产地英文药品名:
ISOSORBIDE MONONITRATE
中文参考商品译名:
单硝酸异山梨酯(依姆多仿制药) 10毫克/片 100片/盒
中文参考药品译名:
单硝酸异山梨酯
中文参考化合物名称:
1,4；3,6-二脱水-D-山梨醇-5-硝酸酯
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产地国家: 美国
原产地英文商品名:
ISOSORBIDE MN(IMDUR GENERIC) 20mg/tab 100tabs/box
原产地英文药品名:
ISOSORBIDE MONONITRATE
中文参考商品译名:
单硝酸异山梨酯(依姆多仿制药) 20毫克/片 100片/盒
中文参考药品译名:
单硝酸异山梨酯
中文参考化合物名称:
1,4；3,6-二脱水-D-山梨醇-5-硝酸酯