Budecort® (Budesonide)

What is Budesonide Inhalation?

Budesonide is a corticosteroid that prevents the release of substances in the body that cause inflammation.

Budesonide Inhalation is used to prevent asthma attacks in adults and children who are at least 6 years old.

Budesonide Inhalation may also be used for purposes not listed in this medication guide.

Important information

Do not use Budesonide Inhalation to treat an asthma attack that has already begun. Budesonide Inhalation is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast-acting inhalation medicine to treat an asthma attack.

You should not use this medicine if you have a severe allergy to milk proteins.

Contact your doctor if your asthma symptoms do not improve after using Budesonide Inhalation for 2 weeks.

Call your doctor right away if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Your dosage of Budesonide Inhalation may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely.

Before taking this medicine

You should not use Budesonide Inhalation if you are allergic to budesonide, or if:

• you have a severe allergy to milk proteins; or

• you are having an asthma attack.

To make sure Budesonide Inhalation is safe for you, tell your doctor if you have:

• liver disease;

• osteoporosis, or low bone mineral density;

• glaucoma, cataracts, or herpes infection of the eyes;

• any type of infection caused by bacteria, fungus, virus, or parasite;

• food or drug allergies;

• a history of tuberculosis; or

• if you are malnourished, if you smoke, or if you are going through menopause.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

Budesonide Inhalation is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Budesonide inhalation can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Budesonide Inhalation can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Budesonide Inhalation is not approved for use by anyone younger than 6 years old.

How should I use Budesonide Inhalation?

Use Budesonide Inhalation exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Budesonide Inhalation is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

This medicine comes with a medication guide for safe and effective use, and directions for priming and cleaning the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use only the inhaler device that comes with your medicine. Do not place the Budesonide Inhalation Flexhaler device in water or try to take it apart.

Always rinse your mouth with water after using this medicine, to help prevent thrush (a fungal infection in the mouth or throat). If you are using a nebulizer with a face mask, wash the mask area of your face after each use.

While using Budesonide Inhalation, your doctor may need to check your vision and bone mineral density.

Using a steroid can weaken your immune system. This can make it easier for you to get sick from being around others who are ill.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

Call your doctor if your symptoms do not improve after the first week of treatment, or if you think your asthma medications are not working as well. If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Asthma is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature, away from moisture, light, and heat. Keep the cover on your inhaler device while not in use.

Store Budesonide Inhalation Respules upright in the foil envelope. When you are ready to use the medicine, remove an ampule and put the strip back in the envelope. Once you have opened an envelope, you must use the ampules within 2 weeks.

The Budesonide Inhalation Flexhaler device has a dose counter that shows how many doses are left inside. The dose-counter indicator may not appear to move until about 5 doses have been used. Do not use an extra dose just because the Flexhaler indicator has not moved to a lower number after just one use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What should I avoid while taking Budesonide Inhalation?

Avoid getting this medicine in your eyes.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Budesonide Inhalation.

Budesonide Inhalation side effects

Get emergency medical help if you have signs of an allergic reaction to Budesonide Inhalation: hives, rash, severe itching; chest pain, difficult breathing, feeling anxious; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening asthma symptoms;

• wheezing, choking, or other breathing problems after using this medication;

• white patches or sores inside your mouth or on your lips;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• signs of infection - fever, chills, body aches, ear pain, nausea, vomiting; or

• signs of low adrenal gland hormones - worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Common Budesonide Inhalation side effects may include:

• runny or stuffy nose, sneezing;

• red, itchy, and watery eyes;

• fever, sore throat, cough;

• nausea, vomiting, diarrhea, stomach pain, loss of appetite;

• nosebleed; or

• headache, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Budesonide Inhalation?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• other steroid medicine (fluticasone, prednisone, dexamethasone, methylprednisolone, and others);

• an antibiotic or antifungal medicine (such as ketoconazole, voriconazole, and others);

• antiviral medicine to treat hepatitis C or HIV/AIDS;

• seizure medication; or

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with budesonide inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.