Budesonide, Inhalation

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KEY POINTS

• This medicine is inhaled through the mouth to prevent asthma attacks, or to treat asthma in children. Use it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: corticosteroid; anti-inflammatory

Generic and brand names: budesonide, inhalation; Pulmicort Flexhaler; Pulmicort Respules

What is this medicine used for?

This medicine is inhaled by mouth to prevent asthma attacks. The Respules may be used to treat asthma in children 12 months to 8 years of age.

If you take oral steroids for your asthma, this medicine may reduce your need for the pills.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you use this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to milk proteins
• Eye problems such as cataracts, glaucoma, or eye infections
• Liver disease
• Osteoporosis
• Tuberculosis (TB)

Also, tell your provider if you are taking prednisone or other steroid medicines, or if you take other medicines for asthma, including nonprescription products. Tell your provider if you have any kind of infection.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider’s approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Use the medicine exactly as your healthcare provider prescribes. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

If you have the Flexhaler, check with your healthcare provider before using this medicine in children under age 6.

If you have the Respules, check with your healthcare provider before using this medicine in children under age 1.

This medicine must be inhaled regularly to be effective. You may feel better in a few days, or you may need to use the medicine for several weeks to receive its full benefit. Do not increase or decrease the dosage on your own. Continue to take any other medicines that your healthcare provider has prescribed for you. Do not stop using this medicine without your provider's approval. If you are not getting results or if your symptoms get worse, contact your healthcare provider.

If you have the Respules, you will use this medicine in a nebulizer. A nebulizer provides a precise amount of medicine as an aerosol mist that you breathe through your mouth and into your lungs. Read all instructions supplied with the equipment and the medicine.

Rinse your mouth with water and spit out the rinse right after you use this medicine. This may reduce the risk of thrush (a fungus infection) in your mouth. It may also help reduce aftertaste, dry mouth, and hoarseness.

An adult should supervise the use of this medicine by a child.

If you are using other inhaled medicines, ask your healthcare provider or pharmacist which you should use first. Use inhaled medicines 10 minutes apart from each other.

What if I miss a dose?

Use this medicine on the schedule your healthcare provider prescribes for you. If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

If you have switched from steroid tablets to this inhaler, your body may not produce enough natural steroids. You may need to take steroid tablets during periods of stress such as injury, surgery, infection, or severe asthma attacks. Talk with your healthcare provider about this.

Do not use this medicine for sudden breathing problems or asthma attacks that have already started. Your healthcare provider will prescribe a short-acting inhaled medicine to use when you have an asthma attack.

If your symptoms do not improve in 2 to 4 weeks, or if they get worse, contact your healthcare provider.

If you use this medicine for a long time, your healthcare provider will want to see you regularly to see how this medicine is affecting you. Keep all appointments for checkups and eye exams.

This medicine may affect growth in children. Talk to your healthcare provider about this.

Treatment with this medicine may affect bone density. Your healthcare provider may order tests to check if this medicine is affecting your bones.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. If you are exposed to an infectious disease, contact your healthcare provider right away. Chickenpox or measles may be more serious than usual while you are using this medicine. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may cause an increase in wheezing or trouble breathing right after taking the medicine. You should always have a fast-acting inhaled bronchodilator medicine with you to treat sudden wheezing. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. Carry an ID card or wear a medical ID bracelet or necklace that says you have asthma and are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Trouble breathing or catching your breath, rash, white patches in or around your mouth, trouble swallowing, fever, chills, muscle aches and pains, unexplained weakness or tiredness, severe nausea or vomiting, fainting or severe dizziness, vision changes.

Other: Sore throat, hoarseness, cough, stuffy or runny nose, ear infection, headache, nausea, vomiting, diarrhea, nosebleed, pink eye.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aldesleukin (Proleukin)
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and telithromycin (Ketek)
• Antidepressants such as nefazodone and sertraline (Zoloft)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Keep this medicine at room temperature. Store the Respules in an upright position, away from heat, high humidity, and bright light. Store the Respules in the foil package. After opening the foil package, use the Respules within 2 weeks. Use each ampule immediately after opening it. Do not refrigerate or freeze this medicine.

Store the Flexhaler in an upright position, away from heat, high humidity, and bright light. Throw away the inhaler after the expiration date or when the dose counter reads 0, whichever comes first.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.