Budesonide and Formoterol (Lexi-Drugs)

Pronunciation

(byoo DES oh nide & for MOH te rol)

Brand Names: US

Symbicort

Brand Names: Canada

Symbicort

Dosing: Adult

Note: If asthma or COPD symptoms occur in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief. The maximum dose is based on the formoterol component; to increase the dose of the inhaled glucocorticoid component, a separate inhaler with a higher budesonide dose per inhalation must be prescribed.

Asthma: Oral inhalation:

Starting dose is based on asthma severity.

Budesonide 80 mcg/formoterol 4.5 mcg or budesonide 160 mcg/formoterol 4.5 mcg: Metered-dose inhaler: 2 inhalations twice daily; if response is inadequate, may increase to higher dose combination after 1 to 2 weeks (maximum: budesonide 160 mcg/formoterol 4.5 mcg: 2 inhalations twice daily).

Symbicort 100 Turbuhaler, Symbicort 200 Turbuhaler [Canadian products]: Dry powder inhaler:

Initial: 1 to 2 inhalations twice daily until symptom control, then titrate to lowest effective dosage to maintain control

Maintenance: 1 to 2 inhalations once or twice daily (maximum: 8 inhalations/day as temporary treatment in periods of worsening asthma)

Symbicort Maintenance and Reliever Therapy (Symbicort SMART) [Canadian product]: Dry powder inhaler:

Maintenance: Symbicort 100 Turbuhaler or Symbicort 200 Turbuhaler: 1 to 2 inhalations twice daily or 2 inhalations once daily

Reliever therapy: Symbicort 100 Turbuhaler or Symbicort 200 Turbuhaler: 1 additional inhalation as needed, may repeat if no relief for up to 6 inhalations total (maximum: 8 inhalations/day)

COPD: Oral inhalation:

Budesonide 160 mcg/formoterol 4.5 mcg: Metered dose inhaler: 2 inhalations twice daily (maximum: 2 inhalations twice daily)

Symbicort 200 Turbuhaler [Canadian product]: Dry powder inhaler: 2 inhalations twice daily (maximum: 2 inhalations twice daily)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution and monitor closely; may lead to accumulation of budesonide and formoterol.

Dosing: Pediatric

Asthma; maintenance treatment: Oral inhalation:

Children 5 to 11 years: Budesonide 80 mcg/formoterol 4.5 mcg: Two inhalations twice daily; maximum daily dose: 4 inhalations (Budesonide 320 mcg/formoterol 18 mcg)/day(Morice 2008; NAEPP 2007)

Children ≥12 years and Adolescents: Note: Initial dose prescribed should be based upon asthma severity:

Budesonide 80 mcg/formoterol 4.5 mcg: Two inhalations twice daily; maximum daily dose: 4 inhalations (Budesonide 320 mcg/formoterol 18 mcg)/day. In patients not adequately controlled following 1 to 2 weeks of therapy, consider the higher dose combination.

Budesonide 160 mcg/formoterol 4.5 mcg: Two inhalations twice daily; maximum daily dose: 4 inhalations (Budesonide 640 mcg/formoterol 18 mcg)/day

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution and monitor closely; may lead to accumulation of budesonide and formoterol.

Use: Labeled Indications

Asthma: Treatment of asthma in patients ≥6 years.

Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce COPD exacerbations.

Limitations of use: Budesonide/formoterol is not indicated for the relief of acute bronchospasm.

Clinical Practice Guidelines

Asthma:

Global Strategy for Asthma Management and Prevention (GINA), 2018 Update

NHLBI and NAEPP The Expert Panel Report 3: “Guidelines for the Diagnosis and Management of Asthma,” Full Report 2007

COPD:

ACCP/CTS, “Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease: American College of Chest Physicians and Canadian Thoracic Society Guideline,” 2014

Canadian Thoracic Society Recommendations for Management of Chronic Obstructive Pulmonary Disease, 2007 Update

GOLD 2018 Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, 2018

Administration: Inhalation

Metered-dose inhaler: For oral inhalation only administered every morning and evening, approximately 12 hours apart. Prior to first use, inhaler must be primed by releasing 2 test sprays into the air; shake well for 5 seconds before each spray. Inhaler must be reprimed if not used for >7 days or if it has been dropped. Shake well for 5 seconds before each use. Discard inhaler after the labeled number of inhalations have been used or within 3 months after removal from foil pouch. Rinse mouth with water (spit out without swallowing) after each use. Do not wash inhaler with water; clean mouthpiece using a dry wipe every 7 days.

