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  药店国别: 美国药房
产地国家: 美国
所属类别: 泌尿生殖系统及泌乳药物->治疗肛疣药物
处方药:处方药
包装规格: 0.25克/包 24包/盒
计价单位:
   
该药品相关信息网址1:
http://www.aldara.com/
该药品相关信息网址2:
http://www.drugs.com/aldara.html
该药品相关信息网址3:
http://www.rxlist.com/aldara-drug.htm
原产地英文商品名:
IMIQUIMOD CREAM 5%(GENERIC FOR ALDARA 5%)0.25g/packet 24packets/box
原产地英文药品名:
IMIQUIMOD
中文参考商品译名:
咪喹莫特5%乳膏(艾达乐5%仿制药)0.25克/包 24包/盒
中文参考药品译名:
咪喹莫特
中文参考化合物名称:
1-(2-甲基丙基)-1H咪唑(4,5-C)喹啉-4-胺
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Treatment of external genital and perianal warts adult
临床试验期:
完成
中文适应病症参考翻译1:
治疗成人外生殖器和肛周尖锐湿疣
药品信息:

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 详细处方信息以本药内容附件PDF文件(2010112920362840.pdf)的“原文Priscribing Information”为准
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部分中文咪喹莫特处方资料(仅供参考)

[药品名称]
通用名:咪喹莫特
英文名:Imiquimod
化学名称为:1-(2-甲基丙基)-1H咪唑(4,5-C)喹啉-4-胺

[适应症] 用于治疗成人外生殖器和肛周尖锐湿疣。

[药理作用] 
    咪喹莫特治疗生殖器疣或肛周疣的作用机制尚不知道。其对培养细胞没有直接的抗病毒作用。对鼠皮肤研究显示,咪喹莫特诱导包括α-干扰素在内的细胞因子的产生。然而,这些发现的临床相关性不清楚。在一个双盲安慰剂对照试验中,209例18岁及18岁以上的生殖气疣/肛周疣的患者,外用5%的咪喹莫特乳膏或赋形剂(对照),每周3次,最长16周。疣基地的平均面积是69 mm2(范围8-5525 mm2)。患者的情况如下 :1004-iMiQ-患者情况参加患者数(N=209)使用5%咪喹莫特乳膏者中(N=109),完成16周治疗未清除者有36人 ;清除者有54人,其中随访(其他患者失访或复发)12周未复发者有39人 ;退出研究者有19人。使用赋形剂乳膏者(N=100)中,完成16周治疗未清除者有62人 ;清除者有11人,其中随访(其他患者失访或复发)12周未复发者有9人 ;退出研究者有27人。完全治愈的患者数如下,平均治愈时间是10周。

[药代动力学]
    对单独外用5 mg[14C]咪喹莫特乳膏的6名健康者的研究发现,[14C]咪喹莫特的经皮吸收是很少的。在血清中也未检测到其放射性活性(较低限度剂量:1 ng/mg),且外用后从尿液和粪便中排出的放射性标记剂量<0.9%。

[毒理研究] 
    尚无对啮齿类动物的致癌性资料。在8种不同致突变系列实验中,没有发现异常,包括ames,鼠淋巴瘤,ChO染色体异位,人类淋巴细胞染色体异位,ShE细胞转化,鼠骨髓细胞遗传学及鼠显著致死试验。在鼠交配、妊娠、分娩及授乳过程中,给予口服8倍于人类的剂量(按mg/m2计算),未见对生殖的影响。

[用法用量]
(1)每周3次(星期一、三、五或二、四、六),临睡前用药。合理用药以发挥本品的最大疗效。建议用药前和用药后洗手。
(2)睡前取适量药膏,均匀涂抹一薄层于疣体部位,轻轻按摩直到药物完全吸收,并保留6-10小时,用药部位不要封包。
(3)在涂药膏后6-10小时请勿洗澡,6-10小时后,用清水和中性肥皂将药物从疣体部位洗掉;
(4)患者应持续使用药膏,直到疣体完全清除,疣体最快2-4周清除,一般多在8-12周清除,用药最多不超过16周。 (5)用药后局部有轻度红斑者,可不必停药而持续使用;如患者感到全身不适或出现较为明显的局部皮肤反应(较明显的的水肿、糜烂、疼痛等)时,应停用药物次数,待反应减轻后再继续用药。

