Budesonide Inhalation Suspension

The potential for acute toxic effects following overdose of PULMICORT RESPULES (budesonide inhalation suspension) is low. If inhaled corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism or growth suppression may occur [see WARNINGS AND PRECAUTIONS, Hypercorticism and Adrenal Suppression].

In mice, the minimal lethal inhalation dose was 100 mg/kg (approximately 410 and 120 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m² basis). In rats there were no deaths at an inhalation dose of 68 mg/kg (approximately 550 and 160 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m² basis). In mice, the minimal oral lethal dose was 200 mg/kg (approximately 810 and 240 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m² basis). In rats, the minimal oral lethal dose was less than 100 mg/kg (approximately 810 and 240 times, respectively, the maximum recommended daily inhalation dose in adults or and children 12 months to 8 years of age on a mg/m² basis).

• It is used to treat asthma.
• It may be given to you for other reasons. Talk with the doctor.
• Do not use budesonide inhalation suspension to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

• If you have an allergy to budesonide or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This is not a list of all drugs or health problems that interact with budesonide inhalation suspension.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take budesonide inhalation suspension. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have your eye pressure checked if you are on this medicine for a long time. Talk with your doctor.
• If you have been taking budesonide inhalation suspension for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine.
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like budesonide inhalation suspension. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• If your normal short-acting puffer (inhaler) dose does not work well, you need to use your short-acting puffer more often than normal, or your breathing gets worse, call your doctor right away.
• This medicine is not helpful during an asthma attack.
• When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using budesonide inhalation suspension while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

The recommended starting dose and highest recommended dose of Budesonide Inhalation Suspension, based on prior asthma therapy, are listed in the following table.

Dosing Recommendations

Dosing recommendations based on previous therapy are as follows:

• Bronchodilators alone: 0.25 mg twice daily
• Inhaled corticosteroids 0.25 mg twice daily up to 0.5 mg twice daily
• Oral corticosteroids: 0.5 mg twice daily

In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.

Directions for Use

Budesonide Inhalation Suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of Budesonide Inhalation Suspension and, therefore, are NOT recommended.

The effects of mixing Budesonide Inhalation Suspension with other nebulizable medications have not been adequately assessed. Budesonide Inhalation Suspension should be administered separately in the nebulizer [see Patient Counseling Information, Administration with a jet nebulizer (17.1)].

A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver Budesonide Inhalation Suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of Budesonide Inhalation Suspension delivered by other nebulizers and compressors have not been established.

Systemic and inhaled corticosteroid use may result in the following:

• Candida albicans infection [see Warnings and Precautions (5.1)]
• Hypersensitivity reactions including anaphylaxis [ see Warnings and Precautions (5.3)]
• Immunosuppression [ see Warnings and Precautions (5.4)]
• Hypercorticism and adrenal suppression [see Warnings and Precautions (5.6)]
• Reduction in bone mineral density [see Warnings and Precautions (5.7)]
• Growth effects in pediatric patients [see Warnings and Precautions (5.8) and Use in Specific Populations, Pediatric Use (8.4)]
• Glaucoma, increased intraocular pressure and cataracts [see Warnings and Precautions (5.9)]
• Eosinophilic conditions and Churg-Strauss syndrome [see Warnings and Precautions (5.11)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidence of common adverse reactions is based on three double-blind, placebo-controlled, randomized U.S. clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥12 months and <2 years of age; 225 patients ≥2 and <4 years of age; and 622 patients ≥4 and ≤8 years of age) were treated with Budesonide Inhalation Suspension or vehicle placebo. The incidence and nature of adverse events reported for Budesonide Inhalation Suspension was comparable to that reported for placebo. The following table shows the incidence of adverse events in U.S. controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and/or inhaled corticosteroids. This population included a total of 605 male and 340 female patients and 78.4% were Caucasian, 13.8% African American, 5.5% Hispanic and 2.3% Other.

The information below includes all adverse reactions by system organ class with an incidence of 1 to < 3%, in at least one Budesonide Inhalation Suspension treatment group where the incidence was higher with Budesonide Inhalation Suspension than with placebo, regardless of relationship to treatment.

