Budesonide Inhalation

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For budesonide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to budesonide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving inhaled budesonide.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking budesonide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using budesonide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using budesonide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bemiparin
• Boceprevir
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clonixin
• Cobicistat
• Conivaptan
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Idelalisib
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Telaprevir
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using budesonide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin
• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of budesonide. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute—Should not be used in patients with this condition.

• Bone problems (e.g., osteoporosis) or
• Cataracts or
• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox, including recent exposure or
• Measles or
• Herpes simplex virus infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Tuberculosis, active or history of—budesonide can reduce the body's ability to fight off these infections.

• Milk protein allergy, severe—Use with caution. The Pulmicort Flexhaler™ contains lactose (milk sugar with milk protein), which may cause side effects for patients with this condition.

Budesonide is a steroid that reduces inflammation in the body.

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

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

Budesonide inhalation is not a rescue medicine. It will not work fast enough to treat an asthma attack. This medicine is used only to prevent asthma attacks.

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

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 Pulmicort 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, 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 Pulmicort 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 Pulmicort 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.

Get emergency medical help if you have signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Asthma -- Maintenance:

FLEXHALER(R)
Initial dose: 360 mcg via oral inhalation twice a day: in some patients an initial dose of 180 mcg twice a day may be adequate
Maintenance dose: May increase dose in 1 to 2 weeks if response is not adequate; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
Maximum dose: 720 mcg twice a day

TURBUHALER(R)
Initial dose: 400 to 2400 mcg via oral inhalation daily in divided doses
Maintenance dose: 200 to 400 mcg via oral inhalation twice a day; higher doses may be necessary for longer or shorter periods of time in some patients; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Once daily dosing may be considered in patients requiring 400 mcg per day; dose should be given in the evening

Comments:
-Improvement in asthma control can occur as early as 24 hours; maximum benefit is usually achieved within 1 to 2 weeks; individual patients may experience a variable onset and degree of symptom relief.
-If asthma symptoms arise, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.

Use: For the maintenance treatment of asthma as prophylactic therapy.

Usual Adult Dose for Crohn's Disease -- Acute:

Enteric coated capsules
Initial dose: 9 mg orally once a day in the morning for up to 8 weeks
-May repeat course for recurring episodes of active disease

Comments:
-Patients with mild to moderate active Crohn's disease involving the ileum and/or ascending colon have been switched from oral prednisolone to this drug with no reported episodes of adrenal insufficiency; prednisolone should be tapered while initiating therapy with this drug.
-Capsules should be swallowed whole; avoid grapefruit juice for the duration of therapy.
-Once patients symptoms are controlled (Crohn's Disease Activity Index [CDAI] less than 150); maintenance dosing should be started.

Use: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

Usual Adult Dose for Crohn's Disease -- Maintenance:

Enteric coated capsules:
6 mg orally once a day in the morning for up to 3 months
-If symptom control is maintained at 3 months, attempt to taper to complete cessation

Comments:
-Maintenance therapy should be started once symptoms are controlled (Crohn's Disease Activity Index [CDAI] less than 150).
-Swallow capsules whole; avoid grapefruit juice for the duration of therapy.
-Continued maintenance treatment beyond 3 months has not been shown to provide substantial benefit.

Use: Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months.

Usual Adult Dose for Ulcerative Colitis:

Extended-release tablets:
Initial dose: 9 mg orally once a day in the morning
Duration of therapy: Up to 8 weeks

Rectal Foam:
For Active Mild to Moderate Distal Ulcerative Colitis Extending up to 40 cm from the Anal Verge:
1 metered dose administered rectally twice a day for 2 weeks, then 1 metered dose administered rectally once a day for 4 weeks

Comments:
-Avoid grapefruit juice for the duration of therapy.

Use: For the induction of remission in patients with active, mild to moderate ulcerative colitis.

Usual Pediatric Dose for Asthma -- Maintenance:

Inhalation Suspension (administer via jet nebulizer):
Age: 1 to 8 years: Initial and maximum dose are based on prior asthma therapy:
-Previously treated with bronchodilators alone: 0.5 mg via oral inhalation once a day or 0.25 mg via oral inhalation twice a day; Maximum daily dose: 0.5 mg
-Previously treated with inhaled corticosteroids: 0.5 mg once a day or 0.25 mg twice a day; may increase up to 0.5 mg twice a day; Maximum daily dose: 1 mg
-Previously treated with oral corticosteroids: 1 mg once a day or 0.5 mg twice a day; Maximum daily dose: 1 mg

Comment: For symptomatic patients who do not respond to non-steroid therapy, an initial inhalation suspension dose of 0.25 mg once a day may be considered.

FLEXHALER(R) Inhalation Powder (oral inhaler):
Age: 6 to 12 years:
-Initial dose: 180 mcg via oral inhalation twice a day; some patients may require an initial dose of 360 mcg twice a day
-Maintenance dose: May increase dose after 1 to 2 weeks if response is not adequate; once asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Maximum dose: 360 mcg twice a day

TURBUHALER(R) Inhalation Powder (oral inhaler):
Age 6 to 12 years:
-Initial dose: 100 to 200 mcg via oral inhalation twice a day
Maintenance dose: Lowest dose that keeps patient symptom-free

TURBUHALER(R) Inhalation Powder (oral inhaler):
Age: Over 12 years:
Initial dose: 400 to 2400 mcg via oral inhalation daily in divided doses
Maintenance dose: 200 to 400 mcg via oral inhalation twice a day; higher doses may be necessary for longer or shorter periods of time in some patients; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Once daily dosing may be considered in patients requiring 400 mcg per day; dose should be given in the evening

Comments:
-Improvement in asthma control can occur as early as 24 hours; maximum benefit is usually achieved within 1 to 2 weeks; individual patients may experience a variable onset and degree of symptom relief.
-If asthma symptoms arise between doses, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.
-Once daily dosing may be used unless it does not provide adequate control, then dosing should be administered as a divided dose, adjusting dose as needed.
-Once asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects.

Use: For the maintenance treatment of asthma as prophylactic therapy.

Usual Pediatric Dose for Crohn's Disease -- Acute:

Age 8 years or older; weight greater than 25 kg

Enteric coated capsules:
9 mg orally once a day in the morning for up to 8 weeks; then 6 mg orally once a day for 2 weeks

Comments:
-Swallow capsules whole; avoid grapefruit juice for the duration of therapy.

Use: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aldesleukin, mifepristone.

This product may interfere with certain lab tests (such as skin tests). Make sure laboratory personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow/red range or increased use of quick-relief inhalers).

Laboratory and/or medical tests (such as cortisol levels, bone density tests, eye exams, height/weight measurements) should be performed regularly to check for side effects. Consult your doctor for more details.

Avoid allergens (such as pollen, pet dander), irritants, smoking/secondhand smoke, and other factors that make asthma worse. Most people with asthma or ongoing lung disease should receive a flu shot annually. Discuss with your doctor.

In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) with the cover on firmly, away from light/moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Store the Canadian product at room temperature between 59 to 86 degrees F (15 to 30 degrees C) with the cover on firmly, away from light/moisture.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.