This medicine is a glucocorticosteroid used to treat Crohn's disease.
Follow the directions for using this medicine provided by your doctor. THIS MEDICINE COMES WITH A PATIENT INFORMATION LEAFLET. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE in the morning at the same time every day. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. AVOID EATING GRAPEFRUIT OR GRAPEFRUIT JUICE while you are taking this medicine. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C) in a tightly-closed container away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. IF YOU MISS A DOSE OF THIS MEDICINE and you are taking 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. DO NOT TAKE 2 doses at once.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking mifepristone. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITIONS may be needed if you are taking ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, rifampin, or macrolides (e.g., erythromycin, clarithromycin). Inform your doctor of any other medical conditions, including liver disease, high blood pressure, osteoporosis, stomach ulcers, cataracts, glaucoma, allergies, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include headache, nausea, vomiting, dizziness, back pain, upset stomach or gas, changes in menstrual cycle, nervousness, tremor, and trouble sleeping. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience a sudden increase in weight, acne, unusual bruising, swollen ankles or face, change in mood or behavior, confusion, chest pain, vision changes, or severe headache. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately.
Carry an identification card at all times that says you are taking this medicine. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.