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 详细处方信息以本药内容附件PDF文件（201142418271119.pdf）的“原文Priscribing Information”为准
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部分中文咪康唑处方资料（仅供参考）

Oravig (咪康唑)含片--鹅口疮治疗药
    2010年4月16日，Strativa制药公司宣布，美国食品药品管理局(FDA)正式批准Oravig (咪康唑)含片用于成年人以及年龄在16岁及儿童口咽念珠菌病(OPC)的治疗，该病的常用名是鹅口疮。
 
    咪康唑是高效、安全、广谱抗真菌药，对致病性真菌几乎都有作用。其机理是抑制真菌细胞膜的固醇合成，影响细胞膜通透性，抑制真菌生长，导致死亡。现在，有关科研人员对Oravig采用了口腔含片创新技术，可附着于牙龈上，直接将咪康唑送达至感染局部，作用长达24h，且少有全身性吸收。Oravig每日只需服用1次，每片含咪康唑50mg。该含片无臭无味，不会影响到患者的日常活动，如进食和饮水。
 
    FDA是基于两项关键性III期临床试验的结果批准了Oravig上市。第1项试验的结果表明，Oravig能使OPC的症状和体征完全消失，且起效速度与Mycelex Troche (克霉唑)相似，但Mycelex Troche每日需服用5次。这项随机双盲双模拟试验在位于美国、加拿大和南非的28个试验中心共招募了577例感染了人免疫缺陷病毒的患者。第2项试验是一项随机开放多中心对照试验，纳入了282例接受了头颈癌放疗的患者，结果显示Oravig用于这类患者人群是安全且有效的，这类患者往往存在唾液流量减少的情况。
 
　　在临床试验中，患者服用Oravig后所报告的最常见(≥2%)不良事件包括：腹泻(6.0%)、恶心(4.6%)、头痛(5.0%)、味觉障碍(2.9%)、上腹疼痛 (2.5%)和呕吐(2.5%)。
 
　　曾有咪康唑给药后出现了包括过敏反应和超敏反应在内的变态反应的报告。一旦发现有超敏反应的征象，应立即停用Oravig。尚无证据表明咪康唑与其他唑类药物存在交叉过敏。对于有唑类药物过敏史的患者，用药后则应密切监测。
 
　　医生在开具Oravig处方时，应提醒患者不得压碎、咀嚼或吞服这种含片。

Generic Name:
Miconazole

Brand Names:
Oravig, M-Zole, Monistat

Oravig Description:
Oravig is an antifungal medication used to treat yeast infections of the mouth and throat. Such infections can cause white patches in the mouth, difficulty swallowing and other symptoms.

Oravig works to fight infection and alleviate these symptoms by inhibiting a fungal enzyme that plays a key role in fungal cell function and survival.

Oravig Side Effects:
The most common side effects of Oravig include:
Diarrhea
Headache
Nausea
Altered sense of taste
Stomach pain
Vomiting

For more information, see our Oravig side effects page.

Oravig Uses:
Oravig is used to treat adults with oropharyngeal candidiasis (OPC). OPC is a fungal infection that occurs due to overgrowth of an organism known as Candida, which exists in the body in the digestive tract. OPC is often referred to as thrush, and is most common in patients with compromised immune systems such as those with the human immunodeficiency virus (HIV).

Oravig Interactions:
Oravig may interact with the following medications:
Diabetes medications
Phenytoin (Dilantin, Phenytek)
Ergot medications
Warfarin and other anticoagulants (Coumadin, Jantoven)

Oravig may interact with other medications or substances that are not listed above. In order to prevent potentially hazardous interactions, patients should talk with their doctor about the use of any other medicines, vitamins or supplements before beginning treatment with Oravig.

Oravig Dosage Information:
Typical Dosage Recommendations
Oravig is administered in the form of a 50 mg buccal tablet. The tablet is to be placed in the upper gum region, where it will dissolve gradually. Patients generally use one tablet of Oravig per day for 14 consecutive days. Patients should alternate the side of the mouth in which they place Oravig with each dose.

Patients should not swallow, chew or crush Oravig tablets. Patients may eat and drink while an Oravig tablet is in place. However, patients should not chew gum.

Missing a Dose of Oravig
If you forget to apply a dose of Oravig, do so as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your normal dosage schedule. Do not apply a double dose of Oravig to compensate for a missed dose.

If you accidentally swallow an Oravig tablet within six hours of inserting it, consume a cup of water and insert another Oravig tablet. If you accidentally swallow an Oravig tablet after six hours of inserting it, simply use your next dose at the appropriately scheduled time.

Oravig Overdose
There have not been any reports of Oravig overdoses. Seek immediate medical attention if you have taken too much of this medication.

Oravig FDA Approval:
April 16, 2010

Oravig Recall/Black Box Warning Information:
Oravig does not carry any black box warnings and has not been associated with any recalls.

Other Warnings
Oravig may cause serious allergic reactions in some patients. Patients should stop using the medication immediately if they experience symptoms of an allergic reaction. Such symptoms may include:
Hives or rash
Swelling of the face or throat
Difficulty breathing or swallowing

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 详细处方信息以本药内容附件PDF文件（201142418271119.pdf）的“原文Priscribing Information”为准
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2011-4-25更新