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Albuterol and budesonide: Drug information

Albuterol and budesonide: Drug information
(For additional information see "Albuterol and budesonide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Airsupra
Pharmacologic Category
  • Beta2 Agonist;
  • Corticosteroid, Inhalant (Oral)
Dosing: Adult
Asthma

Asthma:

Intermittent symptom relief (alternative agent): Note: Use on an as-needed basis (reliever therapy) rather than regularly scheduled. For maintenance therapy, other maintenance treatments are preferred (Ref).

Metered-dose inhaler (albuterol 90 mcg/budesonide 80 mcg per actuation): Oral inhalation: Two inhalations as needed; maximum daily dose 12 inhalations/day.

Dosage Classification for Budesonide Preparations ( GINA 2023 )

Low dose

Medium dose

High dose

Budesonide

200 to 400 mcg/day

>400 to 800 mcg/day

Use noncombination budesonide inhaler.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, budesonide undergoes hepatic metabolism; drug may accumulate with hepatic impairment; monitor closely.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.

1% to 10%:

Gastrointestinal: Oral candidiasis (1% to 2%)

Nervous system: Headache (4%), voice disorder (2%)

Respiratory: Cough (1%)

Contraindications

Hypersensitivity to albuterol, budesonide, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children, in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products or corticosteroids with lower systemic effect due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections (particularly gastroenteritis), or other conditions with severe electrolyte loss. Select surgical patients on long-term, high-dose, inhaled corticosteroid, should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Bronchospasm: Paradoxical bronchospasm that may be life threatening may occur with use of inhaled bronchodilating agents and frequently occurs first use of a new canister; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue immediately and use alternative therapy.

• Hypersensitivity reactions: Hypersensitivity reactions (eg, angioedema, anaphylaxis, bronchospasm, oropharyngeal edema, rash, urticaria) may occur; discontinue use if reaction occurs.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use, if possible, in patients with ocular herpes; respiratory tuberculosis (TB) disease (active TB) or infection (latent TB); or quiescent respiratory tuberculosis infections; or untreated viral, fungal, bacterial or parasitic systemic infections. Exposure to chickenpox or measles should be avoided; if the patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin or pooled IV immunoglobulin may be indicated; if chickenpox develops, treatment with antiviral agents may be considered. If exposure to measles occurs, prophylaxis with pooled IM immunoglobulin may be indicated.

• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while either continuing or interrupting (if necessary) budesonide-containing therapy.

Disease-related concerns:

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, antiseizure medications, oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, hypertension, heart failure). In a scientific statement from the American Heart Association, albuterol has been determined to be an agent that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate to major) (AHA [Page 2016]).

• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.

• Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure.

• Hepatic impairment: Use with caution in patients with hepatic impairment; budesonide undergoes hepatic metabolism; drug may accumulate with hepatic impairment.

• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient).

• Renal impairment: Use with caution in patients with renal impairment.

• Seizure disorders: Use with caution in patients with seizure disorders; beta agonists may result in CNS stimulation/excitation.

Special populations:

• Pediatric: Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Appropriate use: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

• Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed. A spacer device or valved holding chamber is recommended when using a metered-dose inhaler.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol, Inhalation:

Airsupra: Albuterol 90 mcg and budesonide 80 mcg per actuation (10.7 g)

Generic Equivalent Available: US

No

Pricing: US

Aerosol (Airsupra Inhalation)

90-80 mcg/ACT (per gram): $53.27

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral inhalation:

Metered-dose inhaler: For oral inhalation only; shake inhaler well before each spray. Prior to first use, prime inhaler by releasing 4 test sprays into the air. Inhaler must be reprimed by releasing 2 test sprays into the air if not used for >7 days, if it has been dropped, or after weekly cleaning. Rinse mouth with water (spit out without swallowing) after each use. Clean inhaler (remove canister out of actuator and remove mouthpiece cover) 1 time each week by running warm water (not soap) through the mouthpiece of the actuator for ~30 seconds then turn actuator upside down and run warm water through it again for ~30 seconds; allow to air dry completely; do not dry with towel or tissue; once fully dry, reassemble the actuator. Discard inhaler after the labeled number of inhalations have been used, when the dose indicator pointer reaches zero, or 12 months after removal of the foil pouch (whichever comes first). Never immerse the canister in water to determine the amount remaining in the canister (“float test”).

Emergency inhaler use when wet: If you need to use inhaler before it is dry, shake off excess water and insert canister into actuator; shake and spray 2 test puffs into the air and inhale dose; rinse actuator again and follow weekly rinse steps.

Use: Labeled Indications

Asthma/Bronchoconstriction: As needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients ≥18 years of age with asthma.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy

Beta2-Agonists (Short-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Short-Acting). Risk X: Avoid combination

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Oral Inhalation). Management: Consider alternatives to this combination when possible. If combined, monitor for increased corticosteroid adverse effects during coadministration of inhaled budesonide and strong CYP3A4 inhibitors. Risk D: Consider therapy modification

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Methacholine: Beta2-Agonists (Short-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold short-acting beta2 agonists for 6 hours before methacholine use. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Theophylline Derivatives: Beta2-Agonists may enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Theophylline Derivatives may enhance the hypokalemic effect of Beta2-Agonists. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Pregnancy Considerations

Refer to individual monographs.

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (1-877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Breastfeeding Considerations

Budesonide is present in breast milk; excretion of albuterol is not known.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Refer to individual monographs for additional information.

Monitoring Parameters

FEV1, peak flow meter and/or other pulmonary function tests; hypothalamic-pituitary-adrenal axis suppression/adrenal insufficiency; bone mineral density; hepatic impairment; signs/symptoms of oral candidiasis; asthma symptoms; glaucoma/cataracts; BP, heart rate; CNS stimulation; serum glucose, serum potassium.

Mechanism of Action

Albuterol: Relaxes bronchial smooth muscle by action on beta2-receptors.

Budesonide: A corticosteroid which controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, and reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation. Has potent glucocorticoid activity and weak mineralocorticoid activity.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

  1. Airsupra (albuterol and budesonide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; January 2023
  2. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/2023-gina-main-report/. Updated 2023. Accessed August 23, 2023.
  3. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. NIH Publication No. 08-4051. Bethesda, MD: US Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute; 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf. Accessed June 22, 2015.
  4. Page RL 2nd, O'Bryant CL, Cheng D, et al; American Heart Association Clinical Pharmacology and Heart Failure and Transplantation Committees of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Drugs that may cause or exacerbate heart failure: a scientific statement from the American Heart Association. Circulation. 2016;134(6):e32-e69. [PubMed 27400984]
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