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budesonide/formoterol (Rx)Brand and Other Names:Symbicort

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

budesonide/formoterol

aerosol

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

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

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

Dosage Forms & Strengths

budesonide/formoterol

aerosol

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

Asthma

<12 years: Safety and efficacy not established

>12 years: 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

Dosing Considerations

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

budesonide/formoterol and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

            Black Box Warnings

            LABAs, such as formoterol, may increase risk of asthma-related deaths; therefore, they should be used only as additional therapy for patients whose disease is not adequately controlled on other asthma-control medications (eg, low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including formoterol

            Because of risk, use of formoterol without concomitant long-term asthma-controlling medication (eg, inhaled corticosteroid) is contraindicated

            Once asthma control is achieved or maintained, assess at regular intervals; step down therapy (eg, discontinue LABA) if doing so is possible without loss of asthma control, and maintain on long-term asthma-control medication (eg, inhaled corticosteroid)

            Do not use formoterol if asthma is adequately controlled on low- or medium-dose inhaled corticosteroids

            Controlled clinical trials suggest that LABAs increase risk of asthma-related hospitalization in pediatric and adolescent patients; if such patients require addition of LABA to inhaled corticosteroid, use fixed-dose combination product containing both inhaled corticosteroid and LABA to ensure adherence

            Contraindications

            Hypersensitivity

            Primary treatment for acute bronchospasm, status asthmaticus, or exercise-induced bronchospasm

            Cautions

            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

            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

            During stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should resume PO corticosteroids immediately

            Decrease in bone mineral density after long-term administration of corticosteroids; monitor patients at risk

            May decrease growth velocity in children

            Risk of cataracts, glaucoma, and increased IOP

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

            Risk of transient hypokalemia; may not warrant supplementation

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: No data; weigh risks of therapy against benefits, and either discontinue drug or do not nurse

            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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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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