budesonide/formoterol (Rx)

Brand and Other Names:Symbicort
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

budesonide/formoterol

aerosol

  • (80mcg/4.5mcg)/actuation
  • (160mcg/4.5mcg)/actuation
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Asthma

Treatment in patients whose disease is not adequately controlled by long-term medication or whose disease severity warrants treatment with long-acting beta agonist (LABA) and inhaled corticosteroid

160 mcg/9 mcg (2 actuations of 80 mcg/4.5 mcg) q12hr; for more severe asthma, 320 mcg/9 mcg (2 actuations of 160 mcg/4.5 mcg) q12hr; not to exceed 320 mcg/9 mcg q12hr

Chronic Obstructive Pulmonary Disease

Treatment of airflow obstruction

160 mcg/9 mcg (2 actuations of 80 mcg/4.5 mcg) q12hr; not to exceed 320 mcg/9 mcg q12hr

Dosing Considerations

Asthma: If response is inadequate after 1-2 weeks of therapy with 80 mcg/4.5 mcg, switching to 160 mcg/4.5 mcg may provide additional control

Chronic obstructive pulmonary disease (COPD): 160 mcg/4.5 mcg is only approved treatment dose; if dyspnea occurs in period between doses, administer inhaled short-acting beta agonist (SABA) for immediate relief

Dosage Forms & Strengths

budesonide/formoterol

aerosol

  • (80mcg/4.5mcg)/actuation
  • (160mcg/4.5mcg)/actuation
more...

Asthma

Indicated for the treatment of asthma in children aged ≥6 years

<6 years: Safety and efficacy not established

6-12 years: 160 mcg/9 mcg (2 actuations of 80 mcg/4.5 mcg) q12hr

>12 years

  • Starting dose is based on asthma severity
  • 160 mcg/9 mcg (2 actuations of 80 mcg/4.5 mcg) q12hr; for more severe asthma, 320 mcg/9 mcg (2 actuations of 160 mcg/4.5 mcg) q12hr; not to exceed 320 mcg/9 mcg q12hr
  • If response is inadequate after 1-2 weeks of therapy with 80 mcg/4.5 mcg, switching to 160 mcg/4.5 mcg may provide additional control
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Interactions

Interaction Checker

and budesonide/formoterol

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Upper respiratory tract infection (URTI) (8-11%)

            Headache (7-11%)

            Nasopharyngitis (7-11%)

            1-10%

            Pharyngolaryngeal pain (6-9%)

            Stomach discomfort (1-7%)

            Sinusitis (5-6%)

            Oral candidiasis (1-6%)

            Bronchitis (5%)

            Viral URTI (4%)

            Backache (2-3%)

            Influenza (2-3%)

            Nasal congestion (2-3%)

            Vomiting (1- 3%)

            Postmarketing Reports

            Cardiovascular: Angina pectoris, tachycardia, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles, palpitations, hypotension, hypertension

            Endocrine: Hypercorticism, growth velocity reduction (in children)

            Sensory: Cataract, glaucoma, increased intraocular pressure (IOP), skin bruising

            Gastrointestinal (GI): Oropharyngeal candidiasis, nausea

            Immunologic: Immediate and delayed hypersensitivity reactions, such as anaphylactic reaction, angioedema, bronchospasm, urticaria, exanthema, dermatitis, pruritus

            Metabolic: Hyperglycemia, hypokalemia

            Musculoskeletal: Muscle cramps

            Neurologic and psychiatric: Behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness tremor, dizziness

            Respiratory: Dysphonia, cough, throat irritation

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            Warnings

            Contraindications

            Hypersensitivity

            Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures

            Cautions

            Risk of LABAs used as monotherapy

            • Use of LABAs as monotherapy (without inhaled corticosteroids) for asthma is associated with an increased risk of asthma-related death
            • Data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patient
            • These findings are considered a class effect of LABA monotherapy
            • When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

            Do not initiate in patients experiencing rapidly deteriorating or potentially life-threatening asthma or COPD episodes; additionally, increased inhaled SABA use is marker of deteriorating asthma

            Do not use for relief of acute symptoms (rescue therapy)

            Maximum dosage must not be exceeded, because of increased risk of serious cardiovascular effects

            Localized infections with Candida albicans in mouth and pharynx occur in some patients; to reduce risk, mouth must be rinsed after inhalation

            Monitor COPD patients for signs and symptoms of pneumonia and lung infections

            Risk of more serious or fatal course of chickenpox or measles exists in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure

            Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress

            During periods of stress, a severe asthma attack or a severe COPD exacerbation, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction

            Risk of paradoxical bronchospasm, which may be life-threatening; discontinue and treat immediately with inhaled SABA

            Risk of immediate hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm)

            Cardiovascular and central nervous system (CNS) effects due to excess beta-adrenergic stimulation; may result in asthma-related death; use with caution in patients with cardiovascular or convulsive disorders or thyrotoxicosis

            Particular care is needed to transfer patients from systemic to inhaled corticosteroids; potentially fatal adrenal insufficiency may occur before or afterward; taper withdrawal gradually

            Decrease in bone mineral density after long-term administration of corticosteroids; monitor patients at risk; assess bone mineral density initially and periodically thereafter

            May decrease growth velocity in children; monitor

            Risk of cataracts, glaucoma, and increased IOP; monitor

            Risk of systemic eosinophilic conditions, some consistent with Churg-Strauss syndrome

            Risk of transient hypokalemia; may not warrant supplementation

            Risk of overdose if used with additional long-acting beta2-agonist in other combination products

            Hypercorticism and adrenal suppression; may occur with very high dosages or at regular dosage in susceptible individuals; discontinue therapy if such changes occur

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            Pregnancy & Lactation

            Pregnancy

            In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control

            There are no well-controlled human studies that have investigated the effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use of therapy during labor should be restricted to those patients in whom the benefits clearly outweigh risk

            Lactation

            There are no available data on the breastfed child or on milk production; budesonide, like other inhaled corticosteroids, is present in human milk; there are no available data on the presence of formoterol fumarate in human milk; formoterol fumarate is present in rat milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Budesonide: Anti-inflammatory corticosteroid; has potent glucocorticoid activity and weak mineralocorticoid activity

            Formoterol: Long-acting selective beta2-adrenergic agonist with rapid onset of action; acts locally as bronchodilator; stimulates intracellular adenyl cyclase, which results in increased cyclic adenosine monophosphate levels, causing relaxation of bronchial smooth muscle and inhibition of release of mast cell mediators

            Absorption

            Peak plasma time: Budesonide, 20 min; formoterol, 5-10 min

            Peak plasma concentration: Budesonide, 0.6-1.6 nmol/L; formoterol, 136 pmol/L

            Distribution

            Protein bound: Budesonide, 85-90%; formoterol, 46-68%

            Vd: Budesonide, 3 L/kg

            Metabolism

            Metabolized in liver by CYP3A4 (budesonide) or CYP2D6/CYP2C (formoterol; O-demethylation)

            Elimination

            Excretion (budesonide): Urine (60%), feces

            Excretion (formoterol): Urine (62%), feces (24%)

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            Administration

            Oral Inhalation Administration

            Prime before first use by releasing 2 test sprays into air, shaking well for 5 seconds before each spray; repeat priming if inhaler is unused for >7 days or has been dropped

            After inhalation, rinse mouth with water without swallowing

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.