Blood and lymphatic system disorders: cervical lymphadenopathy

Ear and labyrinth disorders: earache

General disorders and administration site conditions: fatigue, flu-like disorder

Immune system disorders: allergic reaction

Infections and infestations: eye infection, herpes simplex, external ear infection, infection

Injury, poisoning and procedural complication: fracture

Metabolism and nutrition disorders: anorexia

Musculoskeletal and connective tissue disorders: myalgia

Nervous system disorders: hyperkinesia

Psychiatric disorders: emotional lability

Respiratory, thoracic, and mediastinal disorders: chest pain, dysphonia, stridor

Skin and subcutaneous tissue disorders: contact dermatitis, eczema, pustular rash, pruritus, purpura

The incidence of reported adverse events was similar between the 447 Budesonide Inhalation Suspension treated (mean total daily dose 0.5 to 1 mg) and 223 conventional therapy-treated pediatric asthma patients followed for one year in three open-label studies.

Post-marketing Experience

The following adverse reactions have been reported during post-approval use of Budesonide Inhalation Suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Some of these adverse reactions may also have been observed in clinical studies with Budesonide Inhalation Suspension.

Endocrine disorders: symptoms of hypocorticism and hypercorticism [see Warnings and Precautions (5.5)]

Eye disorders: cataracts, glaucoma, increased intraocular pressure [see Warnings and Precautions (5.9)]

General disorders and administration site conditions: fever, pain

Immune system disorders: immediate and delayed hypersensitivity reactions including, anaphylaxis, angioedema, bronchospasm, rash, contact dermatitis, and urticaria [see Contraindications (4) and Warnings and Precautions (5.10)]

Infection and Infestation: sinusitis, pharyngitis, bronchitis

Musculoskeletal and connective tissue disorders: avascular necrosis of the femoral head, osteoporosis, growth suppression

Nervous system disorders: headache

Psychiatric disorders: psychiatric symptoms including psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, and anxiety

Respiratory, thoracic, and mediastinal disorders: cough, dysphonia and throat irritation

Skin and subcutaneous tissue disorders: skin bruising, facial skin irritation

Cases of growth suppression have been reported for inhaled corticosteroids including post-marketing reports for Budesonide Inhalation Suspension [see Warnings and Precautions (5.8) and Use In Specific Populations, Pediatric Use (8.4)].

Inhibitors of Cytochrome P4503A4

The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the coadministration of Budesonide Inhalation Suspension with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [ see Warnings and Precautions (5.12) and Clinical Pharmacology, Pharmacokinetics (12.3)].

Mechanism of Action

Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. In standard in vitro and animal models, budesonide has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol (rat croton oil ear edema assay). As a measure of systemic activity, budesonide is 40 times more potent than cortisol when administered subcutaneously and 25 times more potent when administered orally in the rat thymus involution assay. The clinical significance of these findings is unknown.

The activity of Budesonide Inhalation Suspension is due to the parent drug, budesonide. In glucocorticoid receptor affinity studies, the 22R form was two times as active as the 22S epimer. In vitro studies indicated that the two forms of budesonide do not interconvert.

The precise mechanism of corticosteroid actions on inflammation in asthma is not well known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic- and non-allergic-mediated inflammation. The anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Studies in asthmatic patients have shown a favorable ratio between topical anti-inflammatory activities and systemic corticosteroid effects over a wide dose range of inhaled budesonide in a variety of formulations and delivery systems including an inhalation-driven, multi-dose dry powder inhaler and the inhalation suspension for nebulization. This is explained by a combination of a relatively high local anti-inflammatory effect, extensive first pass hepatic degradation of orally absorbed drug (85 to 95%) and the low potency of metabolites (see below).

Pharmacodynamics

The therapeutic effects of conventional doses of orally inhaled budesonide are largely explained by its direct local action on the respiratory tract. To confirm that systemic absorption is not a significant factor in the clinical efficacy of inhaled budesonide, a clinical study in adult patients with asthma was performed comparing 400 mcg budesonide administered via a pressurized metered dose inhaler with a tube spacer to 1400 mcg of oral budesonide and placebo. The study demonstrated the efficacy of inhaled budesonide but not orally administered budesonide, even though systemic budesonide exposure was comparable for both treatments, indicating that the inhaled treatment is working locally in the lung. Thus, the therapeutic effect of conventional doses of orally inhaled budesonide are largely explained by its direct action on the respiratory tract.

