部分中文泼尼松龙处方资料（仅供参考）

泼尼松龙口崩片递交NDA

BioMarin宣布美国FDA已接受了Orapred ODT的新药申请，Orapred ODT为泼尼松龙磷酸钠口腔崩解片。泼尼松龙为一种常用的抗炎药物，用于许多临床病症包括哮喘、关节炎、癌症。FDA在06年6月前审批完毕。
 
Orapred ODT采用了独家的口腔崩解片技术。

學名： Prednisolone (潑尼松龍)

藥理與效用：
Prednisolone (潑尼松龍) 為腎上腺皮質激素類藥物，具有抗炎、抗過敏、免疫抑制等作用，故臨床被廣泛應用於多種疾病上，如自身免疫性疾病(類風濕性關節炎、全身性紅斑狼瘡等)、過敏性疾病(蕁麻疹、過敏性鼻炎、支氣管哮喘等)、血液病及皮膚性疾病等。眼藥水則治療眼睛過敏性及非傳染性發炎。

常見副作用：
低劑量短期服食此藥，嚴重之副作用很少會出現。一般以胃腸道不適的症狀為主，如消化不良、腹脹等。 如長期大劑量服食，則可能會出現因脂質代謝和水鹽代謝紊亂所致的副作用，如滿月臉、水牛背、向心性肥胖、皮膚變薄、暗瘡、多毛、浮腫、低血鉀、高血壓、糖尿等。 因皮質激素抑制機體防禦功能，長期應用可誘發感染。 此藥亦可誘發或加劇胃、十二指腸潰瘍，甚至造成消化道出血或穿孔。 其他副作用如骨質疏鬆、肌肉萎縮、傷口癒合遲緩等，這與激素促進蛋白質分解，抑制其合成及增加鈣、磷排泄有關。

注意事項：
為避免服後腸胃不適，此藥應在餐後服用。 服藥期間，如有任何不適及副作用出現，須告知醫生，以便作出相應的檢查和跟進，切勿自行停藥，因減量過快或突然停藥會影響病情及對身體構成傷害。 如曾與水痘、帶狀疱疹或麻疹等患者有緊密接觸，須及時告知醫生。

相互作用：
此藥可令降血壓藥及降血糖藥的作用下降。 非類固醇消炎止痛藥(NSAIDs)可增加此藥胃腸道出血及潰瘍之副作用發生.

GENERIC NAME: PREDNISOLONE SOLUTION/SYRUP - ORAL (pred-NIS-oh-loan)

BRAND NAME(S): Orapred, Pediapred, Prelone

USES: Prednisolone is a man-made form of a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood problems, immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.

HOW TO USE: Take this medication by mouth, with food or milk to prevent stomach upset, exactly as directed by your doctor. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.There are many brands, strengths, and forms of liquid prednisolone available. Read the dosing instructions carefully for each product because the amount of prednisolone may be different between products. See also Precautions and Storage sections.Follow the dosing schedule carefully. The dosage and length of treatment are based on your medical condition and response to treatment. Your doctor may direct you to take prednisolone 1 to 4 times a day or take a single dose every other day. It may help to mark your calendar with reminders or use a pill box.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.If you have used prednisolone regularly for a long time or in high doses, you may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. See also Precautions section.Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Nausea, heartburn, headache, dizziness, menstrual period changes, trouble sleeping, increased sweating, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.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.Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as cough, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush or a yeast infection. Contact your doctor if you notice white patches in your mouth or a change in vaginal discharge.This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, swelling ankles/feet, unusual weight gain, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, bone pain.This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, consult your doctor immediately: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain.Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, 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: 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.

PRECAUTIONS: Before taking prednisolone, tell your doctor or pharmacist if you are allergic to it; or to prednisone; 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), heart problems (such as heart failure, recent heart attack), high blood pressure, liver disease, kidney disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), brittle bones (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, blood clots, certain mental/mood conditions (such as psychosis, anxiety, depression), low salts in the blood (such as low potassium or calcium), seizures.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.This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This product may contain alcohol, sugar, and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Prednisolone may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.Older adults may be more sensitive to the effects of this drug, especially stomach bleeding.During pregnancy, prednisolone should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended period of time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Some products that may interact with this drug include: aldesleukin, other drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy, natalizumab), large doses of aspirin and aspirin-like drugs (salicylates), nonsteroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ibuprofen), mifepristone, drugs that may cause potassium loss (such as amphotericin B, "water pills" such as hydrochlorothiazide or furosemide), quinolone antibiotics (such as ciprofloxacin, levofloxacin), drugs that can cause bleeding/bruising (including "blood thinners" such as warfarin, antiplatelet drugs such as clopidogrel).Other medications can affect the removal of prednisolone from your body, which may affect how prednisolone works. Examples include estrogens, azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.This product may interfere with certain lab tests (such as skin tests). 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.

OVERDOSE: If overdose is suspected, contact your 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.

NOTES: Do not share this medication with others.If this medication is used for an extended time, laboratory and/or medical tests (such as blood sugar/mineral levels, blood counts, blood pressure, bone density tests, eye exams, height/weight measurements, X-rays) should be performed regularly to check for side effects. Consult your doctor for more details.This medication may cause bone problems (osteoporosis). Lifestyle changes that may help reduce the risk of bone problems while taking this drug for an extended time include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Discuss with your doctor lifestyle changes that might benefit you.
MISSED DOSE: If you are taking this medication once daily and miss a dose, take 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. If you are taking this medication every other day, ask your doctor or pharmacist what you should do if you miss a dose.
STORAGE: Store the US product according to the directions on the product package away from light and moisture. Some US brands must be refrigerated, and others must be stored at room temperature. Consult your pharmacist for more details.Store the Canadian product in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not refrigerate.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 information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
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原产地英文商品名:
ORAPRED SOLUTION 15mg/5ml 237ml/bottle
原产地英文药品名:
PREDNISOLONE SODIUM PHOSPHATE
中文参考商品译名:
ORAPRED溶液剂 15毫克/5毫升 237毫升/瓶
中文参考药品译名:
泼尼松龙磷酸钠
生产厂家中文参考译名:
塩野义制药
生产厂家英文名:
SHIONOGI PHARMA

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原产地英文商品名:
ORAPRED SOLUTION INSTITUTIONAL PACK 15mg/5ml 20mls/bottle 10bottles/Box
原产地英文药品名:
PREDNISOLONE SODIUM PHOSPHATE
中文参考商品译名:
ORAPRED溶液剂团体包装 15毫克/5毫升 20毫升/瓶 10瓶/盒
中文参考药品译名:
泼尼松龙磷酸钠
生产厂家中文参考译名:
塩野义制药
生产厂家英文名:
SHIONOGI PHARMA