美国FDA批准了阿斯特拉捷利康公司的口服糖皮质类固醇布地奈德（budesonide，Entocort EC）改进释放胶囊，用于治疗涉及回肠和/或上行结肠的轻到中度活动性节段性回肠炎。该公司于1月提出此产品的新药上市申请并于4月份获准优先评审，产品将于今年末上市。推荐剂量为3×3毫克胶囊，每晨一次共8 周。

Entocort EC可被直接输送到肠道内，在局部部位起作用以使病变部位的炎症减轻。FDA指出，服用该产品后病人的典型性副作用比其它用于治疗此病的类固醇（如泼尼松龙片）少，因其较快并广泛地被代谢，防止大量药物吸收进入人体。对1000例活动性节段性回肠炎病人研究的结果表明,Entocort EC能使48％～69％的病人显著地改善症状，最常见的不良事件有头疼、呼吸系统感染和恶心。但是，与泼尼松龙相比，服用此产品的病人出现面部肿胀和痤疮的较少。

Budesonide capsules

What are budesonide capsules?

BUDESONIDE (Entocort EC®) is a corticosteroid. It is used in the treatment of Crohn's disease, which is an inflammatory bowel disease. Generic budesonide capsules are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• cataracts or glaucoma
• Cushing's syndrome
• diabetes
• heart problems or previous heart attack
• high blood pressure
• infection such as herpes, measles, tuberculosis, or chickenpox
• liver disease
• myasthenia gravis
• osteoporosis
• psychosis or other mental health problems
• recent surgery
• stomach or intestinal disease, including colitis
• an unusual or allergic reaction to budesonide, other corticosteroids, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take budesonide capsules by mouth. Follow the directions on the prescription label. Swallow the capsules with a drink of water. Do not chew, crush, or break open the capsules. The capsules need to be swallowed whole. If you are only taking budesonide once a day, take it in the morning, which is the time your body normally secretes cortisol. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What drug(s) may interact with oral budesonide?

• anastrozole
• antacids
• barbiturates, medicines used for inducing sleep or treating seizures
• bosentan
• calcium supplements
• certain antifungals, like fluconazole, griseofulvin, itraconazole, ketoconazole, miconazole and oxiconazole
• certain heart medicines like diltiazem, mibefradil, nicardipine and verapamil
• cyclosporine
• danazol
• diltiazem
• certain antibiotics like erythromycin, clarithromycin, nafcillin and troleandomycin
• dexamethasone
• ethosuximide
• grapefruit juice
• isoniazid, INH
• medicines used for seizures such as carbamazepine, ethosuximide, fosphenytoin, phenytoin
• medicines used for ulcers or stomach acid, such as cimetidine or omeprazole
• modafinil
• norfloxacin
• quinidine
• quinine
• rifabutin
• rifampin
• rifapentine
• some HIV medicines, for example indinavir, nelfinavir, ritonavir or saquinqvir
• some medicines for depression, such as fluoxetine, fluvoxamine or nefazodone
• St. John's wort
• troglitazone
• vaccines
• zafirlukast

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking oral budesonide?

If you are taking budesonide regularly, avoid contact with people who have an infection. You may have an increased risk from infection while taking budesonide. Tell your prescriber or health care professional if you are exposed to anyone with measles or chickenpox or if you develop sores or blisters that do not heal properly.

People who are taking certain dosages of budesonide may need to avoid immunization with certain vaccines or may need to have changes in their vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your prescriber or health care professional that you are taking budesonide before receiving any vaccine.

If you are going to have surgery, tell your prescriber or health care professional that you are taking oral budesonide.

Your body may lose potassium while you are taking oral budesonide. Ask your prescriber or health care professional about your diet.

Corticosteroids like budesonide may affect your blood sugar. If you have diabetes, check with your prescriber or health care professional if you need help adjusting the dose of your medicine for diabetes.

Alcohol, grapefruit, and grapefruit juice can increase the risk of getting serious side effects while you are taking budesonide. Avoid grapefruit, grapefruit juice, and alcoholic drinks while taking budesonide.

What side effects may I notice from taking oral budesonide?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• bloody or black, tarry stools
• confusion, excitement, restlessness, a false sense of well-being
• eye pain, decreased or blurred vision
• fever, sore throat, sneezing, cough, or other signs of infection, wounds that will not heal
• frequent passing of urine or painful passing of urine
• hair loss
• hemorrhoids
• increased thirst
• irregular heartbeat, chest pain or high blood pressure
• menstrual problems
• severe mood swings
• muscle cramps or weakness
• numbness or tingling in fingers, toes or other areas
• pain in hips, back, ribs, arms, shoulders, or legs
• rounding out of face
• skin problems, acne, thin and shiny skin
• stomach pain
• swelling of feet or lower legs
• unusual bruising
• unusual tiredness or weakness
• vomiting
• weight gain or weight loss

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• dizziness or drowsiness
• headache
• increased or decreased appetite
• increased sweating
• nausea
• nervousness or difficulty sleeping
• upset stomach
• increased growth of hair on the face or body

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.