[不良反应] 多数病人治疗过程中无任何不良反应。用药数次后,临床上可能出现的不良反应多为轻、中度局部皮肤炎症反应,如:灼热、瘙痒、红斑、水肿、脱屑;少见溃疡、糜烂及疼痛的发生; 偶有短暂低热,以上症状停药后均能迅速消除。如反应轻微,可继续用药;若反应严重应及时停药并就医。

[禁忌症] 对咪喹莫特或赋形剂过敏者。

[注意事项]
(1)治疗局部不可用敷料(如纱布、绷带等)封包。
(2)用药期间避免性接触(生殖器官、肛门或口),包括使用避孕套的性生活(可能会减低避孕套的功效)。
(3)建议用药6-10小时后,用清水和中性肥皂将药物洗掉。
(4)对于包皮过长,未行包皮环切术者,若疣体长在包皮内,应每天将包皮上翻后清洁。
(5)如出现严重不良反应,应及时就医。
(6)在医生指导下使用该药。避免接触眼睛、口、鼻等部位。

[孕妇及哺乳期妇妇用药]
(1)不推荐孕妇应用本品。
(2)不知道局部应用咪喹莫特后乳汁中是否有药物分泌,不推荐哺乳期妇女应用本品。

[儿童用药]没有18岁以下患者用药经验。

[药物过量]
    本品的用药过量不可能是由于其微弱的经皮吸收。动物研究表明咪喹莫特的兔致死剂量超过1600 mg/m2。持续外用过量的本品会导致严重的皮肤反应。临床上报道的最严重的反应是在多次口服咪喹莫特超过200 mg后出现的低血压,经口服或静脉补液后可恢复。

[用药须知] 
给患者的讯息 :应用本品的患者应注意以下的信息和说明,本品对生殖器和肛周疣传播的作用尚不知道。本品可能会损害避孕套和阴道隔膜,因此不主张同时使用。该药仅供外用,避免接触到眼睛。治疗部位不能包扎。当皮肤上有药物时应避免性接触(生殖器、肛周、口)。建议使用本品6-10小时后,用温和肥皂或水清洗治疗部位。患者用药部位或邻近部位皮肤出现诸如红斑、糜烂、表面脱落及水肿等局部反应是常见的。大多数反应是轻至中度的,若出现严重的皮肤反应应立即进行适当处理。未进行包皮环切的男性治疗包皮下疣时应将包皮翻起,并每天清洗。患者应了解在治疗过程中可能会有新的疣出现,因为本品并不能治愈疣。

[贮藏/有效期] 
密封保存。有效期暂定2年。

Aldara
Generic Name: imiquimod topical (i MI kwi mod)
Brand Names: Aldara, Zyclara

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What is Aldara?
Aldara (imiquimod) is an immune response modifier. It is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.

Aldara is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment.

Aldara also treats genital warts that appear on the outside of the body, but this medicine is not a cure for genital warts.

Aldara may also be used for other purposes not listed in this here.

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Important information about Aldara?
Do not use Aldara on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using this medicine.

Using too much Aldara, or using it for too long can increase your risk of severe skin reactions. Follow your doctor's instructions.

Before using Aldara, tell your doctor if you have a weak immune system, an autoimmune disorder, graft-versus-host disease, or if you have recently received a bone marrow transplant or cord blood transplant.

Avoid exposure to sunlight or tanning beds. Aldara can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 15 or higher) daily.

Aldara is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with Aldara. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

Imiquimod will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

If you are treating the genital or rectal area with Aldara, avoid sexual activity while the medicine is on your skin. Aldara can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm for birth control, these items could break if the rubber weakens and an unplanned pregnancy could result.

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Before using Aldara
Do not use Aldara on areas of broken, wounded, or burned skin. If you have any of these conditions, you may need a dose adjustment or special tests:
a weak immune system or autoimmune disorder;
graft-versus-host disease; or
if you have recently received a bone marrow transplant or cord blood transplant.