Delivery of dose: Instruct patient to place mouthpiece gently between teeth, closing lips around inhaler. Instruct patient to inhale deeply, press the top counter, and hold breath for up to 10 seconds or as long as they comfortably can. Remove mouthpiece from mouth prior to exhalation. Patient should not breathe out through the mouthpiece. Wait ≥30 seconds prior to the second inhalation dose.

Dry powder inhaler: Symbicort Turbuhaler [Canadian product]:

To “load” inhaler: Turn red grip on inhaler as far as it will move in one direction, then turn in opposite direction as far as it will go (inhaler is “loaded” with a dose, indicated by a “click”). Prior to first use, this procedure should be done twice, it does not need to be repeated with subsequent uses even when not used regularly.

Delivery of dose: Instruct patient to place mouthpiece gently between teeth, closing lips around inhaler. Instruct patient to inhale deeply and hold breath held for as long as they comfortably can. Remove mouthpiece prior to exhalation. Patient should not breathe out through the mouthpiece. Dose is lost if patient drops, shakes, or exhales into inhaler after a dose has been loaded. After use of the inhaler, patient should rinse mouth/oropharynx with water and spit out rinse solution. Do not wash inhaler with water; clean mouthpiece using a dry wipe every 7 days.

Administration: Pediatric

Inhalation: Prior to first use, inhaler must be primed by releasing 2 test sprays into the air (away from the face); shake well for 5 seconds before each spray. Inhaler must be reprimed if inhaler has not been used for >7 days or has been dropped. Shake well for 5 seconds before each use. Discard after labeled number of inhalations has been used or within 3 months after foil wrap has been removed; do not use immerse in water or use “float test” to determine number of inhalations left.

Storage/Stability

Symbicort 80/4.5, Symbicort 160/4.5: Store at 20°C to 25°C (68°F to 77°F) with mouthpiece down; temperatures above 49°C (120°F) may cause bursting. Contents under pressure; do not puncture, incinerate, or store near heat or open flame. Discard inhaler after the labeled number of inhalations have been used (the dose counter will read “0”) or within 3 months after removal from foil pouch.

Symbicort Turbuhaler [Canadian product]: Store at room temperature of 15°C to 30°C (59°F to 77°F).

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience pharyngitis, throat pain, back pain, common cold symptoms, abdominal pain, or rhinitis. Have patient report immediately to prescriber signs of infection, signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), angina, tachycardia, anxiety, mouth irritation, mouth sores, bone pain, dizziness, passing out, seizures, severe headache, tremors, severe nausea, vomiting, severe loss of strength and energy, insomnia, burning or numbness feeling, flu-like signs, sinusitis, vision changes, eye pain, severe eye irritation, thrush, or signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s013lbl.pdf#page=45, must be dispensed with this medication.

Contraindications

Hypersensitivity to budesonide, formoterol, or any component of the formulation; primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.

Documentation of allergenic cross-reactivity for corticosteroids and/or sympathomimetics are limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to inhaled lactose.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or 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 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. Do not use this product to transfer patients from oral corticosteroid therapy.

• Asthma-related deaths: The use of long-acting beta-2 agonists (LABAs) as monotherapy is associated with an increased risk of asthma-related deaths. In a large, randomized, placebo-controlled US trial, salmeterol was associated with an increase in asthma-related deaths (SMART 2006); risk is considered a class effect of LABA monotherapy. Additional data from other clinical trials suggest LABA monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. However, data from large randomized, double-blind, active-controlled trials do not show a significant increase in the risk of serious asthma-related events (including hospitalizations, intubations, and death) in adult, adolescent, and pediatric (aged 4 to 11 years) patients when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy. In addition, patients receiving fluticasone/salmeterol had fewer severe asthma exacerbations compared with patients receiving fluticasone alone (Peters 2016; Stempel 2016a; Stempel 2016b). Current guidelines recommend the use of an inhaled corticosteroid before adding a LABA (GINA 2018; NIH/NHLBI 2007). Assess patients at regular intervals once asthma control is maintained on combination therapy to determine if step-down therapy is appropriate (without loss of asthma control), and the patient can be maintained on an inhaled corticosteroid only. LABAs are not appropriate in patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

• Bone density: Long-term use of inhaled corticosteroids have been associated with decreases in 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, anticonvulsants or oral corticosteroids); high doses and/or long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response.

• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.

• 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; active or quiescent tuberculosis infections of the respiratory tract; or untreated viral, fungal, or 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 intravenous immunoglobulin may be indicated; if chickenpox develops, treatment with antiviral agents may be considered. If exposure to measles, prophylaxis with pooled intramuscular immunoglobulin may be indicated.

• Lower respiratory infections: Pneumonia and other lower respiratory tract infections have been reported in patients with COPD following the use of inhaled corticosteroids; monitor COPD patients closely since pneumonia symptoms may overlap symptoms of exacerbations.

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

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

• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.

Disease-related concerns:

• Asthma: Appropriate use: Do not use for acute bronchospasm. Short-acting beta-2 agonist (eg, albuterol) should be used for acute symptoms and symptoms occurring between treatments. Do not initiate in patients with significantly worsening or acutely deteriorating asthma.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, or hypertension); beta agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta-2 agonists may also increase risk of arrhythmias and ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

• COPD: Appropriate use: Do not use for acute episodes of COPD. Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Data are not available to determine if LABA use increases the risk of death in patients with COPD.

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

• Hepatic impairment: Use with caution in patients with hepatic impairment; may lead to accumulation of budesonide and formoterol; monitor closely.

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

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use of inhaled corticosteroids. Consider routine eye exams in chronic users.

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

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroidism.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult Drug Interactions for more detailed information.

Special populations:

• Pediatric: LABAs may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. 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:

• Discontinuation of systemic corticosteroids: Withdraw systemic corticosteroid therapy with gradual tapering of dose; consider reducing the daily prednisone dose by 2.5 mg on a weekly basis beginning after at least 1 week of inhalation therapy. Monitor lung function, beta agonist use, asthma symptoms, and for signs and symptoms of adrenal insufficiency (fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal.

Geriatric Considerations

See individual agents.

Pregnancy Considerations

Adverse events were observed in animal reproduction studies using this combination. Refer to individual agents.

Breast-Feeding Considerations

It is not known if formoterol is present in breast milk; budesonide is present in small amounts. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Refer to individual agents.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Reported incidences are for adolescents and adults unless specified otherwise. Also see individual agents.

>10%:

Central nervous system: Headache (7% to 11%; children: ≥3%)

Respiratory: Nasopharyngitis (7% to 11%), upper respiratory tract infection (4% to 11%; children: ≥3%)

1% to 10%:

Gastrointestinal: Abdominal distress (1% to 7%), oral candidiasis (1% to 6%), vomiting (1% to 3%)

Infection: Influenza (2% to 3%)

Neuromuscular & skeletal: Back pain (2% to 3%)

Respiratory: Pharyngolaryngeal pain (6% to 9%), pulmonary infection (7% to 8%), lower respiratory tract infection (3% to 8%), sinusitis (4% to 6%), bronchitis (5%), nasal congestion (3%), pharyngitis (children: ≥3%), rhinitis (children: ≥3%)

<1%, postmarketing, and/or case reports: Agitation, anaphylaxis, angina pectoris, angioedema, atrial arrhythmia, behavioral changes, bronchospasm, bruise, cataract, cough, decreased linear skeletal growth rate (pediatric patients), depression, dermatitis, dizziness, extrasystoles, glaucoma, hypercorticoidism signs and symptoms, hyperglycemia, hypersensitivity reaction, hypertension, hypokalemia, hypotension, immunosuppression, increased intraocular pressure, insomnia, muscle cramps, nausea, nervousness, palpitations, pruritus, restlessness, skin rash, tachycardia, throat irritation, tremor, urticaria, ventricular arrhythmia, voice disorder

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

Refer to individual components.

