Albuterol-Budesonide Inhaled

Albuterol-Budesonide Inhaled is a fixed dose inhaler indicated for as needed treatment or prevention of bronchoconstriction and for prevention of exacerbations in adults with asthma.

• Albuterol-Budesonide Inhaled is available under the following different brand names: Airsupra.

Common side effects of Albuterol-Budesonide Inhaled include:

• headache
• oral thrush
• cough
• difficulty speaking

Serious side effects of Albuterol-Budesonide Inhaled include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• worsening trouble breathing
• coughing
• wheezing
• fast or abnormal heart rate
• high blood pressure
• rash
• redness or swelling
• severe itching
• chest pain
• fever
• chills
• flu-like symptoms
• tiredness
• nausea
• vomiting
• white spots in the mouth or throat
• back pain
• bone fracture
• loss of height 
• fatigue
• weakness
• vision changes

Rare side effects of Albuterol-Budesonide Inhaled include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Inhalation aerosol

• 90 mcg/80 mcg per actuation

Asthma

Adult dosage

• 2 actuations inhaled orally as needed for asthma symptoms
• 2 actuations = albuterol 180 mcg and budesonide 160 mcg
• Not to exceed 6 doses (12 inhalations) per 24 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Albuterol-Budesonide Inhaled has severe interactions with the following drugs:
  • cisapride
  • dronedarone
  • saquinavir
  • thioridazine
• Albuterol-Budesonide Inhaled has serious interactions with the following drugs:
  • amitriptyline
  • amoxapine
  • azithromycin
  • clomipramine
  • desipramine
  • doxepin
  • fexinidazole
  • hydroxychloroquine sulfate
  • imipramine
  • isocarboxazid
  • linezolid
  • lofepramine
  • lonafarnib
  • lopinavir
  • macimorelin
  • maprotiline
• Albuterol-Budesonide Inhaled has moderate interactions with at least 302 other drugs
• Albuterol-Budesonide Inhaled has minor interactions with the following drugs:
  • bendroflumethiazide
  • bumetanide
  • chlorothiazide
  • chlorthalidone
  • cyclopenthiazide
  • ethacrynic acid
  • eucalyptus
  • furosemide
  • hydrochlorothiazide
  • indapamide
  • methyclothiazide
  • metolazone
  • noni juice
  • sage
  • torsemide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to albuterol, budesonide, or any of the excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Albuterol-Budesonide Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Albuterol-Budesonide Inhaled?”

