Ortikos 6 mg capsule,extended release

Generic name:
Budesonide capsules - oral

Pronunciation
(bue-DES-oh-nide)

Brand name(s)
Entocort EC , Ortikos

This medication is used to treat a certain bowel condition (Crohn's disease). While budesonide does not cure this condition, it may decrease symptoms such as pain and diarrhea. Budesonide is an anti-inflammatory drug (corticosteroid hormone). It works by decreasing the body's natural defense response (immune response).

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for certain immune system disorders.

Read the Patient Information Leaflet if available from your pharmacist before you start taking budesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Swallow this medication whole with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects.

If you have trouble swallowing the capsules whole, certain brands may be opened and the contents sprinkled onto a tablespoonful of soft, cool applesauce in a clean container. Stir and take all of the mixture without chewing. Drink a full glass of cool water (8 ounces/240 milliliters) to make sure you have swallowed all of your dose. Take all of the mixture within 30 minutes after preparing it. Do not save the mixture for later use. Ask your pharmacist if you have questions about your particular brand.

The dosage and length of treatment are based on your medical condition, age, and response to treatment.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin taking budesonide. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

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.

Tell your doctor if your condition does not get better or if it gets worse.

This medication usually has fewer side effects than other corticosteroids because budesonide works in the gut and only small amounts are absorbed into the body. Nausea, abdominal pain, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough). This medication may sometimes cause oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• puffy face
• unusual weight gain
• menstrual period changes
• mental/mood changes (such as depression, mood swings, agitation)
• muscle weakness/pain
• bone pain
• thinning skin
• slow wound healing
• increased thirst/urination
• vision problems
• symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds)
• red/purple spots on the skin

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking budesonide, tell your doctor if you are allergic to it; 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 problems (such as cataracts, glaucoma)
• high blood pressure
• liver problems (such as hepatitis B)
• diabetes
• stomach/intestinal problems (such as diverticulitis, ulcer)
• bone loss (osteoporosis)
• current/past infections (such as tuberculosis, herpes)
• bleeding problems
• mental/mood problems (such as psychosis, anxiety, depression)
• a certain adrenal gland tumor (pheochromocytoma)

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. 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 right away 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using budesonide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).

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.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used corticosteroids for a long time may develop hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aldesleukin
• desmopressin
• mifepristone
• drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen)

If your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

This product may interfere with certain lab tests (such as skin tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If this medication is used for a long time, lab and/or medical tests (such as blood count, bone density, eye exams, height/weight measurements) may be done while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

This medication may increase the risk of bone loss (osteoporosis) if used for a long time. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.