Drug Interactions 

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy

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 (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-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

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Risk C: Monitor therapy

Caffeine and Caffeine Containing Products: May enhance the adverse/toxic effect of Formoterol. Caffeine and Caffeine Containing Products may enhance the hypokalemic effect of Formoterol. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. 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

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

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

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

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

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

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

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification

Inhalational Anesthetics: May enhance the arrhythmogenic effect of Formoterol. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Risk D: Consider therapy modification

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

Loop Diuretics: Corticosteroids (Orally Inhaled) 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

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

Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. 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: May enhance the adverse/toxic effect of Formoterol. Theophylline Derivatives may enhance the hypokalemic effect of Formoterol. 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

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) 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

Monitoring Parameters

FEV1, peak flow meter and/or other pulmonary function tests; monitor growth in pediatric patients, symptom relief, monitor for increased use if short-acting beta2-adrenergic agonists (may be a sign of asthma or COPD deterioration); HPA axis suppression; bone mineral density; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium

Advanced Practitioners Physical Assessment/Monitoring

See individual agents.

Nursing Physical Assessment/Monitoring

See individual agents.

Dosage Forms Considerations

Symbicort 6.9 g canisters contain 60 actuations, and the 10.2 g canisters contain 120 actuations.

Dosage Forms: US

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

Aerosol for oral inhalation:

Symbicort 80/4.5: Budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (6.9 g); budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (10.2 g)

Symbicort 160/4.5: Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (6 g); budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (10.2 g)

Dosage Forms: Canada

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

Powder for oral inhalation:

Symbicort 100 Turbuhaler: Budesonide 100 mcg and formoterol dihydrate 6 mcg per inhalation (available in 60 or 120 metered doses) [delivers ~80 mcg budesonide and 4.5 mcg formoterol per inhalation; contains lactose]

Symbicort 200 Turbuhaler: Budesonide 200 mcg and formoterol dihydrate 6 mcg per inhalation (available in 60 or 120 metered doses) [delivers ~160 mcg budesonide and 4.5 mcg formoterol per inhalation; contains lactose]

Anatomic Therapeutic Chemical (ATC) Classification
  • R03AK07
Pricing: US

Aerosol (Symbicort Inhalation)

80-4.5 mcg/ACT (per gram): $35.63

160-4.5 mcg/ACT (per gram): $47.14

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.

Mechanism of Action

Formoterol: Relaxes bronchial smooth muscle by selective action on beta2 receptors with little effect on heart rate; formoterol has a long-acting effect.

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.

Pharmacodynamics/Kinetics

See individual agents.

Onset of action: Asthma: 15 minutes; maximum benefit: may take ≥2 weeks

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Formoterol: Xerostomia (normal salivary flow resumes upon discontinuation). Localized infections with Candida albicans or Aspergillus niger have occurred frequently in the mouth and pharynx with repetitive use of oral inhaler of corticosteroids. These infections may require treatment with appropriate antifungal therapy or discontinuance of treatment with corticosteroid inhaler.

Effects on Bleeding

No information available to require special precautions

Index Terms

Budesonide and Eformoterol; Eformoterol and Budesonide; Formoterol and Budesonide; Formoterol Fumarate Dihydrate and Budesonide

References

Global Initiative for Asthma (GINA). GINA report, Global Strategy for Asthma Management and Prevention. https://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/. Updated 2018. Accessed September 30, 2018.

National Asthma Education and Prevention Program (NAEPP), Expert Panel Report 3, “Guidelines for the Diagnosis and Management of Asthma,” Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. Available at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm

Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26.[PubMed 16424409]

Peters SP, Bleecker ER, Canonica GW, et al. Serious asthma events with budesonide plus formoterol vs. budesonide alone. N Engl J Med. 2016;375(9):850-860. doi: 10.1056/NEJMoa1511190.[PubMed 27579635]

Rennard SI, Tashkin DP, McElhattan J, et al, “Long-Term Efficacy of Budesonide/Formoterol Administered Via One Pressurized Metered-Dose Inhaler in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease [poster],” Chest, 2008, 134:103001S.

Rennard SI, Tashkin DP, McElhatta J, et al, “Long-Term Tolerability of Budesonide and Formoterol Administered in One Pressurized Metered-Dose Inhaler in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease,” Chest, 2008, 134:103003S.