FDA pregnancy category C. It is not known whether Aldara will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. If you are treating the genital or rectal area with Aldara, avoid sexual activity while the medicine is on your skin. Aldara can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm, these items could break if the rubber weakens, and an unplanned pregnancy could result.

It is not known whether imiquimod passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 12 years old. Aldara is for use in treating genital warts in patients who are at least 12 years old. All other uses of this medicine are for adults over 18 only.

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

Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions.

Before applying Aldara, wash your hands and wash the skin area to be treated. Allow the skin to dry for at least 10 minutes before applying the medicine. Always wash your hands after applying the medicine also. Do not use this medicine on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using Aldara.

Aldara is normally used 2 to 5 times per week for up to 16 weeks. How you use this medication will depend on the condition you are treating. Follow your doctor's instructions.

Actinic keratosis:
Usually applied 2 times per week (such as Monday and Thursday, or Tuesday and Friday) for a full 16 weeks. Apply the cream from one Aldara packet to the treatment area, and rub in the cream until it disappears. A single treatment area should be no larger than a 2-inch square. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Superficial basal cell carcinoma:
Usually applied 5 times per week (such as Monday through Friday) for a full 6 weeks. Apply the cream from one Aldara packet to the treatment area and the border of skin around it, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Genital warts:
Usually applied 3 times per week (such as Monday, Wednesday, and Friday) for no longer than 16 weeks. Apply the cream from one Aldara packet to the treatment area, and rub in the cream until it disappears. Do not cover the treated skin areas with any type of plastic bandaging, and avoid nylon underwear. You may wear cotton gauze or underwear over the treated area. Use the medicine before going to bed and leave it on for 6 to 10 hours. Then wash off the medicine with water and a mild soap.

When treating genital warts under the foreskin of an uncircumcised penis, pull back the foreskin and wash it with mild soap and water before applying Aldara. Clean this area daily during treatment. When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination.

Aldara is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with Aldara. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

All conditions:
Your doctor will need to check your skin on a regular basis, especially if you have a more severe skin reaction to the medication. Do not miss any scheduled appointments.

Call your doctor if your skin condition does not improve or if it gets worse during treatment.

Do not use Aldara to treat any skin condition that has not been checked by a doctor. Do not share this medication with anyone else, even if they have the same symptoms you have.

Each packet of Aldara is for a single application only. Throw away the packet after one use, even if there is medicine left in it. If you treat more than one skin area at a time, ask your doctor how many packets to use.

Store at room temperature away from moisture and heat. Keep each packet unopened until you are ready to use it.

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What happens if I miss a dose?
Skip the missed dose and wait until the next time you are getting ready for bed to use the medicine. Do not use extra medicine to make up the missed dose.

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

Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting.

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What should I avoid while using Aldara?
Avoid getting Aldara in your eyes, mouth, and nose, or on your lips. Do not place the cream in your rectum, vagina, or urethra. If it does get into any of these areas, rinse with water.

Do not use Aldara on sunburned, windburned, dry, chapped, irritated, or broken skin. Avoid exposure to sunlight or tanning beds. Aldara can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 15 or higher) daily.

Avoid having unprotected sex. Imiquimod is not a cure for genital warts, and it will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis. Talk with your doctor about safe ways to prevent transmission during sex.

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Aldara side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Aldara: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied.

Less serious Aldara side effects may include:
mild skin irritation, dryness, flaking, scabbing, crusting, redness, or hardening of the skin where the medicine was applied;
changes in the color of treated skin;
flu symptoms such as fever, chills, body aches, tired feeling, swollen glands;
cold symptoms such as stuffy nose, sneezing, sore throat;
headache, back ache, muscle pain;
nausea, diarrhea, upset stomach; or
vaginal itching or discharge.

This is not a complete list of Aldara 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.

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What other drugs will affect Aldara?
It is not likely that other drugs you take orally or inject will have an effect on topically applied Aldara. But many drugs can interact with each other. 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.

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Where can I get more information?
Your pharmacist can provide more information about Aldara.

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

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

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 详细处方信息以本药内容附件PDF文件(2010112920362840.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

2010-11-30更新

更新日期: 2010-11-30
附件:


2010112920362840.pdf    

 
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