Generic Name: budesonide inhalation (byoo DES oh nide)Brand Names: Pulmicort Flexhaler, Pulmicort Respules
Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation.
Budesonide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.
Budesonide may also be used for other purposes not listed in this medication guide.What is the most important information I should know about budesonide inhalation?Do not use budesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack.
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 needs 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.What should I discuss with my healthcare provider before using budesonide inhalation?You should not take this medication if you are allergic to budesonide, or if you are having an acute asthma attack.
Before using budesonide inhalation, tell your doctor if you are allergic to any drugs, or if you have:
herpes simplex infection of your eyes;
any type of bacterial, fungal, or viral infection; or
a history of tuberculosis.
Budesonide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.Do not give this medicine to a child younger than 6 years old without the advice of a doctor.
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. Talk with your doctor about your risk of osteoporosis.
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.Do not use budesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack.
Read all patient instructions that come with your inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
To reduce the chance of developing a yeast infection in your mouth, rinse your mouth with water after using budesonide inhalation. If you are using a nebulizer with a face mask, wash the mask area of your face after each use.If you also use a 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.
Contact your doctor if your asthma symptoms do not improve after using budesonide inhalation for 2 weeks.
Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.
Your dosage needs 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.Call your doctor right away if you feel that this medicine makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.
To be sure budesonide inhalation is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.
Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill.Store this medication at room temperature away from moisture and heat. Keep the cover on your inhaler device while not in use.
Keep the strip of Pulmicort Respules in the foil envelope, protected from light until you are ready to use the medication. After tearing off one ampule, return the strip to the envelope to protect the remaining ampules from light. Store the foil envelope upright. Once you have opened an envelope, you must use the ampules within 2 weeks.
The Pulmicort Flexhaler device has indicator marks to show you how many doses are left inside. These dose-counter marks show increments of 20 doses. The 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 visibly moved to a lower number after one use. Ask your pharmacist if you have questions about using your inhaler device.
Get your budesonide prescription refilled before you run out of medicine completely. Throw the old inhaler device away. It is a disposable container and cannot be refilled with budesonide.
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
An overdose of budesonide inhalation is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
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 steroid medication.
weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
wheezing or breathing problems after using this medication;
worsening respiratory symptoms;
ear pain with fever;
vision problems; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
Less serious side effects may include:
white patches or sores inside your mouth or on your lips;
runny or stuffy nose, sneezing;
sore throat, cough;
nausea, vomiting, diarrhea, stomach pain;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Crohn's Disease -- Acute:
Mild to moderate active Crohn's Disease involving the ileum and or ascending colon:9 mg orally once daily in the morning for up to 8 weeks. Treatment can be tapered to 6 mg daily for 2 weeks prior to complete cessation. For recurring episodes of active Crohn's Disease, repeated eight-week courses can be given. Following 8 week course(s) of treatment for active disease and once the patient's symptoms are controlled, 6 mg once daily is recommended for maintenance of clinical remission up to 3 months.
Usual Adult Dose for Asthma -- Maintenance:
Pulmicort Turbuhaler (200 mcg/inh):Previously treated with bronchodilators alone: I to 2 inhalations (200 mcg to 400 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.Previously treated with inhaled corticosteroids:I to 2 inhalations (200 mcg to 400 mcg) twice daily. Maximum dose: 4 inhalations (800 mcg) twice daily.Previously treated with oral corticosteroids:I to 4 inhalations (400 mcg to 800 mcg) twice daily. Maximum dose: 4 inhalations (800 mcg) twice daily.Pulmicort Flexhaler (90 and 180 mcg/inh):2 inhalations (360 mcg) twice daily. In some patients, a starting dose of 180 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.
Usual Pediatric Dose for Asthma -- Maintenance:
inhalation powder:6 years or older:Pulmicort Turbuhaler (200 mcg/inh):Previously treated with bronchodilators alone or with inhaled corticosteroids:I inhalation (200 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.Previously treated with oral corticosteroids:2 inhalations (400 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.Pulmicort Flexhaler (90 and 180 mcg/inh):1 inhalation (180 mcg) twice daily. In some patients, a starting dose of 360 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.inhalation suspension:1 to 8 years:Previously treated with bronchodilators alone: 0.5 mg total daily dose given once or twice daily in divided doses. Maximum dose: 0.5 mg /day.Previously treated with inhaled corticosteroids:0.5 mg total daily dose given once or twice daily in divided doses. Maximum dose: 1 mg /day.Previously treated with oral corticosteroids:1 mg total daily dose given once or twice daily in divided doses. Maximum dose: 1 mg /day.Symptomatic children not responding to nonsteroidal asthma medications: Initial: 0.25 mg once daily may be considered
Usual Pediatric Dose for Crohn's Disease -- Acute:
Limited data available; optimal dose and duration of treatment not established.Children 6 years or older:Active Crohn's disease (treatment): 9 mg/day given once daily for 7 to 8 weeks.Maintenance of remission: 6 mg/day given once daily for 3 to 4 weeks.Note: One study in children 10 to 19 years of age showed a trend for higher remission rates using an induction dose of 12 mg/day given once daily for 4 weeks, followed by 9 mg/day for 3 weeks, followed by 6 mg/day for 3 weeks.Further studies are needed to establish optimal dosing regimen.
The following drugs can interact with budesonide. Tell your doctor if you are using any of these:
HIV /AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);
an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin);
an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or
a tricyclic antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.
This list is not complete and there may be other drugs that can interact with budesonide inhalation. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.