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 详细处方信息以本药内容附件PDF文件（201162718165713.pdf）的“原文Priscribing Information”为准
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部分中文多塞平处方资料（仅供参考）

多塞平乳膏(DOXEPIN HYDROCHLORIDE CREAM)
【适用症】
多塞平乳膏用于慢性单纯性苔癣，局限性瘙痒症，恶急性、慢性湿疹及异位性皮炎引起的瘙痒。

【注意事项】
（1）多塞平乳膏不能用于眼部及粘膜部位。
（2）由于外用后仍可吸收入血，20%的患者外用后可有嗜睡，特别外用超过10%体表面积时，应提醒患者不要驾驶车辆或操作危险的机器。多塞平乳膏连续使用不得超过8天。
（3）用药时应避免饮酒，因酒能加剧此药的作用。
（4）使用多塞平乳膏前至少两周应停用单胺氧化酶（MAO）抑制剂类药物。

【用法与用量】
外用涂于患处，每日2～3次。

【禁忌症】
（1）因为多塞平乳膏具有抗胆碱作用，而且外用后可在血中检出多塞平乳膏，因此对于未治疗的窄角性青光眼或有尿潴留倾向者、心功能不全、严重肝、肾损伤者以及有癫痫病史者禁用。
（2）既往有严重药物过敏史者禁用。

【儿童用药注意事项】
儿童尽量不用多塞平乳膏。

【孕妇、哺乳期妇女用药注意事项】
孕妇及哺乳期妇女尽量不用多塞平乳膏。

【不良反应】
（1）全身的不良反应一般为嗜睡，还可有口干、头痛、眩晕、疲倦、情绪改变、味觉改变、恶心、焦虑和发热等。
（2）局部的不良反应有一过性刺痛感和/或烧灼感、瘙痒、红斑、皮肤发干等。

【药物相互作用】
与单胺氧化酶抑制剂、三环类抗抑郁药、西咪替丁、乙醇等均有不同程度的相互作用。

【药理】
药理学多塞平乳膏具有阻断H1和H2受体的作用，同时也是胆碱能受体和肾上腺素受体拮抗剂，其阻断H1受体效价比苯海拉明强775倍，比安太乐强56倍，比赛庚啶强11倍。用多塞平乳膏117mg/kg、83mg/kg 、50mg/kg皮肤给药，对右旋糖酐引起的小鼠全身性瘙痒有明显的抑制作用，对小鼠的皮肤血管通透性有明显的降低作用，而且比苯海拉明强，并抑制磷酸组织胺引起的豚鼠过敏反应，对三种过敏模型的抗过敏作用均呈现较好的量效关系。
毒理学多塞平乳膏对完整的以及破损的皮肤产生中度刺激性，但停药一周可完全恢复。小鼠（口服）LD50148～178mg/kg，大鼠346～460mg/kg。

【药物代谢动力学】
局部外用多塞平乳膏后，可在血中检测到有意义的药物浓度。多塞平乳膏代谢迅速，它在肝脏中进行去甲基反应，生成最初活性代谢物去甲基多塞平。多塞平和去甲基多塞平两者代谢途径包括羟基化反应、N-氧化反应、与葡糖醛酸的结合反应，主要以游离和结合方式的代谢物从尿液排泄。多塞平乳膏在体内分布广泛，并与血浆蛋白结合，血浆半衰期8～24小时，多塞平乳膏可越过血脑屏障和胎盘屏障。

【用药过量】
（1）轻度过量可有嗜睡、幻视、口干。
（2）重度过度可有呼吸抑制、低血压、昏迷、惊厥、心律不齐、心动过速、尿潴留、胃肠运动减慢、高血压、反射亢进等。
（3）对此应进行及时对症处理，但由于多塞平乳膏组织及蛋白结合能力较高，未用透析和利尿剂处理作用不大。

【性状】: 多塞平乳膏为乳剂型基质的白色乳膏。

Prudoxin 5 % Topical Cream
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.

Monograph title
DOXEPIN CREAM - TOPICAL

Phonetic pronunciation
(dox-EH-pin)

Common brand name(s)
Zonalon

Uses
This medication is used to relieve troublesome itching from certain skin conditions (e.g., atopic dermatitis, eczema, neurodermatitis). It should be used only for a short time (no more than 8 days). Doxepin is a tricyclic antidepressant. It is not known how this medication decreases itching. Some medication is absorbed into the body when the cream is applied. This medication may work by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. The decrease in itching may be a result of drowsiness or some other effect in the brain that causes you not to notice or be bothered by the itching.