Cautions

• Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, rash, urticaria) reported; discontinue if such reactions occur
• Use sympathomimetic amines cautiously in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines
• Beta-adrenergic agonists may cause hypokalemia in some patients, possibly through intracellular shunting, and thereby potential for adverse cardiovascular effects may occur; decreased serum potassium is usually transient, not requiring supplementation
• Orally inhaled corticosteroids may reduce growth velocity when administered to pediatric patients; safety and effectiveness of albuterol/budesonide have not been established in pediatric patients, and are not indicated for use in this population
• Deterioration of asthma
  • Asthma may deteriorate acutely over several hours or chronically over several days or longer
  • If symptoms continue after using albuterol/budesonide or require more doses than usual, evaluate the patient and treatment regimen
• Paradoxical bronchospasm
  • Treatment may produce paradoxical bronchospasm, which may be life-threatening
  • If paradoxical bronchospasm occurs, discontinue immediately, and initiate alternant therapy
  • Paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister
• Cardiovascular effects
  • Beta2-adrenergic agonists can produce clinically significant cardiovascular (CV) effects (eg, increased pulse rate, blood pressure), ECG changes (flattening of T wave, QT prolongation, ST-segment depression), and/or other symptoms
  • If such effects occur, albuterol/budesonide may need to be discontinued
  • Caution in patients with CV disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
• Maximum daily dose
  • Exceeding the maximum dose may result in an overdose
  • Clinically significant CV effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs
• Immunosuppression and risk of infections
  • Unknown, how the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection
  • Patients taking immunosuppressants are more susceptible to infection; chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients using corticosteroids
  • Review the patient's immunization history and administer necessary vaccinations
  • Immune globulins (eg, VZIG, IG) may be needed if exposure occurs and active infection occurs; consider antiviral agents if chickenpox develops
  • Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent TB infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
• Oropharyngeal candidiasis
  • Inhaled corticosteroid (ICS) may increase the risk for localized infections of the mouth and pharynx with Candida albicans
  • Advise patient to rinse their mouth with water, if available, without swallowing following administration to help reduce risk
  • If oropharyngeal candidiasis develops, treat with appropriate local or systemic (ie, oral) antifungal therapy while treatment with albuterol/budesonide continues
  • For some patients, albuterol/budesonide treatment may need to be interrupted
• Hypercorticism and adrenal suppression
  • Orally inhaled budesonide often helps control asthma symptoms with less suppression of hypothalamic-pituitary-adrenal (HPA) function than therapeutically equivalent oral doses of prednisone
  • Since budesonide is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded
• Reduced bone mineral density
  • Decreases in bone mineral density (BMD) observed with long-term administration of ICS
  • Clinical significance of small changes in BMD about long-term consequences (eg, fracture) is unknown
  • Patients with major risk factors for decreased bone mineral content (eg, prolonged immobilization, family history of osteoporosis, post-menopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass [eg, anticonvulsants, oral corticosteroids]) should be monitored and treated with established standards of care
• Glaucoma and cataracts
  • Glaucoma, increased intraocular pressure, and cataracts were reported following the long-term administration of ICS
  • Consider referral to an ophthalmologist in patients who develop ocular symptoms
• Drug interaction overview
  • Budesonide is a CYP3A4 substrate (major)
  • Strong CYP3A4 inhibitors
    • Caution
      • Strong CYP3A4 inhibitors may increase adverse effects owing to increased budesonide systemic exposure
      • Other short-acting bronchodilators
    • Use judiciously to prevent beta-agonist overdose
    • Additive effects of albuterol with other bronchodilators may occur
  • Beta-blockers
    • Caution
      • Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists (eg, albuterol, but may also produce severe bronchospasm in patients with asthma
      • Therefore, patients with asthma should not normally be treated with beta-blockers
      • However, under certain circumstances (eg, prophylaxis after MI), no acceptable alternatives may be available for these patients
      • In this setting, consider cardioselective beta-blockers, although they should be administered with caution
  • Diuretics
    • Caution; consider monitoring potassium levels
    • ECG changes and/or hypokalemia resulting from nonpotassium sparing diuretics              (eg, loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially if beta-agonist dose exceeded
  • Digoxin
    • Monitor serum digoxin levels if coadministered
    • Mean decreases in serum digoxin levels of 16% and 22% were demonstrated after single-dose IV and oral albuterol, respectively, in normal volunteers who had received digoxin for 10 days
    • The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear
  • Monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (TCAs)
    • Caution
      • MAOIs and TCAs may enhance adverse effects of beta2-agonists
      • Administer albuterol/budesonide with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents

Pregnancy and Lactation

• Albuterol or budesonide: Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol or inhaled budesonide use do not consistently demonstrate a risk of major birth defects or miscarriage
• Pregnancy Exposure Registry
  • The registry monitors pregnancy outcomes in women exposed to asthma medications during pregnancy
  • For more information, contact the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/
• Clinical considerations
  • In women with poorly or moderately controlled asthma, the risk is increased for several perinatal adverse outcomes (eg, preeclampsia in the mother; prematurity, low birth weight, and small gestational age in the neonate)
  • Closely monitor pregnant women with asthma and adjust medication as necessary to maintain optimal asthma control
  • Labor or delivery
  • Because of the potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom the benefits outweigh the risk
  • Serious adverse reactions, including pulmonary edema, were reported during, or following treatment of premature labor with beta2-agonists, including albuterol
• Lactation
  • Data are unavailable on the effects of albuterol/budesonide on breastfed children or on milk production
  • Budesonide, like other inhaled corticosteroids, is present in human milk