Stempel DA, Raphiou IH, Kral KM, et al; AUSTRI Investigators. Serious asthma events with fluticasone plus salmeterol versus fluticasone alone. N Engl J Med. 2016a;374(19):1822-1830. doi: 10.1056/NEJMoa1511049.[PubMed 26949137]

Stempel DA, Szefler SJ, Pedersen S, et al; VESTRI Investigators. Safety of adding salmeterol to fluticasone propionate in children with asthma. N Engl J Med. 2016b;375(9):840-849. doi: 10.1056/NEJMoa1606356.[PubMed 27579634]

Symbicort (budesonide/formoterol) [prescribing information]. Wilmington, DE: AstraZeneca LP; December 2017.

Symbicort Turbuhaler (budesonide/formoterol) [product monograph]. Mississauga, Ontario, Canada: AstraZeneca Canada Inc; October 2016.

Tashkin DP, Rennard SI, Martin P, et al, “Efficacy of Budesonide/Formoterol Administered Via One Pressurized Metered-Dose Inhaler Over 6 Months in Patients With Chronic Obstructive Pulmonary Disease,” Chest, 2008, 134:105001S.

US Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf. Published August 28, 2007.

Brand Names: International

Alenia (LI); BiResp Spiromax (ES, IE); Budefort (BD); Bufomix Easyhaler (NO); Combiwave FB 200 (MY); Duoresp (IE); DuoResp Spiromax (ES, GB, MT, NO); Foracort (LK, MY); Formohale (LK); Oxycort (BD); Symbicort (EG, HR, IS, LK, LT, LU, LV, SI, SK, UA); Symbicort Forte (TH); Symbicort Rapihaler (AU, IL, PH, SG); Symbicort Turbohaler (BE, DE, GB, IE); Symbicort Turbuhaler (AE, AR, AT, AU, BB, BG, BH, BM, BR, BS, BZ, CH, CL, CN, CO, CR, CY, CZ, DK, DO, EE, ET, FI, FR, GR, GT, GY, HK, HN, ID, IT, JM, JO, JP, KR, KW, LB, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PR, PT, PY, RU, SA, SE, SG, SR, SV, TH, TR, TT, TW, UY, VE, VN); Symbiocort Turbuhaler (ES, MX); Symbion (BD); Synbicort (RO); Synbicort Turbuhaler (MT, QA); Vannair (BR, CL, HK, NZ, PE); Vent FB Inhaler (IN); Vylaer (IE)

Budesonide and Formoterol (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(byoo DES oh nide & for MOH te rol)

Brand Names: US

Symbicort

Brand Names: Canada

Symbicort

What is this drug used for?
  • It is used to treat COPD (chronic obstructive pulmonary disease).
  • It is used to treat asthma.
  • This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to budesonide, formoterol, or any other part of this drug.
  • 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.
  • If you are using another drug like this one.
  • This is not a list of all drugs or health problems that interact with this drug.
  • 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 drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • For all uses of this drug:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have high blood sugar (diabetes), talk with your doctor. This drug may raise blood sugar.
  • It may take 2 weeks to see the full effect.
  • Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
  • Do not take more of this drug or use it more often than you have been told. Deaths have happened when too much of this type of drug has been taken. Talk with your doctor.
  • 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.
  • Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
  • Have an eye exam as you have been told by your doctor.
  • This drug 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.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. 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.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • COPD:
  • The chance of getting pneumonia is higher in people with COPD. This drug may raise the chance of getting pneumonia. Talk with the doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • Shakiness.
  • Feeling nervous and excitable.
  • Bone pain.
  • Dizziness or passing out.
  • Seizures.
  • Very upset stomach or throwing up.
  • Feeling very tired or weak.
  • Not able to sleep.
  • A burning, numbness, or tingling feeling that is not normal.
  • Flu-like signs.
  • Sinus pain.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Redness or white patches in mouth or throat.
  • Mouth irritation or mouth sores.
  • This drug can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using this drug, use a rescue inhaler and get medical help right away.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Belly pain.
  • Stuffy nose.
  • Nose or throat irritation.
  • Signs of a common cold.
  • Throat pain.
  • Back pain.
  • Throwing up.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • For breathing in only.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • To gain the most benefit, do not miss doses.
  • Keep using this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Prepare the inhaler before first use, when the inhaler has not been used for more than 7 days, or if it has been dropped. Spray 2 test sprays into the air. Shake well before each test spray.
  • Shake well before use.
  • Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.
  • Put the cap back on after you are done using your dose.
  • This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when you have been told after opening or when the dose counter has a 0 in it, whichever comes first.
  • Never wash the inhaler. Keep it dry.
  • Have your inhaler use checked with your doctor at each visit. Read and follow facts on how to use the inhaler. Make sure you use the inhaler the right way.
  • If you are using more than 1 inhaled drug, ask the doctor which drug to use first.
  • If you get this drug in your eyes, wash right away with water. If you have eye irritation that lasts or a change in eyesight, call your doctor.
What do I do if I miss a dose?
  • Skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature. Throw away any part not used 3 months after taking out of foil package.
  • Protect from heat or open flame. Do not puncture or burn even if it seems empty.
  • Store in a dry place. Do not store in a bathroom.
  • Store with the mouthpiece down.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Budesonide and Formoterol (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(byoo DES oh nide & for MOH te rol)