How to use
Before applying the medication, clean the affected area with mild soap and water, rinse well, and pat dry. Gently rub a small amount of the medication into the affected area in a thin layer, usually 4 times a day. Wait at least 3-4 hours between applications, or use as directed by your doctor. How often the medication is applied and for how long depends on your condition and response to treatment. Usually, this medication is for short-term use only (up to 8 days).Wash hands immediately after use unless the area being treated includes the hands. This medication is for use on the skin only. Avoid getting the product in your eyes, nose, ears, mouth, or vaginal/anal area. If the medication gets in these areas, rinse immediately with clean water.Do not cover the area with plastic or waterproof bandages. Covering the treated area may increase the absorption of the medication through the skin and increase the risk of side effects.Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. Your condition will not improve faster and the risk for side effects will increase. Side effects may increase when you use the cream on a larger area of skin (e.g., more than 10 percent of your body surface). Tell your doctor if you have severe drowsiness while using this product. It may be a sign that you are absorbing too much of the medication. Your doctor may tell you to decrease how often you apply the medication, the amount of medication used, or how much skin to spread the medication over. Follow your doctor's directions carefully.Tell your doctor if your condition does not improve or if it worsens.

Missed dose
If you miss a dose, apply 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 apply more to catch up.

Precautions
Before using doxepin, tell your doctor or pharmacist if you are allergic to it, or to other tricyclic antidepressants (e.g., amitriptyline); 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: certain eye problem (narrow-angle glaucoma), problems urinating (e.g., due to enlarged prostate).Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., bronchitis, emphysema), long-term constipation, long-term heartburn, diabetes, eating disorders (e.g., bulimia), certain eye problem (open-angle glaucoma), heart problems (e.g., irregular heartbeat), kidney problems, liver problems, overactive thyroid (hyperthyroidism), personal or family history of mental/mood conditions (e.g., bipolar disorder, psychosis, suicide), seizures, conditions that may increase your risk of seizures (e.g., other brain disease, alcohol withdrawal).Doxepin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using doxepin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using doxepin safely.This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.To reduce dizziness and lower the risk of fainting, get up slowly when rising from a sitting or lying position.Before having surgery, tell your doctor or dentist that you are using this medication.If you have diabetes, this drug may make your blood sugar levels harder to control. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high or low blood sugar such as fast heartbeat, increased thirst/urination, shakiness, unusual sweating, or hunger. Your anti-diabetic medication or diet may need to be adjusted.Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially dizziness, drowsiness, confusion, and difficulty urinating.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Side effects
Burning/stinging at the application site, drowsiness, dizziness, dry mouth, blurred vision, or changes in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.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: severe constipation, loss of coordination, ringing in the ears, persistent heartburn, mental/mood changes (e.g., agitation, confusion, depression), muscle weakness/spasms, numbness/tingling of the hands/feet, restlessness, decreased sexual ability/interest, trouble urinating, swelling of the hands/feet, weight gain.Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), pain/redness/swelling of arms or legs, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.Seek immediate medical attention if any of these rare but very serious side effects occur: slurred speech, fast/irregular heartbeat, vision changes, fainting, weakness on one side of the body, seizures.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.

Drug 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: arbutamine, cisapride, disopyramide, halofantrine, sibutramine.Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.If you have been taking fluoxetine, wait at least 5 weeks after your last dose before starting this medication.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting doxepin.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine, belladonna alkaloids, scopolamine, drugs for Parkinson's disease such as benztropine), inhaled bronchodilators (e.g., albuterol, salmeterol), certain drugs for high blood pressure (e.g., clonidine, guanadrel, guanethidine, reserpine), digoxin, nasal decongestants (e.g., epinephrine, phenylephrine), levodopa, lithium, stimulants (e.g., amphetamine, epinephrine, methylphenidate), sulfonylurea anti-diabetic medication (e.g., chlorpropamide, tolazamide), thyroid medication, valproic acid, drugs affecting liver enzymes that remove doxepin from your body (e.g., alcohol, barbiturates such as phenobarbital, cimetidine, haloperidol, phenothiazines such as thioridazine, St. John's wort, terbinafine, certain drugs for heart rhythm such as flecainide/propafenone, certain HIV protease inhibitors such as amprenavir/fosamprenavir, certain anti-seizure drugs such as carbamazepine/phenytoin, antidepressants such as amitriptyline, duloxetine, fluvoxamine, paroxetine, sertraline, trazodone).Many drugs besides doxepin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, quinidine, procainamide, sotalol, macrolide antibiotics (such as erythromycin), sparfloxacin, among others. Therefore, before using doxepin, report all medications you are currently using to your doctor or pharmacist.Also report the use of drugs which might increase seizure risk when combined with this medication such as bupropion, isoniazid (INH), theophylline, or tramadol, among others. Consult your doctor or pharmacist for details.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., levetiracetam), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, nefazodone).Check the labels on all your medicines (e.g., antacids, cough-and-cold products, diet aids) because they may contain cimetidine, ingredients that cause drowsiness, or decongestants/stimulants that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.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.

Overdose
This medicine may be harmful if swallowed. If overdose or swallowing 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 call a provincial poison control center. Symptoms of overdose or swallowing may include: confusion, hallucinations, big/wide pupils, fast/irregular heartbeat, severe dizziness, fainting, seizures, loss of consciousness.

Notes
Do not share this medication with others.Use this medication only for the condition for which it was prescribed. Tell all your doctors you use this medication.

Storage
Store at room temperature at or below 80 degrees F (27 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.

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 详细处方信息以本药内容附件PDF文件（201162718165713.pdf）的“原文Priscribing Information”为准
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