Improvement in the control of asthma symptoms following inhalation of Budesonide Inhalation Suspension can occur within 2 to 8 days of beginning treatment, although maximum benefit may not be achieved for 4 to 6 weeks.

Budesonide administered via a dry powder inhaler has been shown in various challenge models (including histamine, methacholine, sodium metabisulfite, and adenosine monophosphate) to decrease bronchial hyperresponsiveness in asthmatic patients. The clinical relevance of these models is not certain.

Pre-treatment with budesonide administered as 1600 mcg daily (800 mcg twice daily) via a dry powder inhaler for 2 weeks reduced the acute (early-phase reaction) and delayed (late-phase reaction) decrease in FEV 1 following inhaled allergen challenge.

HPA Axis Effects

The effects of Budesonide Inhalation Suspension on the hypothalamic-pituitary-adrenal (HPA) axis were studied in three, 12-week, double-blind, placebo-controlled studies in 293 pediatric patients, 6 months to 8 years of age, with persistent asthma. For most patients, the ability to increase cortisol production in response to stress, as assessed by the short cosyntropin (ACTH) stimulation test, remained intact with Budesonide Inhalation Suspension treatment at recommended doses. In the subgroup of children age 6 months to 2 years (n=21) receiving a total daily dose of Budesonide Inhalation Suspension up to 1 mg or placebo (n=3), the mean change from baseline in ACTH-stimulated cortisol levels showed a decline in peak stimulated cortisol at 12 weeks compared to an increase in the placebo group. These mean differences were not statistically significant compared to placebo. Another 12-week study in 141 pediatric patients 6 to 12 months of age with mild to moderate asthma or recurrent/persistent wheezing was conducted. All patients were randomized to receive either 0.5 mg or 1 mg of Budesonide Inhalation Suspension or placebo. A total of 28, 17, and 31 patients in the Budesonide Inhalation Suspension 0.5 mg, 1 mg, and placebo arms respectively, had an evaluation of serum cortisol levels post-ACTH stimulation both at baseline and at the end of the study. The mean change from baseline to Week 12 ACTH-stimulated minus basal plasma cortisol levels did not indicate adrenal suppression in patients treated with Budesonide Inhalation Suspension versus placebo. However, 7 patients in this study (4 of whom received Budesonide Inhalation Suspension 0.5 mg, 2 of whom received Budesonide Inhalation Suspension 1 mg and 1 of whom received placebo) showed a shift from normal baseline stimulated cortisol level (≥500 nmol/L) to a subnormal level (<500 nmol/L) at Week 12. In 4 of these patients receiving Budesonide Inhalation Suspension, the cortisol values were near the cutoff value of 500 nmol/L.

The effects of Budesonide Inhalation Suspension at doses of 0.5 mg twice daily, and 1 mg and 2 mg twice daily (2 times and 4 times the highest recommended total daily dose, respectively) on 24-hour urinary cortisol excretion were studied in 18 patients between 6 to 15 years of age with persistent asthma in a cross-over study design (4 weeks of treatment per dose level). There was a dose-related decrease in urinary cortisol excretion at 2 and 4 times the recommended daily dose. The two higher doses of Budesonide Inhalation Suspension (1 and 2 mg twice daily) showed statistically significantly reduced (43 to 52%) urinary cortisol excretion compared to the run-in period. The highest recommended dose of Budesonide Inhalation Suspension, 1 mg total daily dose, did not show statistically significantly reduced urinary cortisol excretion compared to the run-in period.

Budesonide Inhalation Suspension, like other inhaled corticosteroid products, may impact the HPA axis, especially in susceptible individuals, in younger children, and in patients given high doses for prolonged periods [see Warnings and Precautions (5.5)].

