Budesonide Oral Suspension (Eosinophilic Esophagitis)

Budesonide oral suspension is used to treat eosinophilic esophagitis (EoE; a condition that involves high levels of blood cells in the esophagus [tube that connects the mouth to the stomach] that may damage tissues of the esophagus) in adults and children 11 years of age or older. Budesonide is in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the esophagus of people who have EoE.

Budesonide oral suspension comes as a suspension (liquid) to take by mouth. It is usually taken without food (at least 30 minutes before eating or drinking anything) twice a day for up to 12 weeks. Take budesonide oral suspension at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take budesonide oral suspension exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Budesonide oral suspension comes in stick packs that are intended for single use. Shake the stick pack for at least 10 seconds before opening. After opening the top, squeeze the stick pack from bottom to top to dispense contents directly into the mouth, Repeat this 2 to 3 times until the stick pack is empty. Swallow all of the suspension and avoid eating or drinking anything for 30 minutes. After 30 minutes, rinse mouth with water and spit out the contents without swallowing.

Your doctor may change your dose if needed. Do not change your dose or stop taking budesonide oral suspension unless told to by your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking budesonide oral suspension,

• tell your doctor and pharmacist if you are allergic to budesonide, any other medications, or any of the ingredients in budesonide oral suspension. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking budesonide suspension. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you or anyone in your family has had diabetes (high blood sugar) or glaucoma, or if you have high blood pressure, osteoporosis (a condition in which the bones become thin and weak and break easily), stomach ulcer, cataracts, allergies, or liver disease. tell your doctor if have or had tuberculosis or exposure to tuberculosis, hepatitis B infection, amebiasis (a parasitic infection of the intestine) or have spent time in the tropics or have unexplained diarrhea, fungal infections such as recurrent yeast infections or toenail or foot fungal infections or other chronic fungal infections such as blastomycoses, histoplasmosis, or cryptococcus, strongyloides (threadworm) infection, malaria, or herpes.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking budesonide suspension, call your doctor.
• you should know that this medication should not be generally used in older adults because it can cause is not as safe or effective as other medication(s) that can be used to treat your condition. If you are 65 years of age or older, talk to your doctor about the risks and benefits of taking this medication.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking budesonide suspension.
• tell your doctor if you have never had chicken pox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chicken pox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Budesonide suspension may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dry or sore throat
• stuffy or runny nose, cough, nasal or chest congestion
• dry and itchy skin, sneezing, runny nose or watery eyes

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately {or get emergency medical treatment}:

• acne, rounding of your face, ankle swelling, thicker body hair or facial hair, hump between your shoulders, stretch marks on your skin
• tiredness, weakness, nausea and vomiting, low blood pressure (dizziness when get from laying or sitting down to standing
• fever, chills, abdominal pain, aches, diarrhea, feeling tired
• heartburn, chest pain, trouble swallowing
• purple, brown or red lesions that appear on skin that may be flat or raised
• rash, throat swelling, or difficulty breathing

Budesonide suspension may cause osteoporosis, growth retardation in children. Talk to your doctor about the risks of taking this medication.

Budesonide suspension may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in refrigerator or at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Eohilia^®