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 详细处方信息以本药内容附件PDF文件（201172421472914.pdf）的“原文Priscribing Information”为准
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部分中文Oracea处方资料（仅供参考）

FDA接受痤疮药Oracea新药申请
    CollaGenex近日宣布美国FDA已接受了Oracea 的新药申请，Oracea为首种用于红斑痤疮治疗的口服药物。Oracea在05年8月初递交了NDA，将在06年4月获得受理结果。
   新药申请的提出建立在之前进行的两项3期监床试验基础上。两项试验有53 7名受试者参加，有效率分别为61%与46%，对照组的有效率为29%与20%，有显著统计性意义。其副作用也小于空白对照组。
   在美国有大约1360万人有痤疮，主要是出现在面部，其能引起面部发痒、疼痛、皮肤增厚。

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FDA批准CollaGenex制药公司的红斑痤疮治疗药Oracea
    CollaGenex制药公司5月30日宣布，其用于治疗红斑痤疮成年患者炎症性皮损的多西环素缓释胶囊（doxycycline，Oracea）获得FDA批准。本品是FDA批准的首个全身给药的红斑痤疮治疗药物。
    红斑痤疮是一种主要影响面部皮肤的慢性炎症性疾病，在美国约有1400万例成年患者。在2项关键性双盲安慰剂对照的Ⅲ期临床研究中，本品分别使患者炎症性皮损减少了61%和 46%，而安慰剂组分别为29%和20%，存在统计学意义上的显著差异。在不良反应方面，治疗组和安慰剂组相近。
    本品一天给药1次，制剂含速释和缓释两部分，规格为40 mg。

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Oracea
Generic Name: doxycycline (DOX i SYE kleen)
Brand names: Adoxa, Alodox, Avidoxy, Doryx, Monodox, Oracea, Oraxyl, Periostat, Vibramycin

What is Oracea?
Oracea (doxycycline) is used to treat the inflammatory bumps and pimple-like blemishes caused by rosacea in adults. It works by reducing skin inflammation caused by rosacea.

Oracea is a tetracycline antibiotic. Tetracyclines are often used to treat infections, however this formulation has not been evaluated in the treatment or prevention of infections.

Oracea may also be used for other purposes not listed in this medication guide.

Important information about Oracea
Do not use Oracea if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Oracea can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using Oracea.

You should not take Oracea if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Before taking Oracea, tell your doctor if you have liver disease, kidney disease, asthma, or if you are allergic to sulfites.

Children should not use this medicine. Oracea can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Take Oracea for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Before taking Oracea
You should not take Oracea if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

To make sure you can safely take Oracea, tell your doctor if you have any of these other conditions:
•liver disease;
•kidney disease; or
•asthma or sulfite allergy.

FDA pregnancy category D. Do not use Oracea if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Oracea can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using Oracea.

Doxycycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking this medicine. Children should not use this medicine. Oracea can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

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

Take Oracea with a full glass of water (8 ounces) while sitting or standing. To prevent irritation to your throat, do not lay down right after taking a capsule.

The usual dose of Oracea is one capsule in the morning on an empty stomach. You should take at least one hour before or two hours after a meal.

Do not take Oracea with or right after taking antacids or products that contain calcium, aluminum, magnesium, or iron. Oracea may not work as well.

Do not crush, break, or open a Oracea delayed-release capsule. Swallow the capsule whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Take Oracea for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Do not give this medicine to another person, even if they have the same condition you have.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Oracea. You may need to stop using the medicine for a short time.

Throw away any unused Oracea when it expires or when it is no longer needed. Do not take any Oracea after the expiration date printed on the label. Using expired doxycycline can cause damage to your kidneys.

Store Oracea at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Overdose symptoms may include nausea, vomiting, and diarrhea.

What should I avoid while taking Oracea?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Oracea and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Oracea can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking Oracea.

Oracea side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Oracea: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
•severe headache, dizziness, blurred vision;
•fever, chills, body aches, flu symptoms, swollen glands, rash or itching, joint pain, or general ill feeling;
•urinating less than usual or not at all;
•diarrhea that is watery or bloody
•pale or yellowed skin, dark colored urine, fever, confusion or weakness;
•severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
•loss of appetite, jaundice (yellowing of the skin or eyes); or
•severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious Oracea side effects may include:
•mild nausea, mild diarrhea;
•upset stomach;
•mild skin rash or itching; or
•vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Oracea?
Tell your doctor about all other medicines you use, especially:
•cholesterol-lowering medications such as cholestyramine (Prevalite, Questran) or colestipol (Colestid);
•isotretinoin (Accutane);
•tretinoin (Renova, Retin-A, Vesanoid);
•an antacid such as Tums, Rolaids, Milk of Magnesia, Maalox, and others;
•a product that contains bismuth subsalicylate such as Pepto-Bismol;
•minerals such as iron, zinc, calcium, magnesium, and over-the-counter vitamin and mineral supplements;
•a blood thinner such as warfarin (Coumadin, Jantoven); or
•a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen).

This list is not complete and other drugs may interact with Oracea. 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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 详细处方信息以本药内容附件PDF文件（201172421472914.pdf）的“原文Priscribing Information”为准
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