Pharmacokinetics

Absorption:

In asthmatic children 4 to 6 years of age, the total absolute bioavailability (i.e., lung + oral) following administration of Budesonide Inhalation Suspension via jet nebulizer was approximately 6% of the labeled dose.

In children, a peak plasma concentration of 2.6 nmol/L was obtained approximately 20 minutes after nebulization of a 1 mg dose. Systemic exposure, as measured by AUC and C max, is similar for young children and adults after inhalation of the same dose of Budesonide Inhalation Suspension.

Distribution:

In asthmatic children 4 to 6 years of age, the volume of distribution at steady-state of budesonide was 3 L/kg, approximately the same as in healthy adults. Budesonide is 85 to 90% bound to plasma proteins, the degree of binding being constant over the concentration range (1 to 100 nmol/L) achieved with, and exceeding, recommended doses. Budesonide showed little or no binding to corticosteroid-binding globulin. Budesonide rapidly equilibrated with red blood cells in a concentration independent manner with a blood/plasma ratio of about 0.8.

Metabolism:

In vitro studies with human liver homogenates have shown that budesonide is rapidly and extensively metabolized. Two major metabolites formed via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) catalyzed biotransformation have been isolated and identified as 16α-hydroxyprednisolone and 6β-hydroxybudesonide. The corticosteroid activity of each of these two metabolites is less than 1% of that of the parent compound. No qualitative difference between the in vitro and in vivo metabolic patterns has been detected. Negligible metabolic inactivation was observed in human lung and serum preparations.

Excretion/Elimination:

Budesonide is primarily cleared by the liver. Budesonide is excreted in urine and feces in the form of metabolites. In adults, approximately 60% of an intravenous radiolabeled dose was recovered in the urine. No unchanged budesonide was detected in the urine.

In asthmatic children 4 to 6 years of age, the terminal half-life of budesonide after nebulization is 2.3 hours, and the systemic clearance is 0.5 L/min, which is approximately 50% greater than in healthy adults after adjustment for differences in weight.

Special Populations:

No differences in pharmacokinetics due to race, gender, or age have been identified.

Hepatic Insufficiency:

Reduced liver function may affect the elimination of corticosteroids. The pharmacokinetics of budesonide were affected by compromised liver function as evidenced by a doubled systemic availability after oral ingestion. The intravenous pharmacokinetics of budesonide were, however, similar in cirrhotic patients and in healthy adults.

Nursing Mothers:

The disposition of budesonide when delivered by inhalation from a dry powder inhaler at doses of 200 or 400 mcg twice daily for at least 3 months was studied in eight lactating women with asthma from 1 to 6 months postpartum. Systemic exposure to budesonide in these women appears to be comparable to that in non-lactating women with asthma from other studies. Breast milk obtained over eight hours post-dose revealed that the maximum concentration of budesonide for the 400 and 800 mcg doses was 0.39 and 0.78 nmol/L, respectively, and occurred within 45 minutes after dosing. The estimated oral daily dose of budesonide from breast milk to the infant is approximately 0.007 and 0.014 mcg/kg/day for the two dose regimens used in this study, which represents approximately 0.3% to 1% of the dose inhaled by the mother. Budesonide levels in plasma samples obtained from five infants at about 90 minutes after breast-feeding (and about 140 minutes after drug administration to the mother) were below quantifiable levels (<0.02 nmol/L in four infants and <0.04 nmol/L in one infant) [see Use In Specific Populations, Nursing Mothers (8.3)].

Drug-Drug Interactions

Inhibitors of cytochrome P450 enzymes

Ketoconazole: Ketoconazole, a strong inhibitor of cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4), the main metabolic enzyme for corticosteroids, increased plasma levels of orally ingested budesonide [see Warnings and Precautions (5.12) and Drug Interactions (7.1)].

Cimetidine: At recommended doses, cimetidine, a nonspecific inhibitor of CYP enzymes, had a slight but clinically insignificant effect on the pharmacokinetics of oral budesonide.

