Generic Name: budesonide (bue-DES-oh-nide)
Brand Name: Pulmicort Flexhaler
Budesonide powder is used for:
Preventing asthma symptoms. It may also be used for other conditions as determined by your doctor.
Budesonide powder is an inhaled corticosteroid. It works by decreasing irritation and swelling in the airways, which helps to control or prevent asthma symptoms.
Do NOT use budesonide powder if:
- you are allergic to any ingredient in budesonide powder
- you have had a severe allergy to milk proteins
- you are having an acute asthma attack
Contact your doctor or health care provider right away if any of these apply to you.
Before using budesonide powder:
Some medical conditions may interact with budesonide powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances (eg, milk protein)
- if you have increased pressure in the eye; glaucoma; cataracts; a herpes infection of the eye; a bacterial, fungal, or parasitic infection; a viral infection (eg, chickenpox, shingles); diarrhea; measles; tuberculosis; or osteoporosis
- if you have had a positive tuberculosis skin test or have recently been vaccinated
Some MEDICINES MAY INTERACT with budesonide powder. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Hormonal contraceptives (eg, birth control pills, patches, implants), imidazole antifungals (eg, ketoconazole, itraconazole), or macrolide antibiotics (eg, erythromycin, clarithromycin) because they may increase the risk of budesonide powder's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease budesonide powder's effectiveness
- Live vaccines or ritodrine because the risk of their side effects may be increased by budesonide powder
This may not be a complete list of all interactions that may occur. Ask your health care provider if budesonide powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use budesonide powder:
Use budesonide powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with budesonide powder. Talk to your pharmacist if you have questions about this information.
- Inhale budesonide powder through the mouth.
- You will need to prime a new inhaler before you use it for the first time. Twist the inhaler cover and lift it off. Hold the unit upright (mouthpiece on top) and turn the grip fully in one direction, then fully in the other direction until it clicks. It does not matter which way you turn it first. Repeat. Do not reprime the inhaler. You will only need to prime the inhaler once, even if you do not use it for a long period of time. The inhaler is now ready for use.
- To use a dose, twist the inhaler cover and lift it off. Hold the unit upright (mouthpiece on top) and turn the grip fully in one direction, then fully in the other direction until it clicks. It does not matter which way you turn it first. Do NOT shake the inhaler. Turn your head away from the inhaler and breathe out fully. Place the mouthpiece between your lips and inhale forcefully and deeply. You may not feel the medicine. Remove the inhaler from your mouth and breathe out. Do NOT breathe out through the inhaler. Do not bite or chew the mouthpiece.
- If more than 1 inhalation is needed to complete your dose, repeat the previous steps.
- Replace the mouthpiece cover after each use.
- Rinse your mouth with water after each use to help prevent mouth or throat infections. Do not swallow the rinse water. Spit it out.
- Do not use budesonide powder with a spacer.
- Keep the inhaler clean and dry at all times.
- Budesonide powder has a dose counter located just below the mouthpiece to help you to keep track of how many doses are left in your inhaler. The dose counter will count down every time a dose is loaded; however, it is unlikely that you will see the dose counter move with each dose. You will be able to see that it is moving after intervals of about 5 doses. Do not use this inhaler after the number "0" on the red background has reached the middle of the dose counter window. It may no longer give the correct amount of medicine with each dose.
- Continue to use budesonide powder even if you feel well. Do not miss any doses.
- Use budesonide powder on a regular schedule to get the most benefit from it.
- If you miss a dose of budesonide powder, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use budesonide powder.
Important safety information:
- Improvement in asthma control can occur within 24 hours of beginning treatment; the maximum effect of budesonide powder may take as long as 1 to 2 weeks, or longer. If symptoms do not improve within that period of time or if they become worse, contact your health care provider.
- Do NOT take more than the recommended dose or stop using without checking with your doctor.
- Do not decrease your dose or use for longer than prescribed without checking with your doctor.
- Use caution if you switch from an oral steroid (eg, prednisone) to budesonide powder. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
- Tell your doctor at once if you switch from an oral corticosteroid to budesonide powder and you notice symptoms such as muscle and joint pain, exhaustion, depression, unusual weakness, or severe or persistent nausea or vomiting.
- Budesonide powder may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking budesonide powder. Talk with your doctor before you receive any vaccine.
- Tell your doctor or dentist that you take budesonide powder before you receive any medical or dental care, emergency care, or surgery.
- Budesonide powder will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator with you at all times to treat any breathing problems that may occur between doses of budesonide powder (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
- Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row; more than 1 canister in 8 weeks), or if you have a decrease in your peak flow meter results.
- Budesonide powder may sometimes cause severe breathing problems right after you use a dose. When this problem occurs, it is often after the first use of a new canister or vial. If this happens, use your short-acting bronchodilator and seek medical care at once. Do not use any more doses of budesonide powder unless instructed by your doctor.
- Lab tests, including lung function, adrenal function, bone density, and eye exams, may be performed while you use budesonide powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use budesonide powder.
- Budesonide powder should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using budesonide powder while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking budesonide powder.
Possible side effects of budesonide powder:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Nasal congestion; throat irritation.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); depression; ear pain or discharge; mental or mood changes; new or worsening asthma symptoms (eg, increased wheezing); severe or persistent diarrhea or stomach pain; shortness of breath after using budesonide powder; signs of infection (eg, fever, chills, or sore throat); vision changes; white patches in the mouth or throat.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of budesonide powder:
Store budesonide powder at room temperature, between 68 and 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep budesonide powder out of the reach of children and away from pets.
- If you have any questions about budesonide powder, please talk with your doctor, pharmacist, or other health care provider.
- Budesonide powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take budesonide powder or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about budesonide powder. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to budesonide powder. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using budesonide powder.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.