Brand Names: US

Symbicort

Brand Names: Canada

Symbicort

What is this drug used for?
  • It is used to treat asthma.
  • Do not give this drug to treat an asthma attack. Use a rescue inhaler. Talk with the doctor.
  • If your child has been given this drug for some other reason, talk with the doctor about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is using another drug like this one.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • This drug is not helpful during an asthma attack.
  • If your child has high blood sugar (diabetes), talk with the doctor. This drug can raise blood sugar.
  • It may take 2 weeks to see the full effect.
  • Call the doctor right away if your child has breathing problems that get worse, if the rescue inhaler does not work as well, or if your child needs to use the rescue inhaler more often.
  • Do not give more of this drug or have your child use it more often than you were told. Deaths have happened when too much of this type of drug has been taken. Talk with your child’s doctor.
  • When changing from an oral steroid to another form of 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 the doctor right away if your child has any of these signs. If your child has a bad injury, has surgery, or any type of infection, he/she may need extra doses of oral steroids. These extra steroids will help your child’s body deal with these stresses. Have your child wear medical alert ID (identification).
  • Long-term use may raise the chance of cataracts, glaucoma, or weak bones (osteoporosis). Talk with your child’s doctor.
  • Have your child get an eye exam as you have been told by the doctor.
  • Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid having your child near anyone with chickenpox or measles if your child has not had these health problems before. If your child has been exposed to chickenpox or measles, talk with the doctor.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • Shakiness.
  • Feeling nervous and excitable.
  • Bone pain.
  • Dizziness or passing out.
  • Seizures.
  • Very upset stomach or throwing up.
  • Feeling very tired or weak.
  • Not able to sleep.
  • A burning, numbness, or tingling feeling that is not normal.
  • Flu-like signs.
  • Sinus pain.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Redness or white patches in mouth or throat.
  • Mouth irritation or mouth sores.
  • This drug can cause very bad breathing problems right after your child takes a dose. Sometimes, this may be life-threatening. If your child has trouble breathing, breathing that is worse, wheezing, or coughing after using this drug, have your child use a rescue inhaler and get medical help right away.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Belly pain.
  • Stuffy nose.
  • Nose or throat irritation.
  • Signs of a common cold.
  • Throat pain.
  • Back pain.
  • Throwing up.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • For breathing in only.
  • Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Prepare the inhaler before first use, when the inhaler has not been used for more than 7 days, or if it has been dropped. Spray 2 test sprays into the air. Shake well before each test spray.
  • Shake well before use.
  • Have your child rinse out the mouth after each use. Do not let your child swallow the rinse water. Have your child spit it out.
  • Put the cap back on after your child is done using a dose.
  • This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when you have been told after opening or when the dose counter has a 0 in it, whichever comes first.
  • Never wash the inhaler. Keep it dry.
  • Check your child’s inhaler use with the doctor at each visit. Read and follow facts on how to use the inhaler. Make sure your child uses the inhaler the right way.
  • If your child is using more than 1 inhaled drug, ask your child’s doctor which inhaled drug to give first.
  • If you get this drug in your child’s eyes, wash right away with water. If your child has eye irritation that lasts or a change in eyesight, call the doctor.
What do I do if my child misses a dose?
  • Skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature. Throw away any part not used 3 months after taking out of foil package.
  • Protect from heat or open flame. Do not puncture or burn even if it seems empty.
  • Store in a dry place. Do not store in a bathroom.
  • Store with the mouthpiece down.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.