More common side effects

Some of the more common side effects that can occur with use of budesonide inhalation suspension and inhalation powder/metered dose inhaler (MDI) include:

• respiratory infections. Symptoms can include:

  • stuffy nose
  • sore nose and throat

• runny nose

• cough

• viral infections. Symptoms can include:

  • fever
  • body and muscle aches
  • dehydration
  • nausea
  • vomiting
  • skin rash
  • runny nose
  • sore throat

• stomach problems (gastroenteritis). Symptoms can include:

  • stomach pain
  • diarrhea
  • nausea and vomiting
  • loss of appetite

• ear infections

• Side effects for budesonide metered dose inhaler can include the above, plus:

  • nosebleeds
  • pink eye (conjunctivitis)
  • skin rash

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Mouth or throat infection (thrush or candida). Symptoms can include:

  • redness or white-colored patches in your mouth or throat

• Worsening of your asthma symptoms or sudden asthma attacks

• Infections. Symptoms can include:

  • fever
  • pain throughout your body
  • aches
  • chills
  • tiredness
  • nausea and vomiting

• Adrenal insufficiency. Symptoms can include:

  • tiredness
  • weakness
  • nausea and vomiting
  • low blood pressure, which may make you feel dizzy or faint

• Decreased bone strength (bone density)

• Slowed or delayed growth in children

• Eye problems, such as cataracts and glaucoma. Symptoms can include:

  • blurred vision
  • double vision
  • not being able to see in dim light
  • seeing halos (circles) around lights
  • sensitivity to light
  • not being able to see

• Increased wheezing right after taking the medication

Budesonide can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Medications that might interact with this drug

These medicines may increase the effect of budesonide. This can increase your risk of side effects.

These drugs include:

• clarithromycin
• telithromycin

These medicines may increase the effect of budesonide. This can increase your risk of side effects.

These drugs include:

• ketoconazole
• itraconazole

These medicines may increase the effect of budesonide. This can increase your risk of side effects.

These drugs include:

• nefazodone

These medicines may increase the effect of budesonide. This can increase your risk of side effects.

These drugs include:

• ritonavir
• atazanavir
• indinavir
• saquinavir

People with liver problems

Budesonide is processed by your liver. If you have liver problems, more of the drug stays in your body for a longer time. This increases your risk of side effects. Your doctor may start you on a lowered dose or a different medication schedule. This can help keep levels of this drug from building up too much in your body.

People with risk factors for bone problems

Budesonide can cause decreases in bone strength. If you have a family history of brittle bones, have poor nutrition, are a senior, have gone through menopause, take medicines that can affect bone mass, use tobacco, or are immobile for long periods of time, your doctor will monitor you closely. They will do this to make sure budesonide is safe for you to take.

People with eye problems

Budesonide can cause eye problems, such as increased pressure inside your eyes, glaucoma, and cataracts. Let your doctor know if you have a history of these eye problems. Your doctor will monitor you closely to make sure budesonide is safe for you to take.

Pregnant women

Budesonide is a category B pregnancy drug. That means two things:

1. Studies of the drug in pregnant animals have not shown a risk to the fetus.
2. There aren’t enough studies done in pregnant women to show if the drug poses a risk to the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus.

Women who are breast-feeding

Budesonide may pass into breast milk and may cause side effects in a child who is breast-fed.

Talk to your doctor if you breast-feed your baby. You may need to decide whether to stop breast-feeding or stop taking this medication

For children

Budesonide inhalation suspension:

The safety and effectiveness of this drug hasn’t been confirmed in children younger than 12 months or older than 8 years.

Budesonide inhalation powder/metered dose inhaler:

The safety and effectiveness of this drug hasn’t been confirmed in children younger than 6 years.

When to call the doctor

Call your doctor right away if:

• Your short-acting rescue medicine doesn’t work as well to relieve your symptoms.
• You need to use your short-acting rescue medicine more often than usual.
• Your breathing problems get worse while you’re taking budesonide

Allergies

Budesonide can cause a severe allergic reaction. Symptoms can include:

• skin rash, redness, or swelling
• severe itching
• swelling of the face, mouth, and tongue
• trouble breathing or swallowing
• chest pain

Call 9-1-1 or go to the nearest emergency room if you develop these symptoms.

Don’t take this drug again if you’ve ever had an allergic reaction to it.

Taking it again could be